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Original Investigation |

Effectiveness of a Medical vs Revascularization Intervention for Intermittent Leg Claudication Based on Patient-Reported Outcomes ONLINE FIRST

Emily B. Devine, PhD, PharmD, MBA1,2,3,4,5; Rafael Alfonso-Cristancho, MD, MSc, PhD1,2,5; N. David Yanez, PhD6,7; Todd C. Edwards, PhD3,5,8; Donald L Patrick, PhD, MSPH1,3,5,8; Cheryl A. L. Armstrong, RN, MPH2; Allison Devlin, MS2,5; Rebecca G. Symons, MPH2; Mark H. Meissner, MD9; Ellen L. T. Derrick, MD, MPH10; Danielle C. Lavallee, PhD, PharmD1,2,5; Larry G. Kessler, ScD1,3,5; David R. Flum, MD, MPH1,2,3,5 ; for the Comparative Effectiveness Research Translation Network (CERTAIN) Collaborative
[+] Author Affiliations
1Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle
2Surgical Outcomes Research Center, University of Washington, Seattle
3Department of Health Services, University of Washington, Seattle
4Department of Biomedical Informatics, University of Washington, Seattle
5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle
6Department of Biostatistics, University of Washington, Seattle
7School of Public Health, Oregon Health & Science University, Portland
8Seattle Quality of Life Group, University of Washington, Seattle
9Department of Surgery, University of Washington, Seattle
10Providence Everett Medical Center, Everett, Washington
JAMA Surg. Published online August 17, 2016. doi:10.1001/jamasurg.2016.2024
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Importance  Intermittent claudication (IC) is the most common presentation of infrainguinal peripheral artery disease. Both medical and revascularization interventions for IC aim to increase walking comfort and distance, but there is inconclusive evidence of the comparative benefit of revascularization given the possible risk of limb loss.

Objective  To compare the effectiveness of a medical (walking program, smoking cessation counseling, and medications) vs revascularization (endovascular or surgical) intervention for IC in the community, focusing on outcomes of greatest importance to patients.

Design, Setting, and Participants  Longitudinal (12-month follow-up) prospective observational cohort study conducted between July 3, 2011, and November 5, 2014, at 15 clinics associated with 11 hospitals in Washington State. Participants were 21 years or older with newly diagnosed or established IC.

Interventions  Medical or revascularization interventions.

Main Outcomes and Measures  Primary end points were 12-month change scores on the distance, speed, and stair-climb domains of the Walking Impairment Questionnaire (score range, 0-100). Secondary outcomes were change scores on the Walking Impairment Questionnaire pain domain (score range, 0-100), Vascular Quality of Life Questionnaire (VascuQol) (score range, 1-7), European Quality of Life–5 Dimension Questionnaire (EQ-5D) (score range, 0-1), and Claudication Symptom Instrument (CSI) (score range, 0-4).

Results  A total of 323 adults were enrolled, with 282 (87.3%) in the medical cohort. At baseline, the mean duration of disease was longer for participants in the medical cohort, while those in the revascularization cohort reported more severe disease. Other characteristics were well balanced. At 12 months, change scores in the medical cohort reached significance for the following 3 outcomes: speed (5.9; 95% CI, 0.5-11.3; P = .03), VascuQol (0.28; 95% CI, 0.08-0.49; P = .008), and EQ-5D (0.038; 95% CI, 0.011-0.066; P = .006). In the revascularization cohort, there were significant improvements in the following 7 outcomes: distance (19.5; 95% CI, 7.9-31.0; P = .001), speed (12.1; 95% CI, 1.4-22.8; P = .03), stair climb (11.4; 95% CI, 1.3-21.5; P = .03), pain (20.7; 95% CI, 11.0-30.4; P < .001), VascuQol (1.10; 95% CI, 0.80-1.41; P < .001), EQ-5D (0.113; 95% CI, 0.067-0.159; P < .001), and CSI (−0.63; 95% CI, −0.96 to −0.31; P < .001). Relative improvements (percentage changes) at 12 months in the revascularization cohort over the medical cohort were observed as follows: distance (39.1%), speed (15.6%), stair climb (9.7%), pain (116.9%), VascuQol (41%), EQ-5D (18%), and CSI (13.5%).

Conclusions and Relevance  Among patients with IC, those in the revascularization cohort had significantly improved function (Walking Impairment Questionnaire), better health-related quality of life (VascuQol and EQ-5D), and fewer symptoms (CSI) at 12 months compared with those in the medical cohort, providing important information to inform treatment strategies in the community.

Figures in this Article

Figures

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Figure 1.
Participant Flow Diagram

Shown are the numbers of patients from baseline to 6 months.

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Figure 2.
Walking Impairment Questionnaire (WIQ)

Shown are adjusted score estimates over time. Bars represent SEs.

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Figure 3.
Quality of Life and Symptom Assessment

Shown are adjusted score estimates over time. Bars represent SEs. CSI indicates Claudication Symptom Instrument; EQ-5D, European Quality of Life–5 Dimension Questionnaire; and VascuQoL, Vascular Quality of Life Questionnaire.

Graphic Jump Location

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