Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Centro de estudios en Cardiologia Intervencionista