РИСК И ВЫГОДА РЕПЕРФУЗИОННЫХ СТРАТЕГИЙ В ЛЕЧЕНИИ БОЛЬНЫХ ОСТРЫМ ИНФАРКТОМ МИОКАРДА С ПОДЪЕМОМ СЕГМЕНТА ST

В обзоре обсуждаются реперфузионные стратегии у больных с острым инфарктом миокарда с подъемом сегмента ST (ИМПST) с позиций результатов, представленных в международных клинических исследованиях. Даны современные представления об инвазивной и консервативной стратегиях в лечении ИМПST в реальной клинической практике в европейских странах. Наиболее существенное влияние на выживаемость пациентов имеет время, а не метод реперфузии. Стратегия первичного чрескожного коронарного вмешательства (ЧКВ) может не уменьшать смертность при задержке дверь-баллон более 60 мин по сравнению с немедленным проведением тромболитической терапии (ТЛТ). Стратегия ЧКВ имеет преимущество над ТЛТ только в том случае, если разница во времени между этими стратегиями (дверь-баллон – дверь-игла) менее 2-х часов. При выборе способа реперфузионной терапии следует учитывать риск пациента. Первичное ЧКВ имеет ограничения, связанные с тем, что эта методика не является общедоступной, требует специальной подготовки персонала и специального оснащения. Своевременное проведение ТЛТ является приемлемым стандартом оказания помощи при ИМПST. Этот подход наиболее актуален для России. Однако фармакоинвазивная стратегия должна быть предпочтительной опцией у пациентов, леченных ТЛТ. Особого внимания в обсуждении фибринолитических препаратов заслуживают препараты второго – алтеплаза (Актилизе® ) и третьего поколения – тенектеплаза (Метализе® ). До появления Метализе® непрерывная инфузия Актилизе® рассматривалась как золотой стандарт фармакологической реперфузионной терапии. Введение Метализе® в виде однократного болюса оказывается так же эффективно, как и непрерывно вводимая алтеплаза, но с лучшим профилем безопасности. Проведение ТЛТ на догоспитальном этапе с помощью одного болюса тенектеплазы (Метализе® ) за 5-10 сек предлагает уникальную клиническую возможность для раннего назначения терапии, что способствует максимальному спасению миокарда.

1. Диагностика и лечение больных острым инфарктом миокарда с подъемом сегмента ST ЭКГ. Национальные клинические рекомендации Москва, 2007; 123

2. Ahmed S, Antman EM, Murphy SA, et al. Poor outcomes after fibrinolytic therapy for ST-segment elevation myocardial infarction: impact of age (a meta-analysis of a decade of trials). J Thromb Thrombolysis. 2006;21:119 –129.

3. Andersen HR, Nielsen TT, Rasmussen K, et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med 2003;349:733–742.

4. Angeja BG, Gibson CM, Chin R, et al. Predictors of door-to-balloon delay in primary angioplasty. Am J Cardiol. 2002;89:1156 –1161.

5. Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). J Am Coll Cardiol. 2004; 44:671–719.

6. Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction. Circulation. 2004;110: e82–e292

7. Armstrong P, WEST Steering Committee A comparison of pharmacologic therapy with/without timely coronary intervention vs. primary percutaneous intervention early after ST-elevation myocardial infarction: the WEST (Which Early ST-elevation myocardial infarction Therapy) study. Eur Heart J 2006;27:1530–1538.

8. Berger AK, Radford MJ, Wang Y, Krumholz HM. Thrombolytic therapy in older patients. J Am Coll Cardiol. 2000;36:366 –374.

9. Betriu A, Masotti M. Comparison of mortality rates in acute myocardial infarction treated by percutaneous coronary intervention versus fibrinolysis. Am J Cardiol 2005;95:100-101.

10. Birkhead JS, Walker L, Pearson M. et al. Improving care for patients with acute coronary syndromes: initial results from the National Audit of Myocardial Infarction Project (MINAP). Heart 2004;90:1004–1009.

11. Bjorklund E, Lindahl B, Stenestrand U, Swedish ASSENT-2; RIKSHIA Investigators. Outcome of ST-elevation myocardial infarction treated with thrombolysis in the unselected population is vastly different from samples of eligible patients in a large-scale clinical trial. Am Heart J 2004;148:566–573.

