Real-World Comparison of Drug-Eluting and Bare-Metal Stents in Superficial Femoral Artery Occlusive Disease with Trans-Atlantic Intersociety Consensus B Lesions: A 2-Year, Single-Institute Study.

BACKGROUND: Endovascular stenting has surpassed bypass surgery to become the first-line treatment for superficial femoral artery (SFA) occlusive disease, and various types of stents including bare-metal stents (BMSs), covered stents, and drug-eluting stents (DESs), have been approved for treatment. This retrospective, single-institute study compared the short-term, real-world outcomes of BMSs and DESs for treating SFA occlusive disease.
METHODS: A retrospective chart review was used to enroll 94 patients who received a DES (n = 24) or BMS (n = 70) between 2009 and 2014. All patients had SFA occlusive disease with critical limb ischemia and an intermediate length of SFA occlusion [Trans-Atlantic Intersociety Consensus (TASC)-II B lesions] and were regularly followed for 2 years. All patient characteristics, procedural details, and outcomes were recorded.
RESULTS: The 1-year primary patency rates in the BMS and DES groups were 71.4% and 87.5% (p = 0.169), respectively, and the corresponding 2-year rates were 61.4% and 79.2% (p = 0.139). The target lesion revascularization rate was 38.6% versus 20.8% (p = 0.139), the in-stent restenosis rate was 22.9% versus 0% (p = 0.009), the major limb amputation rate was 4.3% versus 0% (p = 0.568), the peripheral arterial disease-related mortality rate was 8.6% versus 0% (p = 0.332), and the all-cause mortality rate was 11.4% versus 0% (p = 0.109), respectively.
CONCLUSIONS: The 2-year results revealed higher safety, superior efficacy, and greater clinical benefits of DESs than BMSs for treating TASC-II B SFA occlusive disease. However, more cases and long-term follow-up are warranted.