Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants |
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| Authors: | Miriam Brinkert Norman Mangner Noriaki Moriyama Lukas S. Keller Daniel Hagemeyer Lisa Crusius Dirk Lehnick Richard Kobza Mohamed Abdel-Wahab Mika Laine Stefan Stortecky Thomas Pilgrim Fabian Nietlispach Frank Ruschitzka Holger Thiele Axel Linke Stefan Toggweiler |
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| Affiliation: | 1. Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland;2. Heart Center Dresden, Technische Universität Dresden, Department of Internal Medicine and Cardiology, Dresden, Germany;3. Division of Cardiology of the Helsinki University Central Hospital, Helsinki, Finland;4. Department of Cardiology, University Hospital Zurich, Zurich, Switzerland;5. Department of Cardiology, University Hospital Bern, Bern, Switzerland;6. Clinical Trial Unit, Biostatistics and Methodology, University Lucerne, Lucerne, Switzerland;7. Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Department of Internal Medicine/Cardiology, Leipzig, Germany;8. CardioVascularCenter Zurich, Hirslanden Clinic im Park, Zurich, Switzerland |
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| Abstract: | ObjectivesThis study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural interruption of anticoagulation.BackgroundA significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown.MethodsConsecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality.ResultsOf 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 [13.7%] vs. 130 [17.7%]; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36).ConclusionsContinuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation. |
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