Objective After transcatheter aortic valve implantation (TAVI), the optimal regimen of anticoagulant therapy in patients with an additional indication for oral anticoagulation remains a matter of debate. This study investigates the efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients after TAVI in a real-world population.
Methods The German Aortic Valve RegistrY (GARY) is a prospective, multicentre registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 1 41 790 patients from 92 hospitals in Germany were enrolled. Anticoagulatory treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint ‘cardiac and cerebrovascular events’ containing myocardial infarction, stroke, transient ischaemic attack, aortic prosthesis reintervention and all-cause mortality in the first year after TAVI were examined by treatment regimen.
Results Of 45 598 patients (mean age 80.7±5.7 years, 49.3% males) undergoing TAVI, 16 974 patients (37.2%) received an anticoagulant regimen that included VKA or DOAC. Hereof, the majority of patients were prescribed VKA (n=11 333, 66.8%) compared with DOAC (n=5641, 33.2%) with an increase of DOAC use from 9.4% in 2011 to 69.9% in 2019. During the 1-year follow-up, the absolute event rates per 100 person-years for all-cause mortality and the combined endpoint cardiac and cerebrovascular events were 1.9 and 1.3 for VKA-treated and 1.7 and 1.2 for DOAC-treated patients, respectively. After adjustment for baseline confounders, all-cause mortality (HR 0.95, 95% CI 0.88 to 1.01, p=0.114) and cardiac and cerebrovascular event-free survival (HR 0.93, 95% CI 0.86 to 1.01, p=0.071) did not differ significantly between VKA and DOAC groups.
Conclusions This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation.
- heart valve prosthesis
- transcatheter aortic valve replacement
Data availability statement
All data relevant to the study are included in the article or uploaded as supplementary information. Data of this study may not be available because of the ongoing projects using these data.
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Presented at Parts of the results of this work were presented at the 89th Annual Meeting of the German Cardiac Society (DGK) in Mannheim, Germany, in April 2023.
Contributors CH and RP conceived the idea of this study and formulated the study design. EH and ÜB performed the statistical analysis. CH, RP, CF and AB supervised the analysis. CH drafted the manuscript. All authors critically reviewed the manuscript and approved the final draft. CH, CF and AB accept full responsibility for the work and the conduct of the study, have access to the data and control the decision to publish. CH as the guarantor accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
Funding The German Aortic Valve RegistrY is supported by the DGK and DGTHG and receives unrestricted grants by medical device companies, the German Heart Foundation and the German Centre for Cardiovascular Research (DZHK).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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