HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Meschengieser, S. S. Articles by Lazzari, M. A. Search for Related Content PubMed PubMed Citation Articles by Meschengieser, S. S. Articles by Lazzari, M. A.

J Thorac Cardiovasc Surg 1997;113:910-916
© 1997 Mosby, Inc.

SURGERY FOR ACQUIRED HEART DISEASE

LOW-INTENSITY ORAL ANTICOAGULATION PLUS LOW-DOSE ASPIRIN VERSUS HIGH-INTENSITY ORAL ANTICOAGULATION ALONE: A RANDOMIZED TRIAL IN PATIENTS WITH MECHANICAL PROSTHETIC HEART VALVES

Presented in abstracted form in the XIVth Congress of the International Society of Thrombosis and Haemostasis, New York, N.Y., July 1993.

Received for publication August 6, 1996; revisions requested Oct. 21, 1996; revisions received Nov. 19, 1996; accepted for publication Nov. 21, 1996. Address for reprints: Susana S. Meschengieser, Departamento de Hemostasia y Trombosis, Instituto de Investigaciones Hematologicas "Mariano R. Castex," Academia Nacional de Medicina, Pacheco de Melo 3081, Buenos Aires, Argentina 1425.

Abstract

Background: Mechanical heart valve replacement requires lifelong anticoagulant treatment. Aspirin has proved useful in further reducing thromboembolic events when added to oral anticoagulants. However, increased (gastrointestinal) bleeding was observed at the doses previously tested for this combination in heart valve prostheses. Methods: We performed a prospective randomized trial to compare the combination of low-intensity oral anticoagulants (international normalized ratio 2.5 to 3.5) plus aspirin (100 mg/day)(arm A) versus high-intensity oral anticoagulants alone (arm B) (international normalized ratio 3.5 to 4.5). Arm A included 258 patients and arm B 245 patients. The two groups were comparable for all baseline characteristics. Results: The outcomes of the study were embolism, valve thrombosis, and major hemorrhage. The median follow-up was 23 months. The two treatments offered similar antithrombotic protection. The incidence of embolic episodes was 1.32 per 100 patient-years (95% confidence interval 0.53 to 2.7) for arm A and 1.48 per 100 patient-years (95% confidence interval 0.59 to 3.03) for arm B. Major hemorrhage occurred in 1.13 per 100 patient-years (95% confidence interval 0.41 to 2.45) for arm A and 2.33 per 100 patient-years (95% confidence interval 1.17 to 4.14) for arm B. Gastrointestinal bleeding was not increased by this combined reduced dose of aspirin and coumarin.

This article has been cited by other articles:

				J. Dunning, M. Versteegh, A. Fabbri, A. Pavie, P. Kolh, U. Lockowandt, S. A. M. Nashef, and on behalf of the EACTS Audit and Guidelines Commit Guideline on antiplatelet and anticoagulation management in cardiac surgery Eur J Cardiothorac Surg, July 1, 2008; 34(1): 73 - 92. [Abstract] [Full Text] [PDF]

				V. Pengo, G. Palareti, U. Cucchini, M. Molinatti, R. Del Bono, F. Baudo, A. Ghirarduzzi, C. Pegoraro, and S. Iliceto Low-Intensity Oral Anticoagulant Plus Low-Dose Aspirin During the First Six Months Versus Standard-Intensity Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement: A Pilot Study of Low-Intensity Warfarin and Aspirin in Cardiac Prostheses (LIWACAP) Clinical and Applied Thrombosis/Hemostasis, July 1, 2007; 13(3): 241 - 248. [Abstract] [PDF]

				F. Perez-Gomez, J. A. Iriarte, J. Zumalde, J. Berjon, A. Salvador, E. Alegria, M. P. Maluenda, S. Asenjo, R. Perez-Saldana, R. G. de la Torre, et al. Antithrombotic therapy in elderly patients with atrial fibrillation: effects and bleeding complications: a stratified analysis of the NASPEAF randomized trial Eur. Heart J., April 2, 2007; 28(8): 996 - 1003. [Abstract] [Full Text] [PDF]

