Warfarin and aspirin in patients with heart failure and sinus rhythm.
Warfarin and aspirin in patients with heart failure and sinus rhythm.
复制标题
DOI：
10.1056/nejmoa1202299
复制
发表时间：
2012-05-17
期刊：
影响因子：
--
通讯作者：
WARCEF Investigators
中科院分区：
文献类型：
--
作者：
Homma S;Thompson JL;Pullicino PM;Levin B;Freudenberger RS;Teerlink JR;Ammon SE;Graham S;Sacco RL;Mann DL;Mohr JP;Massie BM;Labovitz AJ;Anker SD;Lok DJ;Ponikowski P;Estol CJ;Lip GY;Di Tullio MR;Sanford AR;Mejia V;Gabriel AP;del Valle ML;Buchsbaum R;WARCEF Investigators
对于有窦性心律的心力衰竭患者，华法林和阿司匹林孰优孰劣尚不清楚。我们设计这项试验是为了确定华法林（目标国际标准化比率为2.0:3.5）或阿司匹林（剂量为325 mg /天）对于左心室射血分数（LVEF）降低的窦性心律患者是更好的治疗方法。我们对2305例患者进行了长达6年的随访（平均[±SD]， 3.5±1.8）。主要终点为缺血性卒中、脑出血或任何原因导致的死亡等复合终点中首次事件发生的时间。华法林组的主要结局发生率为7.47 / 100患者年，阿司匹林组为7.93 / 100患者年（华法林组的风险比为0.93；95%可信区间[CI]， 0.79 ~ 1.10; P = 0.40）。因此，两种处理之间没有显著的总体差异。在一项时变分析中，风险比随着时间的推移而变化，在第四年的随访中，华法林比阿司匹林更倾向于华法林，但这一发现仅具有边际显著性（P = 0.046）。与阿司匹林相比，华法林与整个随访期间缺血性卒中发生率的显著降低相关（0.72事件/ 100患者年vs 1.36事件/ 100患者年；风险比0.52;95% CI, 0.33 ~ 0.82; P = 0.005）。华法林组大出血发生率为1.78例/ 100患者年，而阿司匹林组为0.87例/ 100患者年（P<0.001）。两个治疗组的脑出血和颅内出血发生率无显著差异（华法林组为0.27例/ 100患者年，阿司匹林组为0.22例/ 100患者年，P = 0.82）。在处于窦性心律的LVEF降低的患者中，华法林治疗和阿司匹林治疗的主要结局在总体上没有显著差异。华法林降低的缺血性中风风险被增加的大出血风险所抵消。华法林和阿司匹林之间的选择应该个体化。
It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm. We designed this trial to determine whether warfarin (with a target international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean [±SD], 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause. The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P = 0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P = 0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P = 0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P = 0.82). Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized.