Patient-Reported Outcomes After Revascularisation for Intermittent Claudication from the GermanVasc Prospective Cohort Study.

Abstract

This prospective multicentre cohort study investigated patient-reported outcomes (PROM) in patients undergoing invasive revascularisation for intermittent claudication at 35 centres in Germany. Patients were enrolled between 05/2018 and 03/2021 and followed for up to 12 months (NCT03098290). The Physical Component Summary score (PCS-12) of the SF-12 questionnaire, maximum pain-free walking distance, and frequency of leg pain at rest were collected as outcomes. A total of 963 (64% male, median age 68 years) provided sufficient data at follow-up (352 days in median). At index admission physical quality of life was substantially impaired at a median PCS-12 score of 35 (Q1: 28, Q3: 43). At follow-up, median PCS-12 improved to 45 (Q1: 39, Q3: 52) along with substantial improvement in maximum walking distance (+20 minutes) and lower leg pain (-10 points). Not working, retired job and obesity were associated with lack of improvements in PCS-12 during follow-up while obesity, and retired job seemed to particularly prevent improvements in maximum walking distance and reductions in leg pain. Invasive revascularisation with either technical approach markedly improved patient-reported outcomes. Gains were smaller in obese and retired patients with similar trends in those not working and with high comorbidity burden.