Author + information
- Received September 7, 2016
- Revision received January 10, 2017
- Accepted January 27, 2017
- Published online April 3, 2017.
- Ambarish Pandey, MDa,
- Subhash Banerjee, MDa,
- Christian Ngo, MDa,
- Purav Mody, MDa,
- Steven P. Marso, MDa,
- Emmanouil S. Brilakis, MD, PhDa,
- Ehrin J. Armstrong, MD, MSb,
- Jay Giri, MD, MPHc,
- Marc P. Bonaca, MD, MPHd,
- Aruna Pradhan, MD, MPHd,
- Anthony A. Bavry, MD, MPHe and
- Dharam J. Kumbhani, MD, SMa,∗ ()
- aDivision of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas
- bSection of Cardiology, Denver VA Medical Center and University of Colorado School of Medicine, Denver, Colorado
- cCardiovascular Medicine Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
- dDivsion of Cardiovasular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- eDepartment of Medicine, University of Florida, Gainesville, Florida
- ↵∗Address for correspondence:
Dr. Dharam J. Kumbhani, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, Texas 75390-9047.
Objectives The authors performed a meta-analysis of randomized controlled trials to compare the efficacy of initial endovascular treatment with or without supervised exercise training (SET) versus SET alone in patients with intermittent claudication.
Background Current guidelines recommend SET as the initial treatment modality for patients with intermittent claudication, in addition to optimal medical therapy. The role of endovascular therapy as primary treatment for claudication has been controversial.
Methods The primary outcome was treadmill-measured maximal walk distance at the end of follow-up. Secondary outcomes included resting ankle brachial index (ABI) and treadmill-measured ischemic claudication distance on follow-up. Risk of revascularization or amputations was also compared. Pooled estimates of the difference in outcomes between endovascular therapy with or without SET and SET-only groups were calculated using fixed and random effects models.
Results A total of 987 patients from 7 trials were included. In pooled analysis, compared with SET only (reference group), patients that underwent combined endovascular therapy and SET had significantly higher maximum walk distance (standardized mean difference 0.79 [95% confidence interval (CI): 0.18 to 1.39]; weighted mean difference 98.9 [95% CI: 31.4 to 166.4 feet], and lower risk of revascularization or amputation (odds ratio 0.19 [95% CI: (0.09 to 0.40]; p < 0.0001, number needed to treat = 8) over a median follow-up of 12.4 months. By contrast, revascularization was not associated with significant improvement in exercise capacity or risk of future revascularization or amputation, compared with SET alone. Follow-up ABI was significantly higher among patients that underwent endovascular therapy with or without SET as compared with SET alone.
Conclusions Compared with initial SET only, endovascular therapy in combination with SET is associated with significant improvement in total walking distance, ABI, and risk of future revascularization or amputation. By contrast, endovascular therapy-only was not associated with any improvement in functional capacity or clinical outcomes over an intermediate duration of follow-up.
- exercise capacity
- intermittent claudication
- peripheral arterial disease
- supervised exercise training
Dr. Banerjee has received speakers honoraria from Medtronic, CSI, and Gore; and research and educational grants from Boston Scientific and Merck. Dr. Marso has received grants to his institution from The Medicines Company, Novo Nordisk; and personal fees from Novo Nordisk, Abbott Vascular, and AstraZeneca. Dr. Brilakis has received consulting/speaker honoraria from Abbott Vascular, Asahi, Cardinal Health, Elsevier, GE Healthcare, and St. Jude Medical; and research support from InfraRedx and Boston Scientific. Dr. Armstrong has been a consultant for Abbott Vascular, Boston Scientific, Cardiovascular Systems, Medtronic, Merck, and Spectranetics. Dr. Giri has received research funds to his institution from St. Jude Medical. Dr. Bavry has received honoraria from the American College of Cardiology. Dr. Bonanca has received research grant support from AstraZeneca and Merck; and is a consultant for AstraZeneca, Merck, Bayer, and Azalez. Dr. Kumbhani has received honoraria and research support from the American College of Cardiology. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 7, 2016.
- Revision received January 10, 2017.
- Accepted January 27, 2017.
- 2017 American College of Cardiology Foundation