Assessment of the treatment effect of enoxaparin for unstable angina/non-Q-wave myocardial infarction: TIMI 11B-essence meta-analysis

Circulation

Volumn 100, Issue 15, 1999, Pages 1602-1608

  Antman, Elliott M ^a   Cohen, Marc ^b   Radley, David ^c   McCabe, Carolyn ^a   Rush, Janet ^c   Premmereur, Jerome ^c   Braunwald, Eugene ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HAHNEMANN UNIVERSITY HOSPITAL   (United States)

^c SANOFI   (France)

Author keywords

Anticoagulants; Enoxaparin; Heparin; Meta analysis

Indexed keywords

ANTITHROMBIN; DALTEPARIN; ENOXAPARIN; HEPARIN; HIRUDIN; NADROPARIN; PLACEBO;

ARTICLE; BLEEDING; CLINICAL TRIAL; DEATH; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; META ANALYSIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; Q WAVE; UNSTABLE ANGINA PECTORIS;

EID: 0032855125     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.100.15.1602     Document Type: Article

References (53)

1. Telford AM, Wilson C. Trial of heparin versus atenolol in prevention of myocardial infarction in intermediate coronary syndrome. Lancet. 1981; 1:1225-1228.
2. Theroux P, Ouimet H, McCans J, Latour J-G, Joly G, Levy G, Pelletier E, Juneau M, Stasiak J, deGuise P, Pelletier GB, Rinzler D, Waters DD. Aspirin, heparin or both to treat unstable angina. N Engl J Med. 1988; 319:1105-1111.
3. The RISC Group. Risk of myocardial infarction and death during treatment with low dose aspirin and intravenous heparin in men with unstable coronary artery disease. Lancer. 1990;336:827-830.
4. Cohen M, Adams PC, Parry G, Xiong J, Chamberlain D, Wieczorek I, Fox KAA, Chesebro JH, Strain J, Keller C, Kelly A, Lancaster G, Ali J, Kronmal R, Fuster V, and the Antithrombotic Therapy in Acute Coronary Syndromes Research Group. Combination antithrombotic therapy in unstable rest angina and non-Q-wave infarction in nonprior aspirin users: primary end points analysis from the ATACS trial. Circulation. 1994;89: 81-88.
5. Braunwald E, Mark DB, Jones RH, Cheitlin MD, Fuster V, McCauley KM, Edwards C, Green LA, Mushlin AI, Swain JA, Smith EE III, Cowan M, Rose GC, Concannon CA, Grines CL, Brown L, Lytle BW, Goldman L, Topol EJ, Willerson JT, Brown J, Archibald N. Unstable Angina: Diagnosis and Management. Rockville, Md: Agency for Health Care Policy and Research and the National Heart, Lung, and Blood Institute, Public Health Service, US Dept of Health and Human Services; 1994. Clinical Practice Guideline Number 10.
6. Cairns J, Lewis HD Jr, Meade TW, Sutton GC, Theroux P. Antithrombotic agents in coronary artery disease. Chest. 1995;108: 380S-400S.
7. Oler A, Whooley MA, Oler J, Grady D. Adding heparin to aspirin reduces the incidence of myocardial infarction and death in patients with unstable angina: a meta-analysis. JAMA. 1996;276:811-815.
8. Ridker PM, O'Donnell CJ, Hennekens CH. Direct comparison of aspirin plus hirudin, aspirin plus heparin, and aspirin alone among 12,000 patients with acute myocardial infarction not receiving thrombolysis: rationale and design of the first American Study of Infarct Survival (ASIS-1). J Thromb Thrombolysis. 1995;1:119-124.
9. Hirsh J, Fuster V. Guide to anticoagulant therapy, part I: heparin. Circulation. 1994;89:1449-1468.
10. Theroux P, Waters D, Lam J, Juneau M, McCans J. Reactivation of unstable angina after the discontinuation of heparin. N Engl J Med. 1992;327:141-145.
11. Barrowcliffe T, Johnson E, Thomas D. Low Molecular Weight Heparin. Chicester, UK: John Wiley & Sons; 1992.
12. Bounameaux H. Low-Molecular-Weight Heparins in Prophylaxis and Therapy of Thromboembolic Disease. New York, NY: Marcel Dekker Inc; 1994.
13. Weitz JI. Low-molecular-weight heparins. N Engl J Med. 1997;337: 688-698.
14. Gurfinkel E, Fareed J, Antman E, Cohen M, Mautner B. Rationale for the management of coronary syndromes with low-molecular-weight heparins. Am J Cardiol. 1998;82:15L-18L.
