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Title: | Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2 | Authors: | Garot, Philippe Neylon, Antoinette Morice, Marie -Claude Tamburino, Corrado Bleiziffer, Sabine Thiele, Holger Scholtz, Smita Schramm, Rene Cockburn, James Cunnington, Michael Wolf, Alexander Barbanti, Marco Tchetche, Didier Pagnotta, Paolo Gilard, Martine Bedogni, Francesco Van Belle, Eric Vasa-Nicotera, Mauca Chieffo, Alaide BOGAERTS, Kris Hengstenberg, Christian Capodanno, Davide |
Issue Date: | 2022 | Publisher: | EUROPA EDITION | Source: | EuroIntervention, 18 (6) , p. 503 -+ | 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. | Notes: | Garot, P (corresponding author), Hop Jacques Cartier, Inst Cardiovasc Paris Sud, 6 Ave Noyer Lambert, F-91300 Massy, France. pgarot@angio-icps.com |
Keywords: | bleeding;TAVR | Document URI: | http://hdl.handle.net/1942/38903 | ISSN: | 1774-024X | e-ISSN: | 1969-6213 | DOI: | 10.4244/EIJ-D-21-01048 | ISI #: | 000877728200011 | Rights: | Europa Digital & Publishing 2022. All rights reserved | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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bleeding-risk-differences-after-tavr-according-to-the-arc-hbr-criteria-insights-.pdf Restricted Access | Published version | 628.96 kB | Adobe PDF | View/Open Request a copy |
BleedingRiskDifference-Submitted version.pdf Restricted Access | Peer-reviewed author version | 479.08 kB | Adobe PDF | View/Open Request a copy |
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