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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
Author(s) -
Rodriguez Alfredo E.,
RodriguezGranillo Alfredo M.,
Antoniucci David,
Mieres Juan,
FernandezPereira Carlos,
RodriguezGranillo Gaston A.,
Santaera Omar,
Rubilar Bibiana,
Palacios Igor F.,
Serruys Patrick W.
Publication year - 2011
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.23352
Subject(s) - medicine , randomized controlled trial , bare metal , myocardial infarction , cost effectiveness , stroke (engine) , stent , revascularization , surgery , restenosis , mechanical engineering , risk analysis (engineering) , engineering
Objectives : 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. © 2011 Wiley Periodicals, Inc.