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Herz

, Volume 24, Issue 5, pp 378–388 | Cite as

Prognostische Bedeutung der ST-Strecken-Veränderung beim akuten Myokardinfarkt

  • Karl Wescheider
  • Karl -Ludwig Neuhaus
  • Rüdiger Dissmann
  • Ulrich Tebbe
  • Uwe Zeymer
  • Rolf Schröder
Article

Zusammenfassung

Das Ausmaß der Rückbildung der ST-Strecken-Hebung (STR) 180 Minuten nach Beginn einer Streptokinasebehandlung bei akutem Myokardinfarkt bis sechs Stunden nach Symptombeginn ist ein exzellenter prognostischer Frühindikator. In einer Metaanalyse von 3 912 Infarktpatienten wiesen etwa 50% eine komplette STR (STR≥70%) auf. Diese Patienten entwickeln kleine Infarkte und haben eine sehr hohe Überlebenswahrscheinlichkeit. Etwa 20% weisen keine STR (STR<30%) auf. Sie entwickeln große Infarkte und haben ein hohes Sterberisiko. Patienten mit partieller STR haben zwar größere Infarkte, aber die Überlebenschancen sind noch relativ gut.

Mit Hilfe der STR ließ sich unter Berücksichtigung des Alters und der Anzahl weiterer bekannter Risikofaktoren aus Anamnese und Akutphase ein Niedrigrisikokollektiv mit einer so geringen Akut- und Ein-Jahres-Sterblichkeit ermitteln, daß zumindest für dieses Subkollektiv eine routinemäßige Koronarographie in der frühen Postinfarktphase nicht gerechtfertigt ist. Darüber hinaus ist STR geeignet, auch in Hochrisikokollektiven zwischen relativ stärker und weniger stark gefährdeten Patienten zu unterscheiden.

In der Thrombolyseforschung ist STR hervorragend als Surrogatparameter einzusetzen. Insbesondere trifft das für Dosisfindungsstudien, als primärer Endpunkt in Phase-III-Studien und für Interimsanalysen, Subgruppenanalysen, Substudien und Sicherheitsanalysen in großen Mortalitäts-studien zu. STR kann erheblich zur Reduktion der erforderlichen Stichprobenumfänge in klinischen Studien beitragen. Allerdings ist zumindest eine große Mortalitätsstudie unerläßlich, um das Risiko von Hirnblutungen und anderen Blutungskomplikationen zu erfassen.

Schlüsselwörter

Akuter Herzinfarkt ST-Segment-Rückbildung Prognose Niedrigrisikogruppe Ersatzendpunkt 

Impact of prediction of outcome by early ST segment changes in acute myocardial infarction

Abstract

The extent of ST segment elevation resolution (STR) 180 minutes after initiation of streptokinase treatment for acute myocardial infarction within 6 hours after onset of symptoms is an excellent early prognostic indicator that can be easily determined in all patients. This presentation is based on a meta-analysis from 3 thrombolysis studies including 3 912 patients. About 50% of patients had complete STR (≥70%). They had small enzymatic infarct sizes and well preserved left ventricular function associated with an excellent chance of survival. Patients with partial STR (<70 to 30%) developed larger infarcts, but had still a relatively low mortality. To assess the optimal cut-off point that best predicts an increased mortality risk, the squared standardized log odds ratio statistics as a function of the hypothetical cut-off points in STR was used. A cut-off point around 30% STR was associated with an extraordinarily strong predictive power. The 35-day cardiac mortality with STR <30% was 12.7% as compared to 2.1% for patients who had complete STR and 4.2% for those who had partial STR.

Based on STR, age, medical history, and simple parameters at admission, a low risk population can be defined that includes about 50% of all patients aged≤70 years, and 20% of older patients. The 35-day and 1-year mortality rates for the group of younger patients was 1.4% and 2.7%, respectively, and for the older age group 5.0% and 7.9%. It appears highly unlikely that aggressive testing and interventions would have any measurable beneficial effect on such a good outcome.

In thrombolytic therapy comparative trials STR may perform well as a surrogate endpoint, since it is more powerful than 90 minutes post-thrombolytic patency rates and early mortality, in a statistical sense. This is especially true for Phase-II dosefinding studies and the use as a surrogate or even primary endpoint in phase-III trials. In addition, STR may be very helpful for safety monitoring, interim analyses, and subgroup analyses in megatrials with the endpoint mortality. Use of STR can result in a substantial reduction in the required sample size. However, at least 1 pivotal mortality trial cannot be replaced by STR trials, since STR does not reflect the risk of intracranial hemorrhages and other bleeding complications.

