Five-Year Outcomes Analysis of Cordis Cypher Trials Published

According to the investigators, the background of the study is that a delayed arterial healing response after drug-eluting stent implantation has raised concerns about the long-term safety of drug-eluting stents. In this pooled analysis of the four randomized trials, 1,748 patients were assigned to receive either an SES (n = 878) or a BMS (n = 870).

The investigators reported that at 5 years, there was no significant difference in the rate of death, myocardial infarction (MI), or the composite of death/MI between the two groups (15.1% in the SES group vs 13.6% in the BMS group; P = .36). The 5-year incidence of stent thrombosis by the Academic Research Consortium definition did not differ between SES and BMS (definite/probable stent thrombosis, 2.1% vs 2.0%; P = .99). The incidence of very late stent thrombosis was also similar between the SES and BMS groups (1.4% vs 0.7%; P = .22). The annualized rates of definite/probable stent thrombosis after 1 year were 0.4% for SES and 0.2% for BMS. The 5-year incidence of target vessel revascularization was significantly lower in the SES group (15.2% vs 30.1%; P < .0001).

The investigators concluded that in this patient-level pooled analysis, overall use of SES compared with BMS demonstrated persistent superior efficacy at 5 years in terms of a reduction in target vessel revascularization, without an increase in rates of death, MI, or stent thrombosis.