Efficacy and Safety of Magnesium-Based Bioresorbable Scaffolds in All Coronary Artery Diseases: A Systematic Review and Proportional Meta-Analysis

Efficacy and Safety of Magnesium-Based Bioresorbable Scaffolds in All Coronary Artery Diseases: A Systematic Review and Proportional Meta-Analysis | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Systematic Review Efficacy and Safety of Magnesium-Based Bioresorbable Scaffolds in All Coronary Artery Diseases: A Systematic Review and Proportional Meta-Analysis Areej Dar, Mohamed Rifai, Zahin Shahriar, Zuha Tariq, Hafsa Toor, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6767226/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction: Coronary artery disease (CAD) is a major global health concern, often managed through percutaneous coronary intervention (PCI) with stent implantation. Metallic stents, such as bare-metal stents (BMS) and drug-eluting stents (DES), function by mechanically propping open the narrowed artery, preventing acute vessel closure and reducing restenosis. However, their permanent presence in the vessel wall can lead to long-term complications. Magnesium-based bioresorbable scaffolds have been developed as a temporary support that provide initial vessel reinforcement similar to metallic stents. Methods: This analysis was registered under PROSPERO ID: 1018671. Primary outcomes were cardiac death, tTarget vessel myocardial infarction, Device-Oriented Composite Endpoint (DOCE), tTarget lesion failure and target lesion revascularization (T-TLF & CD-TLF); secondary outcomes included scaffold thrombosis, restenosis, change in balloon diameter and procedural success. Results:- This proportional meta-analysis followed PRISMA guidelines and included 16 studies (4 RCTs, 12 observational) up to 2025. Pooled analysis demonstrated a cardiac death rate of 0% (95% CI: 0.00–0.00) and a target vessel myocardial infarction (TVMI) rate of 1% (95% CI: 0.01–0.02). Target lesion failure (TLF) occurred in 6% of cases (95% CI: 0.06–0.07), while device-oriented composite endpoint (DOCE) was observed in 9% (95% CI: 0.03–0.14). Total target lesion revascularization (TLR) and clinically driven TLR (CD-TLR) were 7% (95% CI: 0.04–0.09) and 5% (95% CI: 0.03–0.06). Scaffold thrombosis was consistently 0% at 6, 12, and 24 months. Restenosis was reported in 8% of patients (95% CI: 0.04–0.12), while procedural success was exceptionally high at 99% (95% CI: 0.99-1.00). The average increase in balloon diameter was 0.43 mm (95% CI: 0.27–0.59). Conclusion:- This meta-analysis showed favorable safety outcomes, with a 1% rate of target vessel myocardial infarction (TV-MI) and 6% target lesion failure (TLF), consistent with previous DREAMS trials. Unlike earlier bioresorbable scaffolds like ABSORB, which had higher thrombosis rates, Mg-BRS showed 0% scaffold thrombosis and low revascularization needs, indicating improved degradation and endothelial healing. While Mg-BRS may outperform drug-eluting stents in some cases, study heterogeneity and limited long-term data require cautious interpretation and future randomized trials. Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 INTRODUCTION Coronary artery disease (CAD) is the leading cause of death globally due to cardiovascular complications. One of the most effective treatments involves reopening blocked vessels using cardiovascular stents (CVS), which are classified into self-expandable and balloon-expandable types. First-generation stents were made from inert metal alloys, offering excellent mechanical and radial strength along with corrosion resistance. However, their permanent presence in the body led to complications such as inflammation, restenosis, and increased risk of thrombosis (1). To address these complications, drug-eluting stents (DES) were developed, which release anti-proliferative and anti-thrombotic agents to reduce restenosis (2). Nevertheless, DES still pose risks like late stent thrombosis and delayed endothelialization (3). These limitations paved the way for bioresorbable scaffolds (BRS), which provide mechanical support and drug delivery while being gradually resorbed by the body, restoring normal vessel function over time (4). The first generation of polymer-based BRS, such as the Absorb Bioresorbable Vascular Scaffold (BVS), initially showed promise but was withdrawn due to high rates of scaffold thrombosis and late lumen loss (5). These setbacks prompted the development of magnesium-based BRS, aiming for improved mechanical performance and a more favorable degradation profile. Magnesium scaffolds gained attention due to their excellent radial strength, biocompatibility, biodegradability in body fluids, and faster resorption (6,7). They offer unique benefits such as targeted deliverability, low elastic recoil, high collapse pressure, minimal shortening after inflation, and mechanical strength comparable to stainless steel (8). Magnesium also has anti-inflammatory and anti-thrombotic properties; its degradation produces an electronegative charge that lowers thrombosis risk. Rapid endothelialization has been observed, with most of the scaffold degrading into inorganic salts within 60 days and causing minimal inflammatory response (9). However, the rapid degradation of magnesium in body fluids can lead to gas accumulation and neointimal formation, weakening scaffold integrity. To counter this, magnesium is alloyed with other elements and coated with polymers to slow degradation and improve corrosion resistance. These enhancements are seen in the DREAMS series—an evolution from the original absorbable magnesium scaffold (AMS)—featuring stronger radial force, slower resorption, square struts, and a drug-eluting polymer coating. Second- and third-generation DREAMS (DREAMS 2G and 3G) have further improvements (10). Although some studies on resorbable magnesium scaffolds (RMS) have reported positive outcomes, research remains limited. Studies vary in design, follow-up duration, and patient population. For instance, one RCT reported reliable outcomes at 6 months (12), while another study showed a higher Device-oriented Composite Endpoint (DoCE) in magnesium scaffolds compared to DES (13). Such variability complicates clear conclusions regarding safety and efficacy. Previous meta-analyses have either focused on polymer-based BRS or considered magnesium scaffolds only as a subgroup. Therefore, a dedicated analysis is needed. This systematic review and proportionate meta-analysis aims to evaluate the safety, efficacy, and long-term outcomes of magnesium-based BRS in the management of coronary artery disease. Key outcomes include DoCE (cardiac deaths, target lesion revascularization, target vessel myocardial infarction, target lesion failure), restenosis, scaffold thrombosis, major cardiovascular events, and procedural success. By systematically reviewing available evidence, this article aims to provide insight into the therapeutic potential of magnesium-based BRS and guide future research in interventional cardiology. METHODS Study Design and Protocol Registration: This meta-analysis follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (14). The protocol for the study has been registered and is available on PROSPERO with the ID: (1018671) Data sources and search strategy: An electronic search of PubMed, Google Scholar, Cochrane and Scopus was conducted from their inception to 2025 without any language restrictions. The search utilized key words like: "Magnesium-based bioresorbable scaffold", "Magnesium BRS", "bioresorbable scaffold", "bioresorbable vascular scaffold", "biodegradable stent", "magnesium scaffold", "magnesium stent", "coronary artery disease", "CAD", "coronary stenosis", "coronary restenosis", "myocardial ischemia", "ischemic heart disease", "long-term outcomes", "major adverse cardiac events", "MACE", "target lesion revascularization", "scaffold restenosis", "vascular remodeling", "late lumen loss", "randomized controlled trial", "RCT", "cohort study", "prospective study" etc. In addition, we manually screened the reference list of retrieved trials, previous meta-analyses, and review articles to identify any relevant studies. We selected randomized controlled trials, observational studies, including cohort and case-control studies, for this review. Narrative reviews, systematic reviews, conference abstracts, posters, case reports, letters to the editor, and other articles that did not meet the inclusion criteria were screened for additional potential sources of relevant primary studies. Study selection: Articles retrieved from the literature search were exported to Rayyan AI, where duplicates were identified and removed. Two independent reviewers (I.K., A.D.) carefully assessed the remaining articles, and only those trials that met the previously defined criteria were selected. All trials were initially short-listed based on title and abstract, after which the full article was reviewed to affirm relevance. A third investigator (V.K.) was consulted to resolve any discrepancies. Studies were selected based on the following criteria: (a) Published studies involving adults diagnosed with coronary artery disease who received magnesium-based bioresorbable scaffolds. (b) Studies in which