15. Antman EM, McCabe CH, Gurfinkel EP, Turpie AGG, Bennink PJLM, Salein D, Bayes de Luna A, Fox K, Lablanche JM, Radley D, Premmereur J, Braunwald E, for the TIMI (Thrombolysis In Myocardial Infarction) 11B Investigators. Enoxaparin prevents death and cardiac ischemic events in unstable angina/non-Q-wave myocardial infarction: results of the Thrombolysis In Myocardial Infarction (TIMI) 11B Trial. Circulation. 1999;100:1593-1601.
16. Cohen M, Demers C, Gurfinkel EP, Turpie AGG, Fromell GJ, Goodman S, Langer A, Califf RM, Fox KAA, Premmereur J, Bigonzi F, for the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. N Engl J Med. 1997;337:447-452.
17. Antiplatelet Trialists' Collaboration. Collaborative overview of randomized trials of antiplatelet therapy. I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Br Med J. 1994;308:81-106.
18. Kelsey J, Thompson W, Evans A. Prospective cohort studies, II: further design considerations and analysis. In: Methods in Observational Epidemiology. Oxford, UK: Oxford University Press; 1986:105-127.
19. Robins J, Breslow N, Greenland S. Estimators of the Mantel-Haenszel variance consistent in both sparse data and large-strata limiting models. Biometrics. 1986;42:311-323.
20. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177-188.
21. Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992;327:248-254.
22. Greenland S, Salvan A. Bias in the one-step (Peto) method for pooling study results. Stat Med. 1990;9:247-252.
23. Berlin J, Laird N, Sacks H, Chalmers T. A comparison of statistical methods for combining event rates from clinical trials. Stat Med. 1989; 8:141-151.
24. Cohen M, Bigonzi F, Lelouer V, Gosset F, Fromell GJ, Goodman S. One year follow-up of the ESSENCE trial (Enoxaparin verus Heparin in Unstable Angina and Non-Q-Wave Myocardial Infarction). J Am Coll Cardiol. 1998;31:79A. Abstract.
25. Young E, Cosmi B, Hirsh J. Comparison of the non-specific binding of unfractionated heparin and low molecular weight heparin (enoxaparin) to plasma proteins. Thromb Haemost. 1993;70:625-630.
26. Mombelli G, Marchetti O, Haeberli A, Straub P. Effect of intravenous heparin infusion on thrombin-antithrombin complex and fibrinopeptide A in unstable angina. Am Heart J. 1998;136:1106-1113.
27. Agnelli G. Pharmacological activities of heparin chains: should our past knowledge be revised? Haemostasis. 1996;26:2-9.
28. Brieger D, Dawes J. Long-term persistence of biological activity following administration of enoxaparin sodium (clexane) is due to sequestration of antithrombin-binding low molecular weight fragments: comparison with unfractionated heparin. Thromb Haemost. 1996;75: 740-746.
29. Lindhout T, Hemker H. Anticoagulant mechanism of action of low molecular weight heparins. In: Doutremepuich C, ed. Low Molecular Weight Heparins in Clinical Practice. New York, NY: Marcel Dekker Inc; 1992:23-50.
30. Lane DA, Denton J, Flynn AM, Thunberg L, Lindahl U. Anticoagulant activities of heparin oligosaccharides and their neutralization by platelet factor 4. Biochem J. 1984;218:725-732.
31. Abildgaard U, Lindahl AK, Sandset PM. Heparin requires both antithrombin and extrinsic pathway inhibitor for its anticoagulant effect in human blood. Haemostasis. 1991;21:254-257.
32. Hoppensteadt DA, Jeske W, Fareed J, Bermes EW Jr. The role of tissue factor pathway inhibitor in the mediation of the antithrombotic actions of heparin and low-molecular-weight heparin. Blood Coagul Fibrinolysis. 1995;6(suppl 1):S57-S64.
33. Xiao Z, Theroux P. Platelet activation with unfractionated heparin at therapeutic concentrations and comparisons with a low-molecular-weight heparin and with a direct thrombin inhibitor. Circulation. 1998;97: 251-256.
34. Montalescot G, Philippe F, Ankri A, Vicaut E, Bearez E, Poulard JE, Carrie D, Flammang D, Dutoit A, Carayon A, Jardel C, Chevrot M, Bastard JP, Bigonzi F, Thomas D. Early increase of von Willebrand factor predicts adverse outcome in unstable coronary artery disease: beneficial effects of enoxaparin: French Investigators of the ESSENCE Trial. Circulation. 1998;98:294-299.
35. Antman EM, Handin R. Low-molecular-weight heparins: an intriguing new twist with profound implications. Circulation. 1998;98:287-289.
