Clinical trial NCT00552669: Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
Official title: Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Coronary Restenosis
Keywords: Drug Eluting Stents
Stents Bare Metal
Stent Thrombosis
Coronary revascularization
Survival
Lead sponsor: Centro de estudios en Cardiologia Intervencionista
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
timeFrame: Follow up will be conducted by the coordinating Center at 18 months of follow up
Secondary outcomes:
measure: Major Adverse Cardiovascular Events (MACCE)
timeFrame: 18 Months
measure: Target Vessel Revascularization (TVR)
timeFrame: 18 months
Other outcomes:
Locations:
city: Adrogue
country: Argentina
facility: Clinica IMA
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Sanatorio Las Lomas
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Sanatorio Otamendi y Miroli
Study officials:
affiliation: Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
name: Alfredo E Rodriguez, MD PhD FACC
role: STUDY_CHAIR
affiliation: Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
name: Carlos Fernandez Pereira, MD
role: STUDY_DIRECTOR
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