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Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study
Michael E Farkouh1, Michael Domanski2, George D Dangas3
1Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada.
Insights
Coronary artery bypass grafting (CABG) significantly reduces long-term mortality in diabetic patients with multivessel coronary disease compared to percutaneous coronary intervention with drug-eluting stents (PCI-DES). This survival benefit highlights CABG as a superior revascularization strategy for this high-risk population.
Area of Science:
- Cardiology
- Interventional Cardiology
- Diabetes Mellitus Management
Background:
- The FREEDOM trial initially showed coronary artery bypass grafting (CABG) superiority over percutaneous coronary intervention with drug-eluting stents (PCI-DES) for diabetic patients with multivessel coronary disease (MVD) at 3.8 years.
- Long-term survival data comparing CABG and PCI-DES in this patient group remained unclear.
Purpose of the Study:
- To evaluate the long-term survival outcomes of patients with diabetes mellitus (DM) and MVD who underwent coronary revascularization within the FREEDOM trial.
Main Methods:
- The FREEDOM Follow-On study extended the follow-up of patients originally randomized to PCI-DES or CABG.
- Survival was analyzed using Kaplan-Meier methods and Cox proportional hazards models.
Main Results:
- Over a median follow-up of 7.5 years, all-cause mortality was higher in the PCI-DES group (24.3%) compared to the CABG group (18.3%) in the overall cohort (Hazard Ratio: 1.36; p=0.01).
- In the extended follow-up cohort, while not statistically significant (p=0.076), the trend favored CABG with lower all-cause mortality (18.7%) versus PCI-DES (23.7%).
Conclusions:
- Coronary artery bypass grafting (CABG) demonstrates a long-term survival benefit over PCI-DES in patients with diabetes mellitus and multivessel coronary disease.
- CABG is a preferred revascularization strategy for improving long-term mortality in this diabetic patient population.
Background:
The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) 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.
Objectives:
The purpose of this study was 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-eluting 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:
A total of 25 centers (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 years). 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: 1.36; 95% confidence interval: 1.07 to 1.74; p = 0.01). Of the 943 patients with extended follow-up, the all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group (hazard ratio: 1.32; 95% confidence interval: 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. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).
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