Key Words

Acute myocardial infarction ST segment resolution Prognosis Low-risk group Surrogate endpoint 

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Literatur

  1. 1.
    Barbash GI, Roth A, Hod H, et al. Rapid resolution of ST elevation and prediction of clinical outcome in patients undergoing thrombolysis with alteplase (recombinant tissue-type plasminogen activator): results of the Israeli Study of Early Intervention in Myocardial Infarction. Br Heart J 1990; 64: 241–7.PubMedCrossRefGoogle Scholar
  2. 2.
    Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994; 50: 1029–41.PubMedCrossRefGoogle Scholar
  3. 3.
    Braunwald E, Cannon CP, McCabe CH. Use of composite endpoints in thrombolysis trials of acute myocardial infarction. Am J Cardiol 1993; 72: 3G-12G.PubMedCrossRefGoogle Scholar
  4. 4.
    Califf RM, Harrelson-Woodlief L, Topol EJ. Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials. Circulation. 1990; 82: 1847–53.PubMedGoogle Scholar
  5. 5.
    Claeys MJ, Bosmans J, Veenstra L, et al. Determinants and prognostic implications of persistent ST-segment elevation after primary angioplasty for acute myocardial infarction. Circulation 1999; 99: 1972–77.PubMedGoogle Scholar
  6. 6.
    Dissmann R, Goerke M, von Ameln H, et al. Erkennung der frühen Reperfusion und Vorhersage der linksventrikulären Schädigung aus dem Verlauf der ST-Strecken-Hebung beim akuten Myokardinfarkt mit Thrombolyse. Z Kardiol 1993; 82: 271–8.PubMedGoogle Scholar
  7. 7.
    Dissmann R, Schröder R, Busse U, et al. Early assessment of outcome by ST-segment analysis after thrombolytic therapy in acute myocardial infarction. Am Heart J 1994; 128: 851–7.PubMedCrossRefGoogle Scholar
  8. 8.
    Ellis SG, Ribeiro de Silva E, Heyndrickx G, et al. Randomized comparison of rescue angioplasty with conservative management of patients with early failure of thrombolysis for acute myocardial infarction. Circulation 1994; 90: 2280–4.PubMedGoogle Scholar
  9. 9.
    Fleiss J Statistical methods for rates and proportions, 2nd ed. New York: Wiley, 1981: 61–7.Google Scholar
  10. 10.
    Gruppo Italiano per lo Studio della Streptochinasi nell’ Infarto Miocardico. Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet 1986; 1: 397–402.Google Scholar
  11. 11.
    Hillis LD, Forman S, Braunwald E. Risk stratification before thrombolytic therapy in patients with acute myocardial infarction. J Am Coll Cardiol 1990; 16: 313–5.PubMedGoogle Scholar
  12. 12.
    International Joint Efficacy Comparison of Thrombolytics Randomised, double-blind comparison to reteplase double-bolus administration with streptokinase in acute myocardial infarction (INJECT): trial to investigate equivalence. Lancet 1995; 346: 329–36.CrossRefGoogle Scholar
  13. 13.
    ISIS-2. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction. Lancet 1993; 3: 349–60.Google Scholar
  14. 14.
    Ito H, Maruayama A, Iwakura K, et al. Clinicial implications of the “no-reflow” phenomenon. Circulation 1996; 93: 223–8.PubMedGoogle Scholar
  15. 15.
    Kenner MD, Zajac EJ, Kondos GT, et al. Ability of the no-reflow phenomenon during an acute myocardial infarction to predict left ventricular dysfunction at one-month follow-up. Am J Cardiol 1995; 76: 861–8.PubMedCrossRefGoogle Scholar
  16. 16.
    Kloner RA. Does reperfusion injury exist in humans? J Am Coll Cardiol 1993; 21: 537–45.PubMedGoogle Scholar
  17. 17.
    Lausen B, Schumacher M. Maximally selected rank statistics. Biometrics 1991; 48: 73–85.CrossRefGoogle Scholar
  18. 18.
    Lincoff AM, Topol EJ, Califf RM, et al. Significance of a coronary artery with Thrombolysis in Myocardial Infarction grade 2 flow “patency” (outcome in the Thrombolysis and Angioplasty in Myocardial Infarction Trials. Am J Cardiol 1995; 75: 871–6.PubMedCrossRefGoogle Scholar
  19. 19.
    Madsen JK, Grande P, Saunamäki K, et al. Danish multicenter randomized study of invasive versus conservative treatment in patients with inducible ischemia after thrombolysis in acute myocardial infarction (DANAMI). Circulation 1997; 96: 748–55.PubMedGoogle Scholar
  20. 20.
    Mauri F, Maggioni AP, Francosi MG, et al. A simple electrocardiographic predictor of the outcome of patients with acute myocardial infarction treated with a thrombolytic agent. A GISSI-2 derived analysis. J Am Coll Cardiol 1994; 24: 600–7.PubMedGoogle Scholar
  21. 21.
    Muller JE, Maroko PR, Braunwald E. Precordial electrocardiographic mapping: A technique to assess the efficacy of interventions designed to limit infarct size. Circulation 1978; 57: 1–18.PubMedGoogle Scholar
