POPular PAUSE TAVI - Continuation or interruption of oral anticoagulation during TAVI?

Reported from ESC Congress 2024

Luis Ortega-Paz provides his take on the POPular PAUSE TAVI trial presented by Dirk Jan van Ginkel at the ESC Congress 2024 in London.

Study rationale and objective

The POPular PAUSE TAVI trial was designed as a non-inferiority study to resolve the ongoing question of whether to continue or interrupt oral anticoagulation (OAC) in patients undergoing transcatheter aortic valve implantation (TAVI).

Given that a significant proportion of TAVI patients require OAC due to conditions like atrial fibrillation, the trial aimed to identify the optimal management strategy that minimizes both thromboembolic and bleeding risks.

Methodology

The trial included 858 patients, randomized into two groups: one continued OAC during the TAVI procedure, and the other interrupted OAC.

The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, major vascular complications, and major bleeding within 30 days post-procedure.

Key findings

The trial found that the continuation of OAC was not non-inferior to interruption regarding the primary composite outcome (HR 1.12, 95 % CI -3.1 to 6.6; p non-inferiority = 0.18).

Bleeding complications were significantly higher in the continuation group (31.1 % vs. 21.3 %; HR 1.45, 95 % CI 1.15 to 1.84; p < 0.001), predominantly due to periprocedural bleeding.

Interestingly, thromboembolic events were similar between the continuation and interruption groups (8.8 % vs. 8.2 %; HR 1.07, 95 % CI 0.7 to 1.65; p = 0.75), questioning the assumed protective effect of continued OAC.

Analysis and commentary

The findings of the POPular PAUSE TAVI trial highlight the complexities in managing anticoagulation during TAVI. The observed increase in bleeding risk associated with continuing OAC raises concerns about its routine use, especially since no significant reduction in thromboembolic events was observed. The results suggest that, at least for the general population undergoing TAVI, interrupting OAC might be the safer approach, particularly in patients with high bleeding risk.

Future Research Perspective

While the POPular PAUSE TAVI trial provides critical insights, further studies are needed to establish whether one approach definitively offers better outcomes than the other.

Notably, future research could explore the role of newer anticoagulants and personalized anticoagulation strategies that better balance thromboembolic protection with bleeding risk. A superiority trial could be particularly useful to conclusively determine if one strategy outperforms the other in specific subgroups of patients.

In this context, the ongoing RHEIA trial (NCT04614986) is investigating similar questions, focusing on the safety and efficacy of anticoagulation management strategies in women undergoing TAVI. The main results of the study were presented at the ESC 2024 meeting, but secondary endpoints regarding anticoagulation regimens are still pending to be reported.

References

van Ginkel DJ, et al. Continuation versus Interruption of Oral Anticoagulation during TAVI. NEJM 2024; 1-12.
Nijenhuis VJ, et al. Anticoagulation with or without clopidogrel after TAVI. NEJM 2020; 382:1696-707.
Eltchaninoff H et al. Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial). Am Heart J. 2020;228:27-35. doi:10.1016/j.ahj.2020.06.016

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Author

Luis Ortega-Paz

@Ortega_Paz

Interventional cardiologist / Cardiologist

Jacksonville, United States of America

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