STUDY DESIGN

Patients with adult congenital heart disease (ACHD) and atrial arrhythmia (AA) are constantly burdened with an elevated risk of stroke and other thromboembolic events.¹ Nevertheless, the current landscape of clinical data available on the use of non-vitamin K oral anticoagulants (NOACs) in this subgroup of patients remains imprecise and limited.¹ To better address this knowledge gap and in turn better understand the use of NOACs in these patients, the PROTECT-AR study was designed to evaluate the efficacy and safety of apixaban, one of the NOACs, in the population of ACHD patients with comorbid AA.¹

The clinical outcomes of 2 patient cohorts were evaluated and included and compared in this prospective, multicenter, observational study.¹ The two cohorts were apixaban-treated cohort (n=215) and the historical vitamin-K antagonist (VKA)-treated cohort (n=229) respectively.¹ Analysis was also conducted in a subgroup of patients on apixaban who had also recieved prior VKA treatment (n=73).¹ The apixaban cohort received treatment from 2019 to 2022, with a median follow-up of 28 months.¹ The historical VKA-treated cohort received treatment from 2002 to 2014, with a median follow-up of 48 months.¹ It was noted that the patients from the apixaban cohort were significantly older than the historical VKA-cohort with a median age of 51 vs. 42 years old (p<0.001).¹ They also had significantly higher incidences of diabetes mellitus, heart failure, and major or clinically relevant non-major bleeding events at baseline (p<0.001).¹

The primary efficacy endpoint was the composite incidence of stroke or thromboembolism in the two cohorts, while the safety endpoint compared the incidence of major bleeding.¹

FINDINGS

“In ACHD patients with AA treated with apixaban, the risk of major thromboembolic events and bleeding events are low and comparable to historical VKA clinical data” 

^{Dr. Anastasios Kartas
AHEPA General Hospital of Aristotle University,
Thessaloniki, Greece}