• Sanne Klaphake, Farzin Fakhry, Ellen V Rouwet, Lijckle van der Laan, Jan J Wever, Joep A Teijink, Wolter H Hoffmann, Andre van Petersen, Jerome P van Brussel, Guido N Stultiens, Alex Derom, Ted T den Hoed, Gwan H Ho, Lukas C van Dijk, Nicole Verhofstad, Mariella Orsini, Ingrid Hulst, Marc R van Sambeek, Dimitris Rizopoulos, Marie Jose J E van Rijn, VerhagenHence J MHJMDepartment of Vascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands., and HuninkMyriam G MMGMDepartment of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, MA..
• Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
• Ann. Surg. 2022 Dec 1; 276 (6): e1035e1043e1035-e1043.

ObjectiveThe goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only.BackgroundSupervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up.MethodsThe ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle.ResultsMedian long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149).ConclusionsLong-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment.Trial RegistrationNetherlands Trial Registry Identifier: NTR2249.Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

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