magnesium-based bioresorbable scaffolds were the main intervention for treating coronary artery disease. (c) Study designs including randomized controlled trials, non-randomized trials, retrospective studies, cohort studies, and pilot studies. (d) Articles published in English in peer-reviewed journals with available results. (e) Studies published from the year 2000 onward to reflect the use of modern scaffold technologies. Data extraction: In this meta-analysis, data extraction was systematically conducted to ensure accuracy and relevance. Key information was collected from each study, including Study ID, Country, Study Design, Sample Size, and Sex Distribution (Male/Female). Demographics included Mean Age (± SD), Population Type (e.g., Acute Coronary Syndrome type), and clinical parameters such as Diabetes, Hypertension, Prior MI, TIMI Thrombus Grade, and Lesion Details (Location/Target Vessel, Length, AHA/ACC Classification). Intervention and Control Group data, Scaffold Dimensions (mm), and Total Scaffolds Used were noted, along with Follow-up Duration, DAPT Use, and the need for re-debridement/amputation. Two independent reviewers (I.K., H.T.) performed data extraction to minimize bias, with discrepancies resolved through discussion or consultation with a third reviewer (A.D.). Data were organized and recorded into a standardized Excel sheet to facilitate consistent comparison and synthesis across studies. Outcomes: Primary outcomes were cardiac death, Target vessel myocardial infarction, DOCE, Target lesion failure and target lesion revascularization (T-TLF & CD-TLF); secondary outcomes included scaffold thrombosis, restenosis, change in balloon diameter and procedural success. Quality Assessment: The quality of the included studies was assessed using ROB1 (15) for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale (16) for observational studies. According to ROB1, the evaluation of RCTs focused on potential biases in the following areas: random sequence generation, allocation concealment, blinding of participants and personnel, incomplete outcome data, selective outcome reporting, and other biases. The Newcastle-Ottawa Scale assessed selection, comparability, and outcome measurement in observational studies. Both tools were applied to ensure that only studies meeting the appropriate quality standards were included in the analysis. Statistical analysis: All statistical analyses were conducted using R version 4.3 (17), employing the meta and dmetar packages. For dichotomous outcomes, we performed single-arm meta-analyses using raw proportions (PRAW) with inverse variance weighting, while for continuous outcomes we used raw means (MRAW). We applied common-effect models for primary analyses and random-effects models when appropriate, with model selection based on heterogeneity assessment. Heterogeneity was evaluated using I² statistics interpreted according to the Cochrane Handbook guidelines: 0-40% (low), 30-60% (moderate), 50-90% (substantial), and 75-100% (considerable). For outcomes showing significant heterogeneity (I² > 50%), we performed leave-one-out sensitivity analyses using the dmetar package. All analyses incorporated a continuity correction of 0.5 for zero-cell adjustments. RESULTS Literature Search Results: Our literature search initially yielded 13,516 potential articles, which were reduced to 2,349 after removing duplicates. Title and abstract screening resulted in the exclusion of 1,769 studies. A thorough full-text assessment of 580 articles for eligibility resulted in the exclusion of 564 articles that did not meet the inclusion criteria. Subsequently, sixteen studies (RCTs + Observational studies) were included as shown in PRISMA (figure 1, Supplementary). Baseline Characteristics The detailed characteristics of the included studies are presented in Table 1. A total of sixteen studies were analyzed, comprising four RCTs and twelve observational studies. Of these, two studies were conducted across multiple countries, while the remaining studies were conducted in Spain, Belgium, Poland, Italy, Denmark, the Czech Republic, and the United Arab Emirates. The combined sample size across all studies was 3,837 participants, with a mean age of 59.87 ± 9.65 years. (Table 2) Results of Quality Assessments 1. For Randomized Control Trials (RCTs): Quality assessment of the RCTs using the Cochrane Risk of Bias Tool (ROB 1.0) identified all four studies with an unclear risk of bias in blinding of participants and detection bias, while the remaining domains demonstrated a low or minimal risk across all studies. The outcomes of the quality evaluation are illustrated in (Figure 2,3 Supplementary). 2. For Observational Studies: The quality of the observational studies was evaluated using the Newcastle-Ottawa Scale (NOS), and all included studies were high quality (Table 3, Supplementary). No studies were excluded based on quality concerns. Results of Primary Outcomes Analyzed: 1. Cardiac Death A total of twelve studies reported on cardiac death (figure 4a) with pooled analysis showing an overall proportion of 0% (95% CI: 0.00 to 0.00), with low heterogeneity (I² = 0%) showing reliability across the studies and robustness. This indicates the strong inclination of these stents towards decreasing Cardiac death outcomes in individuals with any CAD strongly making this intervention reliable for the population at target. 2. Target Vessel Myocardial Infarction (TVMI) The analysis of thirteen studies assessing TVMI (figure 4b) revealed a pooled proportion of 1% (95% CI: 0.01 to 0.02), with low heterogeneity (I² = 0%) showing consistency among the studies. This reveals the low chances of TVMI occurrence in our intervened population marking how adverse outcomes can be eliminated via this mechanism of treatment. 3. Target Lesion Failure (TLF) The analysis of a total of six studies evaluating TLF (figure 4b) with resorbable magnesium scaffolds report a proportion of 6% (95% CI: 0.06 to 0.07), with low heterogeneity (I² = 0%). Even though this outcome revealed a slightly larger proportion as compared to previous outcomes, it still showed promising results and was in the lower figures. 4. Device-Oriented Composite Endpoint (DOCE) A total of five studies evaluating DOCE (figure 4c) report a proportion of 9% (95% CI: 0.03 to 0.14), with moderate heterogeneity (I² = 66.8%). The moderate heterogeneity caused us to perform a sensitivity analysis (SA) (figure 5a) that indicated that omission of Wlodarczak et al. 2018 resulted in a marked decrease in heterogeneity from 66.8% to 0%, explaining effect size of this study being the reason for previous high heterogeneity. 5. Total Target Lesion Revascularization (TLR) Nine studies reported a proportion of 7% (95% CI: 0.04 to 0.09) for total TLR (figure 4c), with moderate heterogeneity (I² = 57.2%). Furthermore, sensitivity analysis (figure 5b) indicated heterogeneity dropped to 21% upon exclusion of Gomez-Lara et al. 2020, suggesting this study may be a primary contributor to heterogeneity. 6. Clinically Driven Target Lesion Revascularization (CD-TLR) A total of nine studies (figure 4c) reported a pooled proportion of 5% (95% CI: 0.03 to 0.06) for CD-TLR, with substantial heterogeneity (I² = 63.3%). The SA (figure 5c) showed omission of Wlodarczak (b) et al. (2023) reduced heterogeneity from 63% to 35%. Secondary Outcomes 1. Scaffold Thrombosis Scaffold-induced thrombosis was assessed across multiple follow-up durations (figure 4d): ● At 6 months, data from 9 studies showed a pooled proportion of 0% (95% CI: 0.00 to 0.00), with moderate heterogeneity (I² = 57.2%) which was the highest amongst all subgroups. ● At 12 months, 11 studies reported a proportion of 0% (95% CI: 0.00 to 0.00), with insignificant heterogeneity (I² = 32.3%). ● At 24 months, 7 studies revealed a proportion of 0% (95% CI: 0.00 to 0.01), with insignificant heterogeneity (I² = 36.4%). 2. Restenosis A total of eleven studies reported an incidence of restenosis (figure 4e) with a pooled analysis revealing a proportion of 8% (95% CI: 0.04 to 0.12), with high heterogeneity (I² = 71%). Furthermore, the sensitivity analysis (figure 5d) showed omitting Gomez-Lara et al. 2020 reduced the heterogeneity to (I²=54%). 3. Procedural Success The analysis of twelve studies evaluated procedural success (figure 4f) and revealed a pooled success proportion of 99% (95% CI: 0.99 to 1.00), with no significant heterogeneity (I² = 0.7%). This shows how these stents are surgical successful for almost 99% of the population. 