Abstract 4538: Percutaneous Coronary Intervention With Bare Metal Stents and Oral Sirolimus Has Comparable Safety and Efficacy to Treatment With Drug Eluting Stents but With Significant Lower Cost: 31 Months Cost Saving and Clinical Events Analysis From the Randomized, Controlled ORAR III (Oral Rapamycin in Argentina) Study
Background: We previously reported (AHA 08) 18 months follow up results from patients included in the randomized comparison among drug eluting stents(DES) versus Oral Rapamycin (OR) plus bare metal stents (BMS), ORAR III (Oral Rapamycin in Argentina) study. Trial design required sequential long term follow up to five years.
Methods: 200 patients with de novo coronary lesions were randomized to treatment with OR plus BMS (100 pts/131 vessels) or with DES (100 pts/142 vessels). OR was given as a bolus of 10 mg one day before PCI followed by daily doses of 3 mg plus 180 mg of diltiazem during following 13 days. Primary End points was to compare cumulative costs and cost saving between both strategies of revascularization. Secondary end points were a composite of death, myocardial infarction (MI) and stroke. Target Vessel (TVR), Target Lesion Revascularization (TLR) Stent Thrombosis (ST) were independently analyzed. Costs (U$ Dollars) included procedural resources, hospitalization, medications, repeat revascularization procedures and professional fees.
Results: Baseline demographic, clinical and angiographic characteristics were similar, sample population analyzed in the study included diabetics in 28.5%, vessel size <2.5mm in 32% and overlapped stents in 26% (31% in OR). Clinical follow up was obtained in 100% of survivors, 75% of DES vs 15% of OR pts were taken clopidogrel. At 31 +/− 8.8 months of follow up, the strategy of OR plus BMS resulted cost saving when compared to DES (p=0.001). Initial cost saving advantage was maintained at 31 months of follow up. Non inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. All definitions of ST was meet in 1.5% in OR and 4.9% in DES group p=0.23. Cumulative 31 months cost and follow up clinical events appears in Table⇓.
Conclusion: At 31 months of follow up, an initial strategy with OR plus BMS, was cost saving and with comparable efficcacy to DES.