Esprit BTK Post-Approval Study Reports 6-Month Outcomes

October 16, 2026—Six-month results from Esprit BTK PAS were reported in patients with chronic limb-threatening ischemia (CLTI) treated with the Esprit below-the-knee (BTK) drug-eluting resorbable scaffold (DRS; Abbott).

The findings were presented by Brian DeRubertis, MD, at VIVA 2026, the Vascular Interventional Advances conference.

Esprit BTK PAS, a prospective, single-arm, multicenter, observational postapproval study, is evaluating the real-world safety and effectiveness of the Esprit BTK DRS in patients with infrapopliteal disease and CLTI.

The scaffold provides temporary vessel support and delivers everolimus before resorbing over time, leaving no permanent implant. The study follows the LIFE-BTK randomized trial, which demonstrated superior effectiveness of the scaffold compared with angioplasty.

Enrollment was completed at 210 patients across 50 sites globally, with the current analysis reporting 6-month outcomes for the first 200 enrolled patients.

As reported by VIVA, at baseline, 64% of patients had an index wound, 63% had Rutherford class 5 or 6 disease, 77% had diabetes, and 13% had end-stage renal disease. Mean lesion length was 69 mm, 59% of lesions had moderate-to-severe calcification, 23% were classified as TASC (TransAtlantic Inter-Society Consensus) D, and 43% were total occlusions.

At 6 months, freedom from clinically driven target lesion revascularization was 93.8%, and the composite rate of major adverse limb events (MALE) and perioperative death (POD) was 5.5%. MALE occurred in 3.9% of patients and POD in 1.7%, with no major reinterventions reported. Amputation-free survival was 88%, and complete wound healing was observed in 52.9% of evaluable patients. Mortality and major amputations were concentrated among patients with advanced disease.

The summary presented at VIVA noted that despite substantial clinical and lesion complexity, the Esprit BTK scaffold demonstrated favorable 6-month safety and effectiveness outcomes in patients with CLTI.