4. Change in Balloon Diameter Eleven studies reported the change in balloon diameter (figure 4g) using resorbable magnesium scaffolds. The pooled result showed a mean random effects weighted average (MRAW) of 0.43 mm (95% CI: 0.27 to 0.59), with very high heterogeneity (I² = 94.4%). The SA (figure 5e) revealed that omission of Gomez-Lara et al. (2020) reduced heterogeneity from 95% to 91%. DISCUSSION Coronary artery disease (CAD) remains the leading cause of morbidity and mortality worldwide, necessitating continuous innovation in revascularization strategies. PCI procedures using drug-eluting stents have reduced restenosis rates together with adverse cardiac outcomes. The permanent use of metal stents leads to significant long-term medical complications including late stent thrombosis along with chronic inflammation and vascular dysfunction thus stimulating the development of transitional support structures [ 18 ]. Bioresorbable scaffolds (BRS) serve as a transformative technology in coronary intervention because they support blood vessels briefly before they completely dissolve. The magnesium-based bioresorbable scaffold (Mg-BRS) represents a breakthrough technology since it provides enhanced mechanical capabilities together with excellent biocompatibility features and faster degradation features than conventional polymer scaffolds [ 19 ]. Polymeric scaffolds have lower radial strength than magnesium alloys which cause fewer adverse inflammatory tissue reactions. The scaffold technology provides initial vessel support through its features and reduces the long-term impact of foreign materials which can lead to a decrease in late thrombosis and enhanced vessel remodeling [ 20 ]. A systematic review along with proportional meta-analysis assessed magnesium-based bioresorbable scaffold (Mg-BRS) safety outcomes and therapeutic effects in different coronary artery disease situations. The analyzed studies produced reassuring results that show a 1% [95% CI: 0.01–0.02] rate of TV-MI alongside TLF occurrence at 6% [95% CI: 0.06–0.07]. The assessment of both clinical indicators revealed minimal statistical variation across different study participants (I² = 0%). Analysis of safety outcomes based on follow-up durations revealed that Mg-BRS remained safe throughout a 24-month period because there were no events during the first 6 or 12 months and only 1% of patients experienced target vessel myocardial infarction towards the end of two years [ 21 ]. These results align closely with previous clinical trials investigating the DREAMS scaffold platform, particularly the BIOSOLVE-IV registry, which reported a 12-month TLF rate of 5.9%, and the BIOSOLVE-II/III pooled analysis, where TLF was 5.6% at 12 months and 8.7% at 24 months (Haude et al., 2020). Our findings fall within this range, adding credibility to the growing body of evidence supporting the second-generation Mg-BRS designs. In comparison to polymeric BRS platforms such as ABSORB (Abbott Vascular), which suffered from elevated late scaffold thrombosis rates and prompted market withdrawal, Mg-BRS demonstrates distinct advantages. Notably, polymeric BRS showed scaffold thrombosis rates approaching 1.3–2.0%, with increased late events [ 22 ], whereas the magnesium-based scaffolds in our meta-analysis showed 0% event rates at early and intermediate follow-up intervals, reflecting superior biocompatibility and degradation kinetics. The low TV-MI rate of 1% is clinically meaningful, particularly when juxtaposed with conventional drug-eluting stents (DES), which typically report TV-MI rates in the range of 2–3% at one year [ 23 ]. This suggests that Mg-BRS may not only be comparable but potentially superior in terms of minimizing myocardial damage post-intervention, likely due to its favourable endothelialization profile and reduced long-term metal burden. Moreover, the absence of major heterogeneity in the pooled data implies that the benefits of Mg-BRS are reproducible across patient populations and geographic regions, a critical consideration for global scalability [ 24 ]. However, while the results are encouraging, some caution is warranted. The final pooled event rate from the random-effects model, including broader outcomes beyond TV-MI and TLF, was 8% [95% CI: 4–12%], with substantial heterogeneity (I² = 71%). This variability reflects differences in study protocols, baseline risk factors, operator technique, and potentially, lesion complexity. Smaller studies such as Gomez-Lara et al. and Gutiérrez-Barrios et al. reported higher complication rates ranging from 14–29% likely due to limited sample sizes and inclusion of complex coronary anatomy, while larger-scale registries with over 2000 patients demonstrated significantly lower event rates, enhancing confidence in the generalizability of our findings. Additionally, the early degradation and bioresorption of magnesium, while beneficial in restoring vessel physiology, may raise concerns about late vessel recoil or negative remodelling [ 25 ]. Nevertheless, recent studies using intravascular imaging (e.g., OCT and IVUS) have shown stable late lumen area and positive remodeling at 12–24 months, alleviating these concerns [ 26 ]. Moreover, unlike DES, which remain permanently embedded and can hinder future surgical options, Mg-BRS offer the theoretical advantage of “vascular restoration therapy,” especially attractive for younger patients or those requiring future revascularization strategies. The combination of analysis makes Mg-BRS appear as a compelling replacement for traditional DES and previous BRS versions. Its combination of short-term mechanical support functions well with long-term biocompatibility properties and it produces minimal inflammatory indicators without presenting any detected late adverse effects [ 27 ]. The potential success of magnesium scaffolds rests on these advantages and minimal event rates while future scaffold development aims to enhance design and delivery systems. Mg-BRS requires more research into its extended performance that spans beyond three years and requires direct testing against contemporary ultrathin DES and sirolimus-eluting stents. Standardized protocol development for implant placement and dedicated imaging guidance should be used to enhance outcomes as smaller trials currently demonstrate inconsistent results [ 28 ]. Emerging research must evaluate both the economic advantage and patient satisfaction of Mg-BRS and its effectiveness when used in specific patient groups which include diabetics and chronic kidney disease patients and patients that have bifurcation lesions. The occurrence of scaffold thrombosis was recorded as 0% with 95% CI: 0.00–0.00 throughout 3,192 patients. The research made a substantial progress beyond polymer-based scaffolds because their late and very late scaffold thrombosis rates reached 1–2% in ABSORB trials. These enhancements in degradation properties along with polymer-free construction and advanced design elements of the magnesium alloy lead to a major improvement in outcomes [ 29 ]. DOCE analysis examined the incidence of cardiac death combined with target vessel MI and clinically indicated TLR at 9% [95% CI: 0.03–0.14] while showing moderate heterogeneity (I² = 66.8%). This slightly elevated figure presents an inclusive measure of all device-related events concerning the TV-MI and scaffold thrombosis rates. The observed rates of device-oriented composite endpoints stay within normal boundaries even though they affect complex clinical cases with high risk. The analysis of total target lesion revascularization (T-TLR) revealed a pooled rate of 7% [95% CI: 0.04–0.09] which exhibited acceptable performance just like the BIOSOLVE-IV registry (Haude et al., 2020) indicated TRL occurred between 5–8% at 1–2 years. The lower rate of clinically driven TLR (CD-TLR) amounted to 5% [95% CI: 0.03–0.06] which revealed that revascularization procedures were rare in nature and did not require emergency intervention. The observed revascularization rates stand at a high level when compared to both historical DES implementations as well as early BRS platform implementations. The data from Ormiston et al. demonstrated a 10.1% TLR incidence in ABSORB patients at one year although Xience and similar modern DES systems maintained 5–7% revascularization frequencies [ 30 ]. All final results from patient follow-up indicate an 8% [95% CI: 0.04–0.12] occurrence rate but substantial variability (I² = 71%) can be explained by differences in study sizes and treatment difficulty and operator experience levels. The observed negative effects in studies that demonstrated higher risks were still below clinical thresholds and none of these evaluations linked scaffold failure or procedural death to Mg-BRS design [ 31 ]. The research findings confirm the common opinion that new-generation Mg-BRS devices improve upon the restrictions found in previous polymer-based scaffolding platforms. These outcomes confirm that Mg-BRS provides clinical benefits beyond mechanical assistance by promoting native vessel healing and remodeling after complete scaffold resorption [ 32 ]. The absence of a chronic footprint after Mg-BRS implantation benefits young patients as well as patients who may need bypass procedures in the future. One must proceed with caution based on these initial promising clinical research findings. The research lacks sufficient data to determine how long the results will last more than two to three years post-treatment. The patient selection criteria probably shaped the treatment results because most studies included lower-risk participants who had minimal or no bifurcation lesions and significant vessel calcification [ 33 ]. Despite the promising outcomes observed in this meta-analysis, several limitations should be acknowledged. First, the majority of included studies were observational or single-arm trials, lacking randomized control groups for direct comparison with