Safety and efficacy of non-vitamin K antagonist oral anticoagulants in adults with bioprosthetic pulmonary valve replacement for prevention of thromboembolic events: Mid-term results from the Note registry

Abstract

We aimed to evaluate the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) in adults with congenital heart disease (CHD) who underwent a pulmonary valve replacement (PVR). This is an international, multicenter, prospective study using data from the NOTE registry. All adults with a history of PVR taking NOACs constituted our study population. Follow-up took place at 6 months and yearly thereafter. The primary endpoint were thromboembolic (TE) events and major bleeding (MB). The secondary endpoint was minor bleeding. From January 2013 to June 2021, 29 patients (median age 52 years, interquartile range [43–58], 58% male) with a history of PVR (59% moderately and 31% severely complex CHD) on NOACs were included in the NOTE registry and constituted our study population. Atrial arrhythmia was the exclusive indication for anticoagulant therapy. During a median follow-up of 2 years (IQR 0.8–3.2), no patient experienced TE event. One MB (3.5%) which led to death and 6 minor bleedings (20.7%) occurred on NOACs alone ( Fig. 1 ). The annual incidence rate was 1.6% (95% CI 0.04 to 9.2%) for MB and 8.4% (96% CI 2.7 to 19.6%) for minor bleeding. The overall survival free from TE and MB was 100% and 87.5% respectively at 2.5 years of follow-up. Three invasive cardiac procedures, including 2 percutaneous PVR, were safely performed during the follow-up. On univariate analysis, increase in BLED score (HR 3.5; 95% CI 1.2–10.2, P = 0.02) and female gender (HR (male) 0.08; 95% CI 0.01–0.7; P = 0.02) were predictive factors of bleeding. This prospective study demonstrated excellent efficacy of NOACs at mid-term in patients with CHD and PVR, but suggested an increased risk of bleeding, particularly in women and patients with high BLED score.