Association between Statin Intensity and Femoropopliteal Stent Primary Patency in Peripheral Arterial Disease

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Vance, Timothy W.I. Clark This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4585425/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 03 Aug, 2024 Read the published version in CVIR Endovascular → Version 1 posted 5 You are reading this latest preprint version Abstract Background. Statins are widely used in coronary and peripheral arterial disease, but their impact on patency of stents placed for peripheral arterial disease is not well-studied. The purpose of this study was to evaluate femoropopliteal stent primary patency according to statin intensity at the time of stent placement and compare this effect to other covariates that may influence stent patency. Materials and Methods. A retrospective review identified 278 discrete femoropopliteal stent constructs placed in 216 patients over a 10-year period; Rutherford categories were 2 (3.6%), 3 (12.9%), 4 (21.2%), 5 (49.6%), and 6 (12.6%). Stent locations were common femoral (1.8%), common femoral/superficial femoral (0.7%), superficial femoral (50.7%), superficial femoral/popliteal (32.7%) and popliteal (14.0%) arteries; 63.3% of stents were paclitaxel-eluting. Primary patency of each stent construct was determined with duplex ultrasound, angiography, or computed tomographic angiography. Greater than 50% restenosis or stent occlusion was considered loss of patency. Cox proportional hazard and Kaplan-Meier modeling were used to assess the effect of statin use and additional covariates on stent patency. Results. Patients on any statin at the time of stent placement were half as likely to undergo loss of primary unassisted patency as patients on no statin therapy (hazard ratio, 0.53; 95% confidence interval, 0.19–0.87; P = .004). Moderate/high intensity statin therapy conferred 17 additional months of median stent patency compared to the no statin group. Antiplatelet therapy, anticoagulant therapy, drug-eluting stents (versus bare metal or covered stents), and Rutherford class were not predictive of stent patency (P = 0.52, 0.85, 0.58, and 0.82, respectively). Conclusion. Use of statin therapy at the time of femoropopliteal stent placement was the most predictive examined variable influencing primary unassisted patency. Peripheral arterial disease femoropopliteal stent restenosis statin Figures Figure 1 Figure 2 Figure 3 Figure 4 BACKGROUND Peripheral arterial disease (PAD) is a highly morbid and prevalent disease, affecting at least 8.5 million adults in the United States and more than 230 million adults worldwide ( 1 ). Endovascular therapy of the femoral and popliteal arteries with stent placement is utilized to treat multifocal stenoses and occlusions of these segments and is associated with lower risk of periprocedural complications compared to open surgical treatment ( 2 ). However, stent restenosis and occlusion limit the durability of endovascular treatment, particularly in complex Trans-Atlantic Inter-Society Consensus (TASC) II class C and D lesions ( 2 – 5 ). Statins are a mainstay of treatment for patients with atherosclerotic disease ( 6 – 8 ). In addition to reducing low density lipoprotein levels, statins slow progression of intimal-media thickening and attenuate inflammatory changes implicated in cardiovascular disease ( 9 , 10 ). However, they remain underutilized in patients with PAD ( 11 , 12 ) despite societal consensus guidelines recommending their use ( 13 ). The Heart Protection Study, the largest randomized controlled trial to evaluate the effects of statins in PAD patients, demonstrated that the use of statins reduced the rate of first major vascular events including myocardial infarction, cerebrovascular accidents, and all revascularization procedures in this population with a relative risk reduction of 22% ( 14 ). Later studies have shown that statin use reduces limb loss and mortality in PAD, including in a dose-dependent manner in one study ( 15 – 17 ). Therefore, we hypothesized that statin use increases patency of stents placed for PAD. The purpose of this study was to evaluate femoropopliteal stent patency according to statin intensity at the time of stent placement and compare this effect to other covariates that may influence stent patency. MATERIALS AND METHODS Study Population and Data Collection This was a retrospective study of patients undergoing femoropopliteal stent placement for PAD in the interventional radiology department of a single academic institution. Institutional review board approval and a waiver of informed consent were obtained. The procedural database was searched for patients who underwent stenting from January 2012 to June 2023. Five patients who had had prior bypass involving part of the femoropopliteal segment were excluded. After exclusions, 278 femoropopliteal segments underwent stent placement in 216 patients during this period. These 278 stent constructs consisted of one or more overlapping nitinol stents. Patients with long-segment chronic total occlusions involving the origin of the superficial artery extending to the proximal (P1) segment of the popliteal artery might have undergone placement of two or more overlapping stents, however this construct for the purposes of analysis was considered a single stent. When stenotic arterial segments did not require a stent following angioplasty but a stent was needed proximal and distal to these segments, or during separate encounters due to progression of PAD, then these were analyzed as separate stent constructs. Demographic and comorbid variables collected for each patient included age, sex, body mass index (BMI), smoking history including total pack-years, diabetes mellitus, hypertension, hyperlipidemia, levels of hemoglobin A1c and cholesterol, antiplatelet use, anticoagulant use, statin use, Rutherford category, stent location, and use of a paclitaxel-eluting stent. Demographics of these patients are summarized in Table 1 . Mean patient age was 70.3 years (standard deviation 10.7, range 39–94), and 150 patients were male and 128 female. Rutherford categories were 2 (3.6%), 3 (12.9%), 4 (21.2%), 5 (49.6%), and 6 (12.6%). Table 1 Baseline characteristics of patients who underwent stent placement. Overall (n = 278) No Statin (n = 72) Low Intensity Statin (n = 18) Moderate Intensity Statin (n = 78) High Intensity Statin (n = 105) Female sex 128 (46.0%) 34 (47.2%) 7 (38.9%) 44 (56.4%) 42 (40.0%) Mean age (SD), years 70.3 (10.7) 71.3 (11.5) 65.9 (12.1) 69.7 (10.9) 70.9 (9.5) Mean BMI (SD), kg/m 2 28.0 (6.0) 27.3 (6.0) 25.9 (3.6) 28.8 (6.5) 28.0 (5.9) Comorbidities Current smoker 53 (19.1%) 16 (22.2%) 5 (27.8%) 16 (20.5%) 14 (13.3%) Former smoker 163 (58.6%) 40 (55.6%) 9 (50.0%) 48 (61.5%) 63 (60.0%) Diabetes 172 (61.9%) 36 (50.0%) 15 (83.3%) 52 (66.7%) 66 (62.9%) Hypertension 224 (80.6%) 50 (69.4%) 14 (77.8%) 64 (82.1%) 91 (86.7%) Hyperlipidemia 157 (56.5%) 23 (31.9%) 13 (72.2%) 46 (59.0%) 73 (69.5%) Rutherford classification 2 10 (3.6%) 3 (4.2%) 0 3 (3.8%) 4 (3.8%) 3 36 (12.9%) 7 (9.7%) 3 (16.7%) 14 (17.9%) 12 (11.4%) 4 59 (21.2%) 13 (18.1%) 1 (5.6%) 22 (28.2%) 21 (20.0%) 5 138 (49.6%) 41 (56.9%) 11 (61.1%) 33 (42.3%) 50 (47.6%) 6 35 (12.6%) 8 (11.1%) 3 (16.7%) 6 (7.7%) 18 (17.1%) Antiplatelet therapy 244 (87.8%) 54 (75.0%) 17 (94.4%) 72 (92.3%) 96 (91.4%) Anticoagulation therapy 59 (21.2%) 15 (20.8%) 5 (27.8%) 17 (21.8%) 22 (21.0%) Stent location Common femoral (CFA) 5 (1.8%) 1 (1.4%) 0 3 (3.8%) 1 (1.0%) Superficial femoral (SFA) 141 (50.7%) 37 (51.4%) 9 (50.0%) 42 (53.8%) 50 (47.6%) Popliteal 39 (14.0%) 9 (12.5%) 2 (11.1%) 10 (12.8%) 18 (17.1%) CFA-SFA 2 (0.7%) 0 0 1 (1.3%) 1 (1.0%) SFA-popliteal 91 (32.7%) 25 (34.7%) 7 (38.9%) 22 (28.2%) 35 (33.3%) Stent type Drug-eluting 176 (63.3%) 44 (61.1%) 9 (50.0%) 47 (60.3%) 73 (69.5%) Non-drug-eluting 102 (36.7%) 28 (38.9%) 9 (50.0%) 31 (39.7%) 32 (30.5%) Primary unassisted patency of each stent construct was determined with duplex ultrasound, computed tomographic angiography, and conventional angiography, alone or in combination; greater than 50% restenosis or stent occlusion was considered loss of patency ( 18 ). Stents were censored from the analysis at the time of final imaging if they remained patent at that time. Statin intensity at the time of stent placement was categorized by American Heart Association (AHA) guidelines ( 7 ). Procedural Information Antegrade common femoral artery access was used in 92 cases (33.1%), contralateral common femoral access in 170 (61.2%), transtibial/transpedal in 9 (3.2%), and combined contralateral femoral and transpedal in 7 (2.5%). After diagnostic angiography, balloon angioplasty was performed at the stenotic segment followed by stent deployment and post-dilation. Decision to place a stent was per the discretion of the attending interventional radiologist, but typically in cases in which there was persistent stenosis > 50% following initial balloon angioplasty, flow-limiting dissection not responsive to prolonged balloon angioplasty, or in a segment in which a chronic total occlusion was crossed subintimally. Stent locations were as follows: 5 common femoral (1.8%), 2 common femoral/superficial femoral (0.7%), 141 superficial femoral (50.7%), 91 superficial femoral/popliteal (32.7%), and 39 popliteal (14.0%) artery. Most (63.3%) stents were paclitaxel-eluting. Examples of in-stent restenosis among patients receiving low-intensity statin therapy and high intensity statin therapy are shown in Figs. 1 and 2 . Data Analysis Statin use, age, sex, BMI of 30 kg/m 2 or greater, smoking history and total pack-years, the diagnosis of diabetes, hypertension, hyperlipidemia, coronary artery disease (CAD), and end stage renal disease (ESRD), hemodialysis use, hemoglobin A1c and cholesterol levels, Rutherford score, antiplatelet and anticoagulation medication use, popliteal stent placement, and drug-eluting stent use were analyzed as covariates with univariate Cox proportional hazards modeling to assess for potential effects on stent patency. Multivariate Cox proportional hazards modeling including the statistically significant univariate variables was performed. A Kaplan-Meier analysis was used to compare the duration of primary unassisted patency between the moderate and high intensity statin group and the no statin group. The Mantel-Cox log-rank test was used to evaluate for a difference in median duration of primary patency based on statin use. Statistical analysis was carried out using Stata version 14.1 (Stata Corporation, College Station, TX). A P-value of < 0.05 was considered statistically significant. RESULTS Of the 278 femoropopliteal stents placed, 38 had no imaging follow up from our institution and were excluded from further analysis. 