12. Bjorklund E, Stenestrand U, Lindback J. Pre-hospital thrombolysis delivered by paramedics of is associated with reduced time delay and mortality in ambulance-transported real-life patients with ST-elevation myocardial infarction. Eur Heart J 2006;27:1146-1152.

13. Boersma E and PCAT-2 Trialists’ Collaborative Group. Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous cor onary intervention and in-hospital fibrinolysis in acute myocardial infarction patients. Eur Heart J 2006;27:779-788.

14. Bohmer E, Arnesen H, Abdelnoor Met al. The NORwegian study on District treatment of ST-elevation myocardial infarc tion (NORDISTEMI). Scand Cardiovosc J 2007;41:32-38.

15. Bonnefoy E, Lapostolle F, Leizorovicz A, et al., for Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial Infarction study group. Primary angioplasty versus prehospital fibrinolysis in acute myocardial infarction: a randomised study. Lancet 2002;360: 825-829.

16. Bradley EH, Curry LA, Webster TR. Achieving rapid door-to-balloon times: how top hospitals improve complex clinical systems. Circulation. 2006;113:1079 –1085.

17. Cambou JP, Simon T, Mulak G, Bataille V, Danchin N. The French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction (FAST-MI): study design and baseline characteristics. Arch Mal Coeur Vaiss 2007;100:524–534

18. Cannon CP, Gibson CM, Lambrew CT, et al. Relationship of symptom-onset-to-balloon time and door-to-balloon time with mortality in patients undergoing angioplasty for acute myocardial infarction. JAMA. 2000;283:2941–2947

19. Collet JP, Montalescot G, Le May M, et al. Percutaneous coronary inter vention after fibrinolysis: a multiple meta-analyses approach according to the type of strategy. J Am Coll Cardiol. 2006;48:1326–1335

20. Curtis JP, Portnay EL, Wang Y, et al. The pre-hospital electrocardiogram and time to reperfusion in patients with acute myocardial infarction, 2000–2002: findings from the National Registry of Myocardial Infarction-4. J Am Coll Cardiol. 2006;47:1544 –1552.

21. Danchin N, Coste P, Ferrieres J, et al. for the FAST-MI Investigators. Comparison of Thrombolysis Followed by Broad Use of Percutaneous Coronary Intervention With Primary Percutaneous Coronary Intervention for STSegment-Elevation Acute Myocardial Infarction Data From the French Registry on Acute ST-Elevation Myocardial Infarction (FASTMI). Circulation 2008;118:268–276.

22. Danchin N, Durand E, Blanchard D. Pre-hospital thrombolysis in perspective. Eur Heart J 2008;29:2835-2842

23. De Luca G, Suryapranata H, Zijlstra F, et al. Symptom-onset-to-balloon time and mortality in patients with acute myocardial infarction treated by primary angioplasty. J Am Coll Cardiol. 2003;42:991–997.

24. Di Mario C, Dudek D, Piscione F, et. al. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet 2008:371:559-568.

25. Eagle KA, Lim MJ, Dabbous OH. et al. A validated prediction model for all forms of acute coronary syndrome: estimating the risk of 6-month postdischarge death in an international registry. JAMA 2004;291:2727– 2733.

26. Ellis SG, Tendera M, de Belder MA, et al. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med 2008;358:2205-17.

27. Fibrinolytic Therapy Trialists’ (FTT) Collaborative Group. Indications for fibrinolytic therapy in suspected acute myocardial infarction: collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients. Lancet. 1994;343:311–322.

28. Goldberg RJ, Spencer FA, Fox KAA, et al. Prehospital delay in patients with acute coronary syndromes (from the Global Registry of Acute Coronary Events [GRACE]). Am J Cardiol 2009;103:598–603.

29. Granger CB, White HD, Bates ER, et al. A pooled analysis of coronary arterial patency and left ventricular function after intravenous thrombolysis for acute myocardial infarction. Am J Cardiol. 1994;74:1220 –1228.

