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Randomized Controlled Trial
. 2022 Dec 1;276(6):e1035-e1043.
doi: 10.1097/SLA.0000000000004712. Epub 2020 Dec 23.

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

Sanne Klaphake  1 , Farzin Fakhry  2   3 , Ellen V Rouwet  4 , Lijckle van der Laan  5 , Jan J Wever  6 , Joep A Teijink  7 , Wolter H Hoffmann  8 , Andre van Petersen  9 , Jerome P van Brussel  10 , Guido N Stultiens  11 , Alex Derom  12 , Ted T den Hoed  13 , Gwan H Ho  5 , Lukas C van Dijk  6 , Nicole Verhofstad  7 , Mariella Orsini  8 , Ingrid Hulst  6 , Marc R van Sambeek  7 , Dimitris Rizopoulos  14 , Marie Jose J E van Rijn  1 , Hence J M Verhagen  1 , Myriam G M Hunink  2   15
Affiliations
Randomized Controlled Trial

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

Sanne Klaphake et al. Ann Surg. .

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.

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References

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