Author + information
- Received October 29, 2018
- Revision received March 5, 2019
- Accepted March 6, 2019
- Published online June 12, 2019.
- David Jochheim, MDa,b,
- Marco Barbanti, MDc,
- Giuliana Capretti, MDd,
- Giulio G. Stefanini, MDe,
- Alexander Hapfelmeier, MDf,
- Magda Zadrozny, MDa,
- Moritz Baquet, MDa,b,
- Julius Fischer, MDa,
- Hans Theiss, MDa,
- Denise Todaro, MDc,
- Alaide Chieffo, MDd,
- Patrizia Presbitero, MDe,
- Antonio Colombo, MDd,
- Steffen Massberg, MDa,b,
- Corrado Tamburino, MDc and
- Julinda Mehilli, MDa,b,∗ ()
- aDepartment of Cardiology, Munich University Clinic, Ludwig-Maximilians University, Munich, Germany
- bGerman Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany
- cDepartment of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy
- dDepartment of Cardiology, Università Vita-Salute San Raffaele, Milano, Italy
- eDepartment of Cardiology, Istituto Clinico Humanitas, Rozzano, Italy
- fInstitute of Medical Informatics, Statistics and Epidemiology, Technical University Munich, Munich, Germany
- ↵∗Address for correspondence:
Dr. Julinda Mehilli, Department of Cardiology, Munich University Clinic, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich Germany.
Objectives The purpose of the study was to investigate the impact of oral anticoagulation (OAC) type on clinical outcomes 1 year after transcatheter aortic valve replacement (TAVR).
Background Non–vitamin K oral anticoagulant (NOACs) are superior to vitamin K antagonists (VKAs) in nonvalvular atrial fibrillation (AF), while their comparative performance among patients in need of OAC undergoing TAVR is underinvestigated.
Methods The study enrolled 962 consecutive patients who underwent TAVR in 4 tertiary European centers and were discharged on either NOACs (n = 326) or VKAs (n = 636). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding.
Results Mean age and Society of Thoracic Surgeons score of the population were 81.3 ± 6.3 years and 4.5% (interquartile range: 3.0% to 7.3%); 52.5% were women and a balloon-expandable valve was used in 62.7% of cases. The primary outcome of interest, combined incidence of all-cause mortality, myocardial infarction, and any cerebrovascular event at 1-year after TAVR, was 21.2% with NOACs versus 15.0% with VKAs (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.00 to 2.07; p = 0.050, IPTW-adjusted). The 1-year incidence of any Bleeding Academic Research Consortium bleeds and all-cause mortality were comparable between the NOAC and VKA groups, 33.9% versus 34.1% (HR, 0.97; 95% CI, 0.74 to 1.26; p = 0.838, IPTW-adjusted) and 16.5% versus 12.2% (HR, 1.36; 95% CI, 0.90 to 2.06; p = 0.136, IPTW-adjusted), respectively.
Conclusions Chronic use of both NOACs and VKAs among patients in need of OAC after TAVR are comparable regarding 1-year bleeding risk. The higher ischemic event rate observed with NOACs needs to be evaluated in large randomized trials.
The registry was partially funded by the Munich Heart Alliance partner site of the German Centre for Cardiovascular Research. Dr. Barabanti has served as a consultant for Edwards Lifesciences; and an advisory board member for Biotronik and Medtronic. Dr. Stefanini has received institutional research grants from Boston Scientific; and lecture fees from B. Braun, Biosensors, and Boston Scientific. Dr. Baquet has served as a consultant for Edwards Lifesciences, Biotronik, and Medtronic. Dr. Mehilli has received lecture fees from Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Bristol-Myers Squibb, and Terumo; and institutional research grants from Edwards Lifesciences, Boston Scientific, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 29, 2018.
- Revision received March 5, 2019.
- Accepted March 6, 2019.
- 2019 American College of Cardiology Foundation
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