Rivaroxaban for patients with coronary dissection after drug-coated balloon angioplasty : A Randomized Controlled Trial

Background?After drug-coated balloon (DCB) angioplasty in patients with de novo coronary lesions, coronary dissections can result in the continuous presence of thrombi within the vessel wall, potentially leading to late luminal loss. Rivaroxaban, a novel oral anticoagulant, may mitigate lumen loss attributable to coronary dissection. Objectives: This study was conducted to evaluate the effectiveness and safety of low-dose rivaroxaban in improving outcomes for patients with residual dissections following DCB intervention. Methods: This trial was a prospective, randomized, controlled study including patients with acute coronary syndrome (ACS) who exhibited non-flow-limiting dissections after DCB angioplasty for de novo coronary lesions. The rivaroxaban group received a standard dual antiplatelet therapy (DAPT) regimen along with 2.5 mg of rivaroxaban twice daily for one month, reverting to DAPT thereafter. The control group was treated with standard DAPT for 6 months. All patients underwent coronary angiography at the 6-month mark. The primary endpoint involved late lumen loss in the target vessel at 6 months, and the primary safety endpoint consisted of bleeding events, as classified according to BARC criteria (types 1-3 or 5). This study has been registered with ClinicalTrials.gov, number [NCT05750758][1]. Results?Out of 140 randomized patients, 137 (69 in the rivaroxaban group, 68 in the control group) completed the study. Low-dose rivaroxaban was associated with a significant reduction in late lumen loss compared to controls (-0.12 ± 0.56 mm versus 0.14 ± 0.37 mm, P = 0.002). The rivaroxaban group experienced more minor bleeding events (BARC 1-2), though this was not statistically significant (P = 0.059). Clinical outcomes were similar between groups (P = 0.354). Conclusions?This study demonstrates that the combination of rivaroxaban with dual antiplatelet therapy shows promise in reducing stenosis and enhancing late lumen expansion in lesions with dissections post-DCB intervention, while not escalating the risk of major bleeding. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05750758 ### Funding Statement This work was supported by National Key Research and Development Program of China (2022YFC3602400,2022YFC3602404) , Henan Medical Science and Technology Public Relations Joint Construction Project (LHGJ20220108), National Natural Science Foundation of China (82270474). The funding source did not influence any part of the submitted work, including the study design, collection, analysis, interpretation of data, the writing of the article, or decision to submit for publication. ### 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: The trial was approved by the New Business and Technology Ethics Committee of Fuwai Central China Cardiovascular Hospital, Zhengzhou University (Zhengzhou, China). 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 The data are not publicly available due to their containing information that could compromise the privacy of research participants. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05750758&atom=%2Fmedrxiv%2Fearly%2F2024%2F01%2F07%2F2024.01.04.24300877.atom