  22. 22.
    Neuhaus KL, Tebbe U, Gottwick M, et al. Intravenous recombinant tissue-plasminogen activator and urokinase in acute myocardial infarction: Results of the German Activator Urokinase Study (GAUS). J Am Coll Cardiol 1988; 12: 581–7.PubMedGoogle Scholar
  23. 23.
    Newby LK, Califf RM, Guerci A, et al. Early discharge in the thrombolytic era: An analysis of criteria for uncomplicated infarction from the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) Trial. J Am Coll Cardiol 1996; 27: 625–32.PubMedCrossRefGoogle Scholar
  24. 24.
    Ross AM, Coyne KS, Moreyra E, et al. Extended mortality benefit of early postinfarction reperfusion. Circulation 1998; 97: 1549–56.PubMedGoogle Scholar
  25. 25.
    Saran RK, Been M, Furniss SS, et al. Reduction in ST segment elevation after thrombolysis predicts either coronary reperfusion or preservation of left ventricular function. Br. Heart J 1990; 64: 113–7.PubMedCrossRefGoogle Scholar
  26. 26.
    Schröder R, Dissmann R, Brüggemann T, et al. Extent of early ST segment elevation resolution: A simple but strong predictor of outcome in patients with acute myocardial infarction. J Am Coll Cardiol 1994; 24: 384–91.PubMedGoogle Scholar
  27. 27.
    Schröder R, Wegscheider K, Schröder K, et al. Extent of early ST segment elevation resolution: a strong predictor of outcome in patients with acute myocardial infarction and a sensitive measure to compare thrombolytic regimes. A substudy of the International Joint Efficacy Comparison of Thrombolytics (INJECT) Trial. J Am Coll Cardiol 1995; 26: 1657–64.PubMedCrossRefGoogle Scholar
  28. 28.
    Schröder R, Zeymer U, Wegscheider K, et al. Comparison of the predictive value of ST segment elevation resolution at 90 and 180 minutes after start of streptokinase in acute myocardial infarction. A substudy of the Hirudin for Improvement of Thrombolysis (HIT)-4 Study. Eur Heart J 1999; im Druck.Google Scholar
  29. 29.
    Schröder R. Thrombolyse bei akutem Myokardinfarkt und die Behandlung danach. Informationsblatt Dtsch Ges Kardiol 1998; 2: 112–24.Google Scholar
  30. 30.
    Steg PG, Laperche T, Golmard JL, et al. Efficacy of streptokinase, but not tissue-type plasminogen activator, in achieving 90-minute patency after thrombolysis for acute myocardial infarction decreases with time to treatment. J Am Coll Cardiol 1998; 31: 776–9.PubMedCrossRefGoogle Scholar
  31. 31.
    Tavazzi L, Volpi A, for the GISSI Investigators. Remarks about post-infarction prognosis in light of the experience with the Gruppo Italiano per lo Studio delia Sopravvivenza nell’ Infarto Miocardico (GISSI) Trials. Circulation 1997; 95: 1341–5.PubMedGoogle Scholar
  32. 32.
    Terrin ML, Williams DO, Kleimann NS, et al. Two- and three-year results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II Clinicial Trial. J Am Coll Cardiol 1993; 22: 1763–72.PubMedCrossRefGoogle Scholar
  33. 33.
    The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators. A comparison of reteplase with alteplase for acute myocardial infarction. N Engl. J Med 1997; 337: 1118–23.CrossRefGoogle Scholar
  34. 34.
    The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl. J Med 1993; 329: 673–82.CrossRefGoogle Scholar
  35. 35.
    The ISAM Study Group. A prospective trial of intravenous streptokinase in acute myocardial infarction: mortality, morbidity, and infarct size at 21 days. N Engl. J Med 1986; 314: 1465–71.Google Scholar
  36. 36.
    van t’Hof AW, Liem A, de Boer EJ, et al. Clinical value of 12-lead electrocardiogram after successful reperfusion therapy for acute myocardial infarction. Lancet 1997; 350: 615–9.CrossRefGoogle Scholar
  37. 37.
    Vogt A, von Essen R, Tebbe U, et al. Impact of early perfusion status of the infarct-related artery on short-term mortality after thrombolysis for acute myocardial infarction: retrospective analysis of four German multicenter studies. J Am Coll Cardiol 1993; 21: 1391–5.PubMedCrossRefGoogle Scholar

Copyright information

© Urban & Vogel 1999

Authors and Affiliations

  • Karl Wescheider
    • 1
  • Karl -Ludwig Neuhaus
    • 2
  • Rüdiger Dissmann
    • 3
  • Ulrich Tebbe
    • 4
  • Uwe Zeymer
    • 2
  • Rolf Schröder
    • 5
  1. 1.Universität HamburgHamburgDeutschland
  2. 2.Städtische Kliniken KasselKasselDeutschland
  3. 3.Zentralkrankenhaus BremerhavenBremerhavenDeutschland
  4. 4.Klinikum Lippe-DetmoldDetmoldDeutschland
  5. 5.Universitätsklinikum Benjamin Franklin der FUBerlinDeutschland

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