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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.

Conditions
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Coronary Heart Disease, Coronary Restenosis

Intervention / Treatment
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* Drug: Oral sirolimus
* Device: Drug Eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A--Oral Rapamycin plus BMS<br>Oral sirolimus plus bare metal stent implantation | Drug: Oral sirolimus<br>* 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 .<br>* Other names: Oral rapamycine;|
| Active Comparator: B -- Drug Eluting Stent<br>Drug Eluting Stents | Device: Drug Eluting stent<br>* Any Drug eluting stent<br>* Other names: ZES (Zotarolimus eluting stent);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. | Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions. | Follow up will be conducted by the coordinating Center at 18 months of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events (MACCE) | Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke. | 18 Months | 
| Target Vessel Revascularization (TVR) | Efficacy end point was TVR as revasacularization of the treated vessel. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stents, Stents Bare Metal, Stent Thrombosis, Coronary revascularization, Survival