30. Kalla K, Christ G, Karnik R. Vienna STEMI Registry Group. Implementation of guidelines improves the standard of care: the Viennese registry on reperfusion strategies in ST-elevation myocardial infarction (Vienna STEMI registry). Circulation 2006;113: 2398–2405.

31. Keeley EC, BouraJA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction a quantitative review of 23 ran domized trials. Lancet 2003;361:13-20.

32. Krumholz HM, Anderson JL, Brooks NH. ACC/AHA clinical performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/ American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures on ST-Elevation and Non-ST-Elevation Myocardial Infarction). Circulation. 2006;113: 732–761.

33. Lambert L, Kevin Brown, Eli Segal, et al. Association Between Timeliness of Reperfusion Therapy and Clinical Outcomes in ST-Elevation Myocardial Infarction JAMA, June 2, 2010 – Vol. 303, No. 21

34. Mathew TP, Menown IBA, McCarty D et al. Impact of pre-hospital care in patients with acute myocardial infarction compared with those first managed in-hospital. Eur Heart J 2003;24:161-171

35. Nallamothu BK, Antman EM, Bates ER. Primary percutaneous coronary intervention versus fibrinolytic therapy in acute myocardial infarction: does the choice of fibrinolytic agent impact on the importance of timeto-treatment? Am J Cardiol. 2004; 94:772–774.

36. Nallamothu BK, Bates ER, Herrin J, for the NRMI Investigators. Times to treatment in transfer patients undergoing primary percutaneous coronary intervention in the United States: National Registry of Myocardial Infarction (NRMI)-3/4 analysis. Circulation. 2005;111:761–767.

37. Nallamothu BK, Bates ER. Percutaneous coronary intervention versus fibrinolytic therapy in acute myocardial infarction is timing (almost) everything? Am J Cardiol 2003:92:824-826.

38. Pinto DS, Kirtane AJ, Nallamothu BK, et. al. Hospital delays in reperfusion for ST-elevation myocardial infarction. Implications when selecting a reperfusion strategy. Circulation 2006;114: 2019-2025.

39. Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006;367:569 –578.

40. Ribichini F, Steffenino G, Dellavalle A, et. al. Comparison of thrombolytic therapy and primary coronary angioplasty with liberal stenting for inferior myocardial infarction with precordial ST-segrnent depression: immediate and long-term results of a randomized study. J Am Coll Cardiol 1998;32:1687-1694.

41. Rittersma SZH, van der Wai AC, Koch KT, et. al. Plaque instability frequently occurs days or weeks before occlusive coronary thrombosis–a pathological thrombectomy study in primary percutaneous coronary intervention. Circulation 2005;111:1160-1165.

42. Rogers WJ, Bowlby LJ, Chandra NC, et al. Treatment of myocardial infarction in the United States (1990 to 1993): observations from the National Registry of Myocardial Infarction. Circulation. 1994;90: 2103–2114.

43. Sejersten M, Ripa RS, Maynard C, et al. Timing of ischemic onset estimated from the electrocardiogram is better then historical timing for predicting outcome after reperfusion therapy for acute anterior myocardial infarction: a Danish trial in acute myocardial infarction 2 (DANAMI-2) substudy. Am HeartJ 2007;154: e1-e8.

44. Silber S, Albertsson P, Aviles FF, et al. Guidelines for percutaneous coronary interventions–the task force for percutaneous coronary interventions of the European Society of Cardiology. Eur Heart J 2005;26: 804–847

45. Steg PG, Bonnefoy E, Chabaud S, et al., for the Comparison of Angioplasty and Prehospital Thrombolysis In acute Myocardial infarction (CAPTIM) Investigators. Impact of time to treatment on mortality after prehospital fibrinolysis or primary angioplasty: data from the CAPTIM randomized clinical trial. Circulation. 2003;108:2851–2856.

46. Stenestrand U, Lindback J, Wallentin L, for the RIKS-HIA group. Long-term outcome of primary percutaneous coronary intervention vs prehospital and in-hospital thrombolysis for patients with ST-elevation myocardial infarction. JAMA 2006;296:1749–1756.

