Journal of Thrombosis and Thrombolysis

, Volume 42, Issue 2, pp 167–171 | Cite as

Review of venous thromboembolism and race: the generalizability of treatment guidelines for high-risk populations

  • Lonnie T. SullivanII
  • Larry R. JacksonII
  • Kevin L. ThomasEmail author


The American College of Chest Physicians (ACCP) has established guidelines for the treatment of VTE, but the generalizability to all populations is unclear. In this review we analyzed the rate of reporting and enrollment of blacks and women in clinical trials cited in the ACCP guidelines for treatment of unprovoked VTE. We extracted data from clinical trials cited by the ACCP that compared durations of anticoagulation therapy for the treatment of unprovoked VTE. We excluded trials that treated surgical or cancer patients. For trials that did not report race/ethnicity we contacted the primary investigators via email for enrollment data. The final analysis included 17 randomized clinical trials with a total patient population of N = 13,693. All trials reported data on sex; conversely, 2 trials (11.8 %) reported race/ethnicity within the primary manuscript. We ultimately acquired data on race/ethnicity from the primary investigator in 5 additional trials for a total race/ethnicity data from 7 trials. There were 7573 males (55.3 %) and 6120 females (44.7 %) enrolled in these studies. Among trials that reported race and ethnicity the total patient population was N = 5368; 5171 (96.3 %) white, 115 (2.1 %) black, 65 (1.4 %) Asian and 7 (0.25 %) Hispanic. Racial/ethnic minorities are underreported and under represented in clinical trials forming the cornerstone of ACCP guidelines for the optimal duration for VTE treatment. Conversely, the reporting and inclusion of women was substantive. The guidelines for unprovoked VTE treatment may not be generalizable to racially and ethnically diverse patient populations.