42.5% of stents (102 of 240) lost primary patency in the study period. Median time to loss of primary patency was 8.9 months (range: 0 days to 9.8 years). 38 lost patency within 6 months of placement (37.2%), 33 between 6 months and 1 year (32.4%), 12 between 1 year and 2 years (11.8%), and 19 in greater than two years (18.6%). Among stents that had imaging follow up at one year, primary patency was 53.3% (80 of 150). Among those that had follow up at two years, primary patency was 37.1% (49 of 132). Of the 138 stents that remained patent on imaging, the median duration of imaging follow up was 6.6 months (range: 1 day to 7.4 years). 90 had less than a year of imaging follow up but remained patent to that point, and 108 had less than two years of follow up but remained patent to that point. Patients who were on moderate or high intensity statin therapy at the time of stent placement were half as likely to experience loss of primary patency by univariate Cox regression analysis (HR, 0.50; 95% CI, 0.18–0.82, P = .003) (Table 2 ). Patients who were taking a statin of any intensity at the time of stenting were also half as likely to experience loss of primary patency (HR, 0.53; 95% CI, 0.19–0.87; P = .004). The use of a moderate or high intensity statin was associated with a median increase in duration of stent patency of 16.7 months, with a median time to loss of primary patency of 27.8 months in the statin group and 11.0 months in the group not taking a statin (log-rank test, P = .0006; Fig. 3 ). The presence of hypertension (HR, 0.56; 95% CI, 0.22–0.90, P = .02), male sex (female sex HR, 1.60; 95% CI, 0.53–2.67, P = .02), and CAD (HR, 0.60; 95% CI, 0.22–0.98, P = .03) were also associated with improved primary patency. In multivariate Cox regression analysis including moderate or high intensity statin use, sex, hypertension, and CAD, only hypertension remained significant (HR, 0.53; 95% CI, 0.24–0.82, P = .04) (Table 3 ). To explore whether this finding was attributable to increased statin use among patients with CAD, multivariate modeling was performed after excluding CAD (Table 4 ). This modeling showed similar effects of moderate and high intensity statin therapy on lowering risk of loss of primary patency compared to univariate analysis (HR, 0.54; 95% CI, 0.20–0.88, P = .008), however hypertension was no longer associated with improved primary patency. Female sex was associated with lower primary patency in this model (HR, 1.91; 95% CI, 0.67–3.15, P = .003), as was observed in univariate analysis. Table 2 Factors affecting loss of femoropopliteal stent patency by univariate Cox proportional hazards analysis. Factor Hazard Ratio (95% CI) P value High intensity statin use 0.58 (0.35) 0.035 Moderate or high intensity statin use 0.50 (0.32) 0.003 Any statin use 0.53 (0.34) 0.004 Female sex 1.60 (1.07) 0.022 Age 1.00 (0.98) 0.715 BMI > 30 1.19 (0.78) 0.418 Smoking history 1.02 (0.79) 0.887 Pack-years of smoking 1.01 (0.99) 0.394 Diabetes 1.07 (0.70) 0.755 Hypertension 0.56 (0.34) 0.024 Hyperlipidemia 0.68 (0.44) 0.075 Coronary artery disease 0.60 (0.38) 0.028 End stage renal disease 1.03 (0.55) 0.917 Hemodialysis 1.04 (0.56) 0.902 Hemoglobin a1c 1.13 (0.72) 0.585 Total cholesterol 1.00 (0.99) 0.428 Non-HDL cholesterol 1.00 (0.99) 0.272 Triglycerides 1.00 (1.00) 0.821 Rutherford score 1.06 (0.65) 0.823 Antiplatelet medication 0.81 (0.42) 0.522 Anticoagulation medication 1.05 (0.63) 0.849 Placement of popliteal stent 1.30 (0.86) 0.208 Use of drug-eluting stent 0.89 (0.58) 0.579 Bold font indicates P < .05. Table 3 Factors affecting loss of femoropopliteal stent patency by multivariate Cox proportional hazards analysis. Factor Hazard Ratio (95% CI) P value Moderate or high intensity statin use 0.62 (0.37) 0.072 Female sex 1.50 (0.90) 0.117 Hypertension 0.53 (0.29) 0.044 Coronary artery disease 0.74 (0.44) 0.262 Bold font indicates P < .05. Table 4 Factors affecting loss of femoropopliteal stent patency by multivariate Cox proportional hazards analysis after exclusion of CAD. Factor Hazard Ratio (95% CI) P value Moderate or high intensity statin use 0.54 (0.34) 0.008 Female sex 1.91 (1.24) 0.003 Hypertension 0.64 (0.37) 0.102 Bold font indicates P < .05. Although drug-eluting stents conferred no significant benefit in primary unassisted patency in univariate Cox models, Kaplan-Meier estimates showed somewhat higher patency in the first 12 months. The 3-, 6-, and 12-month primary patency (± standard error of mean) among paclitaxel-eluting stents was 95.0 ± 2.0, 83.2 ± 3.4, and 61.9 ± 4.8%, compared to 88.8 ± 3.5, 73.0 ± 5.6, and 55.2 ± 6.7% ( P < .05) among bare metal stents. Thereafter, the patency rates overlapped through 48 months (log-rank test, P = .09) (Fig. 4 ). DISCUSSION This study demonstrates a significant association of primary patency of femoropopliteal stents with statin therapy. The use of any statin, regardless of statin intensity, was associated with a median increase in duration of stent patency of 17 months. In addition to lowering lipid levels, statins have been shown to modulate inflammatory pathways in cardiovascular disease, including inhibition of major histocompatibility complex class II induction in human smooth muscle cells and fibroblasts ( 19 ). Further, statins are known to change the expression of factors involved in fibrinolysis, including plasminogen activator inhibitor-1 ( 20 ). Together the modulation of these pathways may reduce vascular smooth muscle cell and fibroblast activation that play a central role in in-stent restenosis and/or stent thrombosis ( 9 , 21 , 22 ). Prior studies have demonstrated that statin therapy is associated with lower rates of major vascular events including revascularization procedures, greater amputation-free survival, and lower mortality rates in patients with PAD ( 14 – 17 , 23 , 24 ). Statin use has also been found to correlate directly to improved infrainguinal graft patency ( 25 , 26 ). However, a paucity of data exists which addresses association between statins and stent primary patency ( 27 – 29 ). A diagnosis of CAD, hypertension, and male sex were also associated with lower risk of primary patency loss in univariate analyses. CAD may be associated with a lower risk of patency loss in this analysis because statin use was higher in CAD patients (81.7% of patients with CAD were taking a statin, while 67.7% of patients without CAD were taking one). In line with this hypothesis, a multivariate analysis that included hypertension, CAD, sex, and statin use found that only hypertension remained a significant predictor, but when CAD was excluded statin use was again significant. The reason for the association of stent patency with hypertension in the univariate analysis is unclear and has not been consistently shown in the literature; it may relate to the diagnosis and treatment of hypertension in the CAD versus non-CAD population given that it was no longer significant in the multivariate analysis once CAD was excluded. It is also possible that some of the patients in this study who did not carry the diagnosis did have hypertension but were untreated, while the patients with diagnosed hypertension were more adequately treated and therefore less likely to experience loss of stent patency. Finally, the association of female sex with greater risk of patency loss is consistent with prior work, including a post hoc analysis of the IN.PACT SFA trial that demonstrated a trend of female sex correlating with worse clinical outcomes after endovascular treatment of femoropopliteal disease ( 30 ); further work is needed to more fully characterize gender differences in endovascular therapies for PAD. Interestingly, additional variables that have been previously associated with stent restenosis and the progression of peripheral arterial disease in general were not predictive of the duration of stent patency in this study. These include stent placement in the popliteal artery, factors such as current smoking and use of antiplatelet therapy, and notably, use of a drug-eluting stent ( 31 – 35 ). There are fundamental differences between the clinical trials that have demonstrated differences in patency between drug-eluting and bare metal stents and this study, which may explain the lack of effect of stent type on patency in this population beyond the modest benefit realized with paclitaxel stents within the first 12 months following implantation. This was a real-world patient experience with many complex lesions including chronic total occlusions, as well as inclusion of patients without strict requirements for target vessel diameter, target lesion length, and other specific lesion factors ( 5 , 36 ). ESRD status also did not confer a higher risk of stent patency loss, despite previous studies showing that it correlates to major adverse limb events among chronic limb ischemia patients; tibial occlusive disease may be a larger driver of limb loss in ESRD patients rather than femoropopliteal disease ( 37 ). The current study observed a one-year primary patency rate of 53% and a two-year patency rate of 37%. These results, which reflect a broad spectrum of anatomic location and comorbid patient factors, are within the range of recent studies reporting primary patency rates of 43–85% at one year and 37–71% at two years ( 3 , 4 , 34 , 36 , 38 , 39 ). The varying patency rates across the literature may be due to differences in patient population, lesion complexity, and exclusion criteria; for example, many studies exclude P2 and/or P3 popliteal lesions ( 3 , 32 , 36 ). The use of statins in this population of patients with symptomatic PAD was consistent with prior studies. Despite long-standing recommendations for patients who are at high risk for atherosclerotic cardiovascular disease to be prescribed a high intensity statin—which includes patients with a history of atherosclerotic PAD ( 8 , 13 )—26.4% of patients were not taking a statin at the time of initial intervention and 6.6% were on a low intensity statin. Especially given the association of statin use with stent patency in this study, these rates confirm the need to continue to increase statin use in these patients. Encouragingly, statin use in this study’s population has improved in recent years due to an active