Thromb Haemost 2000; 84(05): 752-757
DOI: 10.1055/s-0037-1614110
Review Article
Schattauer GmbH

Extended Anticoagulation for Prevention of Recurrent Venous Thromboembolism in Carriers of Factor V Leiden

Cost-effectiveness Analysis
Monia Marchetti
1   From the Laboratory of Medical Informatics, Pavia, Italy
,
Angela Pistorio
2   Laboratory of Biostatistics and Epidemiology, IRCCS Policlinico S. Matteo, Pavia, Italy
,
Giovanni Barosi
1   From the Laboratory of Medical Informatics, Pavia, Italy
› Author Affiliations
Further Information

Publication History

Received 14 February 2000

Accepted after resubmission 21 June 2000

Publication Date:
13 December 2017 (online)

Summary

There is much debate over the appropriateness of prescribing prolonged anticoagulation to heterozygous carriers of factor V Leiden suffering a first episode of deep vein thrombosis (DVT). We, thus used meta-analysis to estimate from six eligible studies the summary odds-ratio of recurrent DVT in carriers of factor V Leiden versus noncarriers: 1.36 (CI, 1.05–1.78). After that, we used a decision model to compare lifelong costs and benefits of 6 months standard anticoagulation with those of screening for carriers of factor V Leiden and extending for 2 years their anticoagulation. Screening was a cost-effective strategy, since it provided 2 additional quality-adjusted days of life per patient at the cost of $ 12,833 per quality-adjusted year of life saved, as compared to standard management. However, screening was not costeffective in patients who were predicted to incur fatal bleeding at a rate higher than 0.34% per year or recurrent DVT at a rate lower than 9% in the first 2 years. The screening policy was cost-saving if restricted to patients with idiopathic DVT and compliant to warfarin therapy.

