Official Title: “Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.”

In a previous randomized comparison, oral sirolimus plus bare metal stents compared to bare metal stent implantation alone, demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis(ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2:53-60).Taking in account that 8.3% of patients treated with oral rapamycin plus Bare Metal Stents (ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical restenosis(ERACI III Registry,EuroIntervention 2006)we sought to compare differences in overall cost with both revascularization strategies at one, two, three and five years of follow up assuming that safety and efficacy clinical end points would be similar.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with oral sirolimus plus bare metal stent implantation (100 patients) or DES(100 patients).

Intervention(s) in this Clinical Trial

• Drug: Oral sirolimus
  • Oral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .
• Device: Drug Eluting stent
  • Any Drug eluting stent

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Oral sirolimus plus bare metal stent implantation
• Active Comparator: B
  • Drug Eluting Stents

Primary Measures

• Differences in procedural and follow up cost between Oral sirolimus plus BMS implantation versus and DES in de novo coronary lesions.
  • Time Frame: Follow up will be conducted by the coordinating Center at one ,two,three and five years of follow up
    

Secondary Measures

• Death from any cause,myocardial infarction and stroke. Safety was analyzed as MACCE(major adverse cardiovascular events)including death,MI and stroke.Efficacy end point was Target Vessel and Target Lesion Revascularization
  • Time Frame: Al secondary safety and efficacy end points was analyzed at one ,two,three and five years of follow up
    

Inclusion Criteria:

• Indication of revascularization
• De novo lesions
• Native vessels
• Suitable for stent placement

Exclusion Criteria:

• Acute myocardial infarction within the last 24 hours
• In stent restenosis
• Previous percutaneous coronary intervention within the last 6 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centro de estudios en Cardiologia Intervencionista

Overall Clinical Trial Officials and Contacts

Alfredo E Rodriguez, MD PhD FACC Study Chair Departamento de Cardiologia Intervencionista, Sanatorio Otamendi  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00552669

Study ID Number: 1-Rodriguez

ClinicalTrials.gov Identifier: NCT00552669

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica