Systems of Care
2008; Lippincott Williams & Wilkins; Volume: 118; Issue: 3 Linguagem: Inglês
10.1161/circulationaha.108.790170
ISSN1524-4539
Autores Tópico(s)Antiplatelet Therapy and Cardiovascular Diseases
ResumoHomeCirculationVol. 118, No. 3Systems of Care Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBSystems of CareNeed for Hub-and-Spoke Systems for Both Primary and Systematic Percutaneous Coronary Intervention After Fibrinolysis Harvey D. White Harvey D. WhiteHarvey D. White From Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. Originally published15 Jul 2008https://doi.org/10.1161/CIRCULATIONAHA.108.790170Circulation. 2008;118:219–222Primary percutaneous coronary intervention (PCI) is currently considered the best reperfusion therapy if performed in a timely manner. However, in many developed countries, it is difficult to offer primary angioplasty to more than 20% to 30% of eligible patients because of logistical issues. Fibrinolytic therapy has recently improved, with the addition of clopidogrel resulting in both improved infarct artery patency1 and mortality2 and enoxaparin reducing reinfarction.3 In addition, rescue PCI has been shown to reduce reinfarction after fibrinolytic therapy by 42% (P<0.05),4 and in a meta-analysis of 8 trials that included 1117 patients, rescue PCI resulted in a reduction in death, reinfarction, and heart failure at 6 months from 41.0% to 29.2% (P 6 hours also is supported by a number of trials.12,13 However, the data relating to timing are not robust, and further research is needed.13Several small trials with fibrinolysis and systematic PCI have shown outcomes similar to primary PCI, as has another recent registry from Vienna.14 In the Grupo de Análisis de la Cardiopatía Isquémica Aguda (GRACIA 2) trial,15 fibrinolysis with tenecteplase and enoxaparin and systematic PCI between 3 and 12 hours (median, 4.6 hours) resulted in outcomes similar to primary PCI. Similarly, in the Which Early ST-Elevation Myocardial Infarction Therapy (WEST) study,13 systematic PCI within 24 hours (median, 8.9 hours) after administration of tenecteplase resulted in outcomes similar to primary PCI.In this issue of Circulation, Danchin and colleagues16 report on a registry of 1714 patients with acute ST-elevation myocardial infarction from 223 centers throughout France in October 2005. The registry compared outcomes from primary PCI with those from fibrinolytic therapy with a high rate of rescue and systematic PCI. The registry included 60% of the centers treating myocardial infarction in France. In France, mobile intensive care units (Service d'aide médicale urgente) are staffed by physicians able to give fibrinolytic therapy, clopidogrel, antithrombotic agents, and glycoprotein IIb/IIIa antagonists. Fibrinolysis was administered to 29% of patients, with two thirds receiving fibrinolysis in the ambulance before hospital admission. The time delay between a call to the mobile care unit and administration of fibrinolysis was 40 minutes, whereas the time to primary PCI, which was performed in 33% of patients, was 130 minutes. Strikingly, 40% of eligible patients received no reperfusion therapy.Almost all the patients (96%) who received fibrinolysis underwent coronary angiography while in hospital, with 84% having PCI; the median time from fibrinolysis was 220 minutes. Rescue PCI, which was recommended if there were persisting symptoms or persisting ST-segment elevation 60 minutes after administration of fibrinolysis, was performed in 37% of fibrinolysis patients, with a median time to PCI of 168 minutes. There was a high rate of clopidogrel (91%), low-molecular-weight heparin (56%), and glycoprotein IIb/IIIa antagonist (16%) use in fibrinolysis-treated patients. Perhaps surprisingly, there was no increase in bleeding with fibrinolysis following the high rate of PCI compared with primary PCI (major bleeding, 1.7% versus 2.3%; P=0.353).There has been a marked increase in both primary PCI from 13% in 1995 to 33% in this registry in 2005, along with a marked increase in prehospital fibrinolysis rates from 9.4% in 2000 to 18%.17 These changes have been paralleled by a reduction in hospital mortality from 9.3% to 6.6%. Survival at 12 months was 94.7% for prehospital fibrinolysis, 91.5% for in-hospital fibrinolysis, and 91.8% for primary PCI (P=0.31, fibrinolysis versus primary PCI). In addition, outcomes in patients who were transferred after fibrinolysis were similar to those in patients treated in hospital with primary