The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Drug-Coated Stents Versus Bare-Metal Stents in Academic Research Consortium-Defined High Bleeding Risk Patients

DOI: 10.4244/EIJ-D-20-00749

1. Duke Clinical Research Institute, Durham, NC, USA, United States
2. Hôpital de la Tour, Geneva, Switzerland
3. Biosensors Europe, Morges, Switzerland
4. Cardiovascular Department, Ferrarotto Hospital, University of Catania, and ETNA Foundation, Catania, Italy
5. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
6. Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada
7. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and the Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA
8. Division of Cardiology, Columbia University Medical Center, New York, New York, USA
9. Duke Clinical Research Institute, Durham, NC, USA; Duke University School of Medicine, Durham, NC, USA
10. Ramsay Générale de Santé - Institut Cardiovasculaire Paris Sud, Massy, France
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Aims: To model the safety and effectiveness of drug-coated stents (DCS) vs. bare-metal stents (BMS) in high bleeding risk (HBR) patients according to the Academic Research Criteria (ARC) criteria.

Methods and results: Participants from the LEADERS FREE (LF) and LEADERS FREE (LFII) studies were pooled into one dataset. Participants were treated with 30 days of DAPT. The primary safety (composite of cardiac death, myocardial infarction, or stent thrombosis) and effectiveness (target-lesion revascularization) endpoints were compared between DCS and BMS in the subgroup of patients satisfying the ARC-HBR definition using propensity-score modelling.
From the 3,635 participants included in the combined LF & LFII dataset, 2,898 (79.7%) satisfied 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%) vs. BMS (8.8%) (adjusted HR: 0.70; 95% CI: 0.52-0.94; p=0.016). Safety and effectiveness of DCS vs. BMS were consistent according to ARC-HBR status (p interaction = 0.206 and 0.260, respectively).

Conclusions: DCS are safer and more effective than BMS in an ARC-defined HBR population.

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