				R. G. Hart, S. B. Tonarelli, and L. A. Pearce Avoiding Central Nervous System Bleeding During Antithrombotic Therapy: Recent Data and Ideas Stroke, July 1, 2005; 36(7): 1588 - 1593. [Abstract] [Full Text] [PDF]

				D. V. Nagarajan, P. S. Lewis, P. Botha, and J. Dunning Is addition of anti-platelet therapy to warfarin beneficial to patients with prosthetic heart valves? Interact CardioVasc Thorac Surg, September 1, 2004; 3(3): 450 - 455. [Abstract] [Full Text] [PDF]

				U. Elkayam, H. Singh, A. Irani, and M. W. Akhter Anticoagulation in Pregnant Women With Prosthetic Heart Valves Journal of Cardiovascular Pharmacology and Therapeutics, April 1, 2004; 9(2): 107 - 115. [Abstract] [PDF]

				I Ferreira, L Dos, P Tornos, I Nicolau, G Permanyer-Miralda, and J Soler-Soler Experience with enoxaparin in patients with mechanical heart valves who must withhold acenocumarol Heart, May 1, 2003; 89(5): 527 - 530. [Abstract] [Full Text] [PDF]

				K. Schror Combination of oral anticoagulant and platelet inhibitor drugs: focus on the pharmacological aspects of optimizing antithrombotic therapy in mechanical heart valve replacement Eur. Heart J. Suppl., December 1, 2001; 3(suppl_Q): Q54 - Q59. [Abstract] [PDF]

				M. Perleth and R. Busse Health technology assessment of oral anticoagulation following heart valve replacement Eur. Heart J. Suppl., December 1, 2001; 3(suppl_Q): Q60 - Q64. [Abstract] [PDF]

				E. Muller, R. Bergemann, and GELIA Study Group Economic analysis of bleeding and thromboembolic sequelae after heart valve replacement (GELIA 7) Eur. Heart J. Suppl., December 1, 2001; 3(suppl_Q): Q65 - Q69. [Abstract] [PDF]

				R. Bergemann and E. Muller Economic outcomes after heart valve replacement surgery in Germany Eur. Heart J. Suppl., December 1, 2001; 3(suppl_Q): Q70 - Q72. [Abstract] [PDF]

				J. S Meisner and A. Hla Review: oral anticoagulants plus antiplatelet agents reduce thromboembolism and all cause mortality for heart valve prostheses Evid. Based Med., September 1, 2001; 6(5): 147 - 147. [Full Text] [PDF]

				R. Altman, J. Rouvier, and A. Scazziota State-of-the-Art Review : Secondary Prevention of Myocardial Infarction: Beneficial Effect of Combining Oral Anticoagulant Plus Aspirin: Therapy Based on Evidence Clinical and Applied Thrombosis/Hemostasis, July 1, 2000; 6(3): 126 - 134. [PDF]

				S S Meschengieser, C G Fondevila, M T Santarelli, and M A Lazzari Anticoagulation in pregnant women with mechanical heart valve prostheses Heart, July 1, 1999; 82(1): 23 - 26. [Abstract] [Full Text] [PDF]

				W. R. E. Jamieson, R. T. Miyagishima, G. L. Grunkemeier, E. Germann, C. Henderson, G. J. Fradet, L. H. Burr, and S. V. Lichtenstein Bileaflet mechanical prostheses performance in mitral position Eur J Cardiothorac Surg, June 1, 1999; 15(6): 786 - 794. [Abstract] [Full Text] [PDF]

				Y. Moriyama, K. Nakamura, H. Kariyazono, H. Toyohira, and A. Taira Influence of low-intensity anticoagulation and low-dose antiplatelet agent on coagulation-fibrinolysis system after mechanical prosthetic valve replacement J. Thorac. Cardiovasc. Surg., April 1, 1998; 115(4): 952 - 954. [Full Text] [PDF]