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.
Key Findings
Methods
The THRILLER registry enrolled a large real-world cohort of CLTI patients undergoing popliteal or infrapopliteal endovascular revascularization in seven Dutch hospitals.
Between February 2021 and December 2023, 1,119 interventions in 1,060 limbs (938 patients) were included.
Median follow-up was 43.6 months (Q1-Q3: 35.5-52.7 months).
The design was a prospective multicenter registry of consecutive patients; primary outcomes were limb salvage and amputation-free survival (AFS) at 24 months, estimated with Kaplan-Meier.
Results
The cohort had advanced disease severity at presentation, with most limbs having tissue loss.
78.4% (831/1,060) of limbs were Rutherford 5 and 8.1% (86/1,060) were Rutherford 6.
41.3% (382/926) of limbs were WIfI stage 4.
Results
Technical success of the endovascular interventions was high.
Technical success was achieved in 92.3% (1,033/1,119) of interventions.
Results
Limb salvage and amputation-free survival were significantly worse after technical failure and with increasing WIfI stage and Rutherford category.
Limb salvage and AFS 'decreased significantly after technical failure and with increasing WIfI stage and Rutherford category'.
Results
Rutherford 6 limbs had significantly worse limb salvage and AFS than Rutherford 5 limbs.
Limb salvage: HR 3.07; 95% CI 1.89-4.99; P < 0.001.
AFS: HR 2.07; 95% CI 1.50-2.86; P < 0.001.
Results
The excess AFS risk for Rutherford 6 limbs was concentrated in the first 3 months after intervention.
For AFS, the HR in the first 3 months was 14.13 (95% CI 4.94-40.38) versus Rutherford 4; P < 0.001.
Conclusions
The authors conclude endovascular revascularization for popliteal/infrapopliteal CLTI is safe and effective in preventing limb loss and mortality at 2 years.
Patients with Rutherford 6 limbs face significantly worse outcomes, particularly in the first 3 months.
Background context: over 70% of CLTI patients have below-the-knee disease and endovascular revascularization is increasingly used.
What This Means
This study followed over 900 patients in the Netherlands who had severe blockages in the arteries of the lower leg and foot (chronic limb-threatening ischemia) and were treated with minimally invasive procedures to reopen the vessels. Most had open wounds or tissue loss, and many had advanced disease. The procedures were technically successful in about 92% of cases.
This research suggests the approach is safe and effective at helping patients avoid amputation and death over two years. However, outcomes were worse when the procedure was not technically successful and as disease severity rose. Patients with the most advanced disease (Rutherford 6, with extensive tissue loss) had notably higher risks of amputation or death, especially in the first three months after treatment.
These findings come from a real-world registry rather than a randomized trial, so they describe outcomes rather than compare treatments. They may help clinicians and patients set expectations and consider how disease severity affects the outlook after endovascular treatment.
Stolk D, Hazenberg C, Nugteren M, Bakker O, Dinkelman M, Fioole B, et al.. (2026). Two-Year Outcomes of the Prospective THRILLER Registry on Popliteal and Infrapopliteal Endovascular Interventions for CLTI.. JACC. Cardiovascular interventions. https://doi.org/10.1016/j.jcin.2026.07.044