Download PDF
Thromb Haemost 2010; 103(02): 329-337
DOI: 10.1160/TH09-07-0450
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

Anticoagulation for valvular heart disease in community-based practice

Adam J. Rose
1   Center for Health Quality, Outcomes and Economic Research, Bedford VA Medical Center, Bedford, Massachusetts, USA
2   Department of Medicine, Section of General Internal Medicine, Boston University School of Medicine, Boston, Massachusetts, USA
,
Al Ozonoff
1   Center for Health Quality, Outcomes and Economic Research, Bedford VA Medical Center, Bedford, Massachusetts, USA
3   Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA
,
Lori E. Henault
2   Department of Medicine, Section of General Internal Medicine, Boston University School of Medicine, Boston, Massachusetts, USA
,
Elaine M. Hylek
2   Department of Medicine, Section of General Internal Medicine, Boston University School of Medicine, Boston, Massachusetts, USA
› Author Affiliations Financial support: This study was funded by Bristol-Myers Squibb, the makers of Coumadin® brand warfarin. Bristol-Myers Squibb had no role in the design and conduct of the study, or in the collection, analysis, and interpretation of the data, or in the preparation, review, and approval of the manuscript. Dr. Rose is supported by a career development award from the United States Department of Veterans Affairs Health Services Research and Development Service.
Further Information

Publication History

Received: 14 July 2009

Accepted after major revision: 23 October 2009

Publication Date:
22 November 2017 (online)

Also available at
    Permissions and Reprints

Summary

Little is known about patients who receive oral anticoagulation for valvular heart disease (VHD) in community-based practice. It was this study’s objective to describe the characteristics, management, and outcomes of patients anticoagulated for VHD, compared to patients anticoagulated for atrial fibrillation (AF). We used a nationally-representative cohort of community-based anticoagulation care in the United States. Data collected included indications for therapy, demographics, selected comorbid conditions, international normalised ratio (INR) target ranges, INR control, and clinical outcomes. We identified 1,057 patients anticoagulated for VHD (15.6% of the overall cohort) and 3,396 patients anticoagulated for AF (50.2%). INR variability was similar between the two groups (0.64 vs. 0.69, p = 0.80). Among patients with aortic VHD, for whom a standard (2–3) target INR range is recommended, 461 (84%) had a high target range (2.5–3.5), while 95 (16%) had a standard target range. VHD patients had a higher rate of major haemorrhage compared to AF patients (3.57 vs. 1.78 events per 100 patient-years, incidence rate ratio 2.02, 95% CI 1.33 – 3.06). The rate of stroke/systemic embolus was similar between groups (0.67 vs. 0.97 events per 100 patient-years, incidence rate ratio 0.71, 95% CI 0.32 – 1.57). In our community-based study, approximately 15.6% of patients receiving warfarin were anticoagulated for VHD. VHD patients achieved similar anticoagulation control to patients with AF, as measured by INR variability. Nevertheless, the rate of major haemorrhage was elevated among VHD patients compared to AF patients; this finding requires further investigation.

Disclaimer: The opinions expressed in this manuscript do not necessarily represent the views or policies of the United States Department of Veterans Affairs.