PCI facilities. After propensity matching and score adjustment using the GRACE score and baseline comorbidities, including chronic renal failure, 12-month survival was similar in the fibrinolytic (prehospital and in-hospital administration) and primary PCI groups (93.8% and 93.3%).Of interest in this nonrandomized registry, PCI after fibrinolysis at ≤128 minutes was associated with a higher mortality, consistent with a meta-analysis of facilitated PCI trials7 and the recent Assessment of the Safety and Efficacy of a New Treatment Strategy With Percutaneous Coronary Intervention (ASSENT-4 PCI)8 and Facilitated Intervention for Enhanced Reperfusion Speed to Stop Events (FINESSE) trials.9It is also interesting that mortality increased with rescue PCI with quartile time cuts of ≤128, 129 to 220, and >220 minutes (third and fourth quartiles) after fibrinolysis and rescue PCI (2.6%; 5.4%, 10.2%), whereas mortality decreased with systematic PCI (5.2%, 2.6%, 1.5%), implying that if systematic PCI had been done before 220 minutes, the very high mortality with rescue PCI (10.5%) may have been avoided. However, the rescue patients are highly selected and would be expected to do poorly because they failed lysis and have either ongoing symptoms or hemodynamic compromise. In addition, the longer the delay to systematic PCI is, the more likely it is that nonfatal ischemic events will occur. Unfortunately, this registry provides no information on the occurrence of reinfarction.Given that registries cannot assess the benefits of treatments and that findings need to be confirmed by clinical trials, what are the lessons from the French registry? First, the registry shows the benefit of applying evidence-based guidelines in clinical practice with high rates of clopidogrel and enoxaparin use and short "from first seen to needle" and "from first seen to balloon" times. Second, as in other registries,18 a large group of patients received no reperfusion therapy, and these patients had the highest hospital mortality (9.5%).Primary angioplasty also has improved recently, with the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS) trial19 showing that bivalirudin reduced 30-day mortality from 3.1% to 2.1% (P=0.048) and reduced major bleeding by 41%. This is the first time that an improvement in mortality has been shown with primary angioplasty, and again, the balance of evidence has tilted toward primary angioplasty as the preferred reperfusion strategy if performed in a timely manner.The largest gains in terms of lowering mortality from ST-elevation myocardial infarction are likely to come from the development of systems to apply the evidence that we already have.20 For example, treating the ≈40% of patients who currently do not receive reperfusion18 with primary angioplasty within 2 hours of symptom onset would save 270 lives per 10 000 patients compared with introducing all reperfusion eligible patients to a novel therapy and reducing mortality by 20%, which would save 180 lives.20 Adding a novel therapy to optimal reperfusion (primary PCI within 2 hours) to all eligible patients would save 1 life per 10 000 patients treated.A pharmacoinvasive strategy of rapid administration of fibrinolysis (prehospital or in hospital) followed by systematic PCI within 24 hours would be practical in many communities and most countries. Systems of care may involve "hub-and-spoke" systems in which catheterization laboratories perform primary PCI and patients are directly transported from the surrounding communities or peripheral hospitals or systems in which prehospital or in-hospital fibrinolysis is followed by rescue and systematic PCI. In some communities, both approaches, as shown in this registry from France, may work well together and deliver excellent care to patients.The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.I am grateful to Barbara Semb and Charlene Nell for secretarial assistance.DisclosuresDr White reports having received consulting fees and lecture fees from The Medicines Company and sanofi-aventis and grant support from The Medicines Company, Sanofi-Aventis, Proctor and Gamble, Schering Plough, and Eli Lilly.FootnotesCorrespondence to Professor Harvey White, Green Lane Cardiovascular Service, Auckland City Hospital, Private Bag 92024, Auckland 1030, New Zealand. E-mail [email protected] References 1 Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005; 352: 1179–1189.CrossrefMedlineGoogle Scholar2 Chen ZM, Jiang LX, Chen YP, Xie JX, Pan HC, Peto R, Collins R, Liu LS. