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(Circulation. 1997;96:61-68.)
© 1997 American Heart Association, Inc.
Articles |
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)
From Graz, Austria (W.K.), Göttingen, Germany (A.B.), Glasgow, UK (S.E.H.), New York, NY ( S.M.), Barcelona, Spain (G.S.), Hamilton, Ontario, Canada (A.G.G.T.), Groningen, the Netherlands (J. van der M.), Pharmacia&Upjohn, Stockholm, Sweden (E.O., S.U.), and Pharmacia & Upjohn, Germany (K.L.).
Correspondence to Prof Werner Klein, MD, Division of Cardiology, Department of Internal Medicine, Auenbruggerplatz 15, A-8036 Graz, Austria.
Background Low-molecular-weight heparin has a number of pharmacological and pharmacokinetic advantages over unfractionated heparin that make it potentially suitable, when used in combination with aspirin, for the treatment of unstable coronary artery disease.
Method and Results Patients with unstable angina or non–Q-wave myocardial infarction (1482) were included in the study, which had two phases. In an open, acute phase (days 1 to 6), patients were assigned either twice-daily weight-adjusted subcutaneous injections of dalteparin (120 IU/kg) or dose-adjusted intravenous infusion of unfractionated heparin. In the double-blind, prolonged treatment phase (days 6 to 45), patients received subcutaneously either dalteparin (7500 IU once daily) or placebo. During the first 6 days, the rate of death, myocardial infarction, or recurrence of angina was 7.6% in the unfractionated heparin-treated patients and 9.3% in the dalteparin-treated patients (relative risk, 1.18; 95% confidence interval [CI], 0.84 to 1.66). The corresponding rates in the two treatment groups for the composite end point of death or myocardial infarction were 3.6% and 3.9%, respectively (relative risk, 1.07; 95% CI, 0.63 to 1.80). Revascularization procedures were undertaken in 5.3% and 4.8% of patients in unfractionated heparin and dalteparin groups, respectively (relative risk, 0.88; 95% CI, 0.57 to 1.35). Between days 6 and 45, the rate of death, myocardial infarction, or recurrence of angina was 12.3% in both the placebo and dalteparin groups (relative risk, 1.01; 95% CI, 0.74 to 1.38). The corresponding rates for death or myocardial infarction were 4.7% and 4.3% (relative risk, 0.92; 95% CI, 0.54 to 1.57). Revascularization procedures were undertaken in 14.2% and 14.3% of patients in the placebo and dalteparin groups, respectively.
Conclusions Our results add to previous evidence suggesting that the low-molecular-weight heparin dalteparin administered by twice-daily subcutaneous injection may be an alternative to unfractionated heparin in the acute treatment of unstable angina or non–Q-wave myocardial infarction. Prolonged treatment with dalteparin at a lower once-daily dose in our study did not confer any additional benefit over aspirin (75 to 165 mg) alone.
Key Words: heparin • angina • myocardial infarction
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M.E Bertrand, M.L Simoons, K.A.A Fox, L.C Wallentin, C.W Hamm, E McFadden, P.J de Feyter, G Specchia, and W Ruzyllo Management of acute coronary syndromes: acute coronary syndromes without persistent ST segment elevation. Recommendations of the Task Force of the European Society of Cardiology: Recommendations of the Task Force of the European Society of Cardiology Eur. Heart J., September 1, 2000; 21(17): 1406 - 1432. [PDF]
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T. Hammoud, J.-F. Tanguay, and M. G. Bourassa Management of coronary artery disease: therapeutic options in patients with diabetes J. Am. Coll. Cardiol., August 1, 2000; 36(2): 355 - 365. [Abstract] [Full Text] [PDF]
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C. Heeschen, B.U. Goldmann, W. Terres, and C.W. Hamm Cardiovascular risk and therapeutic benefit of coronary interventions for patients with unstable angina according to the troponin T status Eur. Heart J., July 2, 2000; 21(14): 1159 - 1166. [Abstract] [PDF]
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G. Montalescot, J. P. Collet, L. Lison, R.e. Choussat, A. Ankri, E. Vicaut, K. Perlemuter, F. Philippe, G.e. Drobinski, and D. Thomas Effects of various anticoagulant treatments on von Willebrand factor release in unstable angina J. Am. Coll. Cardiol., July 1, 2000; 36(1): 110 - 114. [Abstract] [Full Text] [PDF]
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S. Kaul and P. K. Shah Low molecular weight heparin in acute coronary syndrome: evidence for superior or equivalent efficacy compared with unfractionated heparin? J. Am. Coll. Cardiol., June 1, 2000; 35(7): 1699 - 1712. [Abstract] [Full Text] [PDF]
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P Abrahamsson, A Rosengren, and M Dellborg Improved long-term prognosis for patients with unstable coronary syndromes 1988-1995 Eur. Heart J., April 1, 2000; 21(7): 533 - 539. [Abstract] [PDF]
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J. I. Weitz and S. M. Bates Beyond Heparin and Aspirin: New Treatments for Unstable Angina and Non-Q-Wave Myocardial Infarction Arch Intern Med, March 27, 2000; 160(6): 749 - 758. [Abstract] [Full Text] [PDF]
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S. C. Clark, N. Vitale, J. Zacharias, and J. Forty Effect of low molecular weight heparin (Fragmin) on bleeding after cardiac surgery Ann. Thorac. Surg., March 1, 2000; 69(3): 762 - 764. [Abstract] [Full Text] [PDF]
