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7 November 2000 | Volume 133 Issue 9 | Pages 687-695
Background: Warfarin is effective in the treatment and prevention of many venous thromboembolic disorders, but it often leads to bleeding.
Objective: To develop a multicomponent program of management of warfarin therapy and to determine its effect on the frequency of warfarin-related major bleeding in older patients.
Design: Randomized, controlled trial.
Setting: University hospital in Cleveland, Ohio.
Patients: 325 patients 65 years of age or older who started warfarin therapy during hospitalization.
Interventions: Patients were stratified according to baseline risk for major bleeding and were randomly assigned to receive the intervention (n = 163) or usual care (n = 162) by their primary physicians for 6 months. The intervention consisted of patient education about warfarin, training to increase patient participation, self-monitoring of prothrombin time, and guideline-based management of warfarin dosing.
Measurements: Major bleeding, death, recurrent venous thromboembolism, and therapeutic control of anticoagulant therapy at 6 months.
Results: In an intention-to-treat analysis, major bleeding was more common at 6 months in the usual care group than in the intervention group (cumulative incidence, 12% vs. 5.6%; P = 0.0498, log-rank test). The most frequent site of major bleeding in both groups was the gastrointestinal tract. Death and recurrent venous thromboembolism occurred with similar frequency in both groups at 6 months. Throughout 6 months, the proportion of total treatment time during which the international normalized ratio was within the therapeutic range was higher in the intervention group than in the usual care group (56% vs. 32%; P < 0.001). After 6 months, major bleeding occurred with similar frequencies in the intervention and usual care groups.
Conclusions: A multicomponent comprehensive program of warfarin management reduced the frequency of major bleeding in older patients. Although the generalizability and cost-effectiveness of this program remain to be demonstrated, these findings support the premise that efforts to reduce the likelihood of major bleeding will lead to safe and effective use of warfarin therapy in older patients.
Author and Article Information
From Case Western Reserve University School of Medicine, University Hospitals of Cleveland, and Cleveland Veterans Affairs Medical Center, Cleveland, Ohio.
Presented in part at the 20th Annual Meeting of the Society of General Internal Medicine, Washington, D.C., 2 May 1997.
Acknowledgments: The authors thank Tracey Flowers for help with preparation of this manuscript; Peter Richards for help with programming; and Tara McElroy, Nancy Gerson, Jose Bocanegra, and Chris Kippes for help with data collection.
Grant Support: By the National Institute on Aging (AG-09657, AG-00712, AG-10418091), the Department of Veterans Affairs Health Services Research and Development Service, the American Federation for Aging Research, and the Claude D. Pepper Older Americans Independence Center of Case Western Reserve University. Dr. Beyth was a Merck/American Federation for Aging Research Fellow in Geriatric Clinical Pharmacology and is a recipient of the National Institute on Aging Clinical Investigator Award. Dr. Landefeld was a Senior Career Development Awardee of the Veterans Affairs Health Services Research and Development Service.
Requests for Single Reprints: Rebecca J. Beyth, MD, MS, Baylor College of Medicine, Section of Health Services Research, Houston Center for Quality of Care and Utilization Studies, Veterans Affairs Medical Center (152), Building 110T, 2002 Holcombe Boulevard, Houston, TX 77030; e-mail, rbeyth{at}bcm.tmc.edu.
Current Author Addresses: Dr. Beyth: Baylor College of Medicine, Section of Health Services Research, Houston Center for Quality of Care and Utilization Studies, Veterans Affairs Medical Center (152), Building 110T, 2002 Holcombe Boulevard, Houston, TX 77030.
Ms. Quinn: Case Western Reserve University, Division of General Internal Medicine and Health Care Research, 10900 Euclid Avenue, Cleveland, OH 44106.
Dr. Landefeld: Division of Geriatrics, University of California, San Francisco, Box 1265, 3333 California Street, Suite 380, San Francisco, CA 94118.
Author Contributions: Conception and design: C.S. Landefeld.
Analysis and interpretation of the data: R.J. Beyth, L.M. Quinn, C.S. Landefeld.
Drafting of the article: R.J. Beyth.
Critical revision of the article for important intellectual content: R.J. Beyth, C.S. Landefeld.
Final approval of the article: R.J. Beyth, C.S. Landefeld.
Statistical expertise: L.M. Quinn, C.S. Landefeld.
Obtaining of funding: C.S. Landefeld.
Administrative, technical, or logistic support: R.J. Beyth, L.M. Quinn.
Collection and assembly of data: R.J. Beyth. ARTICLE
A Multicomponent Intervention To Prevent Major Bleeding Complications in Older Patients Receiving Warfarin
A Randomized, Controlled Trial
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V. Fuster, L. E. Ryden, R. W. Asinger, D. S. Cannom, H. J. Crijns, R. L. Frye, J. L. Halperin, G. N. Kay, W. W. Klein, S. Levy, et al. ACC/AHA/ESC Guidelines for the Management of Patients With Atrial Fibrillation: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the North American Society of Pacing and Electrophysiology Circulation, October 23, 2001; 104(17): 2118 - 2150. [Full Text] [PDF]
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 Guidelines for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to develop guidelines for the management of patients with atrial fibrillation) developed in collaboration with the North American Society of Pacing and Electrophysiology Eur. Heart J., October 2, 2001; 22(20): 1852 - 1923. [PDF]
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A. C. Spyropoulos Prevention of Bleeding in Older Patients Taking Warfarin Ann Intern Med, October 2, 2001; 135(7): 548 - 548. [Full Text] [PDF]
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S. Kajubi Prevention of Bleeding in Older Patients Taking Warfarin Ann Intern Med, October 2, 2001; 135(7): 548 - 549. [Full Text] [PDF]
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Other Articles Noted Evid. Based Nurs., October 1, 2001; 4(4): E1 - 11. [Full Text] [PDF]
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V. Fuster, L. E. Ryden, R. W. Asinger, D. S. Cannom, H. J. Crijns, R. L. Frye, J. L. Halperin, G. N. Kay, W. W. Klein, S. Levy, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary: A Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the North American Society of Pacing and Electrophysiology J. Am. Coll. Cardiol., October 1, 2001; 38(4): 1231 - 1265. [Full Text] [PDF]
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V. Fuster, L. E. Ryden, R. W. Asinger, D. S. Cannom, H. J. Crijns, R. L. Frye, J. L. Halperin, G. N. Kay, W. W. Klein, S. Levy, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the North American Society of Pacing and Electrophysiology J. Am. Coll. Cardiol., October 1, 2001; 38(4): 1266 - 1266. [Full Text] [PDF]
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J. V.L. Sheffield and E. B. Larson Update in General Internal Medicine Ann Intern Med, August 21, 2001; 135(4): 269 - 278. [Full Text] [PDF]
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 M. Laposata Point-of-Care Coagulation Testing: Stepping Gently Forward Clin. Chem., May 1, 2001; 47(5): 801 - 802. [Full Text] [PDF]
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 Prevention of Major Bleeding in Elderly Patients on Warfarin Journal Watch Cardiology, February 2, 2001; 2001(202): 4 - 4. [Full Text]
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