Clinical outcomes and cost-utility after sirolimus-eluting versus bare metal stent implantation

Background Randomized studies have shown beneficial effects of drug-eluting stent (DES) in reducing the risk of repeated revascularization. Other studies have shown higher proportion of death, myocardial infarction (MI) and increased cost concerning DES. However the long term safety and effectiveness of DES have been questioned recently. Methods To compare long term clinical outcomes, health-related quality of life (HRQOL) and cost-utility after sirolimus-eluting stent (SES) and bare metal stent (BMS) implantation in angina patients in China, 1241 patients undergoing percutaneous coronary revascularization (PCI) with either SES (n=632) or BMS (n=609) were enrolled continuously in this prospective, nonrandomized, multi-center registry study. Results Totally 1570 stents were implanted for 1334 lesions. Follow-up was completed in 1205 (97.1%) patients at 12 months. Rates of MI, all causes of death were similar between the two groups. Significant differences were found at rate of cardiovascular re-hospitalization (136 (22.4%) in BMS group vs. 68 (10.8%) in SES group, P=0.001) and recurrent angina (149 (24.5%) vs. 71 (11.3%), P=0.001). Dramatic difference was observed when compared the baseline and 9-month HRQOL scores intra-group (P < 0.001). However no significant difference was found inter-group either in baseline or follow-up HRQOL. Compared with SES, the total cost in BMS was significantly lower on discharge (62 546.0 vs. 78 245.0 Yuan, P=0.001). And follow-up expenditure was remarkably higher in the BMS group than that in the SES group (13 412.0 vs. 8 812.0 Yuan, P=0.0001). Conclusions There were no significant differences on death, in-stent thrombosis, MI irrespective of stent type. SES was superior to BMS on improvement of life quality. SES was with higher cost-utility compared to BMS. Chin Med J 2010;123(20):2797-2802