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005; 366: 1607–1621.CrossrefMedlineGoogle Scholar3 Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, Lopez-Sendon JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006; 354: 1477–1488.CrossrefMedlineGoogle Scholar4 Gershlick AH, Stephens-Lloyd A, Hughes S, Abrams KR, Stevens SE, Uren NG, de Belder A, Davis J, Pitt M, Banning A, Baumbach A, Shiu MF, Schofield P, Dawkins KD, Henderson RA, Oldroyd KG, Wilcox R. Rescue angioplasty after failed thrombolytic therapy for acute myocardial infarction. N Engl J Med. 2005; 353: 2758–2768.CrossrefMedlineGoogle Scholar5 Wijeysundera HC, Vijayaraghavan R, Nallamothu BK, Foody JM, Krumholz HM, Phillips CO, Kashani A, You JJ, Tu JV, Ko DT. Rescue angioplasty or repeat fibrinolysis after failed fibrinolytic therapy for ST-segment myocardial infarction: a meta-analysis of randomized trials. J Am Coll Cardiol. 2007; 49: 422–430.CrossrefMedlineGoogle Scholar6 Collet JP, Montalescot G, Le May M, Borentain M, Gershlick A. Percutaneous coronary intervention after fibrinolysis: a multiple meta-analyses approach according to the type of strategy. J Am Coll Cardiol. 2006; 48: 1326–1335.CrossrefMedlineGoogle Scholar7 Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials. Lancet. 2006; 367: 579–588.CrossrefMedlineGoogle Scholar8 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-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006; 367: 569–578.CrossrefMedlineGoogle Scholar9 Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ. Facilitated PCI in patients with ST-elevation myocardial infarction. 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Presented at: SCAI-ACC i2 Summit/ACC 2008 Late Breaking Clinical Trials II: Acute Myocardial Infarction, Annual Scientific Sessions of the American College of Cardiology 2008; March 30, 2008; Chicago, Ill.Google Scholar12 Fernandez-Aviles F, Alonso JJ, Castro-Beiras A, Vazquez N, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Calvo I, Martinez-Elbal L, San Roman JA, Ramos B. Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial. Lancet. 2004; 364: 1045–1053.CrossrefMedlineGoogle Scholar13 Armstrong PW. 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.CrossrefMedlineGoogle Scholar14 Kalla K, Christ G, Karnik R, Malzer R, Norman G, Prachar H, Schreiber W, Unger G, Glogar HD, Kaff A, Laggner AN, Maurer G, Mlczoch J, Slany J, Weber HS, Huber K. 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.LinkGoogle Scholar15 Fernandez-Aviles F, Alonso JJ, Pena G, Blanco J, Alonso-Briales J, Lopez-Mesa J, Fernandez-Vazquez F, Moreu J, Hernandez RA, Castro-Beiras A, Gabriel R, Gibson CM, Sanchez PL. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J. 2007; 28: 949–960.CrossrefMedlineGoogle Scholar16 Danchin N, Coste P, Ferrières J, Steg P-G, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Guéret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou J-P, Simon T, the FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment–elevation acute myocardial infarction: data from the French Registry on Acute ST-Elevation Myocardial Infarction (FAST-MI). Circulation. 2008; 118: 268–276.LinkGoogle Scholar17 Danchin N, Blanchard D, Steg PG, Sauval P, Hanania G, Goldstein P, Cambou JP, Gueret P, Vaur L, Boutalbi Y, Genes N, LaBlanche JM. Impact of prehospital thrombolysis for acute myocardial infarction on 1-year outcome: results from the French Nationwide USIC 2000 Registry. 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Combined Angioplasty and Pharmacological Intervention Versus Thrombolysis Alone in Acute Myocardial Infarction (CAPITAL AMI study). J Am Coll Cardiol. 2005; 46: 417–424.CrossrefMedlineGoogle Scholar22 Scheller B, Hennen B, Hammer B, Walle J, Hofer C, Hilpert V, Winter H, Nickenig G, Bohm M. Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction. J Am Coll Cardiol. 2003; 42: 634–641.CrossrefMedlineGoogle Scholar23 Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL, for the Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. 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July 15, 2008Vol 118, Issue 3 Advertisement Article InformationMetrics https://doi.org/10.1161/CIRCULATIONAHA.108.790170PMID: 18625904 Originally publishedJuly 15, 2008 Keywordspercutaneous coronary interventionEditorialsfibrinolysisPDF download Advertisement SubjectsMyocardial InfarctionPharmacologyStentThrombosis
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