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

Ran Kornowski, Maayan Konigstein, Michael Jonas, Abid Assali, Hana Vaknin-Assa, Amit Segev, Haim Danenberg, Majdi Halabi, Ariel Roguin, Arthur Kerner, Eli Lev, Grigoris V. Karamasis, Thomas W. Johnson, Richard Anderson, Jonathan Blaxill, Sachin Jadhav, Stephen Hoole, Guy Witberg, Melek Ozgu Issever, Ori Ben-YehudaAndreas Baumbach

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: 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. METHODS AND RESULTS: 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% (P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

Original languageEnglish
Article numbere029051
JournalJournal of the American Heart Association
Volume13
Issue number2
DOIs
StatePublished - 16 Jan 2024
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2024 The Authors.

Keywords

  • antithrombotic therapy
  • coronary artery disease
  • high bleeding risk
  • percutaneous coronary intervention

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