NCT Number: NCT00552669
In 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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Clinica IMA, Adrogué, Buenos Aires, Argentina
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 .
Other names: Oral rapamycine
Any Drug eluting stent
Other names: DES=Drug Eluting Stents), PES (Paclitaxel Eluting Stent), SES (Sirolimus eluting stent), ZES (Zotarolimus eluting stent)
Time frame: Follow up will be conducted by the coordinating Center at 18 months of follow up
Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.
Time frame: 18 Months
Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.
Time frame: 18 months
Efficacy end point was TVR as revasacularization of the treated vessel.
Centro de estudios en Cardiologia Intervencionista
Other
Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.
Acronym: ORAR III
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