Keywords

Warfarin - anticoagulants - quality of health care - heart valve diseases
 

  • References

  • 1 Fuster V, Ryden LE, Cannom DS. et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Circulation 2006; 114: e257-354.
    CrossrefPubMedGoogle Scholar
  • 2 Singer DE, Albers GW, Dalen JE. et al. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 546S-592S.
    CrossrefPubMedGoogle Scholar
  • 3 Kearon C, Kahn SR, Agnelli G. et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 454S-545S.
    CrossrefPubMedGoogle Scholar
  • 4 Salem DN, O’Gara PT, Madias C. et al. Valvular and structural heart disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 593S-629S.
    CrossrefPubMedGoogle Scholar
  • 5 Cortelazzo S, Finazzi G, Viero P. et al. Thrombotic and hemorrhagic complications in patients with mechanical heart valve prosthesis attending an anticoagulation clinic. Thromb Haemost 1993; 69: 316-320.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 6 Acar J, Iung B, Boissel JP. et al. AREVA: multicenter randomized comparison of low-dose versus standard-dose anticoagulation in patients with mechanical prosthetic heart valves. Circulation 1996; 94: 2107-2112.
    CrossrefPubMedGoogle Scholar
  • 7 Baudet EM, Oca CC, Roques XF. et al. A 5 1/2 year experience with the St. Jude Medical cardiac valve prosthesis. Early and late results of 737 valve replacements in 671 patients. J Thorac Cardiovasc Surg 1985; 90: 137-144.
    PubMedGoogle Scholar
  • 8 Bloomfield P, Wheatley DJ, Prescott RJ. et al. Twelve-year comparison of a BjorkShiley mechanical heart valve with porcine bioprostheses. N Engl J Med 1991; 324: 573-579.
    CrossrefPubMedGoogle Scholar
  • 9 Butchart EG, Payne N, Li HH. et al. Better anticoagulation control improves survival after valve replacement. J Thorac Cardiovasc Surg 2002; 123: 715-723.
    CrossrefPubMedGoogle Scholar
  • 10 Emery RW, Arom KV, Nicoloff DM. Utilization of the St. Jude Medical prosthesis in the aortic position. Semin Thorac Cardiovasc Surg 1996; 8: 231-236.
    PubMedGoogle Scholar
  • 11 Fiore AC, Barner HB, Swartz MT. et al. Mitral valve replacement: randomized trial of St. Jude and Medtronic Hall prostheses. Ann Thorac Surg 1998; 66: 707-713.
    CrossrefPubMedGoogle Scholar
  • 12 Hering D, Piper C, Bergemann R. et al. Thromboembolic and bleeding complications following St. Jude Medical valve replacement: results of the German Experience With Low-Intensity Anticoagulation Study. Chest 2005; 127: 53-59.
    CrossrefPubMedGoogle Scholar
  • 13 Horstkotte D, Schulte H, Bircks W. et al. Unexpected findings concerning thromboembolic complications and anticoagulation after complete 10 year follow up of patients with St. Jude Medical prostheses. J Heart Valve Dis 1993; 2: 291-301.
    PubMedGoogle Scholar
  • 14 Horstkotte D, Schulte HD, Bircks W. et al. Lower intensity anticoagulation therapy results in lower complication rates with the St. Jude Medical prosthesis. J Thorac Cardiovasc Surg 1994; 107: 1136-1145.
    PubMedGoogle Scholar
  • 15 Laffort P, Roudaut R, Roques X. et al. Early and long-term (one-year) effects of the association of aspirin and oral anticoagulant on thrombi and morbidity after replacement of the mitral valve with the St. Jude medical prosthesis: a clinical and transesophageal echocardiographic study. J Am Coll Cardiol 2000; 35: 739-746.
    CrossrefPubMedGoogle Scholar
  • 16 Sethia B, Turner MA, Lewis S. et al. Fourteen years’ experience with the Bjork-Shiley tilting disc prosthesis. J Thorac Cardiovasc Surg 1986; 91: 350-361.
    PubMedGoogle Scholar
  • 17 Talwar S, Kapoor CK, Velayoudam D. et al. Anticoagulation protocol and early prosthetic valve thrombosis. Indian Heart J 2004; 56: 225-228.
    PubMedGoogle Scholar
  • 18 Vallejo JL, Gonzalez-Santos JM, Albertos J. et al. Eight years’ experience with the Medtronic-Hall valve prosthesis. Ann Thorac Surg 1990; 50: 429-436.
    CrossrefPubMedGoogle Scholar
  • 19 Vogt S, Hoffmann A, Roth J. et al. Heart valve replacement with the Bjork-Shiley and St Jude Medical prostheses: a randomized comparison in 178 patients. Eur Heart J 1990; 11: 583-591.
    CrossrefPubMedGoogle Scholar
  • 20 Koertke H, Zittermann A, Tenderich G. et al. Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II. Eur Heart J 2007; 28: 2479-2484.
    CrossrefPubMedGoogle Scholar
  • 21 Koertke H, Zittermann A, Wagner O. et al. Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement. Ann Thorac Surg 2007; 83: 24-29.
    CrossrefPubMedGoogle Scholar
  • 22 Cannegieter SC, Rosendaal FR, Wintzen AR. et al. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 1995; 333: 11-17.
    CrossrefPubMedGoogle Scholar
  • 23 Baudet EM, Puel V, McBride JT. et al. Long-term results of valve replacement with the St. Jude Medical prosthesis. J Thorac Cardiovasc Surg 1995; 109: 858-870.
    CrossrefPubMedGoogle Scholar
