CLINICAL RESEARCH: CLINICAL TRIALS
Combined Angioplasty and Pharmacological Intervention Versus Thrombolysis Alone in Acute Myocardial Infarction (CAPITAL AMI Study)
Michel R. Le May, MD, FACC*,
George A. Wells, PhD,
Marino Labinaz, MD, FACC,
Richard F. Davies, MD, FACC,
Michele Turek, MD,
Danielle Leddy, MD,
Justin Maloney, MD,
Tim McKibbin, MD,
Brendan Quinn, MD,
Rob S. Beanlands, MD,
Chris Glover, MD,
Jean-François Marquis, MD,
Edward R. O'Brien, MD, FACC,
William L. Williams, MD, FACC and
Lyall A. Higginson, MD, FACC
Division of Cardiology, University of Ottawa, Ottawa, Ontario, Canada
Manuscript received December 8, 2004;
revised manuscript received April 3, 2005,
accepted April 13, 2005.
* Reprint requests and correspondence: Dr. Michel R. Le May, Ottawa Heart Institute, 40 Ruskin Street, Ottawa, Ontario, Canada K1Y 4W7
(Email: mlemay{at}ottawaheart.ca).
OBJECTIVES: We compared a strategy of tenecteplase (TNK)-facilitated angioplasty with one of TNK alone in patients presenting with high-risk ST-segment elevation myocardial infarction (STEMI).
BACKGROUND: Previous trials show that thrombolysis followed by immediate angioplasty for the treatment of STEMI does not improve ischemic outcomes compared with thrombolysis alone and is associated with excessive bleeding complications. Since the publication of these trials, however, significant pharmacological and technological advances have occurred.
METHODS: We randomized 170 patients with high-risk STEMI to treatment with TNK alone (84 patients) or TNK-facilitated angioplasty (86 patients). The primary end point was a composite of death, reinfarction, recurrent unstable ischemia, or stroke at six months.
RESULTS: At six months, the incidence of the primary end point was 24.4% in the TNK-alone group versus 11.6% in the TNK-facilitated angioplasty group (p = 0.04). This difference was driven by a reduction in the rate of recurrent unstable ischemia (20.7% vs. 8.1%, p = 0.03). There was a trend toward a lower reinfarction rate with TNK-facilitated angioplasty (14.6% vs. 5.8%, p = 0.07). No significant differences were observed in the rates of death or stroke. Major bleeding was observed in 7.1% of the TNK-alone group and in 8.1% of the TNK-facilitated angioplasty group (p = 1.00).
CONCLUSIONS: In patients presenting with high-risk STEMI, TNK plus immediate angioplasty reduced the risk of recurrent ischemic events compared with TNK alone and was not associated with an increase in major bleeding complications.
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Abbreviations and Acronyms
| | ACT = activated clotting time | | ASSENT = Assessment of the Safety and Efficacy of a New Thrombolytic Agent | | CABG = coronary artery bypass graft surgery | | IRA = infarct-related artery | | PCI = percutaneous coronary intervention | | STEMI = ST-segment elevation myocardial infarction | | TIMI = Thrombolysis In Myocardial Infarction | | TNK = tenecteplase |
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|
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|
 |
|

|
 |

|
 |
 
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 |
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|
 |

|
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55(2):
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|
 |
|

|
 |

|
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January 1, 2010;
96(1):
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|
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|
 |
|

|
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|
 |
|

|
 |

|
 |
 
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2(10):
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|
 |
|

|
 |

|
 |
 
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|
 |
|

|
 |

|
 |
 
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|
 |
|

|
 |

|
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|
 |
|

|
 |

|
 |
 
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29(23):
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|
 |
|

|
 |

|
 |
 
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December 1, 2008;
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|
 |
|

