(Circulation. 1995;91:1923-1928.)
© 1995 American Heart Association, Inc.
Articles |
Link Between the Angiographic Substudy and Mortality Outcomes in a Large Randomized Trial of Myocardial Reperfusion
Importance of Early and Complete Infarct Artery Reperfusion
From the National Health Medical Research Council Clinical Trials Centre, University of Sydney, Australia (R.J.S.); Mayo Foundation Clinic, Rochester, Minn (D.R.H.); Green Lane Hospital, Auckland, New Zealand (H.D.W.); Klinikum Charlottenburg der Freie Universität, Berlin, Germany (W.R.R.); Hospital Tenon, Paris, France (A.V.); Thoraxcenter, Erasmus University, Rotterdam, the Netherlands (M.L.S.); Emory Clinic, Atlanta, Ga (D.M.);
Correspondence to R.J. Simes, MD, NHMRC Clinical Trials Centre, Edward Ford Building A27, University of Sydney, NSW 2006, Australia.
Background The Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries (GUSTO-I) trial was designed to test whether thrombolytic strategies achieving more complete, early, sustained coronary artery patency would lead to further reductions in mortality in patients with acute myocardial infarction. An angiographic substudy within GUSTO-I provided a unique opportunity to examine the relation between mortality and degrees of patency among the regimens.
Methods and Results Four thrombolytic strategies were compared in 41 021 patients in GUSTO-I: streptokinase with subcutaneous or intravenous heparin, accelerated tissue plasminogen activator (TPA) with intravenous heparin, and combination streptokinase plus TPA with intravenous heparin. Accelerated TPA was associated with lower 30-day mortality (6.3%) than the other strategies (7.2%, 7.4%, and 7.0%, respectively). Among the 1210 patients in the angiographic substudy randomized to angiography 90 minutes after starting treatment, there was improved patency, particularly Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow, with accelerated TPA over the other regimens (P<.0001). Coronary artery perfusion (TIMI grade 3) at 90 minutes was also a significant predictor of 30-day survival (P<.01). To determine whether differences in mortality among the four strategies matched differences in 90-minute patency, a model was developed for predicting mortality differences in the main trial from the angiographic substudy. The model assumed that any differences in treatment effects on 30-day mortality were mediated through differences in 90-minute patency for the four treatments. The predicted rates were then compared with observed mortality rates of the remaining patients in the main trial for each treatment group. The predicted and observed 30-day mortality rates of the four treatments were streptokinase with subcutaneous heparin, 7.46% versus 7.28%; streptokinase with intravenous heparin, 7.26% versus 7.39%; accelerated TPA, 6.31% versus 6.37%; and streptokinase plus TPA, 6.98% versus 6.96%. The correlation between predicted and observed results was .97, and the proportion of squared error explained (R2) was .92.
Conclusions The close relation between the predicted and observed 30-day mortality rates supports the concept that an important mechanism for improved survival with thrombolytic therapy is achievement of early, complete perfusion. The close match provides a strong biological explanation for the mortality differences seen in GUSTO-I and a sound rationale for the additional survival advantage of the accelerated TPA regimen. Irrespective of which treatment is used, early and complete restoration of infarct artery perfusion represents an essential goal of myocardial reperfusion therapy.
Key Words: reperfusion • myocardial infarction • mortality • angiography • clinical trials • thrombolysis
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A. L. Liem, A. W. J. van 't Hof, J. C. A. Hoorntje, M.-J. de Boer, H. Suryapranata, and F. Zijlstra Influence of treatment delay on infarct size and clinical outcome in patients with acute myocardial infarction treated with primary angioplasty J. Am. Coll. Cardiol., September 1, 1998; 32(3): 629 - 633. [Abstract] [Full Text] [PDF]
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C. F. Lundergan, J. S. Reiner, W. F. McCarthy, K. S. Coyne, R. M. Califf, A. M. Ross, and for the GUSTO-I Angiographic Investigators Clinical predictors of early infarct-related artery patency following thrombolytic therapy: importance of body weight, smoking history, infarct-related artery and choice of thrombolytic regimen: the GUSTO-I experience J. Am. Coll. Cardiol., September 1, 1998; 32(3): 641 - 647. [Abstract] [Full Text] [PDF]
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H. D. White and F. J. J. Van de Werf Thrombolysis for Acute Myocardial Infarction Circulation, April 28, 1998; 97(16): 1632 - 1646. [Abstract] [Full Text] [PDF]
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P. M. Farrehi, C. K. Ozaki, P. Carmeliet, and W. P. Fay Regulation of Arterial Thrombolysis by Plasminogen Activator Inhibitor-1 in Mice Circulation, March 17, 1998; 97(10): 1002 - 1008. [Abstract] [Full Text] [PDF]
