BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom.
Circ Heart Fail. 2013 May;6(3):451-60. doi: 10.1161/CIRCHEARTFAILURE.112.000143. Epub 2013 Apr 10.
We examined the risk of stroke or systemic embolism (SSE) conferred by heart failure (HF) and left ventricular systolic dysfunction (LVSD) in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation Trial (ARISTOTLE), as well as the effect of apixaban versus warfarin.
The risk of a number of outcomes, including the composite of SSE or death (to take account of competing risks) and composite of SSE, major bleeding, or death (net clinical benefit) were calculated in 3 patient groups: (1) no HF/no LVSD (n=8728), (2) HF/no LVSD (n=3207), and (3) LVSD with/without symptomatic HF (n=2736). The rate of both outcomes was highest in patients with LVSD (SSE or death 8.06; SSE, major bleeding, or death 10.46 per 100 patient-years), intermediate for HF but preserved LV systolic function (5.32; 7.24), and lowest in patients without HF or LVSD (1.54; 5.27); each comparison P<0.0001. Each outcome was less frequent in patients treated with apixaban: in all ARISTOTLE patients, the apixaban/warfarin hazard ratio for SSE or death was 0.89 (95% confidence interval, 0.81-0.98; P=0.02); for SSE, major bleed, or death it was 0.85 (0.78-0.92; P<0.001). There was no heterogeneity of treatment effect across the 3 groups.
Patients with LVSD (with/without HF) had a higher risk of SSE or death (but similar rate of SSE) compared with patients with HF but preserved LV systolic function; both had a greater risk than patients without either HF or LVSD. Apixaban reduced the risk of both outcomes more than warfarin in all 3 patient groups.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984.
我们在心房颤动的 Apixaban 减少中风和其他血栓栓塞事件试验（ARISTOTLE）中研究了心力衰竭（HF）和左心室收缩功能障碍（LVSD）所带来的中风或全身性栓塞（SSE）风险，以及阿哌沙班与华法林的疗效差异。
我们在 3 组患者中计算了多种结局的风险，包括 SSE 或死亡的复合终点（为了考虑竞争风险）以及 SSE、大出血或死亡的复合终点（净临床获益），这 3 组患者分别为：（1）无 HF/无 LVSD（n=8728），（2）HF/无 LVSD（n=3207），和（3）LVSD 伴/不伴有症状性 HF（n=2736）。LVSD 患者的两种结局发生率最高（SSE 或死亡 8.06；SSE、大出血或死亡 10.46/100 患者年），HF 但左心室收缩功能正常的患者发生率中等（5.32；7.24），而无 HF 或 LVSD 的患者发生率最低（1.54；5.27）；各项比较 P<0.0001。阿哌沙班治疗的患者中每种结局均较少见：在所有 ARISTOTLE 患者中，阿哌沙班/华法林的 SSE 或死亡风险比为 0.89（95%置信区间，0.81-0.98；P=0.02）；SSE、大出血或死亡的风险比为 0.85（0.78-0.92；P<0.001）。3 组间治疗效果无差异。
与 HF 但左心室收缩功能正常的患者相比，LVSD（伴/不伴 HF）患者的 SSE 或死亡风险更高（但 SSE 发生率相似）；这两组患者的风险均高于无 HF 或 LVSD 的患者。阿哌沙班在所有 3 组患者中均比华法林更能降低这两种结局的风险。
