Long-Term Outcomes of Successful CTO PCI Using Antegrade and Retrograde Dissection and Re-entry Technique

Background There are always concerns regarding the durability of subintimal stenting after contemporary chronic total occlusion (CTO) recanalization.

This prospective, multicenter clinical trial aimed to compare extraplaque (EP) and intraplaque (IP) tracking for long-term clinical outcomes after CTO recanalization. After IVUS assessment of the wire crossing position, the patients were divided into two groups: (1) the EP group with subintimal length (SL) > 10 mm; and (2) the IP group with intraplaque or minor extraplaque (SL ≤ 10 mm). The primary endpoint was binary in-segment restenosis (ISR), and the secondary endpoint was the occurrence of major adverse cardiac events. Angiographic follow-up (FU) was scheduled at 13 months, and clinical FU was continued up to 3 years.

A total of 257 successful CTO patients were enrolled. The mean CTO length in the EP group was 46.6 ± 16.1 mm, and the median extraplaque length was approximately 24.5 mm. The J-CTO score was higher (p<0.001). Angiographic FU at 13 months showed that both groups had similar cumulative rates of ISR (p = 0.704). In the 3-year clinical follow-up, the cumulative incidence of target vessel revascularization (TVR) in both groups and across different tracking techniques showed no significant difference (p > 0.05). Independent predictors of ISR were a total stent length >50 mm and a wire crossing time >2 hours, while multivessel lesions showed an independent association with 3-year TVR.

The specific long extraplaque tracking had comparable angiographic and long-term clinical outcomes to intraplaque tracking, regardless of the crossing technique used. Competing Interest Statement The authors have declared no competing interest. Clinical Trial ClinicalTrials.gov (NCT03769038). Funding Statement Abbott Medical China funded the LOTUS-CTO study but did not provide the medications or coronary devices. Dr.Li Chengxiang has received speaker honoraria from Abbott Medical China. All other authors have reported that they have no relationships relevant to the content of this paper to disclose. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Have been approved by Xijing hospital ethics committee I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Pre-registered Clinical Trial Number This trial was registered on ClinicalTrials.gov (NCT03769038).