Patients with diabetes and multivessel coronary artery disease (MVD) who undergo coronary artery bypass grafting (CABG) may have better odds of survival than those who opt for percutaneous coronary intervention (PCI), according to results from the FREEDOM Follow-On trial.
The original FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial included 1,900 patients from 140 centers between 2005 and 2010 with diabetes and MVD who, in addition to optimal medical therapy, underwent either CABG or PCI. Researchers evaluated all-cause five-year mortality rates and found a 16.3% mortality rate among PCI patients, compared to 10.9% for CABG patients (p = 0.049).
For FREEDOM Follow-On, 25 centers opted in, yielding about half of the original patient population (n = 943, 49.6%); nearly all (97.05%) of the patients were followed by the centers. Among the follow-up patients, 478 underwent PACI, and 465 underwent CABG. Median follow-up time for the follow-up study was 7.5 years.
Throughout the whole follow-up period, 314 patients died (original trial deaths, 204; FREEDOM Follow-O deaths, 110); the PCI group had 159 deaths (24.31%), while the CABG group had 112 (18.30%) (HR: 1.36; 95% CI: 1.07 to 1.74; p = 0.01). When only looking at FREEDOM Follow-On cohort, the PCI group had 99 deaths (23.71%), and the CABG group had 72 (18.69%) (HR: 1.32; 95% CI: 0.97 to 1.78; p = 0.07).
The trial’s findings were discussed at the American Heart Association (AHA) scientific sessions. Study author Valentin Fuster, MD, presented the study.
The length of follow-up made this study different from previous ones, and made it more challenging, according to Fuster.
“This was a difficult study. Following patients for more than five years is hard,” he said.
The results of the present study were published in the Journal of the American College of Cardiology.