Fibrinolytic therapy: is it a treatment of the past?

Abstract

HomeCirculationVol. 107, No. 20Fibrinolytic Therapy Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBFibrinolytic TherapyIs It A Treatment of the Past? Cindy L. Grines, MD, Patrick Serruys, MD and William W. O’Neill, MD Cindy L. GrinesCindy L. Grines From the Division of Cardiology, William Beaumont Hospital, Royal Oak, Mich (C.L.G., W.W.O.), and the Department of Interventional Cardiology, Thoraxcenter, Heartcenter, Erasmus Medical Center, Academisch Ziekenhuis Dijkzigt Rotterdam, The Netherlands (P.S.). Search for more papers by this author , Patrick SerruysPatrick Serruys From the Division of Cardiology, William Beaumont Hospital, Royal Oak, Mich (C.L.G., W.W.O.), and the Department of Interventional Cardiology, Thoraxcenter, Heartcenter, Erasmus Medical Center, Academisch Ziekenhuis Dijkzigt Rotterdam, The Netherlands (P.S.). Search for more papers by this author and William W. O’NeillWilliam W. O’Neill From the Division of Cardiology, William Beaumont Hospital, Royal Oak, Mich (C.L.G., W.W.O.), and the Department of Interventional Cardiology, Thoraxcenter, Heartcenter, Erasmus Medical Center, Academisch Ziekenhuis Dijkzigt Rotterdam, The Netherlands (P.S.). Search for more papers by this author Originally published27 May 2003https://doi.org/10.1161/01.CIR.0000075292.29458.BBCirculation. 2003;107:2538–2542Fibrinolytic therapy has been an important means of establishing reperfusion for decades. However, limitations to the use of thrombolytic therapy include perceived or definite contraindications, intracranial bleeding, inability to establish Thrombosis In Myocardial Infarction (TIMI-3) flow in many patients, and high rates of recurrent ischemia and reocclusion. Accordingly, primary percutaneous coronary intervention (PCI) has emerged as the preferred reperfusion strategy.Nearly all acute myocardial infarction (AMI) patients are eligible for emergency catheterization. Knowledge of the coronary anatomy allows immediate triage to surgery, medical therapy, or primary PCI, when appropriate, and results in earlier hospital discharge compared to thrombolytic therapy.1 Primary PCI establishes TIMI-3 flow in >90% of patients and is associated with reduced rates of recurrent ischemia and reocclusion. With the addition of stenting, reocclusion has been further reduced to 5% at routine 6-month angiography.2,3 Small studies have suggested that pharmacological adjuncts to PCI such as abciximab may improve myocardial perfusion and limit infarct size4,5 without the risk of bleeding observed with thrombolytic therapy.6 Finally, new technologies such as coronary thrombectomy, distal projection, and systemic cooling are easily applied in the catheterization laboratory and may further improve myocardial perfusion and infarct size.Although primary PCI has been in use for more than 25 years, the first trials randomizing PCI to intravenous thrombolytics therapy were not published until 1993.7 A meta-analysis of the first 10 randomized trials demonstrated a reduction in death, reinfarction, and stroke with primary PCI in all subgroups, but the greatest absolute benefit was observed in high-risk patients.8On the basis of these early results, many experienced interventionalists were no longer willing to randomize patients to thrombolytic therapy. Therefore, the next decade of research was focused on perfecting the primary PCI technique, with studies randomizing patients to intraaortic balloon pumps, stents, glycoprotein IIb/IIIa inhibitors, and early discharge.2–5,9,10 High rates of TIMI-3 flow and low mortality rates were consistently observed with primary PCI in these trials, confirming the results of the earlier studies. However, some physicians continued to express concern that too few primary PCI studies had been performed, the results may not be reproducible in less experienced centers, and that withholding thrombolytics while awaiting primary percutaneous transluminal coronary angiography (PTCA) could cause harm.Over the past few years, several additional studies addressed theses issues. To date, 23 trials have randomized 7739 patients to receive thrombolytics (76% of whom were randomized in tissue plasminogen activator [tPA] trials) compared with primary PCI.11 In a meta-analysis of these studies, Keeley et al11 reported that primary PCI was associated with improved 30-day outcomes, including death (7% versus 9%, P=0.0002), nonfatal reinfarction (2.5% versus 6.8%, P<0.0001), and stroke (1% versus 2%, P=0.0004), with absolute differences so great that 60 patients would benefit for every 1000 patients treated (Figure 1). The beneficial results with primary PCI were sustained at long-term follow-up and were observed in both streptokinase- and tPA-treated patients and in situations where transfer (up to 3 hour delay) was required for performance of primary PCI12–14 or PCI was performed in hospitals without on-site surgery.15Download figureDownload PowerPointFigure 1. Meta-analysis of 23 randomized trials of primary PCI versus thrombolysis. CVA indicates cerebrovascular accident. Reprinted with permission from Elsevier Science. Lancet. 