A prospective and randomized comparison of the safety and effects of therapeutic levels of enoxaparin versus unfractionated heparin in chronically anticoagulated patients undergoing elective cardiac catheterization

Heyder Omran; Christoph Hammerstingl; Harald Schmidt; Giso von der Recke; Wilhelm Dieter Paar; Berndt Lüderitz

doi:10.1160/TH02-10-0159

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2003; 90(02): 267-271
DOI: 10.1160/TH02-10-0159

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

A prospective and randomized comparison of the safety and effects of therapeutic levels of enoxaparin versus unfractionated heparin in chronically anticoagulated patients undergoing elective cardiac catheterization

Heyder Omran

¹Department of Medicine Cardiology, University of Bonn, Bonn, Germany

,

Christoph Hammerstingl

¹Department of Medicine Cardiology, University of Bonn, Bonn, Germany

,

Harald Schmidt

¹Department of Medicine Cardiology, University of Bonn, Bonn, Germany

,

Giso von der Recke

¹Department of Medicine Cardiology, University of Bonn, Bonn, Germany

,

Wilhelm Dieter Paar

²Aventis Pharma GmbH, Bad Soden, Germany

,

Berndt Lüderitz

¹Department of Medicine Cardiology, University of Bonn, Bonn, Germany

› Author Affiliations

Abstract

Summary

Consecutive patients with atrial fibrillation and/or prosthetic heart valves, receiving chronic anticoagulation with phenprocoumon and scheduled to undergo cardiac catheterization, were randomized to subcutaneous enoxaparin twice daily (n = 32) or intravenous UFH (n = 36). Cardiac catheterization was performed at an international normalized ratio <1.5. Activated partial thromboplastin times and levels of anti-Factor Xa activity were measured daily. The time until effective anticoagulation (primary endpoint) was significantly shorter for enoxaparin than for UFH (1.1 ± 0.4 days versus 3.7 ± 2.5 days, p <0.0001). The percentage of days of effective anticoagulation was significantly higher in the enoxaparin group than in the UFH group (93.3 ± 9.5% versus 53.7 ± 26.6%, p <0.0001). In conclusion, enoxaparin achieves therapeutic levels of anticoagulation more rapidly and consistently than UFH in chronically anticoagulated patients with prosthetic heart valves and/or atrial fibrillation undergoing cardiac catheterization.

Keywords

Low-molecular-weight heparin - enoxaparin - chronic oral anticoagulation - cardiac catheterization - unfractionated heparin

Full Text

References

References
1 Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation: Stroke Prevention in Atrial Fibrillation III randomised clinical trial. Lancet 1996; 348: 633-8.
2 Stein PD, Alpert JS, Dalen JE. et al. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest 1998; 114: 602S-10S.
3 Bonow RO, Carabello B, de Leon Jr. AC . et al. Guidelines for the management of patients with valvular heart disease. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Valvular Heart Disease). Circulation 1998; 98: 1949-84.
4 Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med 1997; 336: 1506-11.
5 Gohlke-Bärwolf C, Acar J, Oakley C. et al. Guidelines for prevention of thromboembolic events in valvular heart disease. Study Group of the Working Group on Valvular Heart Disease of the European Society of Cardiology. Eur Heart J 1995; 16: 1320-30.
6 Cohen M, Demers C, Gurfinkel EP. et al. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. N Engl J Med 1997; 337: 447-52.
7 Haas S. Prevention of venous thromboembolism: recommendations based on the Inter-national Consensus and the American College of Chest Physicians Sixth Consensus Conference on Antithrombotic Therapy. Clin Appl Thromb Hemost 2001; 7: 171-7.
8 Hyers TM, Agnelli G, Hull RD. et al. Anti-thrombotic therapy for venous thromboembolic disease. Chest 1998; 114: 561S-78S.
9 The Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction. Lancet 2001; 358: 605-13.
10 Ross AM, Molhoek P, Lundergan C. et al. Randomized comparison of enoxaparin, a low-molecular-weight heparin, with unfractionated heparin adjunctive to recombinant tissue plasminogen activator thrombolysis and aspirin: second trial of Heparin and Aspirin Reperfusion Therapy (HART II). Circulation 2001; 104: 648-52.
11 Weitz JI. Low-molecular-weight heparins. N Engl J Med 1997; 337: 688-98.
12 Ginsberg JS. Management of venous thromboembolism. N Engl J Med 1996; 335: 1816-28.
13 Hirsh J, Warkentin TE, Shaughnessy SG. et al. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest 2001; 119: 64S-94S.
14 Omran H, Jung W, Lüderitz B. Risk of thromboembolism after acute cardioversion of atrial fibrillation. Lancet 1998; 352: 1280
15 Omran H, Jung W, Rabahieh R. et al. Left atrial chamber and appendage function after internal atrial defibrillation: a prospective and serial transesophageal echocardiographic study. J Am Coll Cardiol 1997; 29: 131-8.
16 Spandorfer JM, Lynch S, Weitz HH. et al. Use of enoxaparin for the chronically anticoagulated patient before and after procedures. Am J Cardiol 1999; 84: 478-80. A10.
17 Montalescot G, Polle V, Collet JP. et al. Low molecular weight heparin after mechanical heart valve replacement. Circulation 2000; 101: 1083-6.
18 Kereiakes DJ, Grines C, Fry E. et al. NICE 1 and NICE 4 Investigators. National Investigators Collaborating on Enoxaparin. Enoxaparin and abciximab adjunctive pharmacotherapy during percutaneous coronary intervention. J Invasive Cardiol 2001; 13: 272-8.
19 Young JJ, Kereiakes DJ, Grines CL. Low-molecular-weight heparin therapy in percutaneous coronary intervention: the NICE 1 and NICE 4 trials. National Investigators Col-la-borating on Enoxaparin Investigators. J Invasive Cardiol 2000; 12 Suppl E: E14-8; discussion E25-8.
20 Collet JP, Montalescot G, Lison L. et al. Percutaneous coronary intervention after subcutaneous enoxaparin pretreatment in patients with unstable angina pectoris. Circulation 2001; 103: 658-63.