Title
Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.
Phase
Phase 4Lead Sponsor
Centro de estudios en Cardiologia IntervencionistaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Coronary Heart Disease Coronary RestenosisIntervention/Treatment
sirolimus ...Study Participants
200In a previous randomized comparison oral sirolimus plus bare metal stent 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) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.
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).
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 .
Any Drug eluting stent
Oral sirolimus plus bare metal stent implantation
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
| Event Type | Organ System | Event Term | Oral Sirolimus + Bare Metal Stent | Drug Eluting Stents |
|---|
Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.
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 TVR as revasacularization of the treated vessel.