2003;361:13–20.There is no question that primary PCI, when available, is the treatment of choice.15 The significant improvement in mortality, saving 20 lives for every 1000 patients treated, is likely due to higher patency and reduced reinfarction and stroke. Mortality rates after AMI appear to be inversely related to the ability to achieve TIMI-3 flow.1 The greatest benefit of primary PCI may be its ability to achieve TIMI-3 flow in more than 90% of patients, even when the patient is treated in the late stages of infarction. By contrast, thrombolytic therapy has a marked decrease in thrombolytic efficacy in patients treated more than a few hours after symptom onset (Figure 2). Although it has been recommended that PCI must be performed within 90 minutes of presentation, in fact, most of the patients enrolled in primary PCI trials achieved their excellent outcomes with median treatment times of 120 minutes.2,3,9–11 Although observational registries have reported higher mortality in patients with greater time from hospital presentation to PCI, the prospective primary PCI trials found that increased mortality was not due to delay in reperfusion, but rather to greater comorbidities in patients who presented late (advanced age, female gender, prior bypass surgery, diabetes, and thrombolytic ineligibility). Download figureDownload PowerPointFigure 2. In experience centers, primary PCI is able to achieve TIMI-3 flow in >90% of patients, regardless of the duration of the infarction. Conversely, thrombolytic therapy has a marked drop off in efficacy when used in patients with AMI >6 hours in duration. Reprinted with permission from Bruce Brodie (personal communication).Randomized studies have consistently shown primary PCI to be superior to thrombolysis at reducing reinfarction. Reinfarction occurs in lesions with slow flow or severe residual stenosis and may also be exacerbated by thrombolytic-induced platelet aggregation. Primary PCI avoids the thrombolytic-induced platelet aggregation, produces a widely patent artery with minimal residual stenosis, and results in virtually no intracranial bleeding. Given these findings, why would physicians continue to recommend thrombolytic therapy?Advocates of thrombolysis claim that fibrinolysis remains viable given improved pharmacological regimens and the ability to treat patients more quickly. However, attempts to further augment TIMI flow with more potent or higher-dose thrombolytics or more potent anti-thrombotics have all resulted in increased risk of intracranial bleeding. More recently, studies combining low-dose thrombolytic drugs with abciximab have also shown increased rates of intracranial hemorrhage in elderly patients.6 Although combining low molecular weight heparin with thrombolytics was thought to be safe, a recently reported study also demonstrated a significant increase in intracranial bleeding.16 It is unwise to believe that any systemically administered pharmacological agent or agents designed to achieve rapid and sustained thrombolysis will confine its action to the coronary arteries.Stone et al17 demonstrated that the presence of spontaneous (not thrombolytic-induced) reperfusion before primary PCI is beneficial. Accordingly, there has been great interest in the use of full or half-dose thrombolytics to “facilitate” the angioplasty. Although this is an interesting concept, studies conducted to date suggest no benefit and potential harm with the use of thrombolytics before PCI (Table). Even in the situation where primary PCI was delayed because of the need to transfer to a PCI facility, increased bleeding and worse outcomes were observed in patients randomized to thrombolysis before transfer compared with withholding thrombolytics.12,13 There are several ongoing and planned trials which will further evaluate the role of facilitated PCI. However, these trials are designed to exclude patients who benefit the most from primary PCI (those near an available catheterization lab, elderly patients, and those with chest pain lasting more than 6 hours). Furthermore, despite the known beneficial effects of clopidogrel when administered at least a few hours before stenting, its use is “prohibited” before PCI in the ASsessment of the Safety and Efficacy of New Treatment strategy for AMI (ASSENT-4) trial. Thus, the facilitated PCI trials may be designed to put primary PCI in an unfavorable light. Studies Comparing Thrombolytic Pretreatment With PCI AloneRandomized StudyDrugResult With LyticMACE indicates major adverse cardiac events; CABG, coronary artery bypass grafting; and IC-UK, intracoronary urokinase.Williams et al19tPA↑ MACEAmbrose et al20IC-UK↑ Abrupt closure, ↑ MACEO’Neill et al21SK↑ Bleeding, ↑ Em CABGVermeer et al12SK↑ MACEWidimsky et al13SK↑ MACERoss et al18tPA 50 mg↑ Early TIMI 3 flow, Clinical events, EF similarThe recently