NOACs in Adults With Congenital Heart Disease

Abstract and Introduction

Introduction

Non-vitamin K oral anticoagulants (NOACs) are more effective, cause less intracranial bleeding, and are more convenient than vitamin K antagonists (VKAs). The evidence is consistent and convincing at least for patients with non-valvular atrial fibrillation at risk for stroke and systemic embolism, and for patients who have suffered a deep vein thrombosis or pulmonary embolism and are at risk for recurrent events.^[1,2] However, the validity of these improved outcomes is questioned for adults with congenital heart disease (ACHD) in an analysis of a large German claims database published in this issue of the European Heart Journal.^[3] In this database that included >44 000 patients with ACHD, the proportion of anticoagulated patients who received NOACs steadily accrued up to 45% in 2018. Clinical outcomes of 6504 patients with a first prescription for an NOAC (n = 1653) or a VKA (4851) between 2010 and 2016 were analysed. Median follow-up was 90 months. Of concern, there was an excess mortality and there were more thrombo-embolic episodes, more major cardiovascular events, and more bleedings in ACHD patients treated with NOACs compared with VKAs. Even after adjustment, the excess mortality, major cardiovascular events, and bleedings (but not major or intracranial bleedings) persisted (Figure 1).

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Figure 1.

Differential outcomes with NOACs vs. VKAs. MACE, major adverse cardiovascular event; NOAC, non-vitamin K oral antagonist; RCT, randomized clinical trial; RR, relative risk; VKA, vitamin K antagonist. *The analysis of the high-dose NOACs is presented1; **calculated from Cerdà et al.⁶