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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.
MedLine Citation:
PMID:  22109997     Owner:  NLM     Status:  Publisher    
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 report 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 3 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). 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 2 strategies and DES strategy was not more cost-effective as compared to OR plus BMS. (word count 250) © 2011 Wiley-Liss, Inc.
Alfredo E Rodriguez; Alfredo M Rodriguez-Granillo; David Antoniucci; Juan Mieres; Carlos Fernandez-Pereira; Gaston A Rodriguez-Granillo; Omar Santaera Md; Bibiana Rubilar Md; Igor F Palacios; Patrick W Serruys;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-11-22
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  -     ISSN:  1522-726X     ISO Abbreviation:  -     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Wiley-Liss, Inc.
Cardiac Unit, Sanatorio Otamendi, Buenos Aires, Argentina; Centro de Estudios en Cardiologia Intervencionista (CECI), Buenos Aires, Argentina.
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