Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
Study Overview
Brief 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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A--Oral Rapamycin plus BMS
Oral sirolimus plus bare metal stent implantation
Intervention: Oral sirolimus (Drug)
B -- Drug Eluting Stent
Drug Eluting Stents
Intervention: Drug Eluting stent (Device)
Outcomes
Primary Outcomes
Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
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.
Secondary Outcomes
- Major Adverse Cardiovascular Events (MACCE)(18 Months)
- Target Vessel Revascularization (TVR)(18 months)