 
  • References

  • 1 Lensing AW, Prandoni P, Prins MH, Buller HR. Deep-vein thrombosis. Lancet 1999; 353: 479-85.
  • 2 Bertina RM, Koeleman BP, Koster T, Rosendaal FR, Dirven RJ, de Ronde H, van der Velden PA, Reitsma PH. Mutation in blood coagulation factor V associated with resistance to activated protein C. Nature 1994; 369: 64-7.
  • 3 Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, Turpie AG, Green D, Ginsberg JS, Wells P, MacKinnon B, Julian JA. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med 1999; 340: 901-7.
  • 4 Eichinger S, Pabinger I, Stumpflen A, Hirschl M, Bialonczyk C, Schneider B, Mannhalter C, Minar E, Lechner K, Kyrle PA. The risk of recurrent venous thromboembolism in patients with and without factor V Leiden. Thromb Haemost 1997; 77: 624-8.
  • 5 Simioni P, Prandoni P, Lensing AW, Scudeller A, Sardella C, Prins MH, Prins MH, Villalta S, Dazzi F, Girolami A. The risk of recurrent venous thromboembolism in patients with an Arg506 → Gln mutation in the gene for factor V (factor V Leiden). N Engl J Med 1997; 336: 399-403.
  • 6 Rintelen C, Pabinger I, Knobl P, Lechner K, Mannhalter C. Probability of recurrence of thrombosis in patients with and without factor V Leiden. Thromb Haemost 1996; 75: 229-32.
  • 7 Ridker PM, Miletich JP, Stampfer MJ, Goldhaber SZ, Lindpaintner K, Hennekens CH. Factor V Leiden and risks of recurrent idiopathic venous thromboembolism. Circulation 1995; 92: 2800-2.
  • 8 Lindmarker P, Schulman S, Sten-Linder M, Wiman B, Egberg N, Johnsson H. The risk of recurrent venous thromboembolism in carriers and noncarriers of the G1691A allele in the coagulation factor V gene and the G20210A allele in the prothrombin gene. Duration of Anticoagulation. Thromb Haemost 1999; 81: 684-9.
  • 9 De Stefano V, Martinelli I, Mannucci PM, Paciaroni K, Chiusolo P, Casorelle I, Rossi E, Leone G. The risk of recurrent deep venous thrombosis among heterozygous carriers of both factor V Leiden and the G20210A prothrombin mutation. N Engl J Med 1999; 341: 801-6.
  • 10 Margaglione M, D’Andrea G, Colaiazzo D, Cappucci G, del Popolo A, Brancaccio V, Ciampa A, Grandone E, Di Minno G. Coexistence of factor V Leiden and factor II A20210 mutations and recurrent venous thromboembolism. Thromb Haemost 1999; 82: 1583-7.
  • 11 Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22: 719-48.
  • 12 5th American College of Chest Physicians Consensus Conference on Antithrombotic Therapy. Antithrombotic therapy for venous thromboembolic disease. Chest 1998; 124: 561S-78S.
  • 13 Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making 1993; 13: 322-38.
  • 14 Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russel LB. Recommendations of the Panel on Cost-Effectiveness in Health and Medicine. JAMA 1996; 276: 1253-8.
  • 15 Schulman S. Duration of Anticoagulation Study Group. The effect of the duration of anticoagulation and other risk factors on the recurrence of venous thromboembolism. Wien Med Wschr 1999; 149: 66-9.
  • 16 Schulman S, Granqvist S, Holmstrom M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Larfars G, Leijd B, Linder O, Loogna E. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Study Group. N Engl J Med 1997; 336: 393-8.
  • 17 Goldhaber SZ, Visani L, De Rosa M. for ICOPER Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet 1999; 353: 1386-9.
  • 18 Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med 1996; 125: 1-7.
  • 19 Baglin C, Brown K, Luddington R, Baglin T. East Anglian Thrombophilia Study Group. Risk of recurrent venous thromboembolism in patients with the factor V Leiden (FVR506Q) mutation: effect of warfarin and prediction by precipitating factors. Br J Haematol 1998; 100: 764-8.
  • 20 Landefeld CS, Beyth RJ. Anticoagulant-related bleeding: clinical epidemiology, prediction, and prevention. Am J Med 1993; 95: 315-28.
  • 21 Palareti G, Leali N, Coccheri S, Poggi M, Manotti C, D’Angelo A, Pengo V, Erba N, Moia M, Ciavarella N, Devoto G, Berretini M, Musolesi S. Bleeding complications of oral anticoagulant treatment: an inceptioncohort, prospective collaborative study (ISCOAT). Lancet 1996; 348: 423-8.
  • 22 van-der Meer FJ, Rosendaal FR, Vandenbroucke JP, Briet E. Bleeding complications in oral anticoagulant therapy. An analysis of risk factors. Arch Intern Med 1993; 153: 1557-62.
  • 23 White RH, McKittrick T, Takakuwa J, Callahan C, McDonnell M, Fihn S. Management and prognosis of life-threatening bleeding during warfarin therapy. National Consortium of Anticoagulation Clinics. Arch Intern Med 1996; 156: 1197-201.
  • 24 Chiquette E, Amato MG, Bussey HI. Comparison of an anticoagulation clinic with usual medical care: anticoagulation control, patient outcomes, and health care costs. Arch Intern Med 1998; 158: 1641-7.
  • 25 Lenert LA, Soetikno RM. Automated computer interviews to elicit utilities: potential applications in the treatment of deep venous thrombosis. J Am Med Inform Assoc 1997; 04: 49-56.
  • 26 Gage BF, Cardinalli AB, Owens DK. The effects of stroke and stroke prophylaxis with aspirin and warfarin on quality of life. Arch Intern Med 1996; 156: 1829-36.
  • 27 Carod-Artal FJ, Egido-Navarro JA, Gonzales-Gutierrez JL, Varela Ede Seijas. Direct cost of cerebrovascular disease during the first year of follow-up. Rev Neurol 1999; 28: 1123-30.
  • 28 Schulman K, Burke J, Drummond M, Davies L, Carlsson P, Griger J, Harris A, Lucioni C, Gisbert R, Llana T, Tom E, Bloom B, Willke R, Glick H. Resource costing for multinational neurologic clincial trials: methods and results. Health Econ 1998; 07: 629-38.
  • 29 Drummond MF, O’Brien B, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. 2nd ed.. Oxford University Press; Oxford: 1997
  • 30 Cesarone MR, Belcaro G, Nicolaides AN, Laurora G, De Sanctis MT, Incadela L, Barsotti A. Epidemiology and costs of venous diseases in central Italy. The San Valentino Venous Disease Project. Angiology 1997; 48: 583-93.
  • 31 Meinardi JR, Middeldorp S, de Kam PJ, Koopman MMW, van Pampus ECM, Hamulayak K, Buller HR, van der Meer J. Recurrent venous thromboembolism in carriers of the FV:Q506 mutation; results of a prospective study. 15th International Congress on Thrombosis. Antalya, Turkey. October 16-21,1998. Haemostasis 1998; 28 (Suppl. 02) 107.
  • 32 Meinardi JR, Middeldorp S, de Kam PJ, Koopman MMW, van Pampus ECM, Hamulyak K, Prins MH, Buller HR, van der Meer J. Persistent high risk of first recurrence of venous thromboembolism in FV:Q506 carriers; results of a retrospective cohort study. 15th International Congress on Thrombosis. Antalya, Turkey. October 16-21, 1998. Haemostasis 1998; 28 (Suppl. 02) 108.
  • 33 Wright JC, Weinstein MC. Gains in life expectancy from medical interventions-standardizing data on outcomes. N Engl J Med 1998; 339: 380-6.
  • 34 Rosendaal FR, Koster T, Vandenbroucke JP, Reitsma PH. High risk of thrombosis in patients homozygous for factor V Leiden (activated protein C resistance). Blood 1995; 85: 1504-8.
  • 35 Doggen CJ, Cats VM, Bertina RM, Rosendaal FR. Interaction of coagulation defects and cardiovascular risk factors: increased risk of myocardial infarction associated with factor V Leiden or prothrombin 20210A. Circulation 1998; 97: 1037-41.
  • 36 Heit JA, Silverstein MD, Mohr DN, Petterson TM, O’Fallon WM, Melton LJ. Predictors of survival after deep vein thrombosis and pulmonary embolism. A population-based, cohort study. Arch Intern Med 1999; 159: 445-53.
  • 37 Douketis JD, Kearon C, Bates S, Duku EK, Ginsberg JS. Risk of fatal pulmonary embolism in patients with treated venous thromboembolism. JAMA 1998; 279: 458-62.
  • 38 Lloyd A, Aitken JA, Hoffmayer UKO, Kelso EJ, Wakerly EC, Barber ND. Economic evaluation of the use of nadroparin calcium in the prophylaxis of deep vein thrombosis and pulmonary embolism in surgical patients in Italy. Pharmacoeconomics 1997; 12: 475-85.
  • 39 Giannetti J, Gensini G, De Caterina R. A cost-effectiveness analysis of aspirin versus oral anticoagulants after acute myocardial infarction in Italy. Thromb Haemost 1998; 80: 887-93.