Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents (ORAR III)

Centro de estudios en Cardiologia Intervencionista

Status and phase: Completed; Phase 4

Conditions: Coronary Restenosis; Coronary Heart Disease

Treatments: Device: Drug Eluting stent; Drug: Oral sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00552669

02-IMA (Other Identifier)

1-Rodriguez

01-CECI (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A--Oral Rapamycin plus BMS

Experimental group

Description:

Oral sirolimus plus bare metal stent implantation

Treatment:

Drug: Oral sirolimus

B -- Drug Eluting Stent

Active Comparator group

Description:

Drug Eluting Stents

Treatment:

Device: Drug Eluting stent