title: First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial.
abstract: OBJECTIVE
  The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy.
  
  
  RESULTS
  This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis.
  
  
  CONCLUSIONS
  Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.
authors.affiliation: Department of Interventional Cardiology, Heart Institute-InCor, University of São Paulo, São Paulo, Brazil.
authors.forename: Expedito E
authors.initials: EE
authors.lastname: Ribeiro
authors.forename: Carlos M
authors.initials: CM
authors.lastname: Campos
authors.forename: Henrique B
authors.initials: HB
authors.lastname: Ribeiro
authors.forename: Augusto C
authors.initials: AC
authors.lastname: Lopes
authors.forename: Rodrigo B
authors.initials: RB
authors.lastname: Esper
authors.forename: George X
authors.initials: GX
authors.lastname: Meirelles
authors.forename: Marco A
authors.initials: MA
authors.lastname: Perin
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Lemos
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001938:Brazil; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023921:Coronary Stenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D002858:Chromium Alloys; D020123:Sirolimus