effort in IR clinic visits to increase statin adoption and compliance—in the last 5 years, the percent of patients not taking a statin declined to 19.9%, and further declined to 15.8% in the last two years. This study has several limitations. First, it is a retrospective single center study with unmatched patient characteristics within each level of statin therapy. Some patients had limited follow up, which may skew the reported patency rates given that follow up with imaging was required to confirm patency over time. In addition, selected situations where individual non-overlapping stents were present in the same patient were treated as distinct data points in the statistical analysis. There were also several patients who changed statin therapy after the stent was placed—given the overall low numbers of such patients, they were categorized under the statin intensity they were receiving at the time of stent placement. Some variables that have been previously shown to correlate with duration of stent patency, such as stent placement in an area of chronic total occlusion, smaller vessel diameter, and greater stent length, were not assessed in this study ( 31 , 32 ). Finally, the study hypothesis was limited to examining just the effects of statins and other covariates on primary unassisted patency. Those patients who lost primary patency returned to undergo additional interventions to restore patency, but the potential effects of statins on primary assisted and secondary stent patency were not examined. CONCLUSIONS In conclusion, this study demonstrates an association between statin therapy and femoropopliteal stent primary patency, providing additional support for the importance of statin therapy in patients with peripheral arterial disease. As physicians treating this population, interventional radiologists are in an ideal position to ensure that PAD patients are appropriately prescribed statins. Abbreviations Peripheral arterial disease PAD Trans-Atlantic Inter-Society Consensus TASC body mass index BMI standard deviation SD common femoral artery CFA superficial femoral artery SFA American Heart Association AHA coronary artery disease CAD end stage renal disease ESRD hazard ratio HR confidence interval CI. Declarations Ethics approval and consent to participate This study was approved by the institutional review board of our university hospital and a waiver of informed consent were obtained. Consent for publication Not applicable. Availability of data and material The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding Not applicable. Authors’ contributions E.R.S. collected and analyzed data and drafted the manuscript. H.S. contributed to design of the work and collected and analyzed data. A.Z.V. contributed to the conception and design of the work. T.W.I.C. contributed to the conception and design of the work, analyzed data, and revised the manuscript. All authors read and approved the final manuscript. Acknowledgements Not applicable. 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J vascular interventional radiology: JVIR 27(10):1494–1501 Lee CY (2022) Clinical Effect of Revascularization Strategies and Pharmacologic Treatment on Long-Term Results in Patients with Advanced Peripheral Artery Disease with TASC C and D Femoropopliteal Lesions. J Interv Cardiol 2022:3741967 Kohi MP, Brodmann M, Zeller T, Micari A, Baumgartner I, Wang H et al (2020) Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis. Journal of vascular and interventional radiology: JVIR. ;31(9):1410-8.e10 Noory E, Böhme T, Salm J, Beschorner U, Endress L, Bollenbacher R et al (2023) Evaluation of Femoropopliteal In-Stent Restenosis Characteristics Stratified by Stent Design. J Clin Med. ;12(23) Kurata N, Iida O, Takahara M, Asai M, Okamoto S, Ishihara T et al (2023) Comparing Predictors Influencing Restenosis Following High-Dose Drug-Coated Balloon Angioplasty and Fluoropolymer-Based Drug-Eluting Stenting in Femoropopliteal Artery Lesions. J Endovasc Ther. :15266028231209234 Fujihara M, Takahara M, Iida O, Kawasaki D, Soga Y, Tobita K et al (2023) Endovascular Therapy with Interwoven Nitinol Stent Placement after Predilation for Heavily Calcified Femoropopliteal Artery Disease: Results of the BURDOCK Study. J vascular interventional radiology: JVIR 34(11):1929–1937 Dubosq-Lebaz M, Fels A, Chatellier G, Gouëffic Y (2023) Systematic Review and Meta-analysis of Clinical Outcomes After Endovascular Treatment in Patients With Femoropopliteal Lesions Greater Than 150 mm. J Endovasc Ther. :15266028231202709 Shah AJ, Pavlatos N, Kalra DK (2023) Preventive Therapies in Peripheral Arterial Disease. Biomedicines. ;11(12) Fransson T, Gottsäter A, Abdulrasak M, Malina M, Resch T (2023) Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia. Vasc Endovascular Surg 57(7):706–716 Babore Y, Vance AZ, Cohen R, Mantell MP, Levin LS, Troiano M et al (2024) Association between End-Stage Renal Disease and Major Adverse Limb Events after Peripheral Vascular Intervention. J vascular interventional radiology: JVIR 35(1):15–22e2 Nagatomi S, Takahara M, Nakai T, Fujimura N, Yu A, Matsuda D et al (2023) Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement. J Vasc Surg 77(6):1751–1759 Ye M, Ni Q, Zhu Y, Du Y, Wang Y, Guo X et al (2023) Stent Graft vs Drug-Coated Balloon in Endovascular Treatment of Complex Femoropopliteal Artery Lesions: A 2-Center Experience. J Endovasc Ther. :15266028231201097 Cite Share Download PDF Status: Published Journal Publication published 03 Aug, 2024 Read the published version in CVIR Endovascular → Version 1 posted Editorial decision: Major revision 07 Jul, 2024 Reviewers agreed at journal 24 Jun, 2024 Reviewers invited by journal 24 Jun, 2024 Editor assigned by journal 20 Jun, 2024 First submitted to journal 14 Jun, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4585425","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":318145202,"identity":"7df9c292-edb8-426f-ae05-74de6ee321b9","order_by":0,"name":"Elisabeth R Seyferth","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4UlEQVRIiWNgGAWjYLCCCiA2YG8AkRZEajnDwCBhwHMApEWCFC0SCSAmEVr4+Q8fkzhQca/OXPL51Q0/CiQY+Nu7E/BqkZyRliZx4EyxhOXsnLKbPUCHSZw5uwGvFoMbPGbSH9sSJAxu56Td4AFqMZDIxa/F/vz5bxIH/wG13DyTdvMPMVoMGHLYJA42ALXcYD92myhbJG6kGVscOJYgueFMDtttGQMJHoJ+4e8//PDGgZoEfoPjx5/dfPPHRo6/vRe/FiBggcYFjwGYJKQcBJg/QGj2B8SoHgWjYBSMghEIAJWwSlD1/zy0AAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0001-6937-157X","institution":"University of Pennsylvania Health System: Penn Medicine","correspondingAuthor":true,"prefix":"","firstName":"Elisabeth","middleName":"R","lastName":"Seyferth","suffix":""},{"id":318145203,"identity":"62a9e619-e460-4d77-92c0-05e4649ce223","order_by":1,"name":"Helen Song","email":"","orcid":"","institution":"University of Pennsylvania Health System: Penn Medicine","correspondingAuthor":false,"prefix":"","firstName":"Helen","middleName":"","lastName":"Song","suffix":""},{"id":318145204,"identity":"76b3245a-7d41-4d6a-82f2-8fe8612d1b10","order_by":2,"name":"Ansar Z. Vance","email":"","orcid":"","institution":"University of Pennsylvania Health System: Penn Medicine","correspondingAuthor":false,"prefix":"","firstName":"Ansar","middleName":"Z.","lastName":"Vance","suffix":""},{"id":318145205,"identity":"0c26e796-fd1b-4547-a190-92325d81e443","order_by":3,"name":"Timothy W.I. Clark","email":"","orcid":"https://orcid.org/0000-0001-5557-3517","institution":"University of Pennsylvania Health System: Penn Medicine","correspondingAuthor":false,"prefix":"","firstName":"Timothy","middleName":"W.I.","lastName":"Clark","suffix":""}],"badges":[],"createdAt":"2024-06-15 07:47:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4585425/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4585425/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s42155-024-00472-4","type":"published","date":"2024-08-03T15:57:04+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":60620661,"identity":"aa4fdca9-fb40-426b-abe4-2902f6abe503","added_by":"auto","created_at":"2024-07-18 20:53:39","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":988037,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eStatin intolerant patient with early loss of stent patency. \u003c/strong\u003e78-year-old male with Rutherford 5 disease and nonhealing left 2\u003csup\u003end\u003c/sup\u003e and 3\u003csup\u003erd\u003c/sup\u003e toe wounds. The patient refused statins due to myalgias and was not a candidate for PCSK-9 inhibitors.\u003c/p\u003e\n\u003cp\u003eA.\u0026nbsp;\u0026nbsp;\u0026nbsp; Initial angiogram showing popliteal artery occlusion (arrow).\u003c/p\u003e\n\u003cp\u003eB.\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Angiogram following placement of 6 mm x 10 cm paclitaxel-eluting stent.\u003c/p\u003e\n\u003cp\u003eC.\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Angiogram 7 months later after return of rest pain and new forefoot ulcers showing areas of significant in-stent restenosis (arrows), reflecting loss of primary unassisted patency.\u003c/p\u003e\n\u003cp\u003eD.\u0026nbsp;\u0026nbsp;\u0026nbsp; Fluoroscopic image during thrombectomy (Rotarex, Becton Dickinson, Franklin Lakes, NJ).\u003c/p\u003e\n\u003cp\u003eE.\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Post thrombectomy angiogram.\u003c/p\u003e\n\u003cp\u003eF.\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Completion angiogram following angioplasty with a 6 mm paclitaxel-eluting balloon.\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4585425/v1/9c1765e3963907b99f644ebb.jpg"},{"id":60618596,"identity":"5f0fdd37-1017-490c-bb13-444140335279","added_by":"auto","created_at":"2024-07-18 20:37:39","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":746720,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePatient on high intensity statin and sustained stent patency. \u003c/strong\u003e52-year-old woman with lifestyle-disabling claudication without improvement following supervised exercise therapy.\u003c/p\u003e\n\u003cp\u003eA. Initial angiogram showing long segment chronic total occlusion (CTO) of left superficial femoral artery.\u003c/p\u003e\n\u003cp\u003eB. Completion angiogram following subintimal recanalization and bare-metal stenting.\u003c/p\u003e\n\u003cp\u003eC. Initial angiogram after return of severe claudication 73 months later showing occlusion of SFA stent construct (arrows).\u003c/p\u003e\n\u003cp\u003eD. Crossing of stent occlusion required retrograde pedal access and guidewire rendezvous in the common femoral artery (arrow).