Short Term Outcomes of a Prospective Registry of Popliteal and Infrapopliteal Endovascular Interventions for Chronic Limb Threatening Ischaemia

Objective: The prevalence of chronic limb threatening ischaemia (CLTI) is increasing worldwide, resulting in the need for more patients to undergo revascularisation, especially for below the knee pathology. Nevertheless, prospective data on below the knee endovascular interventions are lacking. The aim of the study was to provide large scale, real world data on procedural and short term outcomes of popliteal and infrapopliteal endovascular interventions in patients with CLTI.

Methods: This study is an analysis of the first 1 000 interventions of the Dutch Chronic Lower Limb Threatening Ischaemia Registry (THRILLER). It includes all patients with CLTI undergoing popliteal or infrapopliteal endovascular revascularisation in seven hospitals in the Netherlands. The primary outcomes were limb salvage and amputation free survival (AFS) at three months estimated by the Kaplan-Meier method. Secondary outcomes were procedural complications and primary patency.

Results: Between February 2021 and July 2023, 1 000 endovascular procedures were performed in 840 patients (947 limbs), treating 486 popliteal and 1 209 tibial lesions. Wound, Ischaemia, and foot Infection (WIfI) stages 1 - 4 were present in 16.8%, 17.2%, 25.4%, and 40.6% of the limbs, respectively. Technical success was hampered by arterial perforation, acute thrombosis, and distal embolisation in 8.7%, 1.0%, and 2.3% of the interventions, respectively. Limb salvage was 100.0%, 96.9%, 94.9%, and 86.1% (p < .001), whereas AFS was 96.9%, 93.2%, 86.6%, and 76.4% for WIfI stages 1 - 4 at three months (p < .001), respectively. Primary patency at the 6 - 8 week visit was 86.4% for popliteal and 74.3% for tibial lesions, respectively.

Conclusion: THRILLER presents a large prospective database on outcomes of endovascular CLTI interventions. Popliteal and infrapopliteal endovascular revascularisation for CLTI is safe. Interventions with initial technical success have high rates of limb salvage and survival at three months. The WIfI classification provides a reliable instrument to predict limb salvage and AFS independently at three months.