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. 2021 Jun 25;17(3):240-247.
doi: 10.4244/EIJ-D-20-00749.

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

Guillaume Marquis-Gravel  1 , 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
Affiliations

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

Guillaume Marquis-Gravel et al. EuroIntervention. .

Abstract

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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Conflict of interest statement

G. Marquis-Gravel declares personal fees from Novartis, Servier, JAMP Pharma, Amgen, Alliance BMS-Pfizer, Canadian Heart Research Center (outside the submitted work); and research funding from Bayer, Duke Clinical Research Institute, Université de Montréal, Montreal Heart Institute Foundation, Fonds de Recherche du Québec - Santé (FRQS), and the Canadian Institutes of Health Research (CIHR). P. Urban reports personal fees from Biosensors and Edwards Lifesciences, outside the submitted work, and other from CERC and MedAlliance. S. Copt, S.S. Slama, and H.P. Stoll are full-time paid employees of Biosensors. D. Capodanno and S.J. Pocock report personal fees from Biosensors (outside the submitted work). J.F. Tanguay reports grants from the Duke Clinical Research Institute during the conduct of the study, grants and other from Abbott Vascular, Bayer, and Biosensors, other from BMS-Pfizer Alliance, and grants and other from Novartis outside the submitted work. R. Mehran reports grants, personal fees and other from Abbott Laboratories, grants and other from Abiomed and Bristol-Myers Squibb, grants and personal fees from Chiesi, grants from Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, CERC, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich, other from Merck, The Medicines Company, Spectranetics/Philips/Volcano Corp, Watermark Research Partners, Claret Medical, and Elixir Medical, personal fees from Boston Scientific, CardiaWave, Janssen Scientific Affairs, Medscape/WebMD, Roivant Services, Sanofi, Siemens Medical Solutions, Medtelligence (Janssen Scientific Affairs), ACC, and AMA, outside the submitted work, and non-financial support and other from Idorsia Pharmaceuticals Ltd., and Regeneron Pharmaceuticals. M.C. Morice is a shareholder and the CEO of CERC, one of the contract research organisations conducting LF and LFII. M.W. Krucoff reports grants and personal fees from Biosensors (during the conduct of the study), and from Abbott Vascular, Medtronic, OrbusNeich, Terumo, and Cordis/Johnson & Johnson (outside the submitted work). The other authors have no conflicts of interest to declare. The Guest Editor reports lecture fees paid to his institution from Amgen, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, and Novartis, consultancy fees paid to his institution from Boehringer Ingelheim, and grant support from Bayer Healthcare, Boston Scientific, Biotronik, Edwards Lifesciences, GlaxoSmithKline, Medtronic, and Pfizer.

Figures

Figure 1
Figure 1
Study flow chart. ARC-HBR: Academic Research Consortium High Bleeding Risk; BMS: bare metal stent; DAPT: dual antiplatelet therapy; DCS: drug-coated stent; eGFR: estimated glomerular filtration rate; LF: LEADERS FREE; NSAIDs: non-steroidal anti-inflammatory drugs; PCI: percutaneous coronary intervention
Figure 2
Figure 2
Distribution of ARC-HBR criteria in the pooled LEADERS FREE and LEADERS FREE II studies. ARC-HBR: Academic Research Consortium High Bleeding Risk; BMS: bare metal stent; CKD: chronic kidney disease; DAPT: dual antiplatelet therapy; DCS: drug-coated stent; eGFR: estimated glomerular filtration rate; ICH: intracranial haemorrhage; LF: LEADERS FREE; NSAIDs: non-steroidal anti-inflammatory drugs
Figure 3
Figure 3
Adjusted Kaplan-Meier analysis of the primary safety endpoint according to stent type for the ARC-HBR subset of the combined LEADERS FREE and LEADERS FREE II studies. BMS: bare metal stent; DCS: drug-coated stent
Figure 4
Figure 4
Adjusted Kaplan-Meier analysis of BARC 3-5 bleeding according to ARC-HBR status in the combined LEADERS FREE and LEADERS FREE II studies. ARC-HBR: Academic Research Consortium High Bleeding Risk
Figure 5
Figure 5
BARC 3-5 bleeding events at one year according to ARC-HBR categories. ARC-HBR: Academic Research Consortium High Bleeding Risk
See this image and copyright information in PMC

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