阿哌沙班与华法林在伴有心房颤动和心脏瓣膜病患者中的比较：来自心房颤动患者阿哌沙班减少卒中和其他血栓栓塞事件（ARISTOTLE）试验的结果。
Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.
机构信息
From Research Division, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (A.A.); Duke Clinical Research Institute, Duke Medicine, Durham, NC (R.D.L., P.J.S., C.B.G., J.H.A.); Universidad de La Frontera, Temuco, Chile (F.L.); Mayo Clinic College of Medicine, Rochester, MN (B.J.G.); Bristol-Myers Squibb, Princeton, NJ (M.H.); St. John's Medical College & Research Institute, Bangalore, India (P.P.); Ankara University School of Medicine, Turkey (C.E.); ECLA Estudios Cardiológicos Latinoamérica, Rosario, Argentina (R.D.); INECO Neurociencias Oroño, Rosario, Santa Fe, Argentina (M.C.B.); Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium (J.B.); G. d'Annunzio University, Chieti, Italy and Fondazione Toscana G. Monasterio, Pisa, Italy (R.D.C.); Tokai University School of Medicine, Isehara, Japan (S.G.); National Institute of Cardiology, Warsaw, Poland (W.R.); and Fu Wai Hospital, Beijing, China (J.Z.).
出版信息
Circulation. 2015 Aug 25;132(8):624-32. doi: 10.1161/CIRCULATIONAHA.114.014807. Epub 2015 Jun 23.
BACKGROUND
Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves.
METHODS AND RESULTS
We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, major bleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heart disease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.97 and HR, 0.84; 95%, CI 0.67-1.04; interaction P=0.38), causing less major bleeding (HR, 0.79; 95% CI, 0.61-1.04 and HR, 0.65; 95% CI, 0.55-0.77; interaction P=0.23), and reducing mortality (HR, 1.01; 95% CI, 0.84-1.22 and HR, 0.84; 95% CI, 0.73-0.96; interaction P=0.10).
CONCLUSIONS
More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984.
背景
阿哌沙班获批用于预防非瓣膜性心房颤动患者的中风和全身性栓塞。然而，阿哌沙班用于减少心房颤动中的中风和其他血栓栓塞事件（ARISTOTLE）试验纳入了大量患有心脏瓣膜病的患者，仅排除了有临床意义的二尖瓣狭窄或机械性人工心脏瓣膜的患者。
方法和结果
我们使用 Cox 比例风险模型比较了阿哌沙班和华法林在伴有或不伴有中度或重度心脏瓣膜病的患者中的中风或全身性栓塞、大出血和死亡发生率。在 ARISTOTLE 纳入的 18201 例患者中，4808 例（26.4%）有中度或重度心脏瓣膜病或既往瓣膜手术史。患有心脏瓣膜病的患者中风或全身性栓塞和出血的发生率高于无心脏瓣膜病的患者。在伴有或不伴有心脏瓣膜病的患者中，阿哌沙班在降低中风和全身性栓塞方面没有证据显示优于华法林的差异效应（风险比[HR]，0.70；95%置信区间[CI]，0.51-0.97 和 HR，0.84；95%CI，0.67-1.04；交互 P=0.38），导致大出血减少（HR，0.79；95%CI，0.61-1.04 和 HR，0.65；95%CI，0.55-0.77；交互 P=0.23），并降低死亡率（HR，1.01；95%CI，0.84-1.22 和 HR，0.84；95%CI，0.73-0.96；交互 P=0.10）。
结论
在 ARISTOTLE 中，超过四分之一的非瓣膜性心房颤动患者患有中度或重度心脏瓣膜病。在伴有或不伴有心脏瓣膜病的患者中，阿哌沙班在降低中风或全身性栓塞、减少出血和降低死亡率方面没有证据显示优于华法林的差异效应。
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