Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

Abstract

Background:

Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions.

Objectives:

This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm.

Methods:

All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis >70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1- and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates.

Results:

Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1- and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency (P = .022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing.

Conclusions:

The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.