Venous thromboembolism Black Ethnicity Enrollment 


  1. 1.
    Rosendaal FR, Raskob GE (2014) On world thrombosis day. Lancet 384(9955):1653–1654CrossRefGoogle Scholar
  2. 2.
    Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstrøm J (2007) Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost 5(4):692–699CrossRefPubMedGoogle Scholar
  3. 3.
    Beckman MG, Hooper WC, Critchley SE, Ortel TL (2010) Venous thromboembolism: a public health concern. Am J Prev Med 38(4):S495–S501CrossRefPubMedGoogle Scholar
  4. 4.
    Zakai NA, McClure LA (2011) Racial differences in venous thromboembolism. J Thromb Haemost 9(10):1877–1882CrossRefPubMedGoogle Scholar
  5. 5.
    White RH, Zhou H, Murin S, Harvey D (2005) Effect of ethnicity and gender on the incidence of venous thromboembolism in a diverse population in California in 1996. Thromb Haemost 93(2):298–305PubMedGoogle Scholar
  6. 6.
    White RH, Keenan CR (2009) Effects of race and ethnicity on the incidence of venous thromboembolism. Thromb Res 123:S11–S17CrossRefPubMedGoogle Scholar
  7. 7.
    Buckner TW, Key NS (2012) Venous thrombosis in blacks. Circulation 125(6):837–839CrossRefPubMedGoogle Scholar
  8. 8.
    Aujesky D, Long JA, Fine MJ, Ibrahim SA (2007) African American race was associated with an increased risk of complications following venous thromboembolism. J Clin Epidemiol 60(4):410–416CrossRefPubMedGoogle Scholar
  9. 9.
    Deitelzweig SB, Lin J, Johnson BH, Schulman KL (2011) Venous thromboembolism in the US: does race matter? J Thromb Thrombolysis 31(2):133–138CrossRefPubMedGoogle Scholar
  10. 10.
    White RH, Dager WE, Zhou H, Murin S (2006) Racial and gender differences in the incidence of recurrent venous thromboembolism. Thromb Haemost-Stuttg 96(3):267Google Scholar
  11. 11.
    Liu J, Hickson DA, Musani SK, Talegawkar SA, Carithers TC, Tucker KL, Taylor HA (2013) Dietary patterns, abdominal visceral adipose tissue, and cardiometabolic risk factors in African Americans: the Jackson heart study. Obesity 21(3):644–651CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Austin H, Key NS, Benson JM, Lally C, Dowling NF, Whitsett C, Hooper WC (2007) Sickle cell trait and the risk of venous thromboembolism among blacks. Blood 110(3):908–912CrossRefPubMedGoogle Scholar
  13. 13.
    Payne AB, Miller CH, Hooper WC, Lally C, Austin HD (2014) High factor VIII, von Willebrand factor, and fibrinogen levels and risk of venous thromboembolism in blacks and whites. Risk 24(2):169–174Google Scholar
  14. 14.
    Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Kahn SR (2012) Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis: American College of Chest Physicians evidence-based clinical practice guidelines. Chest J 141(2_suppl):e419S–e494SCrossRefGoogle Scholar
  15. 15.
    Lagerstedt C, Fagher B, Olsson CG, Öqvist B, Albrechtsson U (1985) Need for long-term anticoagulant treatment in symptomatic calf-vein thrombosis. Lancet 326(8454):515–518CrossRefGoogle Scholar
  16. 16.
    Research Committee of the British Thoracic Society (1992) Optimum duration of anticoagulation for deep-vein thrombosis and pulmonary embolism. Lancet 340(8824):873–876Google Scholar
  17. 17.
    Levine MN, Hirsh J, Gent M, Turpie AG, Weitz J, Ginsberg J, Powers P (1995) Optimal duration of oral anticoagulant therapy: a randomized trial comparing four weeks with three months of warfarin in patients with proximal deep vein thrombosis. Thromb Haemost 74(2):606–611PubMedGoogle Scholar
  18. 18.
    Schulman S, Rhedin AS, Lindmarker P, Carlsson A, Lärfars G, Nicol P, Boberg J (1995) A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. N Engl J Med 332(25):1661–1665CrossRefPubMedGoogle Scholar
  19. 19.
    Schulman S, Granqvist S, Holmström M, Carlsson A, Lindmarker P, Nicol P, Boberg J (1997) The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. N Engl J Med 336(6):393–398CrossRefPubMedGoogle Scholar
  20. 20.
    Kearon C, Gent M, Hirsh J, Weitz J, Kovacs MJ, Anderson DR, Julian JA (1999) A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med 340(12):901–907CrossRefPubMedGoogle Scholar
  21. 21.
    Pinede L, Ninet J, Duhaut P, Chabaud S, Demolombe-Rague S, Durieu I, Boissel J (2001) Comparison of 3 and 6 months of oral anticoagulant therapy after a first episode of proximal deep vein thrombosis or pulmonary embolism and comparison of 6 and 12 weeks of therapy after isolated calf deep vein thrombosis. Circulation 103(20):2453–2460CrossRefPubMedGoogle Scholar
  22. 22.
    Agnelli G, Prandoni P, Santamaria MG, Bagatella P, Iorio A, Bazzan M, Ageno W (2001) Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. N Engl J Med 345(3):165–169CrossRefPubMedGoogle Scholar
  23. 23.
    Ridker PM, Goldhaber SZ, Danielson E, Rosenberg Y, Eby CS, Deitcher SR, Glynn RJ (2003) Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism. N Engl J Med 348(15):1425–1434CrossRefPubMedGoogle Scholar
  24. 24.
    Agnelli G, Prandoni P, Becattini C, Silingardi M, Taliani MR, Miccio M, Zonzin P (2003) Extended oral anticoagulant therapy after a first episode of pulmonary embolism. Ann Intern Med 139(1):19–25CrossRefPubMedGoogle Scholar
  25. 25.
    Farraj RS (2004) Anticoagulation period in idiopathic venous thromboembolism. How long is enough? Saudi Med J 25(7):848–851PubMedGoogle Scholar
  26. 26.
    Palareti G, Cosmi B, Legnani C, Tosetto A, Brusi C, Iorio A, Tripodi A (2006) D-dimer testing to determine the duration of anticoagulation therapy. N Engl J Med 355(17):1780–1789CrossRefPubMedGoogle Scholar
  27. 27.
    Campbell IA, Bentley DP, Prescott RJ, Routledge PA, Shetty HGM, Williamson IJ (2007) Anticoagulation for three versus six months in patients with deep vein thrombosis or pulmonary embolism, or both: randomised trial. BMJ 334(7595):674CrossRefPubMedPubMedCentralGoogle Scholar
  28. 28.
    Siragusa S, Malato A, Anastasio R, Cigna V, Milio G, Amato C, Mariani G (2008) Residual vein thrombosis to establish duration of anticoagulation after a first episode of deep vein thrombosis: the duration of anticoagulation based on compression ultrasonography (DACUS) study. Blood 112(3):511–515CrossRefPubMedGoogle Scholar
  29. 29.
    Prandoni P, Prins MH, Lensing AW, Ghirarduzzi A, Ageno W, Imberti D, Agnelli G (2009) Residual thrombosis on ultrasonography to guide the duration of anticoagulation in patients with deep venous thrombosis: a randomized trial. Ann Intern Med 150(9):577–585CrossRefPubMedGoogle Scholar
  30. 30.
    Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Goldhaber SZ (2009) Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 361(24):2342–2352CrossRefPubMedGoogle Scholar
  31. 31.
    Agnelli G, Berkowitz S, Bounameaux H, Büller H, Cohen A, Gallus A, Spadari G (2010) Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 363(26):2499–2510CrossRefPubMedGoogle Scholar
  32. 32.
    Zhang T, Tsang W, Wijeysundera HC, Ko DT (2013) Reporting and representation of ethnic minorities in cardiovascular trials: a systematic review. Am Heart J 166(1):52–57CrossRefPubMedGoogle Scholar
  33. 33.
    Jackson LR II, Peterson ED, Okeagu E, Thomas K (2015) Review of race/ethnicity in non vitamin K antagonist oral anticoagulants clinical trials. J Thromb Thrombolysis 39(2):222–227CrossRefPubMedGoogle Scholar
  34. 34.
    REGULATION (EU) No 536/2014 of the European Parliament And of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECGoogle Scholar
  35. 35.
    Sheikh A, Netuveli G, Kai J, Panesar SS (2004) Comparison of reporting of ethnicity in US and European randomised controlled trials. BMJ 329(7457):87–88CrossRefPubMedPubMedCentralGoogle Scholar
  36. 36.
    Tsang W, Alter DA, Wijeysundera HC, Zhang T, Ko DT (2012) The impact of cardiovascular disease prevalence on women’s enrollment in landmark randomized cardiovascular trials: a systematic review. J Gen Intern Med 27(1):93–98CrossRefPubMedGoogle Scholar
  37. 37.
    Sardar MR, Badri M, Prince CT, Seltzer J, Kowey PR (2014) Underrepresentation of women, elderly patients, and racial minorities in the randomized trials used for cardiovascular guidelines. JAMA Internal Med 174(11):1868–1870CrossRefGoogle Scholar
  38. 38.
    Ford ME, Siminoff LA, Pickelsimer E, Mainous AG, Smith DW, Diaz VA, Tilley BC (2013) Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. Health & social work. hlt001Google Scholar

Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Lonnie T. SullivanII
    • 1
  • Larry R. JacksonII
    • 1
  • Kevin L. Thomas
    • 1
    Email author
  1. 1.Duke Clinical Research InstituteDuke University Department of MedicineDurhamUSA

Personalised recommendations