Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study

Hyeon Jong Yang ,T.C Konings,A Van Dijk,S Chakrabarti,Keri M Shafer ,Tabitha G Moe ,Markus Schwerzmann ,William R Davidson ,Paul Khairy ,Gertjan T Sieswerda ,Jonathan Buber ,Atsushi Mizuno ,Rafael Alonso-González ,Folkert J Meijboom ,Shane Tsai ,Alexander C Egbe ,Magalie Ladouceur ,Marielle Morissens ,Alexander R Opotowsky ,Lina Gumbienė ,Thomas Kronvall ,Marco C Post ,Jamil Aboulhosn ,Gary D Webb ,Koichiro Niwa ,Craig S Broberg ,Judith Bouchardy ,Magdalena Lipczyńska ,Werner Budts ,Giancarlo Scognamiglio ,Christina Christersson ,Tobias Rutz ,Kristofer Skoglund ,Matthias Greutmann ,Gruschen Veldtman ,Berto J Bouma ,Konstantinos Dimopoulos ,Monika Laukytė ,Daniel Tobler ,Barbara J.m Mulder

doi:10.1016/j.ijcard.2019.06.014

Abstract

BackgroundCurrent guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). MethodsAn international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). ResultsIn total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0–2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4–2.0] (n = 6) per year, with 1.1% [95%CI 0.5–2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5–8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80–93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). ConclusionsInitial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.

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