Vitamin K antagonist therapy after transcatheter paravalvular leak closure was an independent predictor of major bleeding (OR 5.4).
Cohort (n=245)
No
What are the clinical outcomes associated with different antithrombotic regimens following transcatheter paravalvular leak closure?
Following transcatheter paravalvular leak closure, VKA-based regimens are the most common antithrombotic strategy and independently predict bleeding, with no apparent benefit from adding antiplatelet therapy.
Odds Ratio: 5.4
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.
Adamczyk-Filipek et al. (Tue,) conducted a cohort in Paravalvular leaks (n=245). Vitamin K antagonists (VKA) vs. Other antithrombotic regimens was evaluated on Ischemic events (stroke, peripheral embolism, or valve thrombosis), major bleeding (BARC ≥3), and all-cause mortality (OR 5.4). Vitamin K antagonist therapy after transcatheter paravalvular leak closure was an independent predictor of major bleeding (OR 5.4).