Abstract 19385: Comparison between Oral Rapamycin Plus Bare Metal Stent versus Drug Eluting Stent for the Prevention of Restenosis in the Treatment of Coronary Disease with Percutaneous Coronary Interventions. Four Years Results from the ORAR III Trial
Background. One and three years results of ORAR III trial previously published showed a significant reduction in costs with oral rapamycin plus bare metal stent (OR) compared with drug eluting stents (DES) without significant differences in death, myocardial infarction (MI) and stroke for the prevention of restenosis. (NCT00552669)
Methods: From January 2006 to September 2007 in 3 hospitals in Buenos Aires, Argentina, 200 patients (pts) were randomized either to OR (n=100) or DES (n=100). Primary endpoint compared clinical efficacy and safety of OR vs DES treatment for denovo coronary lesions evaluated by the composite of death, MI and stroke (D,MI,S); Target Vessel Failure (TVF) defined as cardiac death, MI and Target Vessel Revascularization (TVR) and TVR alone at 4 years of follow up. A sub-analysis of pts over and under 65 years old was also done (40 pts in OR and 48 pts in DES ≥ 65 years). OR was given as a bolus of 10 mg the day before PCI followed by 3 mg/daily during the following 13 days. DES group received clopidogrel for at least one year and OR group for a month. Exclusion criteria were MI in the last 24 hours, in stent restenosis and previous PCI in the last six months.
Results: Baseline demographic, clinical and angiographic characteristics were similar. 1.6 +/- 0.7 vs 1.7 +/- 0.8 (p=0.3) lesions per pt were treated in OR vs DES respectively, and 171 stents in OR vs 176 in DES groups were deployed (p=0.9). 4 years clinical follow up was accomplished in 99% of pts. In DES group 45.9% of pts were still receiving thyenopiridines vs. 18.9% of OR (<0.001). D,MI,S was 11.0% in OR group vs. 23.0% in DES, p=0.02; TVF was 25.0% in OR vs 37.0% in DES, p=0.06 and TVR was 14.5 % in OR group vs 20.8% in DES group, p=0.17. When analyzing pts ≥ 65 years dyslipemia was the only significantly different baseline characteristic. At 4 years D,MI,S was 7.5% (OR) vs. 25.0% (DES), p=0.03, TVF 22.5% (OR) vs 45.8% (DES); p=0.02 and TVR was 14.0% in OR vs 21.9% in DES groups (p=0.26); there were no differences in outcomes of pts < 65 years old.
Conclusions: Four years follow up of this randomized trial revealed significant differences in the composite of death, MI and stroke in favor of OR therapy in overall population and in pts > 65 years old without differences in TVR. No differences were seen between groups under 65 years.
- © 2012 by American Heart Association, Inc.