Four-Year Follow-Up of TYPHOON (Trial to Assess the Use of the CYPHer Sirolimus-Eluting Coronary Stent in Acute Myocardial Infarction Treated With BallOON Angioplasty)

作者：Spaulding Christian^*; Teiger Emmanuel; Commeau Philippe; Varenne Olivier; Bramucci Ezio; Slama Michel; Beatt Keavin; Tirouvanziam Ashok; Polonski Lech; Stella Pieter R; Clugston Richard; Fajadet Jean; de Boisgelin Xavier; Bode Christophe; Carrie Didier; Erglis Andrejs; Merkely Bela; Hosten Stefan; Cebrian Ana; Wang Patrick; Stoll Hans Peter; Henry Patrick

来源：JACC: Cardiovascular Interventions , 2011, 4(1): 14-23.

DOI：10.1016/j.jcin.2010.10.007

• bare-metal stent
• percutaneous coronary intervention
• sirolimus-eluting coronary stent
• target lesion revascularization

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 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 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 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 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.

• 出版日期2011-1