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Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study.

ABSTRACT: 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).

SUBMITTER: Farkouh ME

PROVIDER: S-EPMC6839829 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study.

Farkouh Michael E ME Domanski Michael M Dangas George D GD Godoy Lucas C LC Mack Michael J MJ Siami Flora S FS Hamza Taye H TH Shah Binita B Stefanini Giulio G GG Sidhu Mandeep S MS Tanguay Jean-François JF Ramanathan Krishnan K Sharma Samin K SK French John J Hueb Whady W Cohen David J DJ Fuster Valentin V

Journal of the American College of Cardiology 20181111 6

<h4>Background</h4>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 ...[more]

PMID: 30428398

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Project description:ObjectiveWe sought to assess the relative merits of different revascularization strategies in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease complicated by cardiogenic shock or chronic total occlusion (CTO).BackgroundRecent randomized trials and meta-analysis have suggested that multivessel percutaneous coronary intervention (PCI) is associated with better outcomes in patients with STEMI and multivessel coronary artery disease, however, patients complicated by cardiogenic shock or CTO were excluded.MethodsStudies that compared multivessel PCI (immediate or staged) with culprit-only PCI in patients with STEMI and multivessel coronary artery disease complicated by cardiogenic shock or CTO were included. Random odd ratio (OR) and 95% confidence interval (CI) were conducted.ResultsSixteen studies with 8695 patients complicated by cardiogenic shock and eight studies with 2259 patients complicated by CTO were included. In patients complicated by cardiogenic shock, a strategy of CO-PCI was associated with lower risk for short-term renal failure (OR: 0.75; 95% CI: 0.61-0.93; I2 = 0.0%), with no significant difference in MACE, all-cause mortality, re-infarction, revascularization, cardiac death, heart failure, major bleeding, or stroke compared with an immediate MV-PCI strategy. In patients complicated by CTO, a strategy of CO-PCI was associated with higher risk for long-term MACE (OR: 2.06; 95% CI: 1.39-3.06; I2 = 54.0%), all-cause mortality (OR: 2.89; 95% CI: 2.09-4.00; I2 = 0.0%), cardiac death (OR: 3.12; 95% CI: 2.05-4.75; I2 = 16.8%), heart failure (OR: 1.99; 95% CI: 1.22-3.24; I2 = 0.0%), and stroke (OR: 2.80; 95% CI: 1.04-7.53; I2 = 0.0%) compared with a staged MV-PCI strategy, without any difference in re-infarction, revascularization, or major bleeding.ConclusionsFor patients with STEMI and multivessel coronary artery disease complicated by cardiogenic shock, an immediate multivessel PCI was not advocated due to a higher risk for short-term renal failure, whereas for patients complicated by CTO, a staged multivessel PCI was advocated due to reduced risks for long-term MACE, all-cause mortality, cardiac death, heart failure, and stroke.

Dataset Information

Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study.

Publications

Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study.

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