Author + information
- Received October 13, 2018
- Revision received November 1, 2018
- Accepted November 1, 2018
- Published online February 11, 2019.
- Michael E. Farkouh, MD, MSca,∗ (, )@drmikefarkouh,
- 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, Ontario, Canada
- bUniversity of Maryland School of Medicine, Baltimore, Maryland
- cZena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- dInstituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil
- eBaylor Scott & White Health, Dallas, Texas
- fNew England Research Institutes, Watertown, Massachusetts
- gVA New York Harbor Healthcare System, New York University School of Medicine, New York, New York
- hHumanitas Research Hospital, Milan, Italy
- iAlbany Medical Center, Albany, New York
- jDivision of Medicine, Montreal Heart Institute, Université de Montréal, Montréal, Quebec, Canada
- kUniversity of British Columbia, Vancouver, British Columbia, Canada
- lCardiology Department, Liverpool Hospital, Sydney, New South Wales, Australia
- mSaint-Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri
- nCentro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain
- ↵∗Address for correspondence:
Dr. Michael E. Farkouh, Peter Munk Cardiac Centre, 585 University Avenue—4N474, Toronto, Ontario M5G 2N2, Canada.
- ↵∗∗Dr. Valentin Fuster, Mount Sinai School of Medicine, Cardiovascular Institute, One Gustave Levy Place, Box 1030, New York, New York 10029-6500. OR Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain.
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)
The original FREEDOM trial was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), with grants from Cordis Corporation, a Johnson & Johnson Company at the time, Boston Scientific (providing the stents), Eli Lilly (providing abciximab and an unrestricted research grant), Sanofi, and Bristol-Myers Squibb (providing clopidogrel). The FREEDOM Follow-On study was sponsored by the Joseph and Vicky Safra Foundation. No company or agency provided additional funding for the extended follow-up, and none participated in the review, analysis, and decision to submit the manuscript for publication. Dr. Farkouh has received research grants from Amgen and Novo Nordisk. Dr. Dangas’s spouse has served on the advisory board for Boston Scientific and Abbott Vascular; and has served as a consultant to Abbott Vascular. Dr. Shah has served on the advisory board of Philips Volcano; and has served as a consultant to Terumo. Dr. Stefanini has received a research grant (to his institution) from Boston Scientific; and has received speaker/consultant fees from B.Braun, Biosensors, and Boston Scientific. Dr. Sharma has served on the Speakers Bureau for Abbott Vascular, Boston Scientific, Cardiovascular Systems, Inc., and TriReme. Dr. Cohen has received research grant support to his institution and consulting income (modest) from Medtronic; research grant support from Abbott Vascular; and research grant support to his institution from Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Deepak L. Bhatt, MD, MPH, served as Guest Editor for this paper.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received October 13, 2018.
- Revision received November 1, 2018.
- Accepted November 1, 2018.
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