Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents

NCT ID: NCT00552669

Last Updated: 2010-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-09-30

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).

Conditions

Coronary Heart Disease; Coronary Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

A--Oral Rapamycin plus BMS

Oral sirolimus plus bare metal stent implantation

Group Type: EXPERIMENTAL

Oral sirolimus

Intervention Type: DRUG

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 .

B -- Drug Eluting Stent

Drug Eluting Stents

Group Type: ACTIVE_COMPARATOR

Drug Eluting stent

Intervention Type: DEVICE

Any Drug eluting stent

Interventions

Oral sirolimus

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 .

Intervention Type: DRUG

Drug Eluting stent

Any Drug eluting stent

Intervention Type: DEVICE

Other Intervention Names

Oral rapamycine; DES=Drug Eluting Stents); PES (Paclitaxel Eluting Stent); SES (Sirolimus eluting stent); ZES (Zotarolimus eluting stent)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro de estudios en Cardiologia Intervencionista

OTHER

Sponsor Role: lead

Responsible Party

Centro de Estudios en Cardiologia Intervencionista

Principal Investigators

Alfredo E Rodriguez, MD PhD FACC

Role: STUDY_CHAIR

Departamento de Cardiologia Intervencionista, Sanatorio Otamendi

Carlos Fernandez Pereira, MD

Role: STUDY_DIRECTOR

Departamento de Cardiologia Intervencionista, Sanatorio Otamendi

Locations

Clinica IMA

Adrogué, Buenos Aires, Argentina

Sanatorio Otamendi y Miroli

Buenos Aires, Buenos Aires, Argentina

Sanatorio Las Lomas

San Isidro, Buenos Aires, Argentina

Countries

Argentina

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Reference Type: DERIVED

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Rodriguez AE, Maree A, Tarragona S, Fernandez-Pereira C, Santaera O, Rodriguez Granillo AM, Rodriguez-Granillo GA, Russo-Felssen M, Kukreja N, Antoniucci D, Palacios IF, Serruys PW; ORAR III Investigators. Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study. EuroIntervention. 2009 Jun;5(2):255-64. doi: 10.4244/eijv5i2a40.

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http://www.ncbi.nlm.nih.gov/sites/entrez

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Other Identifiers

01-CECI

Identifier Type: OTHER

Identifier Source: secondary_id

02-IMA

Identifier Type: OTHER

Identifier Source: secondary_id

1-Rodriguez

Identifier Type: -

Identifier Source: org_study_id