Coronary interventions - Mini focus on drug-eluting stents

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

EuroIntervention 2021;17:240-247. DOI: 10.4244/EIJ-D-20-00749

Guillaume Marquis-Gravel
Guillaume Marquis-Gravel1, MD, MSc; Philip Urban2, MD; Samuel Copt3, PhD; Davide Capodanno4, MD; Stuart J. Pocock5, PhD; Sara Sadozai Slama3, MSc, MEng; Hans-Peter Stoll3, MD; Jean-François Tanguay6, MD; Roxana Mehran7, MD; Martin B. Leon8, MD; Sunil V. Rao1,9, MD; Marie-Claude Morice10, MD; Mitchell W. Krucoff1,9, MD
1. Duke Clinical Research Institute, Durham, NC, USA; 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, QC, 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, NY, USA; 8. Division of Cardiology, Columbia University Medical Center, New York, NY, USA; 9. Duke University School of Medicine, Durham, NC, USA; 10. Ramsay Générale de Santé - Institut Cardiovasculaire Paris Sud, Massy, France

Background: More effective and progressively safer generations of drug-elut-ing stents (DES) have replaced bare metal stents (BMS) in rou-tine 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%) 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%) 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.

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bare metal stentsbleedingclinical researchdrug-eluting stents
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