Phase 4
N=200
Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
Coronary Heart Disease · Coronary Restenosis
Bottom Line
View on ClinicalTrials.gov: NCT00552669 ↗Enrolled (actual)
200
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. — 5483; 7658.2 US dollars — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral sirolimus (Drug); Drug Eluting stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centro de estudios en Cardiologia Intervencionista
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. |
5483; 7658.2 | <0.05 sig |
| SECONDARY Major Adverse Cardiovascular Events (MACCE) |
9; 15; 3; 7; 6; 9 | 0.05 |
| SECONDARY Target Vessel Revascularization (TVR) |
14; 15 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00552669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.