other stent platforms such as DES. Second, the follow-up duration in most studies was limited to 12–24 months, which restricts the assessment of very late events, including scaffold resorption-related complications or late target lesion failure. Third, heterogeneity in study design, patient populations, lesion characteristics, and procedural techniques such as variability in lesion preparation and post-dilation may have influenced outcomes. Additionally, several studies had small sample sizes, potentially exaggerating or underestimating the true event rates, and most excluded patients with complex lesions, limiting the generalizability to higher-risk CAD populations. Abbreviations CAD Coronary artery disease CVS Cardiovascular stents DES Drug-eluting stents BRS Bioresorbable scaffolds Mg-BRS Magnesium-based bioresorbable scaffold BVS Bioresorbable Vascular Scaffold DREAMS Drug-eluting absorbable magnesium stent RMS Resorbable magnesium scaffolds RCT Randomized controlled trial DoCE Device-oriented Composite Endpoint PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses MACE Major adverse cardiac events MI Myocardial Infarction TIMI Thrombolysis in Myocardial Infarction TVMI Target Vessel Myocardial Infarction AHA American Heart Association ACC American college of cardiology DAPT Dual antiplatelet therapy TLF Target lesion failure T-TLF Total target lesion failure CD-TLF Clinically driven target lesion revascularization ROB1 Risk of Bias 1 NOS Newcastle Ottawa Scale TLR Target Lesion Revascularization T-TLR Total Target Lesion Revascularization CD-TLR Clinically Driven Target Lesion Revascularization MRAW Mean random effects weighted average PCI Percutaneous coronary intervention CI Confidence Interval OCT Optical Coherence Tomography IVUS Intravascular Ultrasound Declarations Funding Disclosure: None to declare Human Ethics and Consent to participate declarations: Not applicable Author Contribution A.D: Topic selection and screeningI. 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Magnesium Bioresorbable Scaffold (BRS) Magmaris vs Biodegradable Polymer DES Ultimaster in NSTE-ACS Population—12-Month Clinical Outcome. Cardiol Res Pract. 2022;2022:5223317. Ghilardi G, Delmotte P, Brunner P, Dghoughi S, Ghaffari C. Bioresorbable Magnesium-Based Stent: Real-World Clinical Experience and Feasibility of Follow-Up by Coronary Computed Tomography: A New Window to Look at New Scaffolds. Biomedicines. 2023;11(4):1150. Barbato E, Siontis GCM, Pijls NHJ, et al. A new resorbable magnesium scaffold for de novo coronary lesions: DREAMS 3G—one-year results of the BIOMAG-I first-in-human study. EuroIntervention. 2023;19(4):e312–9. Rola P, Janion-Sadowska A, Barycki M, Wójcik J, Kulczycki J, Wójcik K, et al. Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome: Mid-term outcomes (2 years). Cardiol J. 2024;31(2):123–31. Müller M, Ludwig L, Englert H, Riedl KA, Müller MC, Hemkemeyer SA, et al. A novel stent flow chamber system demonstrates reduced thrombogenicity of bioresorbable magnesium scaffolds. Sci Rep. 2024;14(1):26691. Joner M, Ruppelt P, Zumstein P. Preclinical evaluation of degradation kinetics and elemental mapping of first and second generation bioresorbable magnesium scaffolds. EuroIntervention. 2021;16(17):e1401–8. Tovar Forero MN, Zandvoort L, Diletti R, et al. Serial invasive imaging follow-up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold. Catheter Cardiovasc Interv. 2020;95(1):E1–9. Gomez-Lara J, Diletti R, Brugaletta S, et al. Optical coherence tomography analysis after magnesium BRS implantation: insights from the BIOSOLVE-II trial. Rev Esp Cardiol (Engl Ed). 2020;73(10):809–16. Abellas-Sequeiros RA, Gutiérrez-Barrios A, García-Touchard A, et al. Early outcomes with magnesium bioresorbable scaffolds in patients with simple coronary lesions. J Interv Cardiol. 2020;2020:1–7. Bossard M, Madanchi M, Attinger-Toller A, Cioffi GM, Seiler T, Tersalvi G, et al. Long-term outcomes after implantation of magnesium-based bioresorbable scaffolds—insights from an all-comer registry. Front Cardiovasc Med. 2022;9:856930. Galli S, Testa L, Montorsi P, Bedogni F, Pisano F. Twelve-month clinical outcomes of the Magmaris resorbable magnesium scaffold in complex lesions: insights from the IT-MASTERS registry. TCTMD. 2024 Oct 30. Rola P, Janion-Sadowska A, Barycki M, Wójcik J, Kulczycki J, Wójcik K, et al. Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome: mid-term outcomes (2 years). Cardiol J. 2024;31(2):123–31. Müller M, Ludwig L, Englert H, Riedl KA, Müller MC, Hemkemeyer SA, et al. A novel stent flow chamber system demonstrates reduced thrombogenicity of bioresorbable magnesium scaffolds. Sci Rep. 2024;14(1):26691. Haude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, et al. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023;59:101940. Tables Table 1 to 3 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files HIGHLIGHTSmagstemi.docx Table13.docx ptchmagstemi.docx Cite Share Download PDF Status: Posted Version 1 posted 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. 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07:30:34","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":97476,"visible":true,"origin":"","legend":"","description":"","filename":"Table13.docx","url":"https://assets-eu.researchsquare.com/files/rs-6767226/v1/b07802f98edb0b9f570f92f7.docx"},{"id":85370926,"identity":"72f2ff50-2ebe-4aa7-a030-64b6d08afe43","added_by":"auto","created_at":"2025-06-25 07:30:34","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":27236,"visible":true,"origin":"","legend":"","description":"","filename":"ptchmagstemi.docx","url":"https://assets-eu.researchsquare.com/files/rs-6767226/v1/e6f6ee5e5388384286feddac.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy and Safety of Magnesium-Based Bioresorbable Scaffolds in All Coronary Artery Diseases: A Systematic Review and Proportional Meta-Analysis","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eCoronary artery disease (CAD) is the leading cause of death globally due to cardiovascular complications. One of the most effective treatments involves reopening blocked vessels using cardiovascular stents (CVS), which are classified into self-expandable and balloon-expandable types. First-generation stents were made from inert metal alloys, offering excellent mechanical and radial strength along with corrosion resistance. However, their permanent presence in the body led to complications such as inflammation, restenosis, and increased risk of thrombosis (1).\u003c/p\u003e \u003cp\u003eTo address these complications, drug-eluting stents (DES) were developed, which release anti-proliferative and anti-thrombotic agents to reduce restenosis (2). Nevertheless, DES still pose risks like late stent thrombosis and delayed endothelialization (3). These limitations paved the way for bioresorbable scaffolds (BRS), which provide mechanical support and drug delivery while being gradually resorbed by the body, restoring normal vessel function over time (4).\u003c/p\u003e \u003cp\u003eThe first generation of polymer-based BRS, such as the Absorb Bioresorbable Vascular Scaffold (BVS), initially showed promise but was withdrawn due to high rates of scaffold thrombosis and late lumen loss (5). These setbacks prompted the development of magnesium-based BRS, aiming for improved mechanical performance and a more favorable degradation profile. Magnesium scaffolds gained attention due to their excellent radial strength, biocompatibility, biodegradability in body fluids, and faster resorption (6,7). They offer unique benefits such as targeted deliverability, low elastic recoil, high collapse pressure, minimal shortening after inflation, and mechanical strength comparable to stainless steel (8). Magnesium also has anti-inflammatory and anti-thrombotic properties; its degradation produces an electronegative charge that lowers thrombosis risk. Rapid endothelialization has been observed, with most of the scaffold degrading into inorganic salts within 60 days and causing minimal inflammatory response (9).\u003c/p\u003e \u003cp\u003eHowever, the rapid degradation of magnesium in body fluids can lead to gas accumulation and neointimal formation, weakening scaffold integrity. To counter this, magnesium is alloyed with other elements and coated with polymers to slow degradation and improve corrosion resistance. These enhancements are seen in the DREAMS series\u0026mdash;an evolution from the original absorbable magnesium scaffold (AMS)\u0026mdash;featuring stronger radial force, slower resorption, square struts, and a drug-eluting polymer coating. Second- and third-generation DREAMS (DREAMS 2G and 3G) have further improvements (10).\u003c/p\u003e \u003cp\u003eAlthough some studies on resorbable magnesium scaffolds (RMS) have reported positive outcomes, research remains limited. Studies vary in design, follow-up duration, and patient population. For instance, one RCT reported reliable outcomes at 6 months (12), while another study showed a higher Device-oriented Composite Endpoint (DoCE) in magnesium scaffolds compared to DES (13). Such variability complicates clear conclusions regarding safety and efficacy.