title: Comparison of Biolimus Versus Everolimus for Drug-Eluting Stents in the Percutaneous Treatment of Infra-Inguinal Arterial Disease.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy.
authors.forename: Arturo
authors.initials: A
authors.lastname: Giordano
authors.affiliation: Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Ferraro
authors.affiliation: Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Corcione
authors.affiliation: Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Messina
authors.affiliation: Unità Operativa di Interventistica Cardiovascolare, Presidio Ospedaliero Pineta Grande, Castel Volturno, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Maresca
authors.affiliation: Division of Cardiac Surgery, San Giovanni di Dio e Ruggi D`Aragona Hospital, Salerno, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Coscioni
authors.affiliation: Unità Operativa di Emodinamica, Casa di Salute Santa Lucia, San Giuseppe Vesuviano, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Avellino
authors.affiliation: Unità Operativa di Emodinamica, Casa di Salute Santa Lucia, San Giuseppe Vesuviano, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Giordano
authors.affiliation: Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Peruzzi
authors.affiliation: Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.
authors.forename: Antonino G M
authors.initials: AGM
authors.lastname: Marullo
authors.affiliation: Cardiology and Coronary Care Unit, Presidio Ospedaliero S. Giuliano, Giugliano, ASL Napoli 2 Nord, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Napolitano
authors.affiliation: Department of Molecular Medicine and Medical Biotechnology, University of Naples "Federico II", Via S. Pansini 5, 80131 Napoli, Italy.
authors.forename: Maria Fiammetta
authors.initials: MF
authors.lastname: Romano
authors.affiliation: Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D057186:Comparative Effectiveness Research; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D011474:Prosthesis Design; D012189:Retrospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; C518022:umirolimus; D020123:Sirolimus
keywords: Biolimus; drug-eluting stent; everolimus; peripheral artery disease; popliteal artery; stent; superficial femoral artery; umirolimus