Background
To assess the influence of therapy crossovers on treatment comparisons and mortality at 5 years in patients with ischemic heart disease and heart failure randomly assigned to medical therapy alone (MED) or to MED and coronary artery bypass surgery (CABG) in the Surgical Treatment for Ischemic Heart Failure (STICH) trial.
Methods and Results
The influence of early crossover (within the first year following randomization) on 5-year mortality was assessed using time-dependent multivariable Cox models. CABG was performed in 65/602 (10.8%) patients assigned to MED and 55/610 (9.0%) patients assigned to CABG received MED only. Common reasons for crossover from MED to CABG were progressive symptoms or acute decompensation. MED-assigned patients who underwent CABG had lower 5-year mortality than those who received MED only (25% vs. 42%; hazard ratio (HR) 0.50 confidence interval (CI) 0.30-0.85, p=0.008). The main reason for crossover from CABG to MED was patient/family decision. Five patients did not undergo their assigned CABG within a year but died before receiving surgery without status change. They were deemed crossover to MED. The CABG to MED crossover population had higher 5-year mortality compared to those treated with CABG per protocol (59% vs. 33%; HR: 2.01; CI 1.36-2.96, p<0.001). CABG was associated with lower mortality compared to MED in per protocol and several time-dependent analyses (all p<0.05).
Conclusions
CABG reduced mortality in both the per protocol and crossover STICH patient populations. Crossover from assigned therapy therefore diminished the impact of CABG on survival in STICH when analyzed by intention to treat.
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