Non-vitamin K Antagonist Oral Anticoagulants in Adult Congenital Heart Disease: A Single Center Study

Abstract

Purpose: Non-vitamin K antagonist anticoagulants (NOACs) prescription is increasing in adults with congenital heart disease (ACHD), however data on efficacy and safety in ACHD is unclear, particularly in patients (P) with complex CHD. The aim of the study was to review the safety and efficacy of in various types of ACHD.Methods: Evaluation of ACHD P started on NOAC therapy from 2014 to 2020, followed-up for bleeding or thromboembolic events (TE) and mortality. CHA2DS2-VASc and HASBLED scores were calculated and risk factors for bleeding were identified.Results: 93 ACHD P, mean age 52±15 years, 58% female, 55.9% moderate CHD and 23.7% with severe CHD (3.2% Fontan). 66% of P had a CHA2DS2-VASc score ≥2 and 82% HASBLED score ≤2.In a mean follow-up of 41±21 months (400.4 patient-years), there were TE in 2P (1 splenic infarction and 1 pulmonary embolism). The annual risk for TE was 0.49%/patient/year. The cardiovascular mortality was 2% and all-cause mortality 5%, however with no relation to TE or bleeding events.6 P (6.5%) suffered a minor and 3 P (3.2%) suffered a major bleeding, a median time of 12 (IQR 15) months after starting NOAC therapy. The annual risk for bleeding was 2.2%/patient/year.Renal disease (HR 14.6 [95% CI 1.23-73.6], p=0.033 and the HAS-BLED score were predictors of major (adjusted HR 6.97 [95% CI 1.69-28.78], p=0.007) and minor (adjusted HR 3.80 [95% CI 1.48-9.78], p=0.006) bleeding complications.Conclusion: NOACs are a safe and effective option for selected ACHD P, although bleeding complications were not negligible