Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise...

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Rehabilitation Medicine

Background:

• Supervised exercise therapy (SET) is a first-line treatment for intermittent claudication.
• Combination therapy (endovascular revascularization + SET) shows promise, but lacks long-term data.
• The ERASE study aimed to fill this gap by assessing long-term outcomes.

Purpose of the Study:

• To compare the long-term effectiveness of combination therapy versus supervised exercise only for intermittent claudication.
• To evaluate differences in maximum walking distance, pain-free walking distance, and quality of life.
• To assess the incidence of critical limb ischemia and revascularization procedures.

Main Methods:

• Multicenter randomized clinical trial (ERASE study) with patients diagnosed with intermittent claudication.
• Interventions: combination therapy (endovascular revascularization + SET) vs. SET alone.
• Long-term follow-up (median 5.4 years) with intention-to-treat analysis.

Main Results:

• No significant difference in maximum walking distance at 5-year follow-up between groups.
• No significant differences in pain-free walking distance, ankle-brachial index, or quality of life.
• Supervised exercise alone was associated with an increased hazard of revascularization procedures, but fewer total procedures were performed compared to combination therapy.

Conclusions:

• Long-term combination therapy for intermittent claudication offers no significant advantage in walking distance or quality of life over supervised exercise alone.
• While combination therapy may reduce follow-up revascularizations, it increases the total number of procedures when the initial intervention is included.
• Further research is needed to optimize treatment strategies for intermittent claudication.