Author + information
- Received October 13, 2018
- Revision received November 1, 2018
- Accepted November 1, 2018
- Published online November 11, 2018.
- Michael E. Farkouh, MD, MSca,∗ (, )
- Michael Domanski, MDb,
- George D. Dangas, MD, PhDc,
- Lucas C. Godoy, MDa,d,
- Michael J. Mack, MDe,
- Flora S. Siami, MPHf,
- Taye H. Hamza, PhDf,
- Binita Shah, MD, MSg,
- Giulio G. Stefanini, MDh,
- Mandeep S. Sidhu, MDi,
- Jean-François Tanguay, MDj,
- Krishnan Ramanathan, MBChBk,
- Samin K. Sharma, MDc,
- John French, MBChB, PhDl,
- Whady Hueb, MD, PhDd,
- David J. Cohen, MD, MScm,
- Valentin Fuster, MD, PhDc,n,
- for the FREEDOM Follow-On study investigators
- aPeter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, ON, Canada
- bUniversity of Maryland School of Medicine, Baltimore, Maryland, USA
- cZena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
- dInstituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil
- eBaylor Scott & White Health, Dallas, TX, USA
- fNew England Research Institutes, Watertown, MA, USA
- gVA New York Harbor Healthcare System, New York University School of Medicine, New York, NY, USA
- hHumanitas Research Hospital, Milan, Italy
- iAlbany Medical Center, Albany, NY, USA
- jDivision of Medicine, Montreal Heart Institute, Université de Montréal, QC, Canada
- kUniversity of British Columbia, Vancouver, BC, Canada
- lCardiology Department, Liverpool Hospital, Sydney, Australia
- mSaint-Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA
- nCentro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain
- ↵∗Corresponding Authors: Michael E. Farkouh , MD, MSc Peter Munk Cardiac Centre, 585 University Avenue—4N474 Toronto, Ontario, Canada, M5G 2N2 Telephone: +1 416-340-3141 Fax: 416-340-3398
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.
Funding: Joseph and Vicky Safra Foundation
Disclosures: there are no relationships with industry relevant to this paper
Valentin Fuster, MD, PhD, Mount Sinai School of Medicine, Cardiovascular Institute, One Gustave Levy Pl., Box 1030 New York, NY 10029-6500, United States and Centro Nacional de Investigaciones Cardiovasculares Carlos III Madrid, Spain Telephone: (212) 241-7911 Fax: (212) 423-9488 (fax) E-mail: email@example.com, firstname.lastname@example.org
- Received October 13, 2018.
- Revision received November 1, 2018.
- Accepted November 1, 2018.
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