Author + information
- Received March 27, 2019
- Revision received July 22, 2019
- Accepted July 29, 2019
- Published online October 14, 2019.
- Mohammed Qintar, MD, MSca,∗ (, )@MohammedQintar@djc795,
- Karin H. Humphries, DScb,
- Julie E. Park, MMathb,
- Suzanne V. Arnold, MD, MHAa,
- Yuanyuan Tang, PhDa,
- Phillip Jones, MSa,
- Adam C. Salisbury, MD, MSca,
- Faraz Kureshi, MD, MScc,d,
- Michael E. Farkouh, MD, MSce,
- Valentin Fuster, MD, PhDf,g,
- David J. Cohen, MD, MSca and
- John A. Spertus, MD, MPHa
- aSaint Luke’s Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City, Missouri
- bUniversity of British Columbia, Vancouver, British Columbia, Canada
- cAustin Heart, St. David’s Heart and Vascular, Austin, Texas
- dNational Institutes of Health, National Heart, Lung, and Blood Institute, Bethesda, Maryland
- ePeter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada
- fZena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- gCentro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain
- ↵∗Address for correspondence:
Dr. Mohammed Qintar, Saint Luke’s Mid America Heart Institute, 4401 Wornall Road, Kansas City, Missouri 64111.
Background In patients with diabetes and multivessel coronary artery disease (CAD), the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that, on average, coronary artery bypass grafting (CABG) was superior to percutaneous coronary intervention (PCI) for major acute cardiovascular events (MACE) and angina reduction. Nonetheless, multivessel PCI remains a common revascularization strategy in the real world.
Objectives To translate the results of FREEDOM to individual patients in clinical practice, risk models of the heterogeneity of treatment benefit were built.
Methods Using patient-level data from 1,900 FREEDOM patients, the authors developed models to predict 5-year MACE (all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke) and 1-year angina after CABG and PCI using baseline covariates and treatment interactions. Parsimonious models were created to support clinical use. The models were internally validated using bootstrap resampling, and the MACE model was externally validated in a large real-world registry.
Results The 5-year MACE occurred in 346 (18.2%) patients, and 310 (16.3%) had angina at 1 year. The MACE model included 8 variables and treatment interactions with smoking status (c = 0.67). External validation in stable CAD (c = 0.65) and ACS (c = 0.68) demonstrated comparable performance. The 6-variable angina model included a treatment interaction with SYNTAX score (c = 0.67). PCI was never superior to CABG, and CABG was superior to PCI for MACE in 54.5% of patients and in 100% of patients with history of smoking.
Conclusions To help disseminate the results of FREEDOM, the authors created a personalized risk prediction tool for patients with diabetes and multivessel CAD that could be used in shared decision-making for CABG versus PCI by estimating each patient’s personal outcomes with both treatments.
- coronary artery bypass graft
- coronary artery disease
- multivessel disease
- percutaneous coronary intervention
- personalized risk estimate
- shared decision making
Dr. Qintar is supported by The National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number T32HL110837. All data collection, data analyses, the preparation of the manuscript, and the decision to submit the manuscript for publication were done independently of the study sponsor. Dr. Salisbury has received research grant support from Boston Scientific and Gilead; has received honoraria from Medtronic; and has received speaking fees from Abiomed. Dr. Farkouh has received research grants from Amgen and Novo Nordisk. Dr. Cohen has received research grant support from Boston Scientific, Abbott Vascular, and Medtronic; and has received consulting income from Medtronic. Dr. Spertus has received grant funding from the National Institutes of Health, Patient-Centered Outcomes Research Institute (PCORI), Abbott Vascular, and Bayer; has an equity interest in Health Outcomes Sciences; has a copyright to the Seattle Angina Questionnaire; and has served as a consultant to Novartis, Bayer, United Healthcare, and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Gregory J. Dehmer, MD, served as Guest Associate Editor for this paper.
- Received March 27, 2019.
- Revision received July 22, 2019.
- Accepted July 29, 2019.
- 2019 American College of Cardiology Foundation
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