https://doi.org/10.1007/s00392-025-02625-4
1Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 2Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland; 3Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie Mainz, Deutschland; 4Universitätsklinikum Köln Klinik für Herzchirurgie, herzchirurgische Intensivmedizin und Thoraxchirurgie Köln, Deutschland; 5Barmer Institut für Gesundheitssystemforschung Berlin, Deutschland; 6Universitätsklinikum Köln Klinik III für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland
Background: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) procedures are increasingly used. Specific recommendations on antithrombotic strategies following ViV-TAVR are lacking.
Methods: We performed a retrospective analysis of German Statutory Health Claims data on patients undergoing ViV-TAVR stratified by antithrombotic strategies according to prescription within the first 90 days. Antithrombotic therapy included antiplatelet therapy (APT), direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). The composite endpoint was all-cause mortality, stroke and/or systemic embolism (SSE) and mechanical complication of heart valve prosthesis at 12 months. The safety endpoint was extra-, intracranial and gastrointestinal bleeding. Cox proportional hazard regression models were used to compare outcomes.
Results: In total, 908 patients with ViV-TAVR between 2005 and 2022 were identified. Of these, 286 received DOACs, 99 received VKAs, 351 received APT exclusively and 172 had no prescription for antithrombotic therapy. The rate of atrial fibrillation or flutter was 42.7 in the APT group, 88.1% in the DOAC group and 80.8% in the VKA group. The incidence of the composite endpoint was 20.8% in the APT group, 20.3% in the DOAC group and 25.3% in the VKA group. There was no statistically significant difference in the composite endpoint and the safety endpoint between groups in both the univariable and multivariable analyses respectively (Figure 1A; APT vs DOAC: univariable HR 0.98, 95% CI [0.69, 1.38], p=0.9; APT vs. VKA: univariable HR 1.24, 95% CI [0.79, 1.96], p= 0.4; DOAC vs. VKA: univariable HR 1.27, 95% CI [0.79, 2.03], p=0.3). There was also no statistically significant difference when comparing outcomes of DOACs to VKAs and APT in patients without an indication for oral anticoagulation (Figure 1B) or with an indication for oral anticoagulation (Figure 1C). Extra-, intracranial and gastrointestinal bleeding was not statistically different between groups. The rate of SSE in the acetylsalicylic acid (ASA) mono group was higher compared to the dual antiplatelet therapy group (27.3% vs. 12.4%, univariable HR 0.42, 95% CI [0.19, 0.95], p=0.03).
Conclusion: In this analysis of real-world German claims data, antithrombotic strategies and durations varied widely following ViV-TAVR. DOACs seemed to be a safe alternative to VKAs and APT both in patients with and without an indication for oral anticoagulation. ASA monotherapy was associated with higher rates of SSE compared to dual antiplatelet therapy. Given the high risk of bias of this retrospective analysis and the growing use of valve-in-valve procedures, randomized controlled trials are needed to confirm these findings. The high rate of patients with atrial fibrillation that were treated with antiplatelets exclusively stands in contrast to current guideline recommendations and warrants further investigation.