Adults with congenital heart disease (ACHD) and atrial arrhythmias (AA) face an increased risk of thromboembolic events. Limited data exist on the use of non-vitamin K oral anticoagulants for thromboprophylaxis in ACHD. We aimed to assess the effectiveness and safety of apixaban in ACHD patients with AA. PROTECT-AR (NCT03854149) was a prospective, multicenter, observational study conducted from 2019 to 2023. ACHD patients with atrial fibrillation, atrial flutter, or intra-atrial re-entrant tachycardia on routine apixaban treatment were included. The historical control group consisted of patients previously on vitamin K antagonist (VKA), who were analyzed prior to their transition to apixaban. The primary effectiveness endpoint was the composite of stroke or thromboembolism. The primary safety endpoint was major bleeding. The study enrolled 218 ACHD patients with AA on apixaban, of which 73 were previous VKA users. The analysis covered 527 patient-years of prospective exposure to apixaban and 169 patient-years of retrospective exposure to VKA. The annualized rate of stroke or thromboembolism was 0.6% in the apixaban group and 1.8% in the VKA group (absolute difference − 1.2%; upper limit of one-sided 95% confidence interval [CI] 0.9%, lower than the predefined non-inferiority margin of +1.8%, < 0.001). The annualized rate of major bleeding was 1.5% in the apixaban group and 2.4% in the VKA group (hazard ratio 0.64; 95% CI 0.19–2.10, = 0.48). In ACHD patients with AA, routine apixaban use exhibited a non-inferior rate of stroke or thromboembolism compared to historical VKA use, alongside a similar rate of major bleeding.

中文翻译：

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阿哌沙班在成人先天性心脏病和房性心律失常中的应用：PROTECT-AR 研究

患有先天性心脏病 (ACHD) 和房性心律失常 (AA) 的成年人发生血栓栓塞事件的风险增加。关于使用非维生素 K 口服抗凝剂预防 ACHD 血栓形成的数据有限。我们的目的是评估阿哌沙班对患有 AA 的 ACHD 患者的有效性和安全性。 PROTECT-AR (NCT03854149) 是一项于 2019 年至 2023 年进行的前瞻性、多中心、观察性研究。纳入了接受常规阿哌沙班治疗后出现房颤、心房扑动或房内折返性心动过速的 ACHD 患者。历史对照组由之前服用维生素 K 拮抗剂 (VKA) 的患者组成，在转用阿哌沙班之前对他们进行了分析。主要有效性终点是中风或血栓栓塞的复合终点。主要安全终点是大出血。该研究纳入了 218 名服用阿哌沙班且患有 AA 的 ACHD 患者，其中 73 名是既往使用 VKA 的患者。该分析涵盖了阿哌沙班前瞻性暴露的 527 患者年和 VKA 回顾​​性暴露的 169 患者年。阿哌沙班组中风或血栓栓塞的年发生率为 0.6%，VKA 组为 1.8%（绝对差值 − 1.2%；单侧 95% 置信区间 [CI] 上限为 0.9%，低于预先设定的非劣势幅度为 +1.8%，< 0.001)。阿哌沙班组的年化大出血率为 1.5%，VKA 组为 2.4%（风险比 0.64；95% CI 0.19–2.10，= 0.48）。在患有 AA 的 ACHD 患者中，与既往使用 VKA 相比，常规使用阿哌沙班的中风或血栓栓塞发生率不低，而且大出血发生率相似。