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

ABSTRACT 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 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 . 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.