\u003c/p\u003e\n\u003cp\u003eE. Pharmacomechanical thrombectomy of stent construct using 12.5 mg of tissue plasminogen activator and 6 F AngioJet (Boston Scientific, Marlborough, MA) thrombectomy device.\u003c/p\u003e\n\u003cp\u003eF. Completion angiogram following thrombectomy and 6 mm balloon angioplasty.\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4585425/v1/d3640d33aa07130d3b2ea045.jpg"},{"id":60621468,"identity":"88aff896-1274-4af9-bf08-501238c697e0","added_by":"auto","created_at":"2024-07-18 21:01:39","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":677085,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier curve comparing loss of primary femoropopliteal segment stent patency in patients on moderate or high intensity statin therapy versus no statin therapy (log-rank test, \u003cem\u003eP\u003c/em\u003e = .0006).\u003c/p\u003e","description":"","filename":"Figure3Statinvsnone.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4585425/v1/cc8bc0677705fef95aeed8fc.jpg"},{"id":60619573,"identity":"fb97c0e5-6541-4945-a537-b5a60c68a9d5","added_by":"auto","created_at":"2024-07-18 20:45:39","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":676750,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier curve comparing loss of primary femoropopliteal segment stent patency between paclitaxel-eluting stents and bare metal stents (log-rank test, \u003cem\u003eP \u003c/em\u003e= .09).\u003c/p\u003e","description":"","filename":"Figure4DESvsBareStents.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4585425/v1/911df235190e83213800b87d.jpg"},{"id":61793404,"identity":"4fb9ecee-8ae8-472d-9a84-6c1e796a5e4e","added_by":"auto","created_at":"2024-08-05 16:12:08","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3731788,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4585425/v1/054bae57-5bbd-4ee0-bf5f-05a91b0fe5b3.pdf"}],"financialInterests":"","formattedTitle":"Association between Statin Intensity and Femoropopliteal Stent Primary Patency in Peripheral Arterial Disease","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003ePeripheral arterial disease (PAD) is a highly morbid and prevalent disease, affecting at least 8.5\u0026nbsp;million adults in the United States and more than 230\u0026nbsp;million adults worldwide (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Endovascular therapy of the femoral and popliteal arteries with stent placement is utilized to treat multifocal stenoses and occlusions of these segments and is associated with lower risk of periprocedural complications compared to open surgical treatment (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). However, stent restenosis and occlusion limit the durability of endovascular treatment, particularly in complex Trans-Atlantic Inter-Society Consensus (TASC) II class C and D lesions (\u003cspan additionalcitationids=\"CR3 CR4\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eStatins are a mainstay of treatment for patients with atherosclerotic disease (\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). In addition to reducing low density lipoprotein levels, statins slow progression of intimal-media thickening and attenuate inflammatory changes implicated in cardiovascular disease (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). However, they remain underutilized in patients with PAD (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) despite societal consensus guidelines recommending their use (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). The Heart Protection Study, the largest randomized controlled trial to evaluate the effects of statins in PAD patients, demonstrated that the use of statins reduced the rate of first major vascular events including myocardial infarction, cerebrovascular accidents, and all revascularization procedures in this population with a relative risk reduction of 22% (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Later studies have shown that statin use reduces limb loss and mortality in PAD, including in a dose-dependent manner in one study (\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Therefore, we hypothesized that statin use increases patency of stents placed for PAD. The purpose of this study was to evaluate femoropopliteal stent patency according to statin intensity at the time of stent placement and compare this effect to other covariates that may influence stent patency.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Population and Data Collection\u003c/h2\u003e \u003cp\u003eThis was a retrospective study of patients undergoing femoropopliteal stent placement for PAD in the interventional radiology department of a single academic institution. Institutional review board approval and a waiver of informed consent were obtained. The procedural database was searched for patients who underwent stenting from January 2012 to June 2023. Five patients who had had prior bypass involving part of the femoropopliteal segment were excluded. After exclusions, 278 femoropopliteal segments underwent stent placement in 216 patients during this period. These 278 stent constructs consisted of one or more overlapping nitinol stents. Patients with long-segment chronic total occlusions involving the origin of the superficial artery extending to the proximal (P1) segment of the popliteal artery might have undergone placement of two or more overlapping stents, however this construct for the purposes of analysis was considered a single stent. When stenotic arterial segments did not require a stent following angioplasty but a stent was needed proximal and distal to these segments, or during separate encounters due to progression of PAD, then these were analyzed as separate stent constructs.\u003c/p\u003e \u003cp\u003eDemographic and comorbid variables collected for each patient included age, sex, body mass index (BMI), smoking history including total pack-years, diabetes mellitus, hypertension, hyperlipidemia, levels of hemoglobin A1c and cholesterol, antiplatelet use, anticoagulant use, statin use, Rutherford category, stent location, and use of a paclitaxel-eluting stent. Demographics of these patients are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Mean patient age was 70.3 years (standard deviation 10.7, range 39\u0026ndash;94), and 150 patients were male and 128 female. Rutherford categories were 2 (3.6%), 3 (12.9%), 4 (21.2%), 5 (49.6%), and 6 (12.6%).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline characteristics of patients who underwent stent placement.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;278)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo Statin\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;72)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eLow Intensity Statin (n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eModerate Intensity Statin (n\u0026thinsp;=\u0026thinsp;78)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eHigh Intensity Statin (n\u0026thinsp;=\u0026thinsp;105)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale sex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e128 (46.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34 (47.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (38.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e44 (56.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e42 (40.0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean age (SD), years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e70.3 (10.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e71.3 (11.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e65.9 (12.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e69.7 (10.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e70.9 (9.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean BMI (SD), kg/m\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e28.0 (6.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27.3 (6.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25.9 (3.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e28.8 (6.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e28.0 (5.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComorbidities\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCurrent smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e53 (19.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (22.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (27.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e16 (20.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e14 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFormer smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e163 (58.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e40 (55.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e48 (61.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e63 (60.0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e172 (61.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15 (83.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e52 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e66 (62.9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e224 (80.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50 (69.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e14 (77.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e64 (82.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e91 (86.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHyperlipidemia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e157 (56.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23 (31.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13 (72.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e46 (59.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e73 (69.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRutherford classification\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e10 (3.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (4.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3 (3.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e4 (3.8%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e36 (12.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (9.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e14 (17.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e12 (11.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e59 (21.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13 (18.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (5.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e22 (28.