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)

• Published in: JACC. Cardiovascular interventions 2011, Vol.4 (1), p.14-23
• Main Authors: Spaulding, Christian, MD, PhD, Teiger, Emmanuel, MD, PhD, Commeau, Philippe, MD, Varenne, Olivier, MD, PhD, Bramucci, Ezio, MD, Slama, Michel, MD, Beatt, Keavin, MD, Tirouvanziam, Ashok, MD, Polonski, Lech, MD, Stella, Pieter R., MD, PhD, Clugston, Richard, MD, Fajadet, Jean, MD, de Boisgelin, Xavier, MD, Bode, Christophe, MD, Carrié, Didier, MD, Erglis, Andrejs, MD, PhD, Merkely, Bela, MD, Hosten, Stefan, PhD, Cebrian, Ana, PhD, Wang, Patrick, MD, MPH, Stoll, Hans-Peter, MD, Henry, Patrick, MD
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Angioplasty, Balloon, Coronary - mortality; Australia; bare-metal stent; Cardiovascular; Cardiovascular Agents - administration & dosage; Disease-Free Survival; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction - mortality; Myocardial Infarction - therapy; percutaneous coronary intervention; Proportional Hazards Models; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Sirolimus - administration & dosage; sirolimus-eluting coronary stent; Stents; Survival Rate; target lesion revascularization; Thrombosis - etiology; Time Factors; Treatment Outcome
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2010.10.007

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. (The Study to Assess AMI Treated With Balloon Angioplasty [TYPHOON]; NCT00232830 )