Cardiology, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.
Cardiology, University and Emergency Hospital, Bucharest, Romania.
Heart. 2018 Aug;104(15):1292-1299. doi: 10.1136/heartjnl-2017-312272. Epub 2018 Jan 19.
To assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.
There were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model.
Patients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory.
In anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.
ARISTOTLE clinical trial number NCT00412984.
利用来自心房颤动（AF）中减少血栓栓塞事件的阿哌沙班试验（Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial）的数据，评估阿哌沙班与华法林相比，在伴有不同类型的瓣膜性心脏病（VHD）的房颤患者中的卒中/系统性栓塞、大出血和其他结局以及治疗效果。
共有 14793 例已知 VHD 状态的患者，分为有中度或重度二尖瓣反流（MR）（n=3382）、主动脉瓣反流（AR）（n=842）或主动脉瓣狭窄（AS）（n=324）；中度或重度二尖瓣狭窄的患者被排除在试验之外。比较了每种类型与无显著 VHD 的患者之间的基线特征、疗效和安全性结局。使用调整后的模型评估治疗效果。
MR 或 AR 的患者与无 MR 或 AR 的患者相比，卒中/系统性栓塞和出血的发生率相似。AS 的患者有显著更高的卒中/系统性栓塞（呈现为每 100 患者年随访的发生率）发生率（3.47 比 1.36；调整后的 HR（adjHR）2.21，95%CI 1.35 至 3.63）、死亡（8.30 比 3.53；adjHR 1.92，95%CI 1.41 至 2.61）、大出血（5.31 比 2.53；adjHR 1.80，95%CI 1.19 至 2.75）和颅内出血（1.29 比 0.51；adjHR 2.54，95%CI 1.08 至 5.96）发生率。与无 AS 的患者相比，阿哌沙班优于华法林治疗的优势在 MR （HR 0.69，95%CI 0.46 至 1.04 比 HR 0.79，95%CI 0.63 至 1.00；交互 P 值 0.52）和 AR （HR 0.57，95%CI 0.27 至 1.20 比 HR 0.78，95%CI 0.63 至 0.96；交互 P 值 0.52）的患者中相似，而在 AS （HR 0.44，95%CI 0.17 至 1.13 比 HR 0.79，95%CI 0.64 至 0.97；交互 P 值 0.19）的患者中无差异。对于每一个主要和次要的疗效和安全性结局，在伴有任何 VHD 亚类的患者中，阿哌沙班与华法林的治疗效果没有证据表明有不同的效果。
在接受抗凝治疗的房颤患者中，AS 与更高的卒中/系统性栓塞、出血和死亡风险相关。与华法林相比，阿哌沙班的疗效和安全性获益是一致的，无论是否存在 MR、AR 或 AS。
ARISTOTLE 临床试验编号 NCT00412984。
