Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise with Supervised Exercise only for Intermittent Claudication

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 RijnHence J.M. Verhagen, Myriam G.M. Hunink

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Scopus)

Abstract

Objective: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only. Background: Supervised 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. Methods: The 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. Results: Median 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). Conclusions: Long-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 Registration: Netherlands Trial Registry Identifier: NTR2249.

Original languageEnglish
Pages (from-to)E1035-E1043
Number of pages9
JournalAnnals of Surgery
Volume276
Issue number6
DOIs
Publication statusPublished - Dec 2022

Bibliographical note

Funding Information:
MGM Hunink receives Royalties from Cambridge University Press for her textbook on Medical Decision Making, reimbursement of expenses from the European Society of Radiology (ESR) for work on the ESR guidelines for imaging referrals, reimbursement of expenses from the European Institute for Biomedical Imaging Research (EIBIR) for membership of the Scientific Advisory Board, and research funding from the American Diabetes Association, the Netherlands Organization for Health Research and Development, the German Innovation Fund, Netherlands Educational Grant (“Studie Voorschot Middelen”), and the Gordon and Betty Moore Foundation.

Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.

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