文摘
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Objectives
The aim of this study was to assess the long-term safety and efficacy of the CYPHER (Cordis, Johnson and Johnson, Bridgewater, New Jersey) sirolimus-eluting coronary stent (SES) in percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).Background
<p>Concern over the safety of drug-eluting stents implanted during PCI for STEMI remains, and long-term follow-up from randomized trials are necessary. TYPHOON (Trial to assess the use of the cYPHer sirolimus-eluting stent in acute myocardial infarction treated with ballOON angioplasty) randomized 712 patients with STEMI treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary end point, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3 % vs. 14.3 % , p = 0.004) with no increase in adverse events.Methods
<p>A 4-year follow-up was performed. Complete data were available in 501 patients (70 % ), and the survival status is known in 580 patients (81 % ).Results
<p>Freedom from target lesion revascularization (TLR) at 4 years was significantly better in the SES group (92.4 % vs. 85.1 % ; p = 0.002); there were no significant differences in freedom from cardiac death (97.6 % and 95.9 % ; p = 0.37) or freedom from repeat myocardial infarction (94.8 % and 95.6 % ; p = 0.85) between the SES and BMS groups. No difference in definite/probable stent thrombosis was noted at 4 years (SES: 4.4 % , BMS: 4.8 % , p = 0.83). In the 580 patients with known survival status at 4 years, the all-cause death rate was 5.8 % in the SES and 7.0 % in the BMS group (p = 0.61).Conclusions
<p>In the 70 % of patients with complete follow-up at 4 years, SES demonstrated sustained efficacy to reduce TLR with no difference in death, repeat myocardial infarction or stent thrombosis. (The Study to Assess AMI Treated With Balloon Angioplasty [TYPHOON]; )
