Retrievable Scaffold Therapy Combined with Sirolimus-coated Balloon Angioplasty for Infrapopliteal Artery Disease: Final Results from the DEEPER LIMUS Trial.

PURPOSE

To evaluate the safety and efficacy of retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty for treating infrapopliteal artery lesions.

METHODS

The DEEPER LIMUS study enrolled Rutherford class 3 to 5 patients with infrapopliteal artery disease. Patients underwent vessel preparation with retrievable scaffold therapy followed by sirolimus-coated balloon angioplasty. The primary safety outcome measure was a composite of all-cause mortality, major amputation, or clinically driven target lesion revascularization at 6 months. Secondary outcome measures included acute vessel recoil, perioperative death, angiographic late lumen loss between post-procedure and 6 months, as well as primary patency, major amputation, change in Rutherford class, and wound healing through 12 months.

RESULTS

The study included 26 patients (mean age 71 years, 62% male, 88% Rutherford 5) with 28 treated infrapopliteal lesions (36% occluded, 54% TASC B/C). Acute vessel recoil, measured in seven patients, was negligible (2.4 mm after treatment vs. 2.3 mm 15 minutes after deployment). A 6-month primary safety event occurred in 11.5% of patients (1 all-cause mortality, 1 major amputation, 1 clinically driven target lesion revascularization). Late lumen loss at 6 months was 0.7±0.7 mm. At 12 months, primary patency was 89.5%, improvement in Rutherford class was observed in 68.2% of patients, 90% of patients were deemed very low/low major limb amputation risk based on Wound, Ischemia, and foot Infection (WIfI) scores, and no additional major amputations or clinically driven target lesion revascularizations were reported.

CONCLUSIONS

Retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty demonstrated promising safety and efficacy through 12 months in patients with infrapopliteal artery disease.

LEVEL OF EVIDENCE IV

Case Series.