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e21 (20.0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e138 (49.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e41 (56.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11 (61.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e33 (42.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e50 (47.6%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e35 (12.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (11.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e6 (7.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e18 (17.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntiplatelet therapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e244 (87.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e54 (75.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17 (94.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e72 (92.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e96 (91.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnticoagulation therapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e59 (21.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 (20.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (27.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e17 (21.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e22 (21.0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStent location\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCommon femoral (CFA)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5 (1.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (1.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3 (3.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1 (1.0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuperficial femoral (SFA)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e141 (50.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37 (51.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e42 (53.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e50 (47.6%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePopliteal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e39 (14.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (11.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e10 (12.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e18 (17.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCFA-SFA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2 (0.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1 (1.0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSFA-popliteal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e91 (32.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (34.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (38.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e22 (28.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e35 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStent type\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDrug-eluting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e176 (63.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44 (61.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e47 (60.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e73 (69.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNon-drug-eluting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e102 (36.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28 (38.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e31 (39.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e32 (30.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003ePrimary unassisted patency of each stent construct was determined with duplex ultrasound, computed tomographic angiography, and conventional angiography, alone or in combination; greater than 50% restenosis or stent occlusion was considered loss of patency (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Stents were censored from the analysis at the time of final imaging if they remained patent at that time. Statin intensity at the time of stent placement was categorized by American Heart Association (AHA) guidelines (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eProcedural Information\u003c/h2\u003e \u003cp\u003eAntegrade common femoral artery access was used in 92 cases (33.1%), contralateral common femoral access in 170 (61.2%), transtibial/transpedal in 9 (3.2%), and combined contralateral femoral and transpedal in 7 (2.5%). After diagnostic angiography, balloon angioplasty was performed at the stenotic segment followed by stent deployment and post-dilation. Decision to place a stent was per the discretion of the attending interventional radiologist, but typically in cases in which there was persistent stenosis\u0026thinsp;\u0026gt;\u0026thinsp;50% following initial balloon angioplasty, flow-limiting dissection not responsive to prolonged balloon angioplasty, or in a segment in which a chronic total occlusion was crossed subintimally. Stent locations were as follows: 5 common femoral (1.8%), 2 common femoral/superficial femoral (0.7%), 141 superficial femoral (50.7%), 91 superficial femoral/popliteal (32.7%), and 39 popliteal (14.0%) artery. Most (63.3%) stents were paclitaxel-eluting. Examples of in-stent restenosis among patients receiving low-intensity statin therapy and high intensity statin therapy are shown in Figs.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eData Analysis\u003c/h2\u003e \u003cp\u003eStatin use, age, sex, BMI of 30 kg/m\u003csup\u003e2\u003c/sup\u003e or greater, smoking history and total pack-years, the diagnosis of diabetes, hypertension, hyperlipidemia, coronary artery disease (CAD), and end stage renal disease (ESRD), hemodialysis use, hemoglobin A1c and cholesterol levels, Rutherford score, antiplatelet and anticoagulation medication use, popliteal stent placement, and drug-eluting stent use were analyzed as covariates with univariate Cox proportional hazards modeling to assess for potential effects on stent patency. Multivariate Cox proportional hazards modeling including the statistically significant univariate variables was performed. A Kaplan-Meier analysis was used to compare the duration of primary unassisted patency between the moderate and high intensity statin group and the no statin group. The Mantel-Cox log-rank test was used to evaluate for a difference in median duration of primary patency based on statin use. Statistical analysis was carried out using Stata version 14.1 (Stata Corporation, College Station, TX). A P-value of \u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eOf the 278 femoropopliteal stents placed, 38 had no imaging follow up from our institution and were excluded from further analysis. 42.5% of stents (102 of 240) lost primary patency in the study period. Median time to loss of primary patency was 8.9 months (range: 0 days to 9.8 years). 38 lost patency within 6 months of placement (37.2%), 33 between 6 months and 1 year (32.4%), 12 between 1 year and 2 years (11.8%), and 19 in greater than two years (18.6%). Among stents that had imaging follow up at one year, primary patency was 53.3% (80 of 150). Among those that had follow up at two years, primary patency was 37.1% (49 of 132). Of the 138 stents that remained patent on imaging, the median duration of imaging follow up was 6.6 months (range: 1 day to 7.4 years). 90 had less than a year of imaging follow up but remained patent to that point, and 108 had less than two years of follow up but remained patent to that point.\u003c/p\u003e \u003cp\u003ePatients who were on moderate or high intensity statin therapy at the time of stent placement were half as likely to experience loss of primary patency by univariate Cox regression analysis (HR, 0.50; 95% CI, 0.18\u0026ndash;0.82, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.003) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Patients who were taking a statin of any intensity at the time of stenting were also half as likely to experience loss of primary patency (HR, 0.53; 95% CI, 0.19\u0026ndash;0.87; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.004). The use of a moderate or high intensity statin was associated with a median increase in duration of stent patency of 16.7 months, with a median time to loss of primary patency of 27.8 months in the statin group and 11.0 months in the group not taking a statin (log-rank test, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.0006; Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The presence of hypertension (HR, 0.56; 95% CI, 0.22\u0026ndash;0.90, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.02), male sex (female sex HR, 1.60; 95% CI, 0.53\u0026ndash;2.67, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.02), and CAD (HR, 0.60; 95% CI, 0.22\u0026ndash;0.98, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.03) were also associated with improved primary patency. In multivariate Cox regression analysis including moderate or high intensity statin use, sex, hypertension, and CAD, only hypertension remained significant (HR, 0.53; 95% CI, 0.24\u0026ndash;0.82, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.04) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). To explore whether this finding was attributable to increased statin use among patients with CAD, multivariate modeling was performed after excluding CAD (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). This modeling showed similar effects of moderate and high intensity statin therapy on lowering risk of loss of primary patency compared to univariate analysis (HR, 0.54; 95% CI, 0.20\u0026ndash;0.88, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.008), however hypertension was no longer associated with improved primary patency. Female sex was associated with lower primary patency in this model (HR, 1.91; 95% CI, 0.67\u0026ndash;3.15, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.003), as was observed in univariate analysis.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFactors affecting loss of femoropopliteal stent patency by univariate Cox proportional hazards analysis.