CLINICAL STUDIES
A randomized trial comparing primary angioplasty with a strategy of short-acting thrombolysis and immediate planned rescue angioplasty in acute myocardial infarction: the PACT trial
Allan M. Ross, MD, FACC*,
Karin S. Coyne, PhD, RN, MPH*,
Jonathan S. Reiner, MD, FACC*,
Samuel W. Greenhouse, PhD ,
Cynthia Fink, MPH*,
Anthony Frey, MD*,
Eduardo Moreyra, MD, FACC*,
Mouhieddin Traboulsi, MD, FACC ,
Normand Racine, MD ,
Arthur L. Riba, MD, FACC||,
Mark A. Thompson, MD, FACC¶,
Steven Rohrbeck, MD, FACC#,
Conor F. Lundergan, MD* for the PACT Investigators
* Cardiovascular Research Institute of George Washington University, Washington, DC, USA
The Biostatistics Center of George Washington University, Washington, DC, USA
Foothills Hospital, Calgary, Alberta, Canada
Hospital Notre Dame, Montreal, Quebec, Canada
|| Oakwood Hospital, Dearborn, Michigan, USA
¶ Rochester General Hospital, Rochester, New York, USA
# High Point Regional Hospital, High Point, North Carolina, USA
Manuscript received December 24, 1998;
revised manuscript received June 29, 1999,
accepted August 27, 1999.
Reprint requests and correspondence: Dr. Allan M. Ross, The Cardiovascular Research Institute, George Washington University, 2150 Pennsylvania Avenue, NW, Suite 4-239, Washington, DC 20037
allanmross{at}aol.com
OBJECTIVES
The study evaluated the efficacy and safety of a short-acting reduced-dose fibrinolytic regimen to promote early infarct-related artery (IRA) patency during the inherent delay experienced by infarct patients referred for angioplasty as the principal recanalization modality.
BACKGROUND
Previous approaches using long-acting, full-dose thrombolytic infusions rarely showed benefit, but they did increase adverse event rates.
METHODS
Following aspirin and heparin, 606 patients were randomized to a 50-mg bolus of recombinant tissue-type plasminogen activator (rt-PA) (alpha half-life 4.5 min) or to placebo followed by immediate angiography with angioplasty if needed. The end points included patency rates on catheterization laboratory (cath lab) arrival, technical results when PTCA (percutaneous transluminal coronary angioplasty) was performed, complication rates, and left ventricular (LV) function by treatment assignment and time to restored patency following angioplasty.
RESULTS
Patency on cath lab arrival was 61% with rt-PA (28% Thrombolysis in Myocardial Infarction trial [TIMI]-2, 33% TIMI-3), and 34% with placebo (19% TIMI-2, 15% TIMI-3) (p = 0.001). Rescue and primary PTCA restored TIMI-3 in closed arteries equally (77%, 79%). No differences were observed in stroke or major bleeding. Left ventricular function was similar in both treatment groups, but convalescent ejection fraction (EF) was highest with a patent IRA (TIMI-3) on cath lab arrival (62.4%) or when produced by angioplasty within an hour of bolus (62.5%). However, in 88% of angioplasties, the delay exceeded 1 h: convalescent EF 57.3%.
CONCLUSIONS
Tailored thrombolytic regimens compatible with subsequent interventions lead to more frequent early recanalization (before cath arrival), which facilitates greater LV function preservation with no augmentation of adverse events.
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Abbreviations and Acronyms
| | AMI | = acute myocardial infarction | | aPTT | = activated partial thromboplasin times | | Cath lab | = catheter laboratory | | EF | = ejection fraction | | IRA | = infarct-related artery | | LV | = left ventricular | | MI | = myocardial infarction | | PTCA | = percutaneous transluminal coronary angioplasty | | rt-PA | = recombinant tissue-type plasminogen activator | | TIMI | = Thrombolysis in Myocardial Infarction trial |
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C. M. Gibson, J. Karha, S. A. Murphy, D. James, D. A. Morrow, C. P. Cannon, R. P. Giugliano, E. M. Antman, E. Braunwald, and TIMI Study Group
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W. W. O'Neill
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C. L. Grines, P. Serruys, and W. W. O'Neill
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N. S. Kleiman
Combination therapy for acute myocardial infarction: Will it survive?
