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

NCT00552669 | Completed Phase 4 Results DMC

• 3 other identifiers: 1-Rodriguez01-CECI02-IMA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Heart Disease; Coronary Restenosis

Keywords

Drug Eluting Stents; Stents Bare Metal; Stent Thrombosis; Coronary revascularization; Survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Major Adverse Cardiovascular Events (MACCE)

  18 Months

• Target Vessel Revascularization (TVR)

  18 months

Study Arms (2)

A--Oral Rapamycin plus BMS

EXPERIMENTAL

Oral sirolimus plus bare metal stent implantation

Drug: Oral sirolimus

B -- Drug Eluting Stent

ACTIVE COMPARATOR

Drug Eluting Stents

Device: Drug Eluting stent

Interventions

Oral sirolimus 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 .

Also known as: Oral rapamycine

A--Oral Rapamycin plus BMS

Drug Eluting stent DEVICE

Any Drug eluting stent

Also known as: DES=Drug Eluting Stents), PES (Paclitaxel Eluting Stent), SES (Sirolimus eluting stent), ZES (Zotarolimus eluting stent)

B -- Drug Eluting Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication of revascularization
• De novo lesions
• Native vessels
• Suitable for stent placement

You may not qualify if:

• Acute myocardial infarction within the last 24 hours
• In stent restenosis
• Previous percutaneous coronary intervention within the last 6 months

Sponsors & Collaborators

• Centro de estudios en Cardiologia Intervencionista: lead

Study Sites (3)

Clinica IMA

Adrogué, Buenos Aires, 1846, Argentina

Location

Sanatorio Otamendi y Miroli

Buenos Aires, Buenos Aires, 1115, Argentina

Location

Sanatorio Las Lomas

San Isidro, Buenos Aires, 1354, Argentina

Location

Related Publications (39)

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• Rodriguez AE, Rodriguez-Granillo AM, Antoniucci D, Mieres J, Fernandez-Pereira C, Rodriguez-Granillo GA, Santaera O, Rubilar B, Palacios IF, Serruys PW; ORAR III Investigators. Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial. Catheter Cardiovasc Interv. 2012 Sep 1;80(3):385-94. doi: 10.1002/ccd.23352. Epub 2011 Dec 8.

  PMID: 22109997 DERIVED

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  PMID: 20449934 DERIVED

Related Links

• Pubmed abstract of the latest published results.

MeSH Terms

Conditions

Coronary Disease; Coronary Restenosis

Interventions

Sirolimus; Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Stenosis

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Stents; Prostheses and Implants; Equipment and Supplies

Limitations and Caveats

It was an open label design. Multiple approved DES designs were used. Health Care system in Argentina differs from other world ones.

Results Point of Contact

• Title: Alfredo Rodriguez, MD, PHD
• Organization: Centro de Estudios en Cardiologia Intervencionista

rodrigueza@sanatorio-otamendi.com.ar

541149648721

Study Officials

• Alfredo E Rodriguez, MD PhD FACC

  Departamento de Cardiologia Intervencionista, Sanatorio Otamendi

  STUDY CHAIR

• Carlos Fernandez Pereira, MD

  Departamento de Cardiologia Intervencionista, Sanatorio Otamendi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: January 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 2, 2010
• Results First Posted: August 20, 2009

Record last verified: 2009-05

Locations

AR (3)