Patient-reported outcomes including walking function, health-related quality of life and symptoms were significantly higher among patients with intermittent leg claudication who were assigned to an endovascular or surgical revascularization intervention compared with a medical intervention.
The prospective, longitudinal, observational cohort study enrolled 323 adults at 15 clinics associated with 11 hospitals in Washington from July 2011 to September 2013. All participants had newly diagnosed or previously known intermittent claudication. Researchers compared the effectiveness of endovascular or surgical revascularization or medical intervention, consisting of a walking program, smoking-cessation counseling and medication. Their goal was to focus on “outcomes of greatest importance to patients,” according to the abstract.
Overall, 12.7% of patients with intermittent claudication underwent revascularization and 87.3% received medical intervention. The researchers measured patient-reported outcomes based on self-reports at baseline, 6 months and 12 months. The primary endpoint was change in scores on the distance, speed and stair-climb components of the Walking Impairment Questionnaire at 12 months.
At baseline, the revascularization group had a longer mean duration of pre-enrollment disease and the medical group reported greater disease severity.
At 12 months, the medical group demonstrated significant improvement in the following patient-reported outcome measures compared with baseline: walking speed (5.9; 95% CI, 0.5-11.3; P = .03); Vascular Quality of Life questionnaire (VascuQol; 0.28; 95% CI, 0.08-0.49; P = .008) and European Quality of Life-5 Dimension Questionnaire (EQ-5D; 0.038; 95% CI, 0.011-0.066; P = .006), according to the findings.
Also at 12 months, the revascularization group demonstrated significant improvement in all analyzed patient-reported outcomes compared with baseline: walking distance (19.5; 95% CI, 7.9-31.0; P = .001), speed (12.1; 95% CI, 1.2-22.8; P = .02), stair climb (11.4; 95% CI, 1.3-21.5; P = .03), pain (20.7; 95% CI, 11-30.4; P < .001), VascuQol (1.1; 95% CI, 0.8-1.41; P < .001), EQ-5D (0.013; 95% CI, 0.067-0.159; P < .001) and Claudication Systems Instrument (CSI, -0.63; 95% CI, 0.96 to -0.31; P < .001), according to the findings.
The researchers also calculated relative improvements based on percentage change at 12 months. Compared with the medical group, patients in the revascularization group had a relative improvement of 116.9% for pain, 41% for VascuQol, 39.1% for distance, 18% for EQ-5D, 15.6% for speed, 13.5% for CSI and 9.7% for stair climb, according to the findings.
“Revascularization procedures have traditionally been offered only to patients with the most incapacitating claudication, in part because of a low risk of progression of claudication to limb loss and the potential for procedure-related complications that might result in limb loss. The results of this ... study ... suggest that function, health-related quality of life and symptoms improved between baseline and 12 months in both the medical and revascularization cohorts, but the findings indicate that gains were much greater in the revascularization cohort,” Emily B Devine, PhD, PharmD, MBA, from the Pharmaceutical Outcomes Research and Policy Program, University of Washington, and colleagues concluded.
Philip P. Goodney, MD, MS, from the section of vascular surgery at Dartmouth-Hitchcock Medical Center, New Hampshire; the Veterans Affairs Outcomes Group, White River Junction, Vermont; Dartmouth Institute for Health Policy and Clinical Practice; and The Geisel School of Medicine at Dartmouth, and Matthew A. Corriere, MD, MS, from the division of vascular surgery, department of vascular and endovascular surgery, Wake Forest University, discussed the findings in a related editorial.
“Surgeons need to be mindful in developing better ways to treat patients with claudication and carefully measure their patient-reported outcomes. First, the key to treating patients with claudication is good measurement and selection, especially given recent media attention. Second, and just as important, the key to improving patient-reported outcome collection may be making the process easy for the end users, namely, patients and health care professionals, and it may be time to redesign the reporting process with their needs in mind,” Goodney and Corriere wrote. – by Jennifer Byrne
Disclosure: The researchers, Corriere and Goodney report no relevant financial disclosures.