Northwestern University Medical School, Chicago, IL, USA.
J Am Heart Assoc. 2012 Oct;1(5):e003640. doi: 10.1161/JAHA.112.003640. Epub 2012 Oct 25.
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.
多项危险因素干预试验评估了一项针对 12866 名男性的冠心病（CHD）多因素干预措施。预先设定的终点（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）在平均 7 年的随访期间，特殊干预（SI）和常规护理（UC）组之间没有显著差异。事件发生率低于预期，降低了效能。其他非致死性 CVD 结局是预先规定的，但在与 UC 比较的 SI 复合结局中未予考虑。
使用 Cox 回归确定与试验期间发生的非致死性 CVD 事件相关的事后 CVD 死亡率风险。与随后 20 年内 CVD 死亡风险增加 2 倍以上相关的非致死性结局与试验期间死亡相结合，以创建 2 个新的复合结局。为每个复合结局估计了 SI/UC 的风险比和 95%置信区间。在 10 例试验期间的非致死性事件中，有 6 例（P<0.001）与 CVD 死亡风险增加 2 倍以上相关。经历了 CHD 复合结局（CHD 死亡、心肌梗死[临床或连续 ECG 改变]、心力衰竭或冠状动脉手术）的 SI 男性有 520 例，UC 男性有 602 例（SI/UC 风险比=0.86；95%置信区间，0.76-0.97；P=0.01）。经历了 CVD 复合结局（如上文所述的 CHD、其他 CVD 死亡、中风或肾功能损害）的 SI 男性有 581 例，UC 男性有 652 例（风险比=0.89；95%置信区间，0.79-0.99；P=0.04）。
在事后分析中，SI 的 7 年内致命/非致命性 CHD 和 CVD 复合发生率明显低于 UC。这些发现强化了改善饮食/生活方式实践的建议，必要时采用药物治疗，以预防和控制主要 CVD 危险因素。
