Two-Year Outcomes of the Prospective THRILLER Registry on Popliteal and Infrapopliteal Endovascular Interventions for CLTI.
Abstract
Background
Over 70% of patients with chronic limb-threatening ischemia (CLTI) present with below-the-knee disease, and there is a growing trend towards endovascular revascularization.
Objectives
The Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) aimed to provide real-world data on outcomes after popliteal and infrapopliteal endovascular revascularization to guide revascularization strategies.
Methods
This prospective multicenter registry included consecutive CLTI patients undergoing popliteal or infrapopliteal endovascular revascularization in seven Dutch hospitals. Primary outcomes were limb salvage and amputation-free survival (AFS) at 24 months, estimated using the Kaplan-Meier method.
Results
Between February 2021 and December 2023, a total of 1,119 interventions in 1,060 limbs (938 patients) were included, treating 551 popliteal, 1,352 tibial, and 239 pedal lesions. The median follow-up was 43.6 months (Q1-Q3: 35.5-52.7 months). Overall, 78.4% (831/1,060) of the limbs were Rutherford 5 and 8.1% (86/1,060) were Rutherford 6; 41.3% (382/926) were WIfI (Wound, Ischemia, and foot Infection) stage 4. Technical success was achieved in 92.3% (1,033/1,119). Limb salvage and AFS decreased significantly after technical failure and with increasing WIfI stage and Rutherford category. Compared to Rutherford 5, Rutherford 6 limbs had significantly worse limb salvage (HR: 3.07; 95% CI: 1.89-4.99; P < 0.001) and AFS (HR: 2.07; 95% CI: 1.50-2.86; P < 0.001). For AFS, the excess risk of Rutherford 6 was greatest in the first 3 months (HR: 14.13; 95% CI: 4.94-40.38 vs Rutherford 4; P < 0.001).
Conclusions
Endovascular revascularization for popliteal and infrapopliteal disease in patients with CLTI is safe and effective in preventing limb loss and mortality at 2 years, although patients with Rutherford 6 limbs face significantly worse outcomes, particularly in the first 3 months.