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The Task Force on the Management of Acute Myocardi, F. Van de Werf, D. Ardissino, A. Betriu, D. V. Cokkinos, E. Falk, K. A.A. Fox, D. Julian, M. Lengyel, F.-J. Neumann, et al.
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Eur. Heart J.,
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F. Ribichini and W. Wijns
ACUTE MYOCARDIAL INFARCTION: REPERFUSION TREATMENT
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D. A. Morrow, E. M. Antman, A. Sayah, K. C. Schuhwerk, R. P. Giugliano, J. A. deLemos, M. Waller, S. A. Cohen, D. G. Rosenberg, S. S. Cutler, et al.
Evaluation of the time saved byprehospital initiation of reteplase forST-elevation myocardial infarction: Results of the early retavase-thrombolysisin myocardial infarction (ER-TIMI) 19 trial
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F. Van de Werf and D. S. Baim
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C. L. Grines, D. R. Westerhausen Jr, L. L. Grines, J. T. Hanlon, T. L. Logemann, M. Niemela, W. D. Weaver, M. Graham, J. Boura, W. W. O'Neill, et al.
A randomized trial of transfer for primary angioplasty versus on-site thrombolysis in patients with high-risk myocardial infarction: The air primary angioplasty in myocardial infarction study
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F. Zijlstra, N. Ernst, M.-J. de Boer, E. Nibbering, H. Suryapranata, J. C. A. Hoorntje, J.-H. E. Dambrink, A. W. J. van't Hof, and F. W. A. Verheugt
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M. Aschermann and P. Widimsky
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R. A. Kerensky, M. Wade, P. Deedwania, W. E. Boden, C. J. Pepine, and Veterans Affairs Non-Q-Wave Infarction Strategies
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K. Hatada, T. Sugiura, H. Kamihata, S. Nakamura, N. Takahashi, F. Yuasa, and T. Iwasaka
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C. P. Cannon
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G. W. Stone, D. Cox, E. Garcia, B. R. Brodie, M.-C. Morice, J. Griffin, L. Mattos, A. J. Lansky, W. W. O'Neill, and C. L. Grines
Normal Flow (TIMI-3) Before Mechanical Reperfusion Therapy Is an Independent Determinant of Survival in Acute Myocardial Infarction: Analysis From the Primary Angioplasty in Myocardial Infarction Trials
Circulation,
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P. W. Armstrong and D. Collen
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H.C. Herrmann, R.H. Li, and E.M. Ohman
Facilitated percutaneous coronary intervention: results from the SPEED trial
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[Abstract]
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M. A de Belder
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H. C. Herrmann, D. J. Moliterno, E. M. Ohman, A. L. Stebbins, C. Bode, A. Betriu, F. Forycki, J. S. Miklin, W. B. Bachinsky, A. M. Lincoff, et al.
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C. M. Gibson
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F. Zijlstra
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C. P. Cannon, C. M. Gibson, C. T. Lambrew, D. A. Shoultz, D. Levy, W. J. French, J. M. Gore, W. D. Weaver, W. J. Rogers, and A. J. Tiefenbrunn
Relationship of Symptom-Onset-to-Balloon Time and Door-to-Balloon Time With Mortality in Patients Undergoing Angioplasty for Acute Myocardial Infarction
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F. van der Werf
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E. Boersma, M. Akkerhuis, M. L. Simoons, F. Zijlstra, M.-J. de Boer, D. P. Faxon, and J. W. Heger
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E. C. Keeley and W. D. Weaver
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C. M. Gibson, C. P. Cannon, S. A. Murphy, S. J. Marble, H. V. Barron, E. Braunwald, and for the TIMI Study Group
Relationship of the TIMI Myocardial Perfusion Grades, Flow Grades, Frame Count, and Percutaneous Coronary Intervention to Long-Term Outcomes After Thrombolytic Administration in Acute Myocardial Infarction
Circulation,
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