Antithrombotic therapy after percutaneous closure of paravalvular leaks: Patterns of use and clinical outcomes in a single-center retrospective registry.

BACKGROUND

Paravalvular leaks (PVLs) occur in 6%-30% of patients with prosthetic heart valves and may lead to heart failure or hemolytic anemia. Transcatheter PVL closure (tPVLc) is recommended for patients at high surgical risk; however, the optimal postprocedural antithrombotic regimen remains unclear.

AIMS: This study evaluated the outcomes associated with antiplatelet and anticoagulant therapy following tPVLc.

METHODS

This retrospective registry included 245 patients who underwent tPVLc between 2009 and 2023. Clinical and follow-up data were analyzed with a minimum follow-up of 6 months and a median follow-up of 24 months (interquartile range 9.5-40 months). Discharge pharmacotherapy included single antiplatelet therapy in 25 patients (10%), dual antiplatelet therapy in 14 (5.7%), direct oral anticoagulants in 9 (3.7%), vitamin K antagonists (VKA) in 160 (65.3%), and other regimens in 10 (4.1%). The primary endpoints were ischemic events (stroke, peripheral embolism, or valve thrombosis), major bleeding (Bleeding Academic Research Consortium [BARC] ≥3), and all-cause mortality.

RESULTS

During follow-up, 75% of patients received VKA therapy, either alone or in combination with antiplatelet agents. Bleeding events occurred in 11.8% of patients, while ischemic complications were observed in 9.4%. Estimated all-cause mortality (Kaplan-Meier) was 10% at 1 year and 17% at 2 years; over the entire follow-up, 49 patients (20%) died, including 12.2% from cardiovascular causes. VKA therapy was identified as an independent predictor of bleeding (odds ratio [OR], 5.4). Ischemic complications were only associated with higher CHA₂DS₂-VA scores (OR, 1.9 per 1 point). Age, New York Heart Association functional class, and bleeding events were predictors of mortality. Adding acetylsalicylic acid or dual antiplatelet therapy to VKA was not associated with a difference in bleeding risk or ischemic events.

CONCLUSIONS

VKA-based regimens were the dominant antithrombotic strategy after tPVLc and emerged as an independent predictor of bleeding. The numerical differences observed between VKA monotherapy and VKA combined with antiplatelet therapy should be regarded as hypothesis-generating. Prospective randomized comparisons are required.