Impact of Early Intervention on Health Status Outcomes in Peripheral Artery Disease Patients with Chronic Total Occlusion Lesions Using the PORTRAIT Registry

Abstract

To analyze the impact of non-invasive and early invasive treatments on health status in patients with lower extremity peripheral arterial disease (PAD) without and with chronic total occlusions (CTO) after 12 months of follow-up. Using the international (U.S., Netherlands, and Australia) observational longitudinal PORTRAIT registry, we included patients with recent PAD symptoms between June 2011 and December 2015. We assessed the PAD-specific health status at initial visit, 3-, 6- and 12-month follow-up using the Peripheral Arterial Questionnaire (PAQ). On a propensity matched-weighted cohort, we compared patients' characteristics by CTO status and treatment groups as early invasive (revascularization in the 3 months) vs. non-invasive (exercise, medical therapies, or smoking cessation). We then assessed the health status trajectory over 12 months, as 3-way interaction between CTO status, and treatment groups, and months, using a multilevel generalized linear regression model for repeated measures adjusted for baseline health status with random effects at sites- and patients-level. We included 581 participants, with mean age of 66.62±9.33 years, 34.3% female, and 90.8% White, of whom 353 (60.8%) without and 228 (39.2%) with a CTO lesion. Respectively, 96 (27.2%) and 70 (30.7%) patients underwent early invasive treatment (d=0.07). While patients with CTO were more likely to have lower resting ABI, multilevel disease, and to experience severe claudication vs. their counterparts (|d|≥0.20); the patients' health status at baseline with CTO was not different from those without CTO, with mean Summary scores of 45.14±20.26 vs. 45.90±21.24 (d=0.04), respectively. The trajectory did not differ by CTO status (interaction CTO status*month: p=0.517) and was higher in early invasive vs. non-invasive treatment (treatment*month: p<0.001), regardless of CTO status (CTO status*treatment: p=0.981 and CTO status*treatment*month: p=0.264). The score increased over time with the largest improvement occurring at 3 months in both non-invasive (non-CTO: +7.82 95%CI 4.03;11.60 and CTO: +9.27 95%CI 4.45;14.09) and early invasive (non-CTO: +26.17 95%CI 20.06; 32.28 and CTO: +24.52 95%CI 17.40;31.64) groups. The mean score in CTO vs. non-CTO did not differ at each timepoint, with the 12-month mean score of 70.26 (95%CI 67.87; 74.65) vs. 71.17 (95% CI 65.91; 76.44) (p=0.99) in the non-invasive treatment and 84.93 (95%CI 78.90;90.97) vs. 79.20 (95%CI 72.77;86.14) (p=0.31) in the early invasive treatment. Patients with symptomatic PAD undergoing early revascularization exhibited higher health status over time vs. those undergoing non-invasive treatment strategy, irrespective of the presence of CTOs. The degree of the improvement was greater in the 3 months following the initial visit, especially in patients undergoing early revascularization.