Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise With Supervised Exercise Only for Intermittent Claudication.

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.

• Authors: 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, Hence J M Verhagen, Myriam G M Hunink
• Journal: Annals of surgery (Ann Surg) Vol. 276 Issue 6 Pg. e1035-e1043 (12 01 2022) ISSN: 1528-1140 [Electronic] United States
• PMID: 33378308 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

Topics

• Humans
• Intermittent Claudication (surgery)
• Follow-Up Studies
• Quality of Life
• Walking
• Exercise Therapy (methods)
• Treatment Outcome