Multiple risk factor intervention trial revisited: a new perspective based on nonfatal and fatal composite endpoints, coronary and cardiovascular, during the trial.
Multiple risk factor intervention trial revisited: a new perspective based on nonfatal and fatal composite endpoints, coronary and cardiovascular, during the trial.
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DOI：
10.1161/jaha.112.003640
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发表时间：
2012-10
影响因子：
5.4
通讯作者：
MRFIT Research Group
中科院分区：
文献类型：
--
作者：
Stamler J;Neaton JD;Cohen JD;Cutler J;Eberly L;Grandits G;Kuller LH;Ockene J;Prineas R;MRFIT Research Group
多危险因素干预试验评估了12866名男性冠心病（CHD）的多因素干预。在平均7年的随访期内，先验定义的终点（CHD死亡、CHD死亡或非致死性心肌梗死、心血管疾病[CVD]死亡和全因死亡）在特殊干预（SI）组和常规护理（UC）组之间没有显著差异。事件发生率低于预期，降低了功率。预先规定了其他非致死性CVD结局，但未在SI与UC的复合结局比较中考虑。使用考克斯回归确定试验期间发生的非致死性CVD事件相关的试验后CVD死亡风险。在随后的20年中，与CVD死亡风险>2倍相关的非致命性结局与试验期间死亡相结合，以创建2个新的复合结局。估计每个复合结局的SI/UC风险比和95%置信区间。在10例试验期间发生的非致死性事件中，有6例（P<0.001）与>2倍的CVD死亡风险相关。520名SI和602名UC男性患者发生CHD复合结局（CHD死亡、心肌梗死[临床或连续ECG变化]、CHF或冠状动脉手术）（SI/UC风险比= 0.86; 95%置信区间，0.76-0.97; P=0.01）。581名SI和652名UC男性发生CVD复合结局（CHD [如上]、其他CVD死亡、卒中或肾损害）（风险比= 0.89; 95%置信区间，0.79-0.99; P=0.04）。在事后分析中，SI组7年内的复合致死性/非致死性CHD和CVD发生率显著低于UC组。这些发现加强了改善饮食/生活方式的建议，根据需要进行药物治疗，以预防和控制主要的CVD风险因素。
The Multiple Risk Factor Intervention Trial evaluated a multifactor intervention on coronary heart disease (CHD) in 12 866 men. A priori defined endpoints (CHD death, CHD death or nonfatal myocardial infarction, cardiovascular disease [CVD] death, and all-cause death) did not differ significantly between the special intervention (SI) and usual care (UC) groups over an average follow-up period of 7 years. Event rates were lower than anticipated, reducing power. Other nonfatal CVD outcomes were prespecified but not considered in composite outcomes comparing SI with UC. Post-trial CVD mortality risks associated with nonfatal CVD events occurring during the trial were determined with Cox regression. Nonfatal outcomes associated with >2-fold risk of CVD death over the subsequent 20 years were combined with during-trial deaths to create 2 new composite outcomes. SI/UC hazard ratios and 95% confidence intervals were estimated for each composite outcome. Of 10 during-trial nonfatal events, 6 were associated (P<0.001) with >2-fold risk of CVD death. A CHD composite outcome (CHD death, myocardial infarction [clinical or serial ECG change], CHF, or coronary artery surgery) was experienced by 520 SI and 602 UC men (SI/UC hazard ratio = 0.86; 95% confidence interval, 0.76–0.97; P=0.01). A CVD composite outcome (CHD [as above], other CVD deaths, stroke, or renal impairment) was experienced by 581 SI and 652 UC men (hazard ratio = 0.89; 95% confidence interval, 0.79–0.99; P=0.04). In post hoc analyses, composite fatal/nonfatal CHD and CVD rates over 7 years were significantly lower for SI than for UC. These findings reinforce recommendations for improved dietary/lifestyle practices, with pharmacological therapy as needed, to prevent and control major CVD risk factors.