A new study, based on patient-reported outcomes, published online ahead of print on 17 August in JAMA Surgery reports that patients with intermittent claudication who received a revascularisation intervention (either endovascular or surgical) had significantly improved function, better health-related quality of life and fewer symptoms at 12 months compared with those who received medical management.
Intermittent claudication is the most common presentation of infrainguinal peripheral artery disease and manifests as pain in the calf or foot with walking. It is present in more than eight million people worldwide. Both medical and revascularisation interventions for intermittent claudication aim to increase walking comfort and distance, but there is inconclusive evidence of the comparative benefit of revascularisation given the possible risk of limb loss.
Emily B Devine, University of Washington, Seattle, USA, and colleagues compared the effectiveness of a medical management programme (walking programme, smoking cessation counselling, and medications) vs. revascularisation (endovascular or surgical intervention) for intermittent claudication in the community, focusing on outcomes of greatest importance to patients.
The study was conducted at 15 clinics associated with 11 hospitals in Washington State. Participants were 21 years or older with newly diagnosed or established intermittent claudication. The primary endpoints were 12-month change scores on the distance, speed, and stair-climb domains of the Walking Impairment Questionnaire. Secondary outcomes were change scores on the Walking Impairment Questionnaire pain domain, Vascular Quality of Life Questionnaire (VascuQol, which measures the effect of peripheral arterial disease across five domains), European Quality of Life–5 Dimension Questionnaire (EQ-5D, which assesses and quantifies overall health), and Claudication Symptom Instrument (CSI, which assesses claudication symptoms in the leg or foot). Among patients with intermittent claudication, those who had revascularisation had significantly improved walking function, better health-related quality of life, and fewer symptoms of claudication at 12 months compared with those who had medical management (walking programme, smoking cessation counselling, and medications).
A total of 323 adults were enrolled in the study, with 282 (87%) in the medical cohort. At study entry, the average duration of disease was longer for participants in the medical cohort, while those in the revascularisation cohort reported more severe disease. At 12 months, change in scores of various measures in the medical cohort reached significance for the following three outcomes: speed, VascuQol and EQ-5D. In the revascularisation cohort, there were significant improvements in the following seven outcomes: distance, speed, stair climb, pain, VascuQol, EQ-5D, and CSI. Relative improvements (percentage changes) at 12 months in the revascularisation cohort over the medical cohort were observed as follows: distance (39%), speed (16%), stair climb (10%), pain (117%),VascuQol (41%), EQ-50 (18%), and CSI (14%).
“This comparative effectiveness research study of interventions for intermittent claudication demonstrated significantly higher function, better health-related quality of life, and fewer symptoms for those in the revascularisation cohort compared with those in the medical cohort. These results suggest that revascularisation interventions for patients with moderate to severe intermittent claudication represent a reasonable alternative to medical management, providing important information to inform treatment strategies in the community,” the authors write.