Long-term patient-reported outcomes among patients undergoing revascularization vs medical therapy for intermittent claudication

Abstract

Objective: Society for Vascular Surgery guidelines recommend revascularization for patients with intermittent claudication (IC) if it can improve patient function and quality of life. However, it is still unclear if patients with IC achieve a significant functional benefit from surgery compared with medical management alone. This study examines the relationship between IC treatment modality (operative vs nonoperative optimal medical management) and patient-reported outcomes for physical function (PROMIS-PF) and satisfaction in social roles and activities (PROMIS-SA).

Methods: We identified patients with IC who presented for index evaluation in a vascular surgery clinic at an academic medical center between 2016 and 2021. Patients were stratified based on whether they underwent a revascularization procedure during follow-up vs continued nonoperative management with medication and recommended exercise therapy. We used linear mixed-effect models to assess the relationship between treatment modality and PROMIS-PF, PROMIS-SA, and ankle-brachial index (ABI) over time, clustering among repeat patient observations. Models were adjusted for age, sex, diabetes, Charlson Comorbidity Index, Clinical Frailty Score, tobacco use, and index ABI.

Results: A total of 225 patients with IC were identified, of which 40% (n = 89) underwent revascularization procedures (42% bypass; 58% peripheral vascular intervention) and 60% (n = 136) continued nonoperative management. Patients were followed up to 6.9 years, with an average follow-up of 5.2 ± 1.6 years. Patients who underwent revascularization were more likely to be clinically frail (P = .03), have a lower index ABI (0.55 ± 0.24 vs 0.72 ± 0.28; P < .001), and lower baseline PROMIS-PF score (36.72 ± 8.2 vs 40.40 ± 6.73; P = .01). There were no differences in patient demographics or medications between treatment groups. Examining patient-reported outcome trends over time; there were no significant differences in PROMIS-PF between groups, trends over time, or group differences over time after adjusting for covariates (P = .07, P = .13, and P =.08, respectively). However, all patients with IC significantly increased their PROMIS-SA over time (adjusted P = .019), with patients managed nonoperatively more likely to have an improvement in PROMIS-SA over time than those who underwent revascularization (adjusted P = .045).

Conclusions: Patient-reported outcomes associated with functional status and satisfaction in activities are similar for patients with IC for up to 7 years, irrespective of whether they undergo treatment with revascularization or continue nonoperative management. These findings support conservative long-term management for patients with IC.

Keywords: Intermittent claudication; Patient-reported outcome (PRO); Patient-reported outcome measure (PROM); Peripheral artery disease (PAD); Revascularization.

Figure 1:

Selection of patient cohort illustrating patient inclusion and exclusion criteria.

Figure 2:

Kaplan-Meier curve of 7-year survival, stratified by whether patients with intermittent claudication underwent revascularization surgery versus continuing medical management. CI, confidence interval.

Figure 3:

PROMIS patient reported physical function (A) and PROMIS patient reported satisfaction in social roles and activities (B) trends over time. Baseline measurements were collected prior to revascularization or at the index appointment for patients who continued medical management. * P=0.01

Figure 4:

Ankle brachial index trends over time for patients with intermittent claudication over time stratified by whether patients underwent revascularization surgery versus continuing medical management. Baseline measurements were collected prior to revascularization or at the index appointment for patients who continued medical management. * P=0.02; ** P <0.001

Figure 5:

PROMIS patient reported physical function trends for revascularized patients whose ankle brachial index (ABI) improved to the normal range (ABI normal range: 0.9 −1.2) compared to patients whose ABI did not improve after revascularization surgery. *P= 0.007

Figure 6:

Patients with intermittent claudication who underwent revascularization showing the impact of procedure type (open bypass vs. peripheral vascular intervention) on PROMIS patient reported physical function (A) and PROMIS patient reported satisfaction in social roles and activities (B) over 2-year follow up.

Figure 7:

Patients with intermittent claudication who underwent revascularization showing ankle brachial index trends over 2-year follow up stratified by procedure type.