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J. A. Ambrose and G. Dangas Unstable Angina: Current Concepts of Pathogenesis and Treatment Arch Intern Med, January 10, 2000; 160(1): 25 - 37. [Abstract] [Full Text] [PDF]
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T. O. Cheng Low-Molecular-Weight Heparin for Unstable Angina Chest, December 1, 1999; 116(6): 1833 - 1833. [Full Text] [PDF]
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L. Wallentin New trials of LMW heparins -- light and heavy weight as good on short but what about longer distances? Eur. Heart J., November 1, 1999; 20(21): 1522 - 1524. [PDF]
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H. Purcell and K.M. Fox Improving outcome in acute coronary syndromes -- as good as it gets? Eur. Heart J., November 1, 1999; 20(21): 1533 - 1537. [PDF]
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The Frax.I.S. Study Group Comparison of two treatment durations (6 days and 14 days) of a low molecular weight heparin with a 6-day treatment of unfractionated heparin in the initial management of unstable angina or non-Q wave myocardial infarction: FRAX.I.S. (FRAxiparine in Ischaemic Syndrome) Eur. Heart J., November 1, 1999; 20(21): 1553 - 1562. [Abstract] [PDF]
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P. W. Armstrong Pursuing Progress in Acute Coronary Syndromes Circulation, October 12, 1999; 100(15): 1586 - 1589. [Full Text] [PDF]
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E. M. Antman, C. H. McCabe, E. P. Gurfinkel, A. G. G. Turpie, P. J. L. M. Bernink, D. Salein, A. Bayes de Luna, K. Fox, J.-M. Lablanche, D. Radley, et al. 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, October 12, 1999; 100(15): 1593 - 1601. [Abstract] [Full Text] [PDF]
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E. M. Antman, M. Cohen, D. Radley, C. McCabe, J. Rush, J. Premmereur, and E. Braunwald Assessment of the Treatment Effect of Enoxaparin for Unstable Angina/Non-Q-Wave Myocardial Infarction : TIMI 11B-ESSENCE Meta-Analysis Circulation, October 12, 1999; 100(15): 1602 - 1608. [Abstract] [Full Text] [PDF]
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R. L. Bick and J. Rice Long-Term Outpatient Dalteparin (Fragmin) Therapy for Arterial and Venous Thrombosis: Efficacy and Safety--A Preliminary Report Clinical and Applied Thrombosis/Hemostasis, October 1, 1999; 5(1_suppl): S67 - S71. [Abstract] [PDF]
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P. J. Zed, J. E. Tisdale, and S. Borzak Low-Molecular-Weight Heparins in the Management of Acute Coronary Syndromes Arch Intern Med, September 13, 1999; 159(16): 1849 - 1857. [Abstract] [Full Text] [PDF]
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M. Lloyd, C. C Callander, K. Stein, T. Nicholson, and N. Grubb The end of the heparin pump? BMJ, August 28, 1999; 319(7209): 575a - 575. [Full Text]
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C. E. Chambers, S. T Riebel, and M. Kozak Interventional Cardiology: Advances in Percutaneous Techniques for the Treatment of Cardiac Disease Seminars in Cardiothoracic and Vascular Anesthesia, July 1, 1999; 3(2): 109 - 125. [Abstract] [PDF]
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S KENNON and A TIMMIS Management of unstable angina: what role intervention, ask the RITA-3 trialists? Heart, June 1, 1999; 81(6): 565 - 566. [Full Text]
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T. O. Cheng Weight Watching in Heparin Arch Intern Med, May 24, 1999; 159(10): 1142 - 1142. [Full Text] [PDF]
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B. L. Norgaard, K. Andersen, M. Dellborg, P. Abrahamsson, J. Ravkilde, K. Thygesen, and for the TRIM study group Admission risk assessment by cardiac troponin T in unstable coronary artery disease: additional prognostic information from continuous ST segment monitoring J. Am. Coll. Cardiol., May 1, 1999; 33(6): 1519 - 1527. [Abstract] [Full Text] [PDF]
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G. Frostfeldt, G. Ahlberg, G. Gustafsson, G. Helmius, B. Lindahl, A. Nygren, A. Siegbahn, E. Swahn, P. Venge, and L. Wallentin Low molecular weight heparin (dalteparin) as adjuvant treatment to thrombolysis in acute myocardial infarction--a pilot study: Biochemical Markers in Acute Coronary Syndromes (BIOMACS II) J. Am. Coll. Cardiol., March 1, 1999; 33(3): 627 - 633. [Abstract] [Full Text] [PDF]
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 S. M. Bates and J. I. Weitz Prevention of activation of blood coagulation during acute coronary ischemic syndromes: beyond aspirin and heparin Cardiovasc Res, February 1, 1999; 41(2): 418 - 432. [Abstract] [Full Text] [PDF]
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Hotline Editorial Eur. Heart J., January 1, 1999; 20(1): 7 - 10. [PDF]
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R. A. Baughman, S. C. Kapoor, R. K. Agarwal, J. Kisicki, F. Catella-Lawson, and G. A. FitzGerald Oral Delivery of Anticoagulant Doses of Heparin : A Randomized, Double-Blind, Controlled Study in Humans Circulation, October 20, 1998; 98(16): 1610 - 1615. [Abstract] [Full Text] [PDF]
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