| Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study. | |
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MedLine Citation:
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PMID: 20449934 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. METHODS AND RESULTS: Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. CONCLUSIONS: A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions. |
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Authors:
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Alfredo E Rodriguez; Andrew Maree; Sonia Tarragona; Carlos Fernandez-Pereira; Omar Santaera; Alfredo M Rodriguez Granillo; Gaston A Rodriguez-Granillo; Miguel Russo-Felssen; Neville Kukreja; David Antoniucci; Igor F Palacios; Patrick W Serruys; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology Volume: 5 ISSN: 1969-6213 ISO Abbreviation: EuroIntervention Publication Date: 2009 Jun |
Date Detail:
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Created Date: 2010-05-07 Completed Date: 2010-08-12 Revised Date: 2012-01-30 |
Medline Journal Info:
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Nlm Unique ID: 101251040 Medline TA: EuroIntervention Country: France |
Other Details:
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Languages: eng Pagination: 255-64 Citation Subset: IM |
Affiliation:
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Cardiovascular Research Center (CECI), Sanatorio Otamendi, Buenos Aires, Argentina. rodrigueza@sanatorio-otamendi.com.ar |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00552669 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Aged Angioplasty, Balloon, Coronary / adverse effects, economics, instrumentation*, mortality Argentina Cardiovascular Agents / administration & dosage* Coronary Angiography Coronary Artery Disease / drug therapy, economics, mortality, radiography, therapy* Coronary Restenosis / economics, etiology, mortality, prevention & control*, radiography Cost Savings Drug-Eluting Stents* Female Health Care Costs Hospital Mortality Humans Kaplan-Meier Estimate Logistic Models Male Metals* Middle Aged Myocardial Infarction / etiology Proportional Hazards Models Prospective Studies Prosthesis Design Risk Assessment Sirolimus / administration & dosage* Stents* Stroke / etiology Time Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Cardiovascular Agents; 0/Metals; 53123-88-9/Sirolimus |
| Investigator | |
Investigator/Affiliation:
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Alfredo E Rodriguez / ; Igor F Palacios / ; Patrick W Serruys / ; Andrew Maree / ; Sonia Tarragona / ; Jorge Tronge / ; Arnoldo Dubin / ; Cristina Sivori / ; Alejandro Crespo / ; David Antoniucci / ; Omar Santaera / ; Alberto Sampaolesi / ; Miguel Russo-Felssen / ; Valeria Curotto / ; Alfredo M Rodriguez-Granillo / ; Sonia Tarragona / ; Gaston A Rodriguez-Granillo / ; Miguel Rosales / ; Alfredo E Rodriguez / ; Carlos Fernandez-Pereira / ; Juan Mieres / ; Gaston A Rodriguez-Granill / ; Gustavo Risau / ; Pablo Boskis / ; Mario Boskis / ; Carlos Fernandez-Pereira / ; Carlos Mauvecin / ; Gustavo Allende / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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