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFactor\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHazard Ratio (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHigh intensity statin use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.58 (0.35)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.035\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModerate or high intensity statin use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.50 (0.32)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.003\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAny statin use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.53 (0.34)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.004\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale sex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.60 (1.07)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.022\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.00 (0.98)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.715\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI\u0026thinsp;\u0026gt;\u0026thinsp;30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.19 (0.78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.418\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSmoking history\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.02 (0.79)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.887\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePack-years of smoking\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.01 (0.99)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.394\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.07 (0.70)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.755\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.56 (0.34)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.024\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHyperlipidemia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.68 (0.44)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.075\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCoronary artery disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.60 (0.38)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.028\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnd stage renal disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.03 (0.55)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.917\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHemodialysis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.04 (0.56)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.902\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHemoglobin a1c\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.13 (0.72)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.585\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal cholesterol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.00 (0.99)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.428\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNon-HDL cholesterol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.00 (0.99)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.272\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTriglycerides\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.00 (1.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.821\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRutherford score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.06 (0.65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.823\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntiplatelet medication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.81 (0.42)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.522\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnticoagulation medication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.05 (0.63)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.849\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlacement of popliteal stent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.30 (0.86)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.208\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUse of drug-eluting stent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.89 (0.58)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.579\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eBold font indicates P\u0026thinsp;\u0026lt;\u0026thinsp;.05.\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFactors affecting loss of femoropopliteal stent patency by multivariate Cox proportional hazards analysis.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFactor\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHazard Ratio (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModerate or high intensity statin use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.62 (0.37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.072\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale sex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.50 (0.90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.117\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.53 (0.29)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.044\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCoronary artery disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.74 (0.44)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.262\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eBold font indicates P\u0026thinsp;\u0026lt;\u0026thinsp;.05.\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFactors affecting loss of femoropopliteal stent patency by multivariate Cox proportional hazards analysis after exclusion of CAD.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFactor\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHazard Ratio (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModerate or high intensity statin use\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.54 (0.34)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.008\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale sex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.91 (1.24)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.003\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.64 (0.37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.102\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eBold font indicates P\u0026thinsp;\u0026lt;\u0026thinsp;.05.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eAlthough drug-eluting stents conferred no significant benefit in primary unassisted patency in univariate Cox models, Kaplan-Meier estimates showed somewhat higher patency in the first 12 months. The 3-, 6-, and 12-month primary patency (\u0026plusmn;\u0026thinsp;standard error of mean) among paclitaxel-eluting stents was 95.0\u0026thinsp;\u0026plusmn;\u0026thinsp;2.0, 83.2\u0026thinsp;\u0026plusmn;\u0026thinsp;3.4, and 61.9\u0026thinsp;\u0026plusmn;\u0026thinsp;4.8%, compared to 88.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.5, 73.0\u0026thinsp;\u0026plusmn;\u0026thinsp;5.6, and 55.2\u0026thinsp;\u0026plusmn;\u0026thinsp;6.7% (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;.05) among bare metal stents. Thereafter, the patency rates overlapped through 48 months (log-rank test, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.09) (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study demonstrates a significant association of primary patency of femoropopliteal stents with statin therapy. The use of any statin, regardless of statin intensity, was associated with a median increase in duration of stent patency of 17 months. In addition to lowering lipid levels, statins have been shown to modulate inflammatory pathways in cardiovascular disease, including inhibition of major histocompatibility complex class II induction in human smooth muscle cells and fibroblasts (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Further, statins are known to change the expression of factors involved in fibrinolysis, including plasminogen activator inhibitor-1 (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Together the modulation of these pathways may reduce vascular smooth muscle cell and fibroblast activation that play a central role in in-stent restenosis and/or stent thrombosis (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Prior studies have demonstrated that statin therapy is associated with lower rates of major vascular events including revascularization procedures, greater amputation-free survival, and lower mortality rates in patients with PAD (\u003cspan additionalcitationids=\"CR15 CR16\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Statin use has also been found to correlate directly to improved infrainguinal graft patency (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). However, a paucity of data exists which addresses association between statins and stent primary patency (\u003cspan additionalcitationids=\"CR28\" citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA diagnosis of CAD, hypertension, and male sex were also associated with lower risk of primary patency loss in univariate analyses. CAD may be associated with a lower risk of patency loss in this analysis because statin use was higher in CAD patients (81.7% of patients with CAD were taking a statin, while 67.7% of patients without CAD were taking one). In line with this hypothesis, a multivariate analysis that included hypertension, CAD, sex, and statin use found that only hypertension remained a significant predictor, but when CAD was excluded statin use was again significant. The reason for the association of stent patency with hypertension in the univariate analysis is unclear and has not been consistently shown in the literature; it may relate to the diagnosis and treatment of hypertension in the CAD versus non-CAD population given that it was no longer significant in the multivariate analysis once CAD was excluded. It is also possible that some of the patients in this study who did not carry the diagnosis did have hypertension but were untreated, while the patients with diagnosed hypertension were more adequately treated and therefore less likely to experience loss of stent patency. Finally, the association of female sex with greater risk of patency loss is consistent with prior work, including a post hoc analysis of the IN.PACT SFA trial that demonstrated a trend of female sex correlating with worse clinical outcomes after endovascular treatment of femoropopliteal disease (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e); further work is needed to more fully characterize gender differences in endovascular therapies for PAD.