The Retrospective Nested Case-Control 5 Years Clinical Follow-up Study Of Sirolimus-Eluting Stents Versus Bare Metal Stents

Objective: Although previous studies have documented persistent clinical benefit of sirolimus-eluting stents (SES, Cypher, Johnson & Johnson Co) in reducing the need for target vessel revascularization without an increase in myocardial infarction (MI) or heart-cause mortality, their long-term safety and efficacy in routine clinical practice remains uncertain.Methods: In retrospective nested case-control study, which the response rate of patients is 80%, we studied 251 patients who underwent Cypher stents (DES) and Coroflex stents (BMS) treatment from 2002 to 2003, and investigated their MI, repeat target vessel revascularization (TLR) and heart-cause mortality after stented PCI five years. We compared long- term clinical outcomes in 168 patients treated with DES with 83 patients treated with BMS.Results: Compared to BMS patients, CYPHER patients demonstrated significantly improved event-free survival with respect to (OR=0.988; 95%CI: 0.177-5.506; P=0.989) and repeat target vessel revascularization (OR=2.56; 95%CI:0.549-11.576; P=0.356), with no significant difference in the incidence of cumulative MI(OR=2.56;95%CI:0.549-11.576; P=0.356). Time of TLR is 22.1±14.1 months in CYPHER group and 9.2±6.5 months in BMS group ( P=0.028).Conclusion: Comparing with BMS, DES in clinical practice can reduce repeat target vessel revascularization, improve patients'life quality without increasing heart-cause mortality and the incidence of cumulative MI. The acute, sub-acute, late and very late stent thrombosis occurrence rates were almost the same as the BMS group. The stent restenosis rate was lower than that of BMS group's.