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E. J. Topol Toward a New Frontier in Myocardial Reperfusion Therapy : Emerging Platelet Preeminence Circulation, January 20, 1998; 97(2): 211 - 218. [Full Text] [PDF]
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W. D. Weaver, R. J. Simes, A. Betriu, C. L. Grines, F. Zijlstra, E. Garcia, L. Grinfeld, R. J. Gibbons, E. E. Ribeiro, M. A. DeWood, et al. Comparison of Primary Coronary Angioplasty and Intravenous Thrombolytic Therapy for Acute Myocardial Infarction: A Quantitative Review JAMA, December 17, 1997; 278(23): 2093 - 2098. [Abstract] [PDF]
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The Global Use of Strategies to Open Occluded Coro A Comparison of Reteplase with Alteplase for Acute Myocardial Infarction N. Engl. J. Med., October 16, 1997; 337(16): 1118 - 1123. [Abstract] [Full Text] [PDF]
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The Continuous Infusion versus Double-Bolus Admini A Comparison of Continuous Infusion of Alteplase with Double-Bolus Administration for Acute Myocardial Infarction N. Engl. J. Med., October 16, 1997; 337(16): 1124 - 1130. [Abstract] [Full Text] [PDF]
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H. D. White, P. E. Aylward, M. J. Frey, A. A. J. Adgey, R. Nair, W. S. Hillis, Y. Shalev, M. A. Brown, J. K. French, R. Collins, et al. Randomized, Double-blind Comparison of Hirulog Versus Heparin in Patients Receiving Streptokinase and Aspirin for Acute Myocardial Infarction (HERO) Circulation, October 7, 1997; 96(7): 2155 - 2161. [Abstract] [Full Text]
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The Global Use of Strategies to Open Occluded Coro A Clinical Trial Comparing Primary Coronary Angioplasty with Tissue Plasminogen Activator for Acute Myocardial Infarction N. Engl. J. Med., June 5, 1997; 336(23): 1621 - 1628. [Abstract] [Full Text] [PDF]
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E. M. Ohman, N. S. Kleiman, G. Gacioch, S. J. Worley, F. I. Navetta, J. D. Talley, H. V. Anderson, S. G. Ellis, M. D. Cohen, D. Spriggs, et al. Combined Accelerated Tissue-Plasminogen Activator and Platelet Glycoprotein IIb/IIIa Integrin Receptor Blockade With Integrilin in Acute Myocardial Infarction: Results of a Randomized, Placebo-Controlled, Dose-Ranging Trial Circulation, February 18, 1997; 95(4): 846 - 854. [Abstract] [Full Text]
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E. J. Topol, R. M. Califf, F. Van de Werf, M. Simoons, J. Hampton, K. L. Lee, H. White, J. Simes, and P. W. Armstrong Perspectives on Large-Scale Cardiovascular Clinical Trials for the New Millennium Circulation, February 18, 1997; 95(4): 1072 - 1082. [Full Text]
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J. S. Reiner, C. F. Lundergan, A. Fung, K. Coyne, S. Cho, N. Israel, J. Kazmierski, G. Pilcher, J. Smith, S. Rohrbeck, et al. Evolution of Early TIMI 2 Flow After Thrombolysis for Acute Myocardial Infarction Circulation, November 15, 1996; 94(10): 2441 - 2446. [Abstract] [Full Text]
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W. P. Fay, J. G. Murphy, and W. G. Owen High Concentrations of Active Plasminogen Activator Inhibitor-1 in Porcine Coronary Artery Thrombi Arterioscler Thromb Vasc Biol, October 1, 1996; 16(10): 1277 - 1284. [Abstract] [Full Text]
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M. J. Kern, J. A. Moore, F. V. Aguirre, R. G. Bach, E. A. Caracciolo, T. Wolford, A. F. Khoury, C. Mechem, and T. J. Donohue Determination of Angiographic (TIMI Grade) Blood Flow by Intracoronary Doppler Flow Velocity During Acute Myocardial Infarction Circulation, October 1, 1996; 94(7): 1545 - 1552. [Abstract] [Full Text]
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P. Stubbs, P. Collinson, D. Moseley, T. Greenwood, and M. Noble Prognostic Significance of Admission Troponin T Concentrations in Patients With Myocardial Infarction Circulation, September 15, 1996; 94(6): 1291 - 1297. [Abstract] [Full Text]
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C. W. White Simplicity's Virtue Scorned : Precision Comes to TIMI Flow Grading and the Results Are . . . Surprising Circulation, March 1, 1996; 93(5): 853 - 856. [Full Text]
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J. S. Forrester New Standard for Success of Thrombolytic Therapy : An Earnest Proposal Circulation, October 15, 1995; 92(8): 2026 - 2028. [Full Text]
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E. J. Topol and S. E. Nissen Our Preoccupation With Coronary Luminology : The Dissociation Between Clinical and Angiographic Findings in Ischemic Heart Disease Circulation, October 15, 1995; 92(8): 2333 - 2342. [Abstract] [Full Text]
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J. W. Kennedy Optimal Management of Acute Myocardial Infarction Requires Early and Complete Reperfusion Circulation, April 1, 1995; 91(7): 1905 - 1907. [Full Text]
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