\u003c/p\u003e \u003cp\u003eInterestingly, additional variables that have been previously associated with stent restenosis and the progression of peripheral arterial disease in general were not predictive of the duration of stent patency in this study. These include stent placement in the popliteal artery, factors such as current smoking and use of antiplatelet therapy, and notably, use of a drug-eluting stent (\u003cspan additionalcitationids=\"CR32 CR33 CR34\" citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). There are fundamental differences between the clinical trials that have demonstrated differences in patency between drug-eluting and bare metal stents and this study, which may explain the lack of effect of stent type on patency in this population beyond the modest benefit realized with paclitaxel stents within the first 12 months following implantation. This was a real-world patient experience with many complex lesions including chronic total occlusions, as well as inclusion of patients without strict requirements for target vessel diameter, target lesion length, and other specific lesion factors (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). ESRD status also did not confer a higher risk of stent patency loss, despite previous studies showing that it correlates to major adverse limb events among chronic limb ischemia patients; tibial occlusive disease may be a larger driver of limb loss in ESRD patients rather than femoropopliteal disease (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe current study observed a one-year primary patency rate of 53% and a two-year patency rate of 37%. These results, which reflect a broad spectrum of anatomic location and comorbid patient factors, are within the range of recent studies reporting primary patency rates of 43\u0026ndash;85% at one year and 37\u0026ndash;71% at two years (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e). The varying patency rates across the literature may be due to differences in patient population, lesion complexity, and exclusion criteria; for example, many studies exclude P2 and/or P3 popliteal lesions (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe use of statins in this population of patients with symptomatic PAD was consistent with prior studies. Despite long-standing recommendations for patients who are at high risk for atherosclerotic cardiovascular disease to be prescribed a high intensity statin\u0026mdash;which includes patients with a history of atherosclerotic PAD (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u0026mdash;26.4% of patients were not taking a statin at the time of initial intervention and 6.6% were on a low intensity statin. Especially given the association of statin use with stent patency in this study, these rates confirm the need to continue to increase statin use in these patients. Encouragingly, statin use in this study\u0026rsquo;s population has improved in recent years due to an active effort in IR clinic visits to increase statin adoption and compliance\u0026mdash;in the last 5 years, the percent of patients not taking a statin declined to 19.9%, and further declined to 15.8% in the last two years.\u003c/p\u003e \u003cp\u003eThis study has several limitations. First, it is a retrospective single center study with unmatched patient characteristics within each level of statin therapy. Some patients had limited follow up, which may skew the reported patency rates given that follow up with imaging was required to confirm patency over time. In addition, selected situations where individual non-overlapping stents were present in the same patient were treated as distinct data points in the statistical analysis. There were also several patients who changed statin therapy after the stent was placed\u0026mdash;given the overall low numbers of such patients, they were categorized under the statin intensity they were receiving at the time of stent placement. Some variables that have been previously shown to correlate with duration of stent patency, such as stent placement in an area of chronic total occlusion, smaller vessel diameter, and greater stent length, were not assessed in this study (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). Finally, the study hypothesis was limited to examining just the effects of statins and other covariates on primary unassisted patency. Those patients who lost primary patency returned to undergo additional interventions to restore patency, but the potential effects of statins on primary assisted and secondary stent patency were not examined.\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eIn conclusion, this study demonstrates an association between statin therapy and femoropopliteal stent primary patency, providing additional support for the importance of statin therapy in patients with peripheral arterial disease. As physicians treating this population, interventional radiologists are in an ideal position to ensure that PAD patients are appropriately prescribed statins.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePeripheral arterial disease\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePAD\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTrans-Atlantic Inter-Society Consensus\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTASC\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ebody mass index\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBMI\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003estandard deviation\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSD\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ecommon femoral artery\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCFA\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003esuperficial femoral artery\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSFA\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eAmerican Heart Association\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eAHA\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ecoronary artery disease\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCAD\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eend stage renal disease\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eESRD\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ehazard ratio\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHR\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003econfidence interval\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCI.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the institutional review board of our university hospital and a waiver of informed consent were obtained.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eE.R.S. collected and analyzed data and drafted the manuscript. H.S. contributed to design of the work and collected and analyzed data. A.Z.V. contributed to the conception and design of the work. T.W.I.C. contributed to the conception and design of the work, analyzed data, and revised the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eCriqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW et al (2021) Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation 144(9):e171\u0026ndash;e91\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAru RG, Tyagi SC (2022) Endovascular treatment of femoropopliteal arterial occlusive disease: Current techniques and limitations. Semin Vasc Surg 35(2):180\u0026ndash;189\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBosiers M, Setacci C, De Donato G, Torsello G, Silveira PG, Deloose K et al (2020) ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions. J Endovasc Ther 27(2):287\u0026ndash;295\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBausback Y, Wittig T, Schmidt A, Zeller T, Bosiers M, Peeters P et al (2019) Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease. J Am Coll Cardiol 73(6):667\u0026ndash;679\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGou\u0026euml;ffic Y, Sauguet A, Desgranges P, Feugier P, Rosset E, Ducasse E et al (2020) A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions: The BATTLE Trial. 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J Am Coll Cardiol. ;63(25 Pt B):2889\u0026thinsp;\u0026ndash;\u0026thinsp;934.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ et al (2019) 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 74(10):1376\u0026ndash;1414\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLibby P, Ridker PM, Maseri A (2002) Inflammation and atherosclerosis. Circulation 105(9):1135\u0026ndash;1143\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBedi US, Singh M, Singh PP, Bhuriya R, Bahekar A, Molnar J et al (2010) Effects of statins on progression of carotid atherosclerosis as measured by carotid intimal\u0026ndash;medial thickness: a meta-analysis of randomized controlled trials. J Cardiovasc Pharmacol Ther 15(3):268\u0026ndash;273\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSingh N, Ding L, Devera J, Magee GA, Garg PK (2021) Prescribing of Statins After Lower Extremity Revascularization Procedures in the US. JAMA Netw Open 4(12):e2136014\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMeltzer AJ, Sedrakyan A, Connolly PH, Ellozy S, Schneider DB (2018) Risk Factors for Suboptimal Utilization of Statins and Antiplatelet Therapy in Patients Undergoing Revascularization for Symptomatic Peripheral Arterial Disease. Ann Vasc Surg 46:234\u0026ndash;240\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE et al (2017) 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 135(12):e686\u0026ndash;e725\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGroup HPSC (2007) Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions. J Vasc Surg 45(4):645\u0026ndash;654 discussion 53\u0026thinsp;\u0026ndash;\u0026thinsp;4\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArya S, Khakharia A, Binney ZO, DeMartino RR, Brewster LP, Goodney PP et al (2018) Association of Statin Dose With Amputation and Survival in Patients With Peripheral Artery Disease. Circulation 137(14):1435\u0026ndash;1446\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eParmar GM, Novak Z, Spangler E, Patterson M, Passman MA, Beck AW et al (2019) Statin use improves limb salvage after intervention for peripheral arterial disease. J Vasc Surg 70(2):539\u0026ndash;546\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchanzer A, Hevelone N, Owens CD, Beckman JA, Belkin M, Conte MS (2008) Statins are independently associated with reduced mortality in patients undergoing infrainguinal bypass graft surgery for critical limb ischemia. J Vasc Surg 47(4):774\u0026ndash;781\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSacks