Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants

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

Tutkimustuotos: ArtikkelijulkaisuArtikkeliTieteellinenvertaisarvioitu

Abstrakti

Objectives: This 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. Background: A significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown. Methods: Consecutive 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. Results: Of 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). Conclusions: Continuation 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.

Alkuperäiskielienglanti
LehtiJACC: Cardiovascular Interventions
Vuosikerta14
Numero2
Sivut135-144
Sivumäärä10
ISSN1936-8798
DOI - pysyväislinkit
TilaJulkaistu - 25 tammik. 2021
OKM-julkaisutyyppiA1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä, vertaisarvioitu

Lisätietoja

Funding Information:
Dr. Mangner has received speaker honoraria from Edwards Lifesciences, Medtronic, Novartis, Sanofi Genzyme, and AstraZeneca; and has received consultant honoraria from Biotronik, outside the submitted work. Dr. Kobza has received institutional grants from Abbott Vascular, Boston Scientific, Biosense Webster, Biotronik, Medtronic, and Sis-Medical. Dr. Linke has received institutional grants from Novartis; and has received personal fees from Medtronic, Abbott Vascular, Edwards Lifesciences, Boston Scientific, AstraZeneca, Novartis, and Pfizer. Dr. Stortecky has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; and has been a consultant for Boston Scientific, BTG, and Teleflex. Dr. Nietlispach has been a consultant for Edwards Lifesciences and Abbott Vascular. Dr. Pilgrim has received institutional research grants from Edwards Lifesciences, Biotronik, and Boston Scientific; and has received personal fees from Biotronik and Boston Scientific. Dr. Toggweiler has been a proctor for Boston Scientific, Medtronic, Biosensors/New Valve Technology, and Abbott Vascular; has been a consultant for Carag, Medira, Boston Scientific, Medtronic, Biosensors/New Valve Technology, and Abbott Vascular; has received institutional research grants from Boston Scientific and Fumedica; and holds equity in Hi-D Imaging. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Publisher Copyright:
© 2021 American College of Cardiology Foundation

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