47. Tadel Kocjancic S, Zorman S, Jazbec A, et al. Effectiveness of primary percutaneous coronary intervention for acute ST-elevation myocardial infarction from a 5-year single-center experience. Am J Cardiol 2008;101:162–168.

48. Tarantini G, Cacciavillani L, Corbetti F, et al.Duration of ischemia is a major determinant of transmurality and severe microvascular obstruction after primary angioplasty: a study performed with contrast-enhanced magnetic resonance. J Am Coll. Cardiol. 2005;46:1229-1235.

49. Tarantini G, Razzolini R, Napodano M, Bilato C, et. al. Acceptable reperfusion delay to prefer primary angioplasty over fibrin-specific thrombolytic therapy is affected (mainly) by the patient’s mortality risk: 1 h does not fit all. Eur Heart J 2010;31:676-683.

50. Tarantini G, Razzolini R, Ramondo A, et. al. Explanation for the survival benefit of primary angiopiasty over thrombolytic therapy in patients with ST-elevation acute myocardial infarction. Am J Cardiol 2005;96: 1503- 1505.

51. Terkelsen CJ, Lassen JF, Norgaard BL, et al. Mortality rates in patients with ST-elevation vs. non-ST-elevation acute myocardial infarction: observations from an unselected cohort. Eur Heart J 2005;26:18–26.

52. The Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT- 4 PCI) investigators. Primary versus tenecteplase facilitated percutaneous coronary intervention in patients with ST-elevation acute myocardial Infarction: the ASSENT-4 PCI randomised trial. Lancet 2006:367: 69-578.

53. The Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO lIb) Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. N Engl J Med 1997;336:1621-1628.

54. The GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med. 1993;329:1615–1622.

55. Thune JJ, Hoefsten DE, Lindholm MG, et. al. for the Danish Multicenter Randomized Study on Fibrinolytic Therapy versus Acute Coronary Angiopiasty in Acute Myocardial Infarction (DANAMl)-2 Investigators. Simple risk stratification at the admission to identify patients with reduced mortality from primary angiopiasty. Circulation 2005;112: 2017-2021.

56. Van de Werf F, Bax J, Betriu A, et. al. Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J 2008;29:2909-2945.

57. Vermeer F, Oude Ophuis AJ, van der Berg EJ, et. al. Prospective randomised comparison between thrombolysis, rescue PTCA, and pri mary PTCA in patients with extensive myocardial infarction admitted to a hospital without PTCA facilities: a safety and feasibility study. Heart 1999:82:426-431.

58. Widimsky P, Wijns W, Fajadet J, et al Reperfusion therapy for ST elevation acute myocardial infarction in Europe: description of the current situation in 30 countries. Eur Heart J 2010; 31: 943–957

59. Widimsky P, Budesinsky T, Vorac D, ‘PRAGUE’ Study Group Investigators. Long distance transport for primary angioplasty vs. immediate thrombolysis in acute myocardial infarction. Final results of the randomized national multicentre trial–PRAGUE-2. Eur Heart J 2003;24:94–104.

60. Widimsky P, Groch L, Zelizko M, et. al. Multicentre randomized trial comparing transport to primary angioplasty vs immedi ate thrombolysis vs combined strategy for patients with acute myocardial infarction presenting to a community hospital without a catheterization laboratory. The PRAGUE study. Eur Heart J 2000:21:823-831.

61. Widimsky P, Motovska Z, Bilkova D, et. al. The impact of age and Kiilip class on outcomes of primary percutaneous coronary intervention. Insight from the PRAGUE-1 and -2 trials and Registry. EuroIntervention 2007:2:481-486.

62. Widimsky P. Primary angioplasty vs. thrombolysis: the end of the controversy? Eur Heart J 2010;31:634-636

63. Widimsky P., Janousek S., Vojacek J. on behalf of the Czech Society of Cardiology. Guidelines for the diagnosis and treatment of acute myocardial infarction. Cor et Vasa 2002;44: K123-K143.

64. Zahn R, Vogt A, Zeymer U, In-hospital time to treatment of patients with acute ST elevation myocardial infarction treated with primary angioplasty: determinants and outcome: results from the registry of percutaneous coronary interventions in acute myocardial infarction of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausarzte. Heart. 2005;91:1041–1046.