Background:
In patients with symptomatic peripheral artery disease (PAD), a key treatment goal is to improve their health status; their symptoms, function, and quality of life (QoL). While medical therapy with lifestyle changes is recommended in all, revascularization can be a consideration to alleviate PAD symptoms. We sought to compare the real-world impact of either treatment strategy on patients’ health status improvement.
Methods:
Patients with new or worsening PAD symptoms (Rutherford category 1-3), from 10 U.S. specialty vascular clinics between 2011-2015, who either underwent early revascularization (using stent, angioplasty or surgery within 3 months of enrolment) or medical management alone (statin, aspirin, cilostazol, supervised exercise therapy, risk factor (diabetes, hypertension) management) were identified from the Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry. The Peripheral Artery Questionnaire (PAQ) was used to assess patients’ disease-specific health status at enrollment and at 3, 6 and 12 months of follow up. The differences in PAQ overall summary scores, and each subdomain, were compared using an adjusted generalized linear model for repeated measures (Figure 1).
Results:
Among 797 patients (mean age of 68.6 years, 58.1% male), 226 underwent early revascularization and 571 were managed medically. At baseline, patients in the revascularization vs. medical management cohort had lower PAQ summary scores (mean ± SD; 42.6 ± 20.7 vs. 48.5 ± 22.3, P<0.001) and QoL scores (43.4 ± 23.9 vs. 50.4 ± 26.4, P<0.001). Over 1 year of follow-up, patients who underwent revascularization reported significantly higher health status over time than patients managed medically without revascularization (P <0.001 for all PAQ sub-domains; Figure 1).
Conclusion:
Patients with PAD who received early revascularization had worse health status at baseline, but they reported a greater degree of improvement over 1 year of follow-up when compared to patients managed medically without revascularization. Summarizing real-world health status benefits following a PAD diagnosis is critical to help guide preference-sensitive decisions on PAD management.
Identifying real-world evidence data sources in peer-reviewed publications: planning the Assessing Peripheral Artery Disease in Clinical Practice (APHELIA) study