published Comparison of Angioplasty and Prehospital Thrombolysis In acute Myocardial Infarction (CAPTIM) trial22 compared prehospital thrombolysis to primary PCI and found no statistically significant benefit to primary PCI. However, it should be pointed out that this trial did not enroll the necessary sample size and was prematurely stopped because of poor recruitment. Secondly, 26% of thrombolytic patients required rescue angioplasty for failed thrombolysis, which represents 10 times higher utilization than other trials.11 Finally, even though CAPTIM enrolled a very low-risk population, a 24% improvement in the primary endpoint of combined death, reinfarction, or disabling stroke was observed in the primary PTCA arm.A meta-analysis of 6 trials comparing prehospital to in-hospital thrombolysis demonstrated a 1% improvement in survival.23 However, several issues need to be pointed out. First, primary PCI has a greater (2%) absolute improvement in survival compared with in-hospital thrombolysis.11 Secondly, all prehospital trials excluded AMI patients with chest pain >6 hours, and half of the trials excluded patients with pain >4 hours. Therefore, patients were highly selected to have the best chance of reperfusion (Figure 2). Moreover, given the facts that 50% of AMI patients do not call 911 but rather drive themselves to the hospital, only 4% of all chest pain calls to emergency medical systems (EMS) are eligible for thrombolytic therapy, and a physician does not cover EMS run, prehospital thrombolysis has not been embraced in the United States. A more practical approach to improving the time to PCI-mediated reperfusion is to have EMS technicians obtain an ECG in the field.24 If ST-segment elevation is observed, the nearest angioplasty center should be notified to prepare the catheterization laboratory and the patient should be transferred directly to that facility.However, not all angioplasty operators are proficient at performing PCI. To date, the randomized trials were conducted by relatively high-volume operators who either had years of primary PCI experience or who underwent extensive training and scrutiny before study participation. There may be a substantial learning curve when initiating a primary PCI program.25 Moreover, registry data demonstrated that in high-volume centers, primary PCI outcomes were superior, but in low-volume centers, primary PCI outcomes were similar to thrombolytic therapy.26 This raises the question whether small hospitals should spend the time, effort, and money to initiate primary PCI programs. Because time to reperfusion is less critical with PCI than with thrombolytic therapy, efforts may be better directed at providing prehospital ECGs and efficient transport systems for regional performance of primary PCI.In conclusion, the available data demonstrate that primary PCI is superior to thrombolysis in reducing death, reinfarction, intracranial bleeding, recurrent ischemia, and infarct vessel reocclusion. Primary PCI without thrombolysis to facilitate reperfusion is the treatment of choice if it can be performed within 3 hours by a competent operator. We should work toward a goal of obtaining ECGs in the field, and transferring patients with ST elevation from home directly to a “heart attack center.”The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.FootnotesCorrespondence to Cindy L. Grines, MD, Division of Cardiology, William Beaumont Hospital, 3601 W. 13 Mile Rd, Royal Oak, MI 48073-6769. E-mail [email protected] References 1 Grines CL. Clinical debate: primary angioplasty: the strategy of choice. N Engl J Med. 1996; 335: 1313–1317.MedlineGoogle Scholar2 Grines CL, Cox DA, Stone GW, et al. Coronary angioplasty with or without stent implantation for acute myocardial infarction. N Engl J Med. 1999; 341: 1949–1956.CrossrefMedlineGoogle Scholar3 Stone GW, Grines CL, Cox DA, et al. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med. 2002; 346: 957–966.CrossrefMedlineGoogle Scholar4 Montalescot G, Barragan P, Wittenberg O, et al. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001; 344: 1895–1903.CrossrefMedlineGoogle Scholar5 Neumann F-J, Blasini R, Schmitt C, et al. Effect of glycoprotein IIb/IIIa receptor blockade on recovery of coronary flow and left ventricular function after the placement of coronary artery stents in acute myocardial infarction. Circulation. 1998: 98: 2695–2701.CrossrefMedlineGoogle Scholar6 Topol EJ, Califf RM, van de Werf F, et al. Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomized trial. Lancet. 2001; 357: 1905–1914.CrossrefMedlineGoogle Scholar7 Grines CL, Browne KF, Marco J, et al. A comparison of immediate angioplasty with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1993; 32: 673–679.Google Scholar8 PCAT Collaborators. Primary coronary angioplasty compared with intravenous thrombolytic therapy for acute myocardial infarction: six-month follow up and analysis of individual patient data from randomized trials. Am Heart J. 2003; 145: 47–57.CrossrefMedlineGoogle Scholar9 Stone GW, Marsalese D, Brodie BR, et al. A prospective, randomized evaluation of prophylactic intraaortic balloon counterpulsation in high risk patients with acute myocardial infarction treated with primary angioplasty. J Am Coll Cardiol. 