For patients with moderate to severe intermittent claudication, revascularization may offer more function, better quality of life, and superior symptom improvement than medical management, according to a recent prospective study.
Focusing on patient-centered outcomes, researchers compared the effectiveness at 12 months of medical management (n=282) versus endovascular or surgical revascularization (n=41) at 15 clinics associated with 11 hospitals in Washington State. Results were published online on Aug. 17 by JAMA Surgery.
For the primary outcomes, researchers used patients' self-reported walking distance, speed, and stair climb, as measured by the modified Walking Impairment Questionnaire. Secondary outcomes were scores on the questionnaire's pain domain, the Vascular Quality of Life Questionnaire, the European Quality of Life–5 Dimension Questionnaire, and the Claudication Symptom Instrument.
In the medical cohort, 40 of 66 smokers (60.6%) were counseled about smoking cessation, 126 of 282 participants (44.7%) discussed a walking program with their physicians, and 95 participants received a prescription for cilostazol or pentoxifylline. In the medically managed group, mean improvements at 12 months were statistically significant for 3 patient-reported outcome measures: speed (P=0.03), Vascular Quality of Life (P=0.008), and European Quality of Life (P=0.006). The remaining scores remained stable over time.
The revascularization cohort saw significant mean improvements at 12 months in all outcomes: distance (P=0.001), speed (P=0.03), stair climb (P=0.03), pain (P<0.001), Vascular Quality of Life (P<0.001), European Quality of Life (P<0.001), and Claudication Symptom Instrument (P<0.001). Compared with the medical cohort, percentage changes in all outcomes were 39.1%, 15.6%, 9.7%, 116.9%, 41%, 18%, and 13.5%, respectively.
The study authors noted limitations, such as the modest number of participants who enrolled in the vascularization cohort and how follow-up data collection was limited to self-report. In addition, participants undergoing revascularization had moderate to severe disease of shorter duration, whereas more than one-third of those in the medical cohort had mild disease, which points to the possibility of coding bias because lifestyle-limiting claudication is the only widely accepted indication for revascularization.
Despite these findings, it may be premature for interventionalists to treat more patients with claudication and measure patient-reported outcomes during the process, according to an accompanying editorial. The systems involved in surgical treatment may not be ready to measure patient-reported outcomes, and the study failed to test the effectiveness of robust and standardized medical management, the editorialist wrote.