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. 2024 Feb 12;17(3):405-418.
doi: 10.1016/j.jcin.2023.11.038.

Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement

Bashir Alaour  1 , Enrico Ferrari  2 , Dik Heg  3 , David Tueller  4 , Thomas Pilgrim  1 , Olivier Muller  5 , Stephane Noble  6 , Raban Jeger  7 , Oliver Reuthebuch  8 , Stefan Toggweiler  9 , Christian Templin  10 , Peter Wenaweser  11 , Fabian Nietlispach  12 , Maurizio Taramasso  13 , Christoph Huber  6 , Marco Roffi  6 , Stephan Windecker  1 , Stefan Stortecky  14
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Free article

Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement

Bashir Alaour et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Studies comparing long-term outcomes between non-vitamin K antagonist (VKA) oral anticoagulant agents (direct oral anticoagulant agents [DOACs]) and VKA anticoagulant agents after transcatheter aortic valve replacement (TAVR) are scarce, with conflicting results.

Objectives: The aim of this study was to examine the periprocedural, short-term, and long-term safety and effectiveness of DOACs vs VKAs in patients undergoing TAVR via femoral access with concomitant indications for oral anticoagulation.

Methods: Consecutive patients undergoing transfemoral TAVR in the prospective national SwissTAVI Registry between February 2011 and June 2021 were analyzed. Net clinical benefit (a composite of all-cause mortality, myocardial infarction, stroke, and life-threatening or major bleeding) and the primary safety endpoint (a composite of life-threatening and major bleeding) were compared between the VKA and DOAC groups at 30 days, 1 year, and 5 years after TAVR.

Results: After 1:1 propensity score matching, 1,454 patients were available for analysis in each group. There was no significant difference in the rate of the net clinical benefit and the safety endpoints between the groups as assessed at 30 days and 1 and 5 years post-TAVR between VKAs and DOACs. VKAs were associated with significantly higher rates of 1- year (HR: 1.28; 95% CI: 1.01-1.62) and 5-year (HR: 1.25; 95% CI: 1.11-1.40) all-cause mortality. Long-term risk for disabling stroke was significantly lower in the VKA group after excluding periprocedural events (HR: 0.64; 95% CI: 0.46-0.90).

Conclusions: At 5 years after TAVR, VKAs are associated with a higher risk for all-cause mortality, a lower risk for disabling stroke, and a similar rate of life-threatening or major bleeding compared with DOACs. (SwissTAVI Registry; NCT01368250).

Keywords: aortic valve stenosis; non–vitamin K antagonist oral anticoagulant; oral anticoagulation; transcatheter aortic valve replacement; vitamin K antagonist.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Heg is affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in the design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest, see http://www.ctu.unibe.ch/research/declaration_of_interest/index_eng.html. Dr Stortecky has received research grants to the institution from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific; and has received speaker fees from Boston Scientific. Dr Ferrari is a consultant for Edwards Lifesciences; has received research grants to the institution from Edwards Lifesciences and Medtronic; and has received speaker fees from Edwards Lifesciences. Dr Templin has received institutional grants from Abbott Vascular, Medtronic, and SMT; and has received consulting grants from Biotronik, MicroPort, and Innova. Dr Muller has received institutional research grants from Edwards Lifesciences; and has received honoraria from Edwards Lifesciences and Abbott Vascular. Dr Noble has received institutional research grants from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific; and is a consultant for Medtronic. Dr Roffi has received institutional research grants from Cordis, Medtronic, Biotronik, Terumo, and Boston Scientific. Dr Jeger has received grants to the institution from Abbott, Amgen, AstraZeneca, Bayer, B. Braun Melsungen, Biosense Webster, Biotronik, Boston Scientific, Bristol Myers Squibb, Cardionovum, Cordis, Daiichi Sankyo, Edwards Lifesciences, GE Medical Systems, MCM Medsys, Medtronic, Novartis, Pfizer, Terumo, and Vascular Medical. Dr Toggweiler serves as a consultant and proctor for Medtronic, Boston Scientific, Edwards Lifesciences, and Biosensors; serves as a proctor for Edwards Lifesciences and Abbott Vascular; serves as a consultant for Medira, Shockwave Medical, Teleflex, atHeart Medical, Cardiac Dimensions, and Polares Medical; has received institutional research grants from Boston Scientific, Fumedica, and Novartis; has received speaker honoraria from Sanofi, AstraZeneca, ReCor Medical, and Daiichi Sankyo; and holds equity in Hi-D Imaging. Dr Pilgrim has received research, travel, or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; and has received speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Dr Wenaweser is a proctor for Edwards Lifesciences and Medtronic. Dr Nietlispach is a consultant for Edwards Lifesciences and Abbott. Dr Taramasso is a consultant for or has received consultancy fees from Abbott, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, MEDIRA, CoreMedic, Pi-Cardia, VentriMend, CardioValve, CoreQuest, and Hi-D Imaging. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse, Fumedica, Guerbet, Idorsia, Inari Medical, Infraredx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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