D, Marinelli DL, Martin LG, Spies JB (2003) Reporting standards for clinical evaluation of new peripheral arterial revascularization devices. J vascular interventional radiology: JVIR 14(9 Pt 2):S395\u0026ndash;404\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKwak B, Mulhaupt F, Myit S, Mach F (2000) Statins as a newly recognized type of immunomodulator. Nat Med 6(12):1399\u0026ndash;1402\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBourcier T, Libby P (2000) HMG CoA reductase inhibitors reduce plasminogen activator inhibitor-1 expression by human vascular smooth muscle and endothelial cells. Arterioscler Thromb Vasc Biol 20(2):556\u0026ndash;562\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAttiq A, Afzal S, Ahmad W, Kandeel M (2024) Hegemony of inflammation in atherosclerosis and coronary artery disease. Eur J Pharmacol. :176338\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDai Z, Xu G (2017) Restenosis after carotid artery stenting. Vascular 25(6):576\u0026ndash;586\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShehada Y, Bisdas T, Argyriou A, Torsello G, Tsilimparis N, Beropoulis E et al (2022) Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease. Vascular. :17085381221126217\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStavroulakis K, Borowski M, Torsello G, Bisdas T (2017) Association between statin therapy and amputation-free survival in patients with critical limb ischemia in the CRITISCH registry. J Vasc Surg 66(5):1534\u0026ndash;1542\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbbruzzese TA, Havens J, Belkin M, Donaldson MC, Whittemore AD, Liao JK et al (2004) Statin therapy is associated with improved patency of autogenous infrainguinal bypass grafts. J Vasc Surg 39(6):1178\u0026ndash;1185\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHenke PK, Blackburn S, Proctor MC, Stevens J, Mukherjee D, Rajagopalin S et al (2004) Patients undergoing infrainguinal bypass to treat atherosclerotic vascular disease are underprescribed cardioprotective medications: effect on graft patency, limb salvage, and mortality. J Vasc Surg 39(2):357\u0026ndash;365\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWalter DH, Sch\u0026auml;chinger V, Elsner M, Mach S, Auch-Schwelk W, Zeiher AM (2000) Effect of statin therapy on restenosis after coronary stent implantation. Am J Cardiol 85(8):962\u0026ndash;968\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim W, Gandhi RT, Pe\u0026ntilde;a CS, Herrera RE, Schernthaner MB, Acu\u0026ntilde;a JM et al (2016) The Influence of Statin Therapy on Restenosis in Patients Who Underwent Nitinol Stent Implantation for de Novo Femoropopliteal Artery Disease: Two-Year Follow-up at a Single Center. J vascular interventional radiology: JVIR 27(10):1494\u0026ndash;1501\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee CY (2022) Clinical Effect of Revascularization Strategies and Pharmacologic Treatment on Long-Term Results in Patients with Advanced Peripheral Artery Disease with TASC C and D Femoropopliteal Lesions. J Interv Cardiol 2022:3741967\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKohi MP, Brodmann M, Zeller T, Micari A, Baumgartner I, Wang H et al (2020) Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis. Journal of vascular and interventional radiology: JVIR. ;31(9):1410-8.e10\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNoory E, B\u0026ouml;hme T, Salm J, Beschorner U, Endress L, Bollenbacher R et al (2023) Evaluation of Femoropopliteal In-Stent Restenosis Characteristics Stratified by Stent Design. J Clin Med. ;12(23)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKurata N, Iida O, Takahara M, Asai M, Okamoto S, Ishihara T et al (2023) Comparing Predictors Influencing Restenosis Following High-Dose Drug-Coated Balloon Angioplasty and Fluoropolymer-Based Drug-Eluting Stenting in Femoropopliteal Artery Lesions. J Endovasc Ther. :15266028231209234\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFujihara M, Takahara M, Iida O, Kawasaki D, Soga Y, Tobita K et al (2023) Endovascular Therapy with Interwoven Nitinol Stent Placement after Predilation for Heavily Calcified Femoropopliteal Artery Disease: Results of the BURDOCK Study. J vascular interventional radiology: JVIR 34(11):1929\u0026ndash;1937\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDubosq-Lebaz M, Fels A, Chatellier G, Gou\u0026euml;ffic Y (2023) Systematic Review and Meta-analysis of Clinical Outcomes After Endovascular Treatment in Patients With Femoropopliteal Lesions Greater Than 150 mm. J Endovasc Ther. :15266028231202709\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShah AJ, Pavlatos N, Kalra DK (2023) Preventive Therapies in Peripheral Arterial Disease. Biomedicines. ;11(12)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFransson T, Gotts\u0026auml;ter A, Abdulrasak M, Malina M, Resch T (2023) Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX\u0026reg; Versus Bare Metal Stent Zilver Flex\u0026reg; for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia. Vasc Endovascular Surg 57(7):706\u0026ndash;716\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBabore Y, Vance AZ, Cohen R, Mantell MP, Levin LS, Troiano M et al (2024) Association between End-Stage Renal Disease and Major Adverse Limb Events after Peripheral Vascular Intervention. J vascular interventional radiology: JVIR 35(1):15\u0026ndash;22e2\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNagatomi S, Takahara M, Nakai T, Fujimura N, Yu A, Matsuda D et al (2023) Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement. J Vasc Surg 77(6):1751\u0026ndash;1759\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYe M, Ni Q, Zhu Y, Du Y, Wang Y, Guo X et al (2023) Stent Graft vs Drug-Coated Balloon in Endovascular Treatment of Complex Femoropopliteal Artery Lesions: A 2-Center Experience. J Endovasc Ther. :15266028231201097\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"cvir-endovascular","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cire","sideBox":"Learn more about [CVIR Endovascular](https://www.springer.com/journal/42155)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/cire/default.aspx","title":"CVIR Endovascular","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Peripheral arterial disease, femoropopliteal stent, restenosis, statin","lastPublishedDoi":"10.21203/rs.3.rs-4585425/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4585425/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e \u003cb\u003eBackground.\u003c/b\u003e Statins are widely used in coronary and peripheral arterial disease, but their impact on patency of stents placed for peripheral arterial disease is not well-studied. The purpose of this study was to evaluate femoropopliteal stent primary patency according to statin intensity at the time of stent placement and compare this effect to other covariates that may influence stent patency.\u003c/p\u003e \u003cp\u003e\u003cb\u003eMaterials and Methods.\u003c/b\u003e A retrospective review identified 278 discrete femoropopliteal stent constructs placed in 216 patients over a 10-year period; Rutherford categories were 2 (3.6%), 3 (12.9%), 4 (21.2%), 5 (49.6%), and 6 (12.6%). Stent locations were common femoral (1.8%), common femoral/superficial femoral (0.7%), superficial femoral (50.7%), superficial femoral/popliteal (32.7%) and popliteal (14.0%) arteries; 63.3% of stents were paclitaxel-eluting. Primary patency of each stent construct was determined with duplex ultrasound, angiography, or computed tomographic angiography. Greater than 50% restenosis or stent occlusion was considered loss of patency. Cox proportional hazard and Kaplan-Meier modeling were used to assess the effect of statin use and additional covariates on stent patency.\u003c/p\u003e \u003cp\u003e \u003cb\u003eResults.\u003c/b\u003e Patients on any statin at the time of stent placement were half as likely to undergo loss of primary unassisted patency as patients on no statin therapy (hazard ratio, 0.53; 95% confidence interval, 0.19\u0026ndash;0.87; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;.004). Moderate/high intensity statin therapy conferred 17\u003c/p\u003e \u003cp\u003eadditional months of median stent patency compared to the no statin group. Antiplatelet therapy, anticoagulant therapy, drug-eluting stents (versus bare metal or covered stents), and Rutherford class were not predictive of stent patency (P\u0026thinsp;=\u0026thinsp;0.52, 0.85, 0.58, and 0.82, respectively).\u003c/p\u003e \u003cp\u003e \u003cb\u003eConclusion.\u003c/b\u003e Use of statin therapy at the time of femoropopliteal stent placement was the most predictive examined variable influencing primary unassisted patency.\u003c/p\u003e","manuscriptTitle":"Association between Statin Intensity and Femoropopliteal Stent Primary Patency in Peripheral Arterial Disease","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-18 20:37:34","doi":"10.21203/rs.3.rs-4585425/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2024-07-08T03:37:20+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2024-06-24T13:48:16+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-06-24T07:34:40+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-06-21T01:43:24+00:00","index":"","fulltext":""},{"type":"submitted","content":"CVIR Endovascular","date":"2024-06-15T03:47:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"cvir-endovascular","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cire","sideBox":"Learn more about [CVIR Endovascular](https://www.springer.com/journal/42155)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/cire/default.aspx","title":"CVIR Endovascular","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"e53f7e69-9800-4723-a144-889cfabd9416","owner":[],"postedDate":"July 18th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-08-05T16:00:13+00:00","versionOfRecord":{"articleIdentity":"rs-4585425","link":"https://doi.org/10.1186/s42155-024-00472-4","journal":{"identity":"cvir-endovascular","isVorOnly":false,"title":"CVIR Endovascular"},"publishedOn":"2024-08-03 15:57:04","publishedOnDateReadable":"August 3rd, 2024"},"versionCreatedAt":"2024-07-18 20:37:34","video":"","vorDoi":"10.1186/s42155-024-00472-4","vorDoiUrl":"https://doi.org/10.1186/s42155-024-00472-4","workflowStages":[]},"version":"v1","identity":"rs-4585425","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4585425","identity":"rs-4585425","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}