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)

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 Carri, Andrejs Erglis, B. Merkely, Stefan Hosten, Ana Cebrian, Patrick Wang & 2 others Hans Peter Stoll, Patrick Henry

Research output: Contribution to journalArticle

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Abstract

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)

Original languageEnglish
Pages (from-to)14-23
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume4
Issue number1
DOIs
Publication statusPublished - Jan 2011

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Sirolimus
Angioplasty
Stents
Myocardial Infarction
Metals
Percutaneous Coronary Intervention
Balloon Angioplasty
Thrombosis
Safety
Drug-Eluting Stents
Survival
Cause of Death

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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). / 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; Carri, Didier; Erglis, Andrejs; Merkely, B.; Hosten, Stefan; Cebrian, Ana; Wang, Patrick; Stoll, Hans Peter; Henry, Patrick.

In: JACC: Cardiovascular Interventions, Vol. 4, No. 1, 01.2011, p. 14-23.

Research output: Contribution to journalArticle

Spaulding, C, Teiger, E, Commeau, P, Varenne, O, Bramucci, E, Slama, M, Beatt, K, Tirouvanziam, A, Polonski, L, Stella, PR, Clugston, R, Fajadet, J, De Boisgelin, X, Bode, C, Carri, D, Erglis, A, Merkely, B, Hosten, S, Cebrian, A, Wang, P, Stoll, HP & Henry, P 2011, '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)', JACC: Cardiovascular Interventions, vol. 4, no. 1, pp. 14-23. https://doi.org/10.1016/j.jcin.2010.10.007
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 ; Carri, Didier ; Erglis, Andrejs ; Merkely, B. ; Hosten, Stefan ; Cebrian, Ana ; Wang, Patrick ; Stoll, Hans Peter ; Henry, Patrick. / 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). In: JACC: Cardiovascular Interventions. 2011 ; Vol. 4, No. 1. pp. 14-23.
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abstract = "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)",
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author = "Christian Spaulding and Emmanuel Teiger and Philippe Commeau and Olivier Varenne and Ezio Bramucci and Michel Slama and Keavin Beatt and Ashok Tirouvanziam and Lech Polonski and Stella, {Pieter R.} and Richard Clugston and Jean Fajadet and {De Boisgelin}, Xavier and Christophe Bode and Didier Carri and Andrejs Erglis and B. Merkely and Stefan Hosten and Ana Cebrian and Patrick Wang and Stoll, {Hans Peter} and Patrick Henry",
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T1 - 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)

AU - Spaulding, Christian

AU - Teiger, Emmanuel

AU - Commeau, Philippe

AU - Varenne, Olivier

AU - Bramucci, Ezio

AU - Slama, Michel

AU - Beatt, Keavin

AU - Tirouvanziam, Ashok

AU - Polonski, Lech

AU - Stella, Pieter R.

AU - Clugston, Richard

AU - Fajadet, Jean

AU - De Boisgelin, Xavier

AU - Bode, Christophe

AU - Carri, Didier

AU - Erglis, Andrejs

AU - Merkely, B.

AU - Hosten, Stefan

AU - Cebrian, Ana

AU - Wang, Patrick

AU - Stoll, Hans Peter

AU - Henry, Patrick

PY - 2011/1

Y1 - 2011/1

N2 - 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)

AB - 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)

KW - bare-metal stent

KW - percutaneous coronary intervention

KW - sirolimus-eluting coronary stent

KW - target lesion revascularization

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DO - 10.1016/j.jcin.2010.10.007

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