Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2
Philippe Garot, Antoinette Neylon, Marie‐Claude Morice, Corrado Tamburino, Sabine Bleiziffer, Hölger Thiele, Smita Scholtz, René Schramm, James Cockburn, Michael S. Cunnington, Alexander Wolf, Marco Barbanti, Didier Tchétché, Paolo Pagnotta, Martine Gilard, Francesco Bedogni, Éric Van Belle, Mariuca Vasa‐Nicotera, Alaide Chieffo, Kris Bogaerts, Christian Hengstenberg, Davide Capodanno
Abstract
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 his-tory 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 to 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.