Randomized clinical trial of duplex ultrasound surveillance after endovascular therapy for chronic limb-threatening
Marcos Roberto Godoy1, Francisco Cardoso Brochado-Neto1, Marcus Vinícius Martins Cury1
1Department of Vascular and Endovascular Surgery, Institute of Medical Assistance to the State Public Servant, Sao Paulo, Brazil.
Insights
Duplex ultrasound (DUS) surveillance improved femoropopliteal primary assisted patency and secondary patency rates compared to ankle-brachial index (ABI) surveillance after endovascular therapy for chronic limb-threatening ischemia. Amputation-free survival did not differ between groups.
Area of Science:
- Vascular Surgery
- Interventional Radiology
- Medical Imaging
Background:
- Chronic limb-threatening ischemia (CLTI) poses significant risks, necessitating effective post-treatment surveillance.
- Femoropopliteal endovascular therapy (EVT) is a common treatment for CLTI.
- Optimizing surveillance strategies after EVT is crucial for patient outcomes.
Purpose of the Study:
- To compare duplex ultrasound (DUS) surveillance with ankle-brachial index (ABI) surveillance after femoropopliteal EVT in CLTI patients.
- To assess the impact of surveillance method on key vascular patency and survival endpoints.
Main Methods:
- A single-center randomized controlled trial involving 203 CLTI patients undergoing infra-inguinal EVT.
- Patients were randomized to ABI or DUS surveillance groups.
- Primary endpoints included primary assisted patency (PAP), secondary patency (SP), and amputation-free survival (AFS).
Main Results:
- No significant difference in overall primary patency rate between ABI and DUS groups (56% vs 59%, P=.30).
- DUS surveillance showed statistically significant improvements in PAP (67% vs 78%, P=.04) and SP (78% vs 86%, P=.02) rates.
- No significant differences were observed in AFS, overall survival (OS), or freedom from reintervention (FFR) rates.
Conclusions:
- DUS surveillance offers a significant benefit for femoropopliteal PAP and SP rates post-EVT in CLTI patients.
- While patency improved, AFS, OS, and FFR rates were similar between DUS and ABI surveillance groups.
- Findings support increased consideration of DUS for surveillance after endovascular revascularization.
Objective:
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).
Methods:
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.
Results:
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).
Conclusions:
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.
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