Direct oral anticoagulants in adults with congenital heart disease - a single centre study

Direct oral anticoagulants (DOACs) have been proven to be safe and effective in patients with acquired heart disease. However, data regarding their use in adults with congenital heart disease (ACHD) is scarce.

All ACHD under DOAC were retrospectively identified. Bleeding and thromboembolic events were registered. CHADS₂, CHA₂DS₂-VASc and HASBLED scores were calculated. Risk factors for bleeding and thromboembolic events were identified.

215 ACHD patients (111 female, 48.4 ± 15.5 years) were included. CHD was severe in 44.2%, moderate in 23.7%, and simple in 32.1%. Indications for anticoagulation were: atrial arrhythmias (66.8%), cerebrovascular accidents (32.7%), pulmonary thromboembolism (3.7%), deep vein thrombosis (11.2%), atrial thrombi (6.5%), and Fontan circulation/TCPC (5.6%). Mean follow-up was 15.8 ± 15.8 months. Nine patients suffered a major and eight a minor bleeding. Thromboembolic events occurred in two patients. The annual risk for bleeding was 3.1%/patient/year and for thromboembolic events 0.7%/patient/year. A CHADS₂-Score >2, HASBLED >3, and renal disease were identified as risk factors for bleeding (minor and major bleeding) in a univariate analysis. In the multivariate analysis, renal disease remained as an independent predictor for bleeding (HR 6.13, CI [1.04-36.27], p < 0.05). It was also the only risk factor for major bleedings (HR 13.75, CI [2.60-72.54], p = 0.002). Risk factors for thromboembolic events were not identified.

A low rate of thromboembolic events was observed in ACHD patients under DOAC therapy. Bleeding complications were not negligible. Special attention has to be paid to those patients with advanced renal failure.