\u003c/p\u003e \u003cp\u003ePrevious meta-analyses have either focused on polymer-based BRS or considered magnesium scaffolds only as a subgroup. Therefore, a dedicated analysis is needed. This systematic review and proportionate meta-analysis aims to evaluate the safety, efficacy, and long-term outcomes of magnesium-based BRS in the management of coronary artery disease. Key outcomes include DoCE (cardiac deaths, target lesion revascularization, target vessel myocardial infarction, target lesion failure), restenosis, scaffold thrombosis, major cardiovascular events, and procedural success. By systematically reviewing available evidence, this article aims to provide insight into the therapeutic potential of magnesium-based BRS and guide future research in interventional cardiology.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy Design and Protocol Registration:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis meta-analysis follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (14). \u0026nbsp;The protocol for the study has been registered and is available on PROSPERO with the ID: (1018671)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData sources and search strategy:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAn electronic search of PubMed, Google Scholar, Cochrane and Scopus was conducted from their inception to 2025 without any language restrictions. The search utilized key words like:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026quot;Magnesium-based bioresorbable scaffold\u0026quot;, \u0026quot;Magnesium BRS\u0026quot;, \u0026quot;bioresorbable scaffold\u0026quot;, \u0026quot;bioresorbable vascular scaffold\u0026quot;, \u0026quot;biodegradable stent\u0026quot;, \u0026quot;magnesium scaffold\u0026quot;, \u0026quot;magnesium stent\u0026quot;, \u0026quot;coronary artery disease\u0026quot;, \u0026quot;CAD\u0026quot;, \u0026quot;coronary stenosis\u0026quot;, \u0026quot;coronary restenosis\u0026quot;, \u0026quot;myocardial ischemia\u0026quot;, \u0026quot;ischemic heart disease\u0026quot;, \u0026quot;long-term outcomes\u0026quot;, \u0026quot;major adverse cardiac events\u0026quot;, \u0026quot;MACE\u0026quot;, \u0026quot;target lesion revascularization\u0026quot;, \u0026quot;scaffold restenosis\u0026quot;, \u0026quot;vascular remodeling\u0026quot;, \u0026quot;late lumen loss\u0026quot;, \u0026quot;randomized controlled trial\u0026quot;, \u0026quot;RCT\u0026quot;, \u0026quot;cohort study\u0026quot;, \u0026quot;prospective study\u0026quot; etc.\u003c/p\u003e\n\u003cp\u003eIn addition, we manually screened the reference list of retrieved trials, previous meta-analyses, and review articles to identify any relevant studies. We selected randomized controlled trials, observational studies, including cohort and case-control studies, for this review. Narrative reviews, systematic reviews, conference abstracts, posters, case reports, letters to the editor, and other articles that did not meet the inclusion criteria were screened for additional potential sources of relevant primary studies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy selection:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eArticles retrieved from the literature search were exported to Rayyan AI, where duplicates were identified and removed. Two independent reviewers (I.K., A.D.) carefully assessed the remaining articles, and only those trials that met the previously defined criteria were selected. All trials were initially short-listed based on title and abstract, after which the full article was reviewed to affirm relevance. A third investigator (V.K.) was consulted to resolve any discrepancies. Studies were selected based on the following criteria:\u003cbr\u003e\u0026nbsp;(a) Published studies involving adults diagnosed with coronary artery disease who received magnesium-based bioresorbable scaffolds.\u003c/p\u003e\n\u003cp\u003e(b) Studies in which magnesium-based bioresorbable scaffolds were the main intervention for treating coronary artery disease.\u003c/p\u003e\n\u003cp\u003e(c) Study designs including randomized controlled trials, non-randomized trials, retrospective studies, cohort studies, and pilot studies.\u003c/p\u003e\n\u003cp\u003e(d) Articles published in English in peer-reviewed journals with available results.\u003c/p\u003e\n\u003cp\u003e(e) Studies published from the year 2000 onward to reflect the use of modern scaffold technologies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData extraction:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this meta-analysis, data extraction was systematically conducted to ensure accuracy and relevance. Key information was collected from each study, including Study ID, Country, Study Design, Sample Size, and Sex Distribution (Male/Female). Demographics included Mean Age (\u0026plusmn; SD), Population Type (e.g., Acute Coronary Syndrome type), and clinical parameters such as Diabetes, Hypertension, Prior MI, TIMI Thrombus Grade, and Lesion Details (Location/Target Vessel, Length, AHA/ACC Classification). Intervention and Control Group data, Scaffold Dimensions (mm), and Total Scaffolds Used were noted, along with Follow-up Duration, DAPT Use, and the need for re-debridement/amputation.\u003c/p\u003e\n\u003cp\u003eTwo independent reviewers (I.K., H.T.) performed data extraction to minimize bias, with discrepancies resolved through discussion or consultation with a third reviewer (A.D.). Data were organized and recorded into a standardized Excel sheet to facilitate consistent comparison and synthesis across studies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eOutcomes:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrimary outcomes were cardiac death, Target vessel myocardial infarction, DOCE, Target lesion failure and target lesion revascularization (T-TLF \u0026amp; CD-TLF); secondary outcomes included scaffold thrombosis, restenosis, change in balloon diameter and procedural success.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eQuality Assessment:\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;The quality of the included studies was assessed using ROB1 (15) for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale (16) for observational studies. According to ROB1, the evaluation of RCTs focused on potential biases in the following areas: random sequence generation, allocation concealment, blinding of participants and personnel, incomplete outcome data, selective outcome reporting, and other biases. The Newcastle-Ottawa Scale assessed selection, comparability, and outcome measurement in observational studies. Both tools were applied to ensure that only studies meeting the appropriate quality standards were included in the analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStatistical analysis:\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll statistical analyses were conducted using R version 4.3 (17), employing the meta and dmetar packages. For dichotomous outcomes, we performed single-arm meta-analyses using raw proportions (PRAW) with inverse variance weighting, while for continuous outcomes we used raw means (MRAW). We applied common-effect models for primary analyses and random-effects models when appropriate, with model selection based on heterogeneity assessment. Heterogeneity was evaluated using I\u0026sup2; statistics interpreted according to the Cochrane Handbook guidelines: 0-40% (low), 30-60% (moderate), 50-90% (substantial), and 75-100% (considerable). For outcomes showing significant heterogeneity (I\u0026sup2; \u0026gt; 50%), we performed leave-one-out sensitivity analyses using the dmetar package. All analyses incorporated a continuity correction of 0.5 for zero-cell adjustments.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eLiterature Search Results:\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003eOur literature search initially yielded 13,516 potential articles, which were reduced to 2,349 after removing duplicates. Title and abstract screening resulted in the exclusion of 1,769 studies. A thorough full-text assessment of 580 articles for eligibility resulted in the exclusion of 564 articles that did not meet the inclusion criteria. Subsequently, sixteen studies \u003cem\u003e(RCTs + Observational studies)\u003c/em\u003e were included as shown in PRISMA (figure 1, Supplementary).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eBaseline Characteristics\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;The detailed characteristics of the included studies are presented in Table 1. A total of sixteen studies were analyzed, comprising four RCTs and twelve observational studies. Of these, two studies were conducted across multiple countries, while the remaining studies were conducted in Spain, Belgium, Poland, Italy, Denmark, the Czech Republic, and the United Arab Emirates. The combined sample size across all studies was 3,837 participants, with a mean age of 59.87 \u0026plusmn; 9.65 years. (Table 2)\u003cbr\u003e\u0026nbsp;\u003cbr\u003e\u003cstrong\u003e\u003cem\u003eResults of Quality Assessments\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. \u003cstrong\u003e\u003cem\u003eFor Randomized Control Trials (RCTs):\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eQuality assessment of the RCTs using the Cochrane Risk of Bias Tool (ROB 1.0) identified all four studies with an unclear risk of bias in blinding of participants and detection bias, while the remaining domains demonstrated a low or minimal risk across all studies. The outcomes of the quality evaluation are illustrated in (Figure 2,3 Supplementary).