Cordis Cypher's Long-Term Safety and Efficacy Supported by 4-Year TYPHOON Data

January 19, 2011—Christian Spaulding, MD, et al published 4-year follow-up data from the TYPHOON (Trial to Assess the Use of the Cypher Sirolimus-Eluting Coronary Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty) study in the Journal of the American College of Cardiology: Cardiovascular Interventions (2011;4:14–13). The aim of this study was to assess the long-term safety and efficacy of the Cypher sirolimus-eluting stent (SES) (Cordis Corporation, Bridgewater, NJ) in percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI).

According to the investigators, long-term follow-up from randomized trials is necessary to address concerns that remain regarding the safety of drug-eluting stents that are implanted during PCI for STEMI. TYPHOON randomized 712 patients who had STEMI and were treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary endpoint, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3% vs 14.3%; P = .004), with no increase in adverse events.

The TYPHOON investigators performed 4-year follow-up with the complete data available for 501 patients (70%) and the survival status known in 580 patients (81%).

The investigators reported that freedom from target lesion revascularization at 4 years was significantly better in the SES group compared to the BMS group (92.4% vs 85.1%; P = .002). There were no significant differences in freedom from cardiac death (97.6% vs 95.9%; P = .37) or freedom from repeat myocardial infarction (94.8% vs 95.6%; P = .85) between the SES and BMS groups. There was no difference in definite/probable stent thrombosis noted at 4 years (4.4% vs 4.8%; P = .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% in the BMS group (P = .61).

The investigators concluded that in the 70% of patients with complete follow-up at 4 years, SES showed sustained efficacy in reducing target lesion revascularization with no difference in death, repeat myocardial infarction, or stent thrombosis.