Does endovascular treatment of infra-inguinal arterial disease with drug-eluting stents offer better results than angioplasty with or without bare metal stents?

Abstract

A best evidence topic in vascular and endovascular surgery was developed according to a structured protocol. The question addressed was whether treatment of infra-inguinal arterial occlusive disease with drug-eluting stents (DESs) provides improved outcomes compared with bare metal stents (BMSs) or percutaneous balloon angioplasty (PTA) alone. Altogether, 136 papers were found using the reported searches, of which 5 provided the best evidence to answer the question. All papers represent either level 1 or 2 evidence. The authors, journal, date, country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Main outcome measures varied among the studies, and included patency, in-stent restenosis, target lesion revascularization, major adverse events, clinical improvement and limb salvage. Evidence on the comparative efficacy of DESs in femoro-popliteal arterial disease is mainly based on two randomized, controlled trials. Paclitaxel-eluting stents were evaluated in the Zilver PTX trial and demonstrated superior 2-year results to either BMSs or PTA, as indicated/shown by patency (DES vs PTA, 74.8 vs 26.5%, P < 0.01), clinical benefit (DES vs PTA, P < 0.01) and event-free survival (DES vs PTA, 86.6 vs 77.9%, P = 0.02). However, the SIROCCO trial found that the sirolimus-eluting stent did not exhibit statistically significant differences in 2-year in-stent restenosis (22.9 vs 21.1%) and target lesion revascularization (6 vs 13%) compared with the BMS. Treatment of infra-politeal arterial disease with DESs was related with superior outcomes to those of BMSs, as indicated/shown by patency, freedom from target lesion revascularization and freedom from major adverse events. Furthermore, the ACHILLES trial, the only published trial comparing the infra-popliteal DES with PTA, revealed lower angiographic restenosis (22.4 vs 41.9%, P = 0.019) and greater vessel patency (75 vs 57.1%, P = 0.025) in the DES group at 1 year. However, data related to clinical parameters in patients with critical limb ischaemia secondary to infrageniculate arterial disease, such as limb salvage and ulcer healing, are insufficient. In conclusion, treatment of infra-inguinal arterial disease with DES is safe and seems to be superior to treatment with PTA alone or BMS. The role of DES in sustained improvement in clinical outcome end-points, such as limb salvage, remains to be elucidated.

Keywords: Angioplasty; Drug-eluting stents; Endovascular; Femoro-politeal disease; Infra-popliteal disease.