Multiple risk factor intervention trial revisited: a new perspective based on nonfatal and fatal composite endpoints,coronary and cardiovascular,during the trial.

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.