Philippe Garot1, MD; Antoinette Neylon1, MD; Marie-Claude Morice1, MD; Corrado Tamburino2, MD, PhD; Sabine Bleiziffer3, MD; Holger Thiele4, MD; Smita Scholtz5, MD; Rene Schramm3, MD, PhD; James Cockburn6, MD; Michael Cunnington7, MD; Alexander Wolf8, MD; Marco Barbanti9, MD; Didier Tchetché10, MD; Paolo Pagnotta11, MD; Martine Gilard12, MD; Francesco Bedogni13, MD; Eric Van Belle14, MD; Mariuca Vasa-Nicotera15, MD; Alaide Chieffo16, MD; Kris Bogaerts17, PhD; Christian Hengstenberg18, MD; Davide Capodanno2, MD, PhD
1. Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France; 2. Division of Cardiology Azienda Ospedaliero Universitaria "Policlinico‐Vittorio Emanuele" University of Catania, Catania, Italy; 3. Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhein-Westfalia, University Hospital, Ruhr-University Bochum, Bad Oeynhausen, Germany; 4. Department of Cardiology, Leipzig Heart Center, University of Leipzig, Leipzig, Germany; 5. Department of Interventional Cardiology, Heart and Diabetes Center North Rhine Westfalia, Bad Oeynhausen, Germany; 6. Department of Cardiology, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom; 7. Department of Cardiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; 8. Department of Interventional Cardiology, Elisabeth Hospital Essen, Essen, Germany; 9. Department of Cardio-Thoracic-Vascular diseases and transplantation, Azienda Ospedaliero-Universitaria Policlinico “G. Rodolico-San Marco”, Catania, Italy; 10. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France; 11. Department of Cardiovascular Medicine, Humanitas Clinical and Research Center, Milano, Italy; 12. Department of Cardiology, Brest University Hospital, Brest, France; 13. Cardiology Department, IRCCS Policlinico San Donato, Milano, Italy; 14. Department of Cardiology, Lille University Hospital, Lille, France; 15. Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany; 16. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; 17. KU Leuven, Faculty of Medicine, I-BioStat, Leuven, Belgium and UHasselt, I-BioStat, Hasselt, Belgium; 18. Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
Background: The Academic Research Consortium – High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding.
Aims: We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR).
Methods: Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR−) patients.
Results: Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: –2.72-6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications.
Conclusions: The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.
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