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JACC Cardiovasc Interv · Jan 2011
Randomized Controlled Trial Multicenter Study Comparative StudyFour-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).
- Christian Spaulding, Emmanuel Teiger, Philippe Commeau, Olivier Varenne, Ezio Bramucci, Michel Slama, Keavin Beatt, Ashok Tirouvanziam, Lech Polonski, Pieter R Stella, Richard Clugston, Jean Fajadet, Xavier de Boisgelin, Christophe Bode, Didier Carrié, Andrejs Erglis, Bela Merkely, Stefan Hosten, Ana Cebrian, Patrick Wang, Hans-Peter Stoll, and Patrick Henry.
- Cochin Hospital, Assistance-Publique Hôpitaux de Paris, Paris Descartes University and INSERM U 970, Paris, France. cspauldi@its.jnj.com
- JACC Cardiovasc Interv. 2011 Jan 1; 4 (1): 14-23.
ObjectivesThe 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).BackgroundConcern 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.MethodsA 4-year follow-up was performed. Complete data were available in 501 patients (70%), and the survival status is known in 580 patients (81%).ResultsFreedom 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).ConclusionsIn 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).Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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