ABSTRACT

BACKGROUND - The FREEDOM trial demonstrated that for patients with diabetes mellitus (DM) and multivessel coronary disease (MVD), coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention with drug-eluting stents (PCI-DES) in reducing the rate of major adverse cardiovascular and cerebrovascular events after a median follow-up of 3.8 years. It is not known, however, whether CABG confers a survival benefit after an extended follow-up period.

OBJECTIVE - To evaluate the long-term survival of DM patients with MVD undergoing coronary revascularization in the FREEDOM trial.

METHODS - The FREEDOM trial randomized 1,900 patients with DM and MVD to undergo either PCI with sirolimus or paclitaxel eluting stents or CABG on a background of optimal medical therapy. After completion of the trial, enrolling centers and patients were invited to participate in the FREEDOM Follow-On study. Survival was evaluated using Kaplan-Meier analysis, and Cox proportional hazards models were used for subgroup and multivariate analyses.

RESULTS - Twenty-five centers (out of 140 original centers) agreed to participate in the FREEDOM Follow-On study and contributed a total of 943 patients (49.6% of the original cohort) with a median follow-up of 7.5 years (range, 0 to 13.2). Of the 1,900 patients, there were 314 deaths during the entire follow-up period (204 deaths in the original trial and 110 deaths in the FREEDOM Follow-On). The all-cause mortality rate was significantly higher in the PCI-DES group than in the CABG group (24.3% [159 deaths] vs. 18.3% [112 deaths]; hazard ratio[HR], 1.36; 95% confidence interval[CI], 1.07 to 1.74; p=0.01). Of the 943 patients with extended follow-up, all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group (HR, 1.32; 95%CI, 0.97 to 1.78; p= 0.076).

CONCLUSIONS - In patients with DM and MVD, coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up.

Copyright © 2018. Published by Elsevier Inc.