36. Fareed J, Jeske W, Hoppensteadt D, Clarizio R, Walenga JM. Low-molecular-weight heparins: pharmacologic profile and product differentiation. Am J Cardiol. 1998;82:3L-10L.
37. Beguin S, Lindhout T, Hemker HC. The mode of action of heparin in plasma. Thromb Haemost. 1988;60:457-462.
38. Beguin S, Mardiguian J, Lindhout T, Hemker HC. The mode of action of low molecular weight heparin preparation (PK10169) and two of its major components on thrombin generation in plasma. Thromb Haemost. 1989;61:30-34.
39. Mardiguian J. Methods of preparation of low molecular weight heparins. In: Doutremepuich C, ed. Low Molecular Weight Heparins in Clinical Practice. New York, NY: Marcel Dekker Inc; 1992:7-12.
40. Nightingale SL. Appropriate use of low-molecular weight heparins (LMWHs). JAMA. 1993;270:1672.
41. Klein W, Buchwald A, Hillis SE, Monrad S, Sanz G, Turpie AGG, van der Meer J, Olaisson E, Undeland S, Ludwig K, for the FRIC Investigators. Comparison of low-molecular-weight heparin with unfractionated heparin acutely and with placebo for 6 weeks in the management of unstable coronary artery disease: Fragmin in Unstable Coronary Artery Disease Study (FRIC). Circulation. 1997;96:61-68.
42. Verbeugt FWA. Hotline sessions at the 20th European Congress of Cardiology. Eur Heart J. 1999;20:7-10.
43. FRISC Study Group. Low molecular weight heparin (Fragmin) during instability in coronary artery disease (FRISC). Lancet. 1996;347:561-568.
44. Antman EM, for the TIMI 9A Investigators. Hirudin in acute myocardial infarction: safety report from the Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI) 9A trial. Circulation 1994;90: 1624-1630.
45. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIa Investigators. A randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. Circulation 1994;90:1631-1637.
46. Neuhaus KL, von Essen R, Tebbe U, Jessel A, Heinrichs H, Mäurer W, Döring W, Harmjanz D, Kötter V, Kalhammer E, Simon E, Horacek T. Safety observations from the pilot phase of the randomized r-hirudin for improvement of thrombolysis (HIT-III) study: a study of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALK). Circulation. 1994;90:1638-1642.
47. Thrombin Inhibition in Myocardial Ischaemia (TRIM) study group. A low molecular weight, selective thrombin inhibitor, inogatran, vs heparin, in unstable coronary artery disease in 1209 patients: a double-blind, randomized, dose-finding study. Eur Heart J. 1997;18:1416-1425.
48. Wallentin L. New antithrombotic treatment in unstable coronary syndrome-for whom? Lancet. 1999;353:423-424.
49. Antman EM, for the TIMI 9B Investigators. Hirudin in acute myocardial infarction: thrombolysis and thrombin inhibition in myocardial infarction (TIMI) 9B trial. Circulation. 1996;94:911-921.
50. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb Investigators. A comparison of recombinant hirudin with heparin for the treatment of acute coronary syndromes. N Engl J Med. 1996;335:775-782.
51. Organisation to Assess Strategies for Ischemic Syndromes (OASIS-2) Investigators. Effects of recombinant hirudin (lepirudin) compared with heparin on death, myocardial infarction, refractory angina, and revascularization procedures in patients with acute myocardial ischemia without ST elevation: a randomised trial. Lancet. 1999;353:429-438.
52. Rao AK, Sun L, Chesebro JH, Fuster V, Harrington RA, Schwartz D, Gallo P, Matos D, Topol EJ, for the Hirudin in Unstable Angina Trial. Distinct effects of recombinant desulfatohirudin (Revasc) and heparin on plasma levels of fibrinopeptide A and prothrombin fragment F1.2 in unstable angina: a multicenter trial. Circulation. 1996;94: 2389-2395.
53. Mark DB, Cowper PA, Berkowitz SD, Davidson-Ray L, DeLong ER, Turpie AGG, Califf RM, Weatherley B, Cohen M. Economic assessment of low-molecular-weight heparin (enoxaparin) versus unfractionated heparin in acute coronary syndrome patients: results from the ESSENCE randomized trial. Circulation. 1998;97:1702-1707.