\u003cp\u003e\u003cstrong\u003e\u003cem\u003e2. For Observational Studies:\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;The quality of the observational studies was evaluated using the Newcastle-Ottawa Scale (NOS), and all included studies were high quality (Table 3, Supplementary). No studies were excluded based on quality concerns.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eResults of Primary Outcomes Analyzed:\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e1. Cardiac Death\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;A total of twelve studies reported on cardiac death (figure 4a) with pooled analysis showing an overall proportion of 0% (95% CI: 0.00 to 0.00), with low heterogeneity (I\u0026sup2; = 0%) showing reliability across the studies and robustness. This indicates the strong inclination of these stents towards decreasing Cardiac death outcomes in individuals with any CAD strongly making this intervention reliable for the population at target.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e2. Target Vessel Myocardial Infarction (TVMI)\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;The analysis of thirteen studies assessing TVMI (figure 4b) revealed a pooled proportion of 1% (95% CI: 0.01 to 0.02), with low heterogeneity (I\u0026sup2; = 0%) showing consistency among the studies. This reveals the low chances of TVMI occurrence in our intervened population marking how adverse outcomes can be eliminated via this mechanism of treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e3. Target Lesion Failure (TLF)\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;The analysis of a total of six studies evaluating TLF (figure 4b) with resorbable magnesium scaffolds report a proportion of 6% (95% CI: 0.06 to 0.07), with low heterogeneity (I\u0026sup2; = 0%). Even though this outcome revealed a slightly larger proportion as compared to previous outcomes, it still showed promising results and was in the lower figures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e4. Device-Oriented Composite Endpoint (DOCE)\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;A total of five studies evaluating DOCE (figure 4c) report a proportion of 9% (95% CI: 0.03 to 0.14), with moderate heterogeneity (I\u0026sup2; = 66.8%). The moderate heterogeneity caused us to perform a sensitivity analysis (SA) (figure 5a) that indicated that omission of Wlodarczak et al. 2018 resulted in a marked decrease in heterogeneity from 66.8% to 0%, explaining effect size of this study being the reason for previous high heterogeneity.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e5. Total Target Lesion Revascularization (TLR)\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;Nine studies reported a proportion of 7% (95% CI: 0.04 to 0.09) for total TLR (figure 4c), with moderate heterogeneity (I\u0026sup2; = 57.2%). Furthermore, sensitivity analysis (figure 5b) indicated heterogeneity dropped to 21% upon exclusion of Gomez-Lara et al. 2020, suggesting this study may be a primary contributor to heterogeneity.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e6. Clinically Driven Target Lesion Revascularization (CD-TLR)\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;A total of nine studies (figure 4c) reported a pooled proportion of 5% (95% CI: 0.03 to 0.06) for CD-TLR, with substantial heterogeneity (I\u0026sup2; = 63.3%). The SA (figure 5c) showed omission of Wlodarczak (b) et al. (2023) reduced heterogeneity from 63% to 35%.\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eSecondary Outcomes\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e1. Scaffold Thrombosis\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;Scaffold-induced thrombosis was assessed across multiple follow-up durations (figure 4d):\u003c/p\u003e\n\u003cp\u003e● At 6 months, data from 9 studies showed a pooled proportion of 0% (95% CI: 0.00 to 0.00), with moderate heterogeneity (I\u0026sup2; = 57.2%) which was the highest amongst all subgroups.\u003c/p\u003e\n\u003cp\u003e● At 12 months, 11 studies reported a proportion of 0% (95% CI: 0.00 to 0.00), with insignificant heterogeneity (I\u0026sup2; = 32.3%).\u003c/p\u003e\n\u003cp\u003e● At 24 months, 7 studies revealed a proportion of 0% (95% CI: 0.00 to 0.01), with insignificant heterogeneity (I\u0026sup2; = 36.4%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e2. Restenosis\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;A total of eleven studies reported an incidence of restenosis (figure 4e) with a pooled analysis revealing a proportion of 8% (95% CI: 0.04 to 0.12), with high heterogeneity (I\u0026sup2; = 71%). Furthermore, the sensitivity analysis (figure 5d) showed omitting Gomez-Lara et al. 2020 reduced the heterogeneity to (I\u0026sup2;=54%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e3. Procedural Success\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;The analysis of twelve studies evaluated procedural success (figure 4f) and revealed a pooled success proportion of 99% (95% CI: 0.99 to 1.00), with no significant heterogeneity (I\u0026sup2; = 0.7%). This shows how these stents are surgical successful for almost 99% of the population.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e4. Change in Balloon Diameter\u003c/em\u003e\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;Eleven studies reported the change in balloon diameter (figure 4g) using resorbable magnesium scaffolds. The pooled result showed a mean random effects weighted average (MRAW) of 0.43 mm (95% CI: 0.27 to 0.59), with very high heterogeneity (I\u0026sup2; = 94.4%). The SA (figure 5e) revealed that omission of Gomez-Lara et al. (2020) reduced heterogeneity from 95% to 91%.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eCoronary artery disease (CAD) remains the leading cause of morbidity and mortality worldwide, necessitating continuous innovation in revascularization strategies. PCI procedures using drug-eluting stents have reduced restenosis rates together with adverse cardiac outcomes. The permanent use of metal stents leads to significant long-term medical complications including late stent thrombosis along with chronic inflammation and vascular dysfunction thus stimulating the development of transitional support structures [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Bioresorbable scaffolds (BRS) serve as a transformative technology in coronary intervention because they support blood vessels briefly before they completely dissolve. The magnesium-based bioresorbable scaffold (Mg-BRS) represents a breakthrough technology since it provides enhanced mechanical capabilities together with excellent biocompatibility features and faster degradation features than conventional polymer scaffolds [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Polymeric scaffolds have lower radial strength than magnesium alloys which cause fewer adverse inflammatory tissue reactions. The scaffold technology provides initial vessel support through its features and reduces the long-term impact of foreign materials which can lead to a decrease in late thrombosis and enhanced vessel remodeling [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA systematic review along with proportional meta-analysis assessed magnesium-based bioresorbable scaffold (Mg-BRS) safety outcomes and therapeutic effects in different coronary artery disease situations. The analyzed studies produced reassuring results that show a 1% [95% CI: 0.01\u0026ndash;0.02] rate of TV-MI alongside TLF occurrence at 6% [95% CI: 0.06\u0026ndash;0.07]. The assessment of both clinical indicators revealed minimal statistical variation across different study participants (I\u0026sup2; = 0%). Analysis of safety outcomes based on follow-up durations revealed that Mg-BRS remained safe throughout a 24-month period because there were no events during the first 6 or 12 months and only 1% of patients experienced target vessel myocardial infarction towards the end of two years [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. These results align closely with previous clinical trials investigating the DREAMS scaffold platform, particularly the BIOSOLVE-IV registry, which reported a 12-month TLF rate of 5.9%, and the BIOSOLVE-II/III pooled analysis, where TLF was 5.6% at 12 months and 8.7% at 24 months (Haude et al., 2020). Our findings fall within this range, adding credibility to the growing body of evidence supporting the second-generation Mg-BRS designs. In comparison to polymeric BRS platforms such as ABSORB (Abbott Vascular), which suffered from elevated late scaffold thrombosis rates and prompted market withdrawal, Mg-BRS demonstrates distinct advantages. Notably, polymeric BRS showed scaffold thrombosis rates approaching 1.3\u0026ndash;2.0%, with increased late events [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], whereas the magnesium-based scaffolds in our meta-analysis showed 0% event rates at early and intermediate follow-up intervals, reflecting superior biocompatibility and degradation kinetics.