1997; 29: 1459–1467.CrossrefMedlineGoogle Scholar10 Grines CL, Marsalese D, Brodie B, et al. Safety and cost effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. J Am Coll Cardiol. 1998; 31: 967–972.CrossrefMedlineGoogle Scholar11 Keeley EC, Boura JA, Grines CL. Comparison of primary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003; 361: 13–20.CrossrefMedlineGoogle Scholar12 Vermeer F, Oude Ophius AJ, vd Berg EJ, et al. Prospective randomized comparison between thrombolysis, rescue PTCA, and primary PTCA in patients with extensive myocardial infarction admitted to a hospital without PTCA facilities: a safety and feasibility study. Heart. 1999; 82: 426–431.CrossrefMedlineGoogle Scholar13 Widimsky P, Groch L, Zelizko M, et al. Multicentre randomized trial comparing transport to primary angioplasty vs immediate thrombolysis combined with strategy for patients with acute myocardial infarction admitted to a hospital without a catheterization laboratory: the PRAGUE study. Eur Heart J. 2000; 21: 823–831.CrossrefMedlineGoogle Scholar14 Grines CL, Westerhausen DR, Grines LL, et al. A randomized trial of transfer for primary angioplasty versus on-site thrombolysis in patients with high-risk myocardial infarction. J Am Coll Cardiol. 2002; 39: 1713–1719.CrossrefMedlineGoogle Scholar15 Aversano T, Aversano LT, Passamani E, et al. Thrombolytic therapy vs primary percutaneous coronary intervention for myocardial infarction in patients presenting to hospitals without on-site cardiac surgery: a randomized controlled trial. JAMA. 2002; 287: 1943–1951.CrossrefMedlineGoogle Scholar16 Wallentin L, Armstrong P, Granger C, et al. Assessment of the safety and efficacy of a new thrombolytic regimen in the prehospital setting (ASSENT III PLUS). Presented at the American Heart Association Scientific Sessions, Chicago, Ill, November 17–20, 2002.Google Scholar17 Stone GW, Cox D, Garcia E, et al. Normal flow (TIMI-3) before mechanical reperfusion therapy in an independent determinant of survival in acute myocardial infarction: analysis from the PAMI trials. Circulation. 2001; 104: 636–641.CrossrefMedlineGoogle Scholar18 Ross AM, Coyne KS, Reiner JS, et al. 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. J Am Coll Cardiol. 1999; 34: 1954–1962.CrossrefMedlineGoogle Scholar19 Williams DO, Braunwald E, Thompson B, et al. Results of percutaneous transluminal coronary angioplasty in unstable angina and non-Q-wave myocardial infarction: observations from the TIMI IIIB trial. Circulation. 1996; 94: 2749–2755.CrossrefMedlineGoogle Scholar20 Ambrose JA, Almeida OD, Sharma SK, et al. Adjunctive thrombolytic therapy during angioplasty for ischemic rest angina: results of the TAUSA trial. Circulation. 1994; 90: 69–77.CrossrefMedlineGoogle Scholar21 O’Neill WW, Weintraub R, Grines CL, et al. A prospective placebo-controlled randomized trial of intravenous streptokinase and angioplasty therapy for acute myocardial infarction. Circulation. 1992; 86: 1710–1717.CrossrefMedlineGoogle Scholar22 Bonnefoy E, Lapostolle F, Leizorovicz A, et al. Primary angioplasty versus prehospital fibrinolysis in acute myocardial infarction: a randomised study. Lancet. 2002; 360: 825–829.CrossrefMedlineGoogle Scholar23 Morrison LJ, Verbeek PR, McDonald AC, et al. Mortality and prehospital thrombolysis for acute myocardial infarction: a meta-analysis. JAMA. 2000; 283: 2686–2692.CrossrefMedlineGoogle Scholar24 Wall T, Albright J, Livingston B, et al. Prehospital ECG transmission speeds reperfusion for patients with acute myocardial infarction. N C Med J. 2000; 61: 104–108.MedlineGoogle Scholar25 Caputo RP, Ho KKL, Stoler RC, et al. Effect of continuous quality improvement analysis on the delivery of primary percutaneous transluminal coronary angioplasty for acute myocardial infarction. Am J Cardiol. 1997; 79: 1159–1164.CrossrefMedlineGoogle Scholar26 Magid DJ, Calonge BN, Rumsfeld JS, et al. Relation between hospital primary angioplasty volume and mortality for patients with acute MI treated with primary angioplasty vs thrombolytic therapy. JAMA. 2000; 284: 3131–3138.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited ByO’Connor R, Al Ali A, Brady W, Ghaemmaghami C, Menon V, Welsford M and Shuster M (2015) Part 9: Acute Coronary Syndromes, Circulation, 132:18_suppl_2, (S483-S500), Online publication date: 3-Nov-2015. Armstrong P and Willerson J (2015) Treatment of Acute ST-Elevation Myocardial Infarction Coronary Artery Disease, 10.1007/978-1-4471-2828-1_19, (505-532), . 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May 27, 2003Vol 107, Issue 20 Advertisement Article InformationMetrics https://doi.org/10.1161/01.CIR.0000075292.29458.BBPMID: 12777318 Originally publishedMay 27, 2003 PDF download Advertisement