Randomized clinical trial of duplex ultrasound surveillance after endovascular therapy for chronic limb-threatening ischemia.

Abstract

This study aimed to assess whether duplex ultrasound (DUS) surveillance yielded a better outcome compared with ankle-brachial index (ABI) surveillance after femoropopliteal endovascular therapy (EVT) in a cohort of patients affected by chronic limb-threatening ischemia (CLTI). A single-center randomized controlled trial was conducted on consecutive admissions of patients with CLTI who underwent infra-inguinal EVT between March 2018 and January 2021. On the day after the operation, 203 patients were randomized to the ABI group (n = 103) or DUS group (n = 100) for follow-up at 1, 3, 6, 9, and 12 months, and every 6 months thereafter. The primary endpoint was femoropopliteal primary assisted patency (PAP), secondary patency (SP), and amputation-free survival (AFS) rates, and secondary endpoints included overall survival (OS) and freedom from reintervention (FFR) rates. Survival curves were presented as Kaplan-Meier plots. Log-rank tests were performed to compare the differences between the groups. After the early postprocedural period (≤30 days), 185 patients alive with a patent treated segment remained in the study (ABI group, n = 98; DUS group, n = 87). The average age was 72.3 years (55.7% female; 84.3% had hypertension; 81% had diabetes; and 88.6% had tissue loss). The overall mean follow-up period was 517 days (95% confidence interval, 440-574 days), with no statistical differences between the groups. Survival curves using the Kaplan-Meier method were reported considering a follow-up time of 540 days. There were no statistical differences in primary patency rate between the ABI group and the DUS group (56% vs 59%, respectively; P = .30). However, there was a statistical difference between the groups in PAP rate (67% vs 78%, respectively; P = .04) and SP rate (78% vs 86%, respectively; P = .02). There were no statistically significant differences between the groups in AFS rate (69% vs 82%, respectively; P = .07), OS rate (73% vs 83%, respectively; P = .20), and in FFR rate (66% vs 65%, respectively; P = 1.0). This single-center randomized controlled trial of patients with CLTI showed a significant benefit in terms of improved femoropopliteal PAP and SP rates in patients who underwent follow-up with DUS surveillance after infra-inguinal EVT; however, there was no difference in AFS, OS, and FFR rates between the groups. Our findings may contribute to the more comprehensive use of DUS surveillance after endovascular revascularization.