\u003c/p\u003e \u003cp\u003eThe low TV-MI rate of 1% is clinically meaningful, particularly when juxtaposed with conventional drug-eluting stents (DES), which typically report TV-MI rates in the range of 2\u0026ndash;3% at one year [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. This suggests that Mg-BRS may not only be comparable but potentially superior in terms of minimizing myocardial damage post-intervention, likely due to its favourable endothelialization profile and reduced long-term metal burden. Moreover, the absence of major heterogeneity in the pooled data implies that the benefits of Mg-BRS are reproducible across patient populations and geographic regions, a critical consideration for global scalability [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. However, while the results are encouraging, some caution is warranted. The final pooled event rate from the random-effects model, including broader outcomes beyond TV-MI and TLF, was 8% [95% CI: 4\u0026ndash;12%], with substantial heterogeneity (I\u0026sup2; = 71%). This variability reflects differences in study protocols, baseline risk factors, operator technique, and potentially, lesion complexity. Smaller studies such as Gomez-Lara et al. and Guti\u0026eacute;rrez-Barrios et al. reported higher complication rates ranging from 14\u0026ndash;29% likely due to limited sample sizes and inclusion of complex coronary anatomy, while larger-scale registries with over 2000 patients demonstrated significantly lower event rates, enhancing confidence in the generalizability of our findings. Additionally, the early degradation and bioresorption of magnesium, while beneficial in restoring vessel physiology, may raise concerns about late vessel recoil or negative remodelling [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Nevertheless, recent studies using intravascular imaging (e.g., OCT and IVUS) have shown stable late lumen area and positive remodeling at 12\u0026ndash;24 months, alleviating these concerns [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Moreover, unlike DES, which remain permanently embedded and can hinder future surgical options, Mg-BRS offer the theoretical advantage of \u0026ldquo;vascular restoration therapy,\u0026rdquo; especially attractive for younger patients or those requiring future revascularization strategies. The combination of analysis makes Mg-BRS appear as a compelling replacement for traditional DES and previous BRS versions. Its combination of short-term mechanical support functions well with long-term biocompatibility properties and it produces minimal inflammatory indicators without presenting any detected late adverse effects [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. The potential success of magnesium scaffolds rests on these advantages and minimal event rates while future scaffold development aims to enhance design and delivery systems. Mg-BRS requires more research into its extended performance that spans beyond three years and requires direct testing against contemporary ultrathin DES and sirolimus-eluting stents. Standardized protocol development for implant placement and dedicated imaging guidance should be used to enhance outcomes as smaller trials currently demonstrate inconsistent results [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Emerging research must evaluate both the economic advantage and patient satisfaction of Mg-BRS and its effectiveness when used in specific patient groups which include diabetics and chronic kidney disease patients and patients that have bifurcation lesions. The occurrence of scaffold thrombosis was recorded as 0% with 95% CI: 0.00\u0026ndash;0.00 throughout 3,192 patients. The research made a substantial progress beyond polymer-based scaffolds because their late and very late scaffold thrombosis rates reached 1\u0026ndash;2% in ABSORB trials. These enhancements in degradation properties along with polymer-free construction and advanced design elements of the magnesium alloy lead to a major improvement in outcomes [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. DOCE analysis examined the incidence of cardiac death combined with target vessel MI and clinically indicated TLR at 9% [95% CI: 0.03\u0026ndash;0.14] while showing moderate heterogeneity (I\u0026sup2; = 66.8%). This slightly elevated figure presents an inclusive measure of all device-related events concerning the TV-MI and scaffold thrombosis rates. The observed rates of device-oriented composite endpoints stay within normal boundaries even though they affect complex clinical cases with high risk. The analysis of total target lesion revascularization (T-TLR) revealed a pooled rate of 7% [95% CI: 0.04\u0026ndash;0.09] which exhibited acceptable performance just like the BIOSOLVE-IV registry (Haude et al., 2020) indicated TRL occurred between 5\u0026ndash;8% at 1\u0026ndash;2 years. The lower rate of clinically driven TLR (CD-TLR) amounted to 5% [95% CI: 0.03\u0026ndash;0.06] which revealed that revascularization procedures were rare in nature and did not require emergency intervention. The observed revascularization rates stand at a high level when compared to both historical DES implementations as well as early BRS platform implementations. The data from Ormiston et al. demonstrated a 10.1% TLR incidence in ABSORB patients at one year although Xience and similar modern DES systems maintained 5\u0026ndash;7% revascularization frequencies [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. All final results from patient follow-up indicate an 8% [95% CI: 0.04\u0026ndash;0.12] occurrence rate but substantial variability (I\u0026sup2; = 71%) can be explained by differences in study sizes and treatment difficulty and operator experience levels. The observed negative effects in studies that demonstrated higher risks were still below clinical thresholds and none of these evaluations linked scaffold failure or procedural death to Mg-BRS design [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. The research findings confirm the common opinion that new-generation Mg-BRS devices improve upon the restrictions found in previous polymer-based scaffolding platforms. These outcomes confirm that Mg-BRS provides clinical benefits beyond mechanical assistance by promoting native vessel healing and remodeling after complete scaffold resorption [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. The absence of a chronic footprint after Mg-BRS implantation benefits young patients as well as patients who may need bypass procedures in the future. One must proceed with caution based on these initial promising clinical research findings. The research lacks sufficient data to determine how long the results will last more than two to three years post-treatment. The patient selection criteria probably shaped the treatment results because most studies included lower-risk participants who had minimal or no bifurcation lesions and significant vessel calcification [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite the promising outcomes observed in this meta-analysis, several limitations should be acknowledged. First, the majority of included studies were observational or single-arm trials, lacking randomized control groups for direct comparison with other stent platforms such as DES. Second, the follow-up duration in most studies was limited to 12\u0026ndash;24 months, which restricts the assessment of very late events, including scaffold resorption-related complications or late target lesion failure. Third, heterogeneity in study design, patient populations, lesion characteristics, and procedural techniques such as variability in lesion preparation and post-dilation may have influenced outcomes. Additionally, several studies had small sample sizes, potentially exaggerating or underestimating the true event rates, and most excluded patients with complex lesions, limiting the generalizability to higher-risk CAD populations.