title: Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial.
abstract: OBJECTIVE
  The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy.
  
  
  BACKGROUND
  OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown.
  
  
  METHODS
  In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR.
  
  
  RESULTS
  Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test.
  
  
  CONCLUSIONS
  At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS.
authors: Cardiac Unit, Sanatorio Otamendi, Buenos Aires, Argentina. arodriguez@centroceci.com.ar
authors: Alfredo E
authors: AE
authors: Rodriguez
authors: Alfredo M
authors: AM
authors: Rodriguez-Granillo
authors: David
authors: D
authors: Antoniucci
authors: Juan
authors: J
authors: Mieres
authors: Carlos
authors: C
authors: Fernandez-Pereira
authors: Gaston A
authors: GA
authors: Rodriguez-Granillo
authors: Omar
authors: O
authors: Santaera
authors: Bibiana
authors: B
authors: Rubilar
authors: Igor F
authors: IF
authors: Palacios
authors: Patrick W
authors: PW
authors: Serruys
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001118:Argentina; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000191:economics*; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D023903:Coronary Restenosis / Q000191:economics / Q000209:etiology; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D054855:Drug-Eluting Stents / Q000191:economics*; D005260:Female; D017048:Health Care Costs; D017721:Hospital Costs; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals / Q000191:economics*; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000191:economics / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000191:economics* / Q000295:instrumentation / Q000401:mortality; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000191:economics*; D015607:Stents / Q000191:economics*; D020521:Stroke / Q000191:economics / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D020123:Sirolimus