  • 24 Go AS, Hylek EM, Chang Y. et al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice?. J Am Med Assoc 2003; 290: 2685-2692.
    CrossrefPubMedGoogle Scholar
  • 25 Palareti G, Leali N, Coccheri S. et al. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy. Lancet 1996; 348: 423-428.
    CrossrefPubMedGoogle Scholar
  • 26 Fihn SD, McDonell M, Martin D. et al. Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin Optimized Outpatient Follow-up Study Group. Ann Intern Med 1993; 118: 511-520.
    CrossrefPubMedGoogle Scholar
  • 27 van der Meer FJ, Rosendaal FR, Vandenbroucke JP. et al. Bleeding complications in oral anticoagulant therapy. An analysis of risk factors. Arch Intern Med 1993; 153: 1557-1562.
    CrossrefPubMedGoogle Scholar
  • 28 Rose AJ, Ozonoff A, Henault LE. et al. Warfarin for atrial fibrillation in community-based practise. J Thromb Haemost 2008; 6: 1647-1654.
    CrossrefPubMedGoogle Scholar
  • 29 Kent DL, Vermes D, McDonell M. et al. A model for planning optimal follow-up for outpatients on warfarin anticoagulation. Warfarin Optimal Outpatient Follow-up Study Group. Med Decis Making 1992; 12: 132-141.
    CrossrefPubMedGoogle Scholar
  • 30 Rosendaal FR, Cannegieter SC, van der Meer FJ. et al. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993; 69: 236-239.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 31 Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692-694.
    CrossrefPubMedGoogle Scholar
  • 32 Stein PD, Alpert JS, Bussey HI. et al. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest 2001; 119: 220S-227S.
    CrossrefPubMedGoogle Scholar
  • 33 Stein PD, Alpert JS, Dalen JE. et al. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest 1998; 114: 602S-610S.
    CrossrefPubMedGoogle Scholar
  • 34 Cappelleri JC, Fiore LD, Brophy MT. et al. Efficacy and safety of combined anticoagulant and antiplatelet therapy versus anticoagulant monotherapy after mechanical heart-valve replacement: a metaanalysis. Am Heart J 1995; 130: 547-552.
    CrossrefPubMedGoogle Scholar
  • 35 Meschengieser SS, Fondevila CG, Frontroth J. et al. Low-intensity oral anticoagulation plus low-dose aspirin versus high-intensity oral anticoagulation alone: a randomized trial in patients with mechanical prosthetic heart valves. J Thorac Cardiovasc Surg 1997; 113: 910-916.
    CrossrefPubMedGoogle Scholar
  • 36 Turpie AG, Gent M, Laupacis A. et al. A comparison of aspirin with placebo in patients treated with warfarin after heart-valve replacement. N Engl J Med 1993; 329: 524-529.
    CrossrefPubMedGoogle Scholar
  • 37 Salem DN, Daudelin HD, Levine HJ. et al. Antithrombotic therapy in valvular heart disease. Chest 2001; 119: 207S-219S.
    CrossrefPubMedGoogle Scholar
  • 38 Salem DN, Levine HJ, Pauker SG. et al. Antithrombotic therapy in valvular heart disease. Chest 1998; 114: 590S-601S.
    CrossrefPubMedGoogle Scholar
  • 39 Salem DN, Stein PD, Al-Ahmad A. et al. Antithrombotic therapy in valvular heart disease--native and prosthetic: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 457S-482S.
    CrossrefPubMedGoogle Scholar
  • 40 Wikipedia.. Artificial Heart Valve. Available at: http://en.wikipedia.org/wiki/artificial_heart_valve Last accessed: October 15, 2009.
    PubMedGoogle Scholar
  • 41 Cabana MD, Rand CS, Powe NR. et al. Why don‘t physicians follow clinical practice guidelines? A framework for improvement. J Am Med Assoc 1999; 282: 1458-1465.
    CrossrefPubMedGoogle Scholar
  • 42 Garcia DA, Regan S, Henault LE. et al. Risk of thromboembolism with short-term interruption of warfarin therapy. Arch Intern Med 2008; 168: 63-69.
    CrossrefPubMedGoogle Scholar
  • 43 Clark NP, Witt DM, Delate T. et al. Thromboembolic consequences of subtherapeutic anticoagulation in patients stabilized on warfarin therapy: the low INR study. Pharmacotherapy 2008; 28: 960-967.
    CrossrefPubMedGoogle Scholar
  • 44 Garcia DA, Ageno W, Libby EN. et al. Perioperative anticoagulation for patients with mechanical heart valves: a survey of current practice. J Thromb Thrombolysis 2004; 18: 199-203.
    CrossrefPubMedGoogle Scholar
  • 45 Ansell J, Hirsh J, Hylek E. et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 160S-198S.
    CrossrefPubMedGoogle Scholar
  • 46 National Institutes of Health: Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study).. ClinicalTrials.gov identifier: NCT00786474. Available at: www.clinicaltrials.gov. Last accessed: October 15, 2009.
    PubMedGoogle Scholar
  • 47 Hylek EM, Evans-Molina C, Shea C. et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007; 115: 2689-2696.
    CrossrefPubMedGoogle Scholar
  • 48 van Leeuwen Y, Rosendaal FR, Cannegieter SC. Prediction of hemorrhagic and thrombotic events in patients with mechanical heart valve prostheses treated with oral anticoagulants. J Thromb Haemost 2008; 6: 451-456.
    CrossrefPubMedGoogle Scholar