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eCAD\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCoronary artery disease\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eCVS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCardiovascular stents\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDES\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDrug-eluting stents\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eBRS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBioresorbable scaffolds\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eMg-BRS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMagnesium-based bioresorbable scaffold\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eBVS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBioresorbable Vascular Scaffold\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDREAMS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDrug-eluting absorbable magnesium stent\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eRMS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eResorbable magnesium scaffolds\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eRCT\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRandomized controlled trial\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDoCE\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDevice-oriented Composite Endpoint\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003ePRISMA\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePreferred Reporting Items for Systematic Reviews and Meta-Analyses\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eMACE\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMajor adverse cardiac events\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eMI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMyocardial Infarction\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eTIMI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eThrombolysis in Myocardial Infarction\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eTVMI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTarget Vessel Myocardial Infarction\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eAHA\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eAmerican Heart Association\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eACC\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eAmerican college of cardiology\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDAPT\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDual antiplatelet therapy\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eTLF\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTarget lesion failure\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eT-TLF\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTotal target lesion failure\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eCD-TLF\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eClinically driven target lesion revascularization\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eROB1\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRisk of Bias 1\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eNOS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNewcastle Ottawa Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eTLR\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTarget Lesion Revascularization\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eT-TLR\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTotal Target Lesion Revascularization\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eCD-TLR\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eClinically Driven Target Lesion Revascularization\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eMRAW\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMean random effects weighted average\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003ePCI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePercutaneous coronary intervention\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eCI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eConfidence Interval\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eOCT\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eOptical Coherence Tomography\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eIVUS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eIntravascular Ultrasound\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding Disclosure:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone to declare\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHuman Ethics and Consent to participate\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;declarations:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eA.D: Topic selection and screeningI. Q, H.T,F.Y.S: Secondary screeningZ.T, Z.S: Data extractionM.R: Data analysis and synthesisA.D: Result interpretation and writingV.K.K: Quality AssessmentB.Q, G.K, A.A: Manuscript writingM.A: Study compilation\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWang S, Du C, Shen X, Wu X, Ouyang S, Tan J, et al. Rational design, synthesis and prospect of biodegradable magnesium alloy vascular stents. J Magnes Alloy. 2023;11(9):3012\u0026ndash;37. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jma.2023.07.020\u003c/span\u003e\u003cspan address=\"10.1016/j.jma.2023.07.020\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eASGE Technology Committee, Tokar JL, Banerjee S, Barth BA, Desilets DJ, Kaul V, et al. Drug-eluting/biodegradable stents. 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Front Cardiovasc Med. 2022;9:856930.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGalli S, Testa L, Montorsi P, Bedogni F, Pisano F. Twelve-month clinical outcomes of the Magmaris resorbable magnesium scaffold in complex lesions: insights from the IT-MASTERS registry. TCTMD. 2024 Oct 30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRola P, Janion-Sadowska A, Barycki M, W\u0026oacute;jcik J, Kulczycki J, W\u0026oacute;jcik K, et al. Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome: mid-term outcomes (2 years). Cardiol J. 2024;31(2):123\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eM\u0026uuml;ller M, Ludwig L, Englert H, Riedl KA, M\u0026uuml;ller MC, Hemkemeyer SA, et al. A novel stent flow chamber system demonstrates reduced thrombogenicity of bioresorbable magnesium scaffolds. Sci Rep. 2024;14(1):26691.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaude M, Wlodarczak A, van der Schaaf RJ, Torzewski J, Ferdinande B, Escaned J, et al. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study. EClinicalMedicine. 2023;59:101940.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 to 3 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-6767226/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6767226/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction:\u003c/h2\u003e \u003cp\u003eCoronary artery disease (CAD) is a major global health concern, often managed through percutaneous coronary intervention (PCI) with stent implantation. Metallic stents, such as bare-metal stents (BMS) and drug-eluting stents (DES), function by mechanically propping open the narrowed artery, preventing acute vessel closure and reducing restenosis. However, their permanent presence in the vessel wall can lead to long-term complications. Magnesium-based bioresorbable scaffolds have been developed as a temporary support that provide initial vessel reinforcement similar to metallic stents.\u003c/p\u003e\u003ch2\u003eMethods:\u003c/h2\u003e \u003cp\u003eThis analysis was registered under PROSPERO ID: 1018671. Primary outcomes were cardiac death, tTarget vessel myocardial infarction, Device-Oriented Composite Endpoint (DOCE), tTarget lesion failure and target lesion revascularization (T-TLF \u0026amp; CD-TLF); secondary outcomes included scaffold thrombosis, restenosis, change in balloon diameter and procedural success.\u003c/p\u003e\u003ch2\u003eResults:-\u003c/h2\u003e \u003cp\u003e This proportional meta-analysis followed PRISMA guidelines and included 16 studies (4 RCTs, 12 observational) up to 2025. Pooled analysis demonstrated a cardiac death rate of 0% (95% CI: 0.00\u0026ndash;0.00) and a target vessel myocardial infarction (TVMI) rate of 1% (95% CI: 0.01\u0026ndash;0.02). Target lesion failure (TLF) occurred in 6% of cases (95% CI: 0.06\u0026ndash;0.07), while device-oriented composite endpoint (DOCE) was observed in 9% (95% CI: 0.03\u0026ndash;0.14). Total target lesion revascularization (TLR) and clinically driven TLR (CD-TLR) were 7% (95% CI: 0.04\u0026ndash;0.09) and 5% (95% CI: 0.03\u0026ndash;0.06). Scaffold thrombosis was consistently 0% at 6, 12, and 24 months. Restenosis was reported in 8% of patients (95% CI: 0.04\u0026ndash;0.12), while procedural success was exceptionally high at 99% (95% CI: 0.99-1.00). The average increase in balloon diameter was 0.43 mm (95% CI: 0.27\u0026ndash;0.59).\u003c/p\u003e\u003ch2\u003eConclusion:-\u003c/h2\u003e \u003cp\u003eThis meta-analysis showed favorable safety outcomes, with a 1% rate of target vessel myocardial infarction (TV-MI) and 6% target lesion failure (TLF), consistent with previous DREAMS trials. Unlike earlier bioresorbable scaffolds like ABSORB, which had higher thrombosis rates, Mg-BRS showed 0% scaffold thrombosis and low revascularization needs, indicating improved degradation and endothelial healing. While Mg-BRS may outperform drug-eluting stents in some cases, study heterogeneity and limited long-term data require cautious interpretation and future randomized trials.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of Magnesium-Based Bioresorbable Scaffolds in All Coronary Artery Diseases: A Systematic Review and Proportional Meta-Analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-25 07:30:29","doi":"10.21203/rs.3.rs-6767226/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"4c6f4597-196d-4abb-b283-56be075aee88","owner":[],"postedDate":"June 25th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-25T07:30:29+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-25 07:30:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6767226","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6767226","identity":"rs-6767226","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}