Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk

• Published in: Journal of the American Heart Association 2024-01, Vol.13 (2), p.e029051
• Main Authors: Kornowski, Ran, Konigstein, Maayan, Jonas, Michael, Assali, Abid, Vaknin-Assa, Hana, Segev, Amit, Danenberg, Haim, Halabi, Majdi, Roguin, Ariel, Kerner, Arthur, Lev, Eli, Karamasis, Grigoris V, Johnson, Thomas W, Anderson, Richard, Blaxill, Jonathan, Jadhav, Sachin, Hoole, Stephen, Witberg, Guy, Issever, Melek Ozgu, Ben-Yehuda, Ori, Baumbach, Andreas
• Format: Article
• Language: English
• Subjects: Acute Coronary Syndrome - drug therapy; antithrombotic therapy; coronary artery disease; Coronary Artery Disease - drug therapy; Drug Therapy, Combination; Drug-Eluting Stents; Hemorrhage - chemically induced; high bleeding risk; Humans; Original Research; percutaneous coronary intervention; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - methods; Platelet Aggregation Inhibitors - therapeutic use; Prospective Studies; Sirolimus - analogs & derivatives; Stents; Thrombosis - etiology; Treatment Outcome
• ISSN: 2047-9980; 2047-9980
• DOI: 10.1161/JAHA.122.029051

Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR. This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (