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The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry.

ABSTRACT: The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy.A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients.The randomized cohort was 63.1 ± 9.1 years old and 29% female, with a median diabetes duration of 10.2 ± 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 ± 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 ± 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 ± 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts.The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD.

SUBMITTER: Bansilal S

PROVIDER: S-EPMC4536808 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

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The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry.

Bansilal Sameer S Farkouh Michael E ME Hueb Whady W Ogdie May M Dangas George G Lansky Alexandra J AJ Cohen David J DJ Magnuson Elizabeth A EA Ramanathan Krishnan K Tanguay Jean-Francois JF Muratov Victoria V Sleeper Lynn A LA Domanski Michael M Bertrand Michel E ME Fuster Valentin V

American heart journal 20121001 4

<h4>Background</h4>The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy.<h4>Methods</h4>A total of 1,900 diabetic participants with M ...[more]

PMID: 23067919

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Project description:BackgroundThe 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.ObjectivesThe purpose of this study was to evaluate the long-term survival of DM patients with MVD undergoing coronary revascularization in the FREEDOM trial.MethodsThe 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.ResultsA 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).ConclusionsIn 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).

Project description:Background: The relative benefit of immediate complete revascularization, staged complete revascularization, and culprit-only percutaneous coronary intervention (PCI) remains unclear in hemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. The aim of this study was to compare the clinical outcomes of the 3 PCI strategies in this population. Methods: We followed a pre-specified protocol (PROSPERO number: CRD42020183801). A comprehensive search of the electronic databases including PubMed, EMBASE and Cochrane Library from inception through February 21, 2020 was conducted. Randomized trials evaluating the comparative efficacy and safety of at least 2 of the 3 PCI strategies were identified. The primary endpoint was the composite of cardiovascular mortality or myocardial infarction (MI) during the longest follow-up. Pairwise and network meta-analyses were performed with random-effects model. Results: Eleven trials including 6,942 patients were analyzed. Pairwise meta-analysis noted that immediate complete revascularization and staged complete revascularization were respectively associated with a 52 and 27% reduction in the risk of cardiovascular death or MI (relative risk [RR] 0.48, 95% confidence interval [CI] 0.32-0.73, I2 = 0%; and RR 0.73, 95% CI 0.61-0.88, I2 = 0%, respectively), compared with culprit-only PCI. The risk of cardiovascular death or MI was not statistically different in staged and immediate complete revascularization groups (RR 0.88, 95% CI 0.45-1.72, I2 = 0%). Network meta-analysis obtained almost similar results compared with pairwise meta-analysis, and immediate complete revascularization had a 77% probability of being the best strategy for reducing cardiovascular death or MI among the 3 PCI strategies. Conclusion: The current evidence suggests that both immediate and staged complete revascularization were associated with a reduction of cardiovascular death or MI compared with culprit-only PCI. Further trials are warranted to directly compare immediate vs. staged complete revascularization in this population. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, PROSPERO [CRD42020183801].

Dataset Information

The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry.

Publications

The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry.

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