|
 |

|
 |
 
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July 29, 2008;
118(5):
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[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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July 15, 2008;
118(3):
219 - 222.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. G. Goodman, V. Menon, C. P. Cannon, G. Steg, E. M. Ohman, and R. A. Harrington
Acute ST-Segment Elevation Myocardial Infarction: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
Chest,
June 1, 2008;
133(6_suppl):
708S - 775S.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Sabate
Revascularization of the Infarct-Related Artery: Never Too Late to Do Well
J. Am. Coll. Cardiol.,
March 4, 2008;
51(9):
965 - 967.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. W. Smalling, G. M. Giesler, V. R. Julapalli, A. E. Denktas, S. M. Sdringola, M. T. Vooletich, J. J. McCarthy, R. N. Bradley, D. E. Persse, B. K. Richter, et al.
Pre-Hospital Reduced-Dose Fibrinolysis Coupled With Urgent Percutaneous Coronary Intervention Reduces Time to Reperfusion and Improves Angiographic Perfusion Score Compared With Prehospital Fibrinolysis Alone or Primary Percutaneous Coronary Intervention: Results of the PATCAR Pilot Trial
J. Am. Coll. Cardiol.,
October 16, 2007;
50(16):
1612 - 1614.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Sanz, R. W. Smalling, D. L. Brewer, W. J. French, L. A. Smaha, H. H. Ting, and D. E. Casey
Development of Systems of Care for ST-Elevation Myocardial Infarction Patients: The Physician Perspective
Circulation,
July 10, 2007;
116(2):
e39 - e42.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
T. J. Kiernan, H. H. Ting, and B. J. Gersh
Facilitated percutaneous coronary intervention: current concepts, promises, and pitfalls
Eur. Heart J.,
July 1, 2007;
28(13):
1545 - 1553.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. Labarere, L. Belle, M. Fourny, N. Genes, J.-M. Lablanche, D. Blanchard, J.-P. Cambou, N. Danchin, and for the Unite de Soins Intensifs Coronaires 2000 I
Outcomes of Myocardial Infarction in Hospitals With Percutaneous Coronary Intervention Facilities
Arch Intern Med,
May 14, 2007;
167(9):
913 - 920.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. Legutko, Z. Siudak, D. Dudek, and L. Rzeszutko
Percutaneous Coronary Intervention vs Thrombolysis for ST-Elevation Myocardial Infarction
JAMA,
March 28, 2007;
297(12):
1314 - 1314.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J Kendall
The optimum reperfusion pathway for ST elevation acute myocardial infarction: development of a decision framework
Emerg. Med. J.,
January 1, 2007;
24(1):
52 - 56.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M Sejersten, Y Birnbaum, R S Ripa, C Maynard, G S Wagner, P Clemmensen, and for the DANAMI-2 Investigators
Influences of electrocardiographic ischaemia grades and symptom duration on outcomes in patients with acute myocardial infarction treated with thrombolysis versus primary percutaneous coronary intervention: results from the DANAMI-2 trial
Heart,
November 1, 2006;
92(11):
1577 - 1582.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J.-P. Collet, G. Montalescot, M. Le May, M. Borentain, and A. Gershlick
Percutaneous Coronary Intervention After Fibrinolysis: A Multiple Meta-Analyses Approach According to the Type of Strategy
J. Am. Coll. Cardiol.,
October 3, 2006;
48(7):
1326 - 1335.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
W. B. Borden and D. P. Faxon
Facilitated Percutaneous Coronary Intervention
J. Am. Coll. Cardiol.,
September 19, 2006;
48(6):
1120 - 1128.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
P. Kaul, W.-C. Chang, A. M. Lincoff, P. Aylward, A. Betriu, C. Bode, R. M. Califf, E. M. Ohman, V. Guetta, P. G. Steg, et al.
Optimizing use of revascularization and clinical outcomes in ST-elevation myocardial infarction: insights from the GUSTO-V trial
Eur. Heart J.,
May 2, 2006;
27(10):
1198 - 1206.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol.,
April 18, 2006;
47(8):
1689 - 1706.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
E. Boersma and The Primary Coronary Angioplasty vs. Thrombolysis
Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients
Eur. Heart J.,
April 1, 2006;
27(7):
779 - 788.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al.
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)
J. Am. Coll. Cardiol.,
January 3, 2006;
47(1):
216 - 235.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, A. K. Jacobs, M. J. Kern, S. B. King III, D. A. Morrison, W. W. O'Neill, H. V. Schaff, P. L. Whitlow, et al.
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention--Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)
Circulation,
January 3, 2006;
113(1):
156 - 175.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
W. J. Cantor, F. Brunet, C. P. Ziegler, A. Kiss, and L. J. Morrison
Immediate angioplasty after thrombolysis: a systematic review
Can. Med. Assoc. J.,
December 6, 2005;
173(12):
1473 - 1481.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H.-J. Dieker, M. A. Brouwer, and F. W.A. Verheugt
ESC guidelines for percutaneous coronary interventions
Eur. Heart J.,
November 2, 2005;
26(22):
2475 - 2475.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
Is There an Advantage of Immediate PCI After Fibrinolysis for STEMI?
Journal Watch Emergency Medicine,
October 12, 2005;
2005(1012):
1 - 1.
[Full Text]
|
 |
|

|
 |

|
 |
 
Fibrinolysis-Facilitated PCI for STEMI?
Journal Watch Cardiology,
September 23, 2005;
2005(923):
3 - 3.
[Full Text]
|
 |
|
|