Abstract 6032: Percutaneous Coronary Intervention with Bare Metal Stents and Oral Sirolimus has Comparable Safety and Efficacy to Treatment with Drug Eluting Stents but with Significant Cost Saving: Long Term Follow Up Results From the Randomized, Controlled ORAR III (Oral Rapamycin in Argentina) Study
Previous randomized study have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. 200 patients with de novo coronary lesions were randomized to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary End points was to compare cumulative costs (including hospital and follow up) at one, two, three and five years of follow up. The secondary end point included death, myocardial infarction (MI) and stroke and was analyzed as Major Adverse Cardiovascular Events (MACCE). Target Vessel (TVR) and Target Lesion Revascularization (TLR) were independently analyzed. Costs included procedural resources, hospitalization, medications, repeat revascularization procedures and professional fees. In DES group lesions were treated with Paclitaxel eluting stents in 60%, with Sirolimus eluting stents in 6% and with Zotarolimus eluting stents in 34%. Dual antiplatelet therapy was given for one year in DES and one month in OR groups. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 + 7 months of follow up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). Similar incidence of TLR with DES (8.2%) and OR (7%) was seen p=ns. Non inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. In DES group no differences in TLR or TVR accorded DES design were seen. Cumulative 18 months cost and follow up clinical events appears in Table A⇓ strategy of OR plus BMS was significant cost saving compared to DES in patients undergoing PCI for de novo coronary lesions, although larger randomized studies are warranted.