Drug-coated stents versus bare metal stents in Academic Research Consortium-defined high bleeding risk patients

Guillaume Marquis-Gravel, Philip Urban, Samuel Copt, Davide Capodanno, Stuart J. Pocock, Sara Sadozai Slama, Hans Peter Stoll, Jean François Tanguay, Roxana Mehran, Martin B. Leon, Sunil V. Rao, Marie Claude Morice, Mitchell W. Krucoff

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Background: More effective and progressively safer generations of drug-eluting stents (DES) have replaced bare metal stents (BMS) in routine clinical practice. However, patients considered to be at high bleeding risk (HBR) have traditionally been underrepresented in pivotal DES trials. Aims: The aim of this study was to model the safety and effectiveness of drug-coated stents (DCS) versus BMS in HBR patients according to the Academic Research Consortium (ARC) criteria. Methods: Participants from the LEADERS FREE (LF) and LEADERS FREE II (LFII) studies were pooled into one data set. Participants were treated with 30 days of DAPT. The primary safety (composite of cardiac death, myocardial infarction, or stent thrombosis) and effectiveness (target lesion revascularisation) endpoints were compared between DCS and BMS in the subgroup of patients satisfying the ARC-HBR definition using propensity-score modelling. Results: From the 3,635 participants included in the combined LF and LFII data set, 2,898 (79.7%) satis fied the ARC-HBR criteria (DCS: 1,923 ; BMS: 975). The primary safety endpoint occurred in 184 (9.8%) and in 132 (13.8%) participants in the DCS and BMS groups, respectively (adjusted HR 0.72, 95% CI: 0.57-0.91 ; p=0.006). The risk of the primary effectiveness endpoint was also significantly lower with DCS (6.2%) versus BMS (8.8%) (adjusted HR 0.70, 95% CI: 0.52-0.94 ; p=0.016). The safety and effectiveness of DCS versus BMS were consistent according to ARC-HBR status (p for interaction=0.206 and 0.260, respectively). Conclusions: DCS are safer and more effective than BMS in an ARC-defined HBR population Europa Digital & Publishing 2021. All rights reserved.

Original languageEnglish
Pages (from-to)240-247
Number of pages8
Issue number3
StatePublished - Jun 2021


  • Bare metal stents
  • Bleeding
  • Clinical research
  • Drug-eluting stents


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