Background: Drug-eluting stents (DES) are now considered the most promising device to treat
peripheral artery disease (PAD) and minimize restenosis. There is uncertainty however on the best antirestenotic
drug for such devices. In particular, biolimus (i.e. umirolimus) and everolimus are two of the
most promising agents, given the extensive data in support of their coronary safety and efficacy, but their
comparative effectiveness for peripheral interventions is not established.
Methods: Building upon our extensive experience in the percutaneous treatment of infra-inguinal artery
disease with DES, we compared the acute and longterm outlook of patients treated with biolimus-eluting
stents (BES) and everolimus-eluting stents (EES). We collected baseline, procedural and outcome details
on all patients undergoing infra-inguinal BES or EES implantation. The endpoints of interest were death,
amputation, revascularization, their composite, and change in Fontaine class. A total of 80 patients were
included (20 treated with BES and 60 with EES). Most features were similar in the two groups, despite
longer lesions in the EES group. Unadjusted analysis showed similar results irrespective of the drug used,
with composite endpoint occurring, respectively, in 4 (20.0%) and 10 (16.7%) (p=0.741).
Results and Conclusion: However, analysis with inverse probability of treatment weighting showed significant
differences in the risk of revascularization (hazard ratio of BES vs EES=9.55 [95% confidence
interval 2.16-42.23], p=0.003) and composite endpoint (hazard ratio=5.11 [1.33-19.62], p=0.018). In conclusion,
EES appear superior to BES for endovascular therapy of infrainguinal artery disease. Dedicated
randomized trials are required to definitely confirm or disprove these findings.