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Cardiovascular

Cardiovascular disease, including heart disease and stroke, is a major global health concern and the leading cause of death and disability worldwide. At Boehringer Ingelheim we address unmet medical need by providing innovative treatments that improve the care of patients suffering from a range of cardiovascular conditions including irregular heart beats (atrial fibrillation), stroke, blood clots in deep veins or lungs (deep vein thrombosis or pulmonary embolism), high blood pressure (hypertension) or heart attack (myocardial infarction).

Deep Vein Thrombosis (DVT) is a serious but usually treatable medical condition. DVT occurs when a blood clot forms within a deep vein in a leg, thigh or even the arm. If part of the clot breaks off and travels to the lung, it can cause a potentially life-threatening condition known as pulmonary embolism (PE) which is the most serious complication of DVT. It is essential that patients with DVT or PE are quickly diagnosed then treated to prevent clot growth and future clot formation. 

Venous thromboembolism treatment (VTE) is common, with DVT and PE estimated to be the third most prevalent cardiovascular disorders after coronary heart disease and stroke.1 Over 750,000 DVT and PE events are estimated to occur annually in six major EU countries (France, Germany, Italy, Spain, Sweden, UK)2 and over 900,000 events in the US.3 Although venous thromboembolism is both treatable and preventable, 40 percent of people who experience a DVT or PE will have a recurrent event within 10 years of the first event.4 Pulmonary embolism is a serious complication of DVT5, and the leading cause of preventable death in hospital.6 Those who survive may be left with permanent damage to the affected lung and other vital organs, and are at risk of complications such as chronic thromboembolic pulmonary hypertension (CTEPH).7 Undiagnosed venous thromboembolic events pose a further significant burden on healthcare systems and lead to considerable underestimation of prevalence, and ultimately deaths worldwide.2 In India, around 2,31,132 VTE events occur annually8, and around 53.6% hospitalized Indian patients are at an increased risk of VTE.9

A number of anticoagulant treatment options are currently recommended to treat and provide protection against DVT and PE. Effective treatment options are available for patients at every stage of the conditions:

Acute DVT & PE treatment – Patients who experience a venous event rapidly and/or severely that requires immediate treatment to dissolve the thrombosis and restore blood flow to the affected area as quickly as possible

Prevention of recurrent DVT & PE, or secondary prevention long-term treatment – Patients at risk of recurrent venous events. 

The availability of non-vitamin K antagonist oral anticoagulants (NOACs) that – in contrast to traditional vitamin K antagonists – do not require regular blood testing and are not associated with numerous limitations like food-interactions or drug-interactions, may help to advance DVT/PE treatment, better prevent recurrent events and improve clinical outcomes.18,19

Prevention of venous thromboembolic events in patients who have undergone orthopaedic surgery

Patients undergoing major orthopedic surgery, such as total hip (THR) or total knee (TKR) joint replacement procedures, are at high risk of venous thromboembolism (VTE) and bleeding. Postoperative VTE, such as deep vein thrombosis (DVT) or pulmonary embolism (PE), results in significant mortality, morbidity, and health-care resource expenditure. 

Without thromboprophylaxis, the incidence of asymptomatic DVT has been reported to be 40–60%, with approximately 5–10% of deaths among hospitalized patients being associated with PE. Mild and moderate renal impairment has been shown to be associated with an increased risk of unprovoked and provoked VTE in the general population.

Major orthopaedic surgery causes trauma. Hip replacement surgery results in damage to blood vessels around the operation site, enhanced local and systemic activation of the coagulation cascade, reduced blood flow for several weeks, and suppression of fibrinolysis. Increased coagulant activity, combined with impaired venous hemodynamics, increases the risk of VTE. 

The risk of VTE following hip replacement surgery may be compounded by:

  • Factors related to the patient (age, inherited procoagulant conditions resulting in blood abnormalities) or clinical factors (malignancy).
  • Oral contraceptives or hormone replacement therapy, which also increases the risk of thrombosis.

References

  1. Lloyd-Jones DM, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004;110:1042-6.
  2. Fuster V, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation – executive summary. Circulation 2006;114:700-52.
  3. Atrial Fibrillation in India: Information, Symptoms, Treatment. http://www.articlesbase.com/health-articles/atrial-fibrillation-in-india-information-symptoms-treatment-1389859.html. (Accessed on May 2013)
  4. Kannel WB, et al. Final Draft Status of the Epidemiology of Atrial Fibrillation. Med Clin North Am. 2008;92(1):17–40.
  5. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed Dec 2010 at www.who.int/cardiovascular_diseases/en/ cvd_atlas_15_burden_stroke.pdf .
  6. Wolf PA, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22(8):983-8.
  7. Marini C, et al. Contribution of atrial fibrillation to incidence and outcome of ischaemic stroke: results from a population-based study. Stroke 2005;36:1115-9
  8. Lin HJ, et al. Stroke severity in atrial fibrillation: the Framingham study. Stroke 1996;27:1760-4.
  9. We recognize that the Internet serves a global community. The pharmaceutical industry, however, is subject to country specific regulatory considerations, which affect the information we can provide on our products. In addition the registration status of pharmaceutical products may not be the same in different regions of the world and the approved product labels may also differ according to country specific requirements. 
  10. Goldhaber SZ. Pulmonary embolism thrombolysis: a clarion call for international collaboration. J Am Coll Cardiol 1992;19:246–247.Cohen AT, et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost 2007;98:756-764.
  11. Cohen AT, et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost 2007;98:756-764.
  12. Roger VL. et al. Heart disease and stroke statistics—2012 update: A report from the American Heart Association. Circulation 2012;125(1):e2-e220.
  13. Prandoni P. et al. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica 2007;92(02):199–205.
  14. Heit JA, et al. Predictors of survival after deep vein thrombosis and pulmonary embolism. Arch Intern Med 1999;159:445-453.
  15. BMJ Best Practice. VTE Prophylaxis. Available at: http://bestpractice.bmj.com/best-practice/monograph/1087.html
  16. Pengo V. et al. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004;350:2257-64.
  17. Ray, G. & Behera, M. Venous Thromboembolism - Indian Perspective. Med. Update 20, 329–334 (2010).
  18. Pinjala, R. & ENDORSE-India investigators. Venous thromboembolism risk & prophylaxis in the acute hospital care setting (ENDORSE), a multinational cross-sectional study: results from the Indian subset data. Indian J. Med. Res. 136, 60–67 (2012).
  19. Kearon C and Aki EA. Duration of anticoagulant therapy for deep vein thrombosis and pulmonary embolism. Blood 2014;123:1794–1801.
  20. Camm AJ., et al. Guidelines for the management of atrial fibrillation. Eur Heart J. 2010;31(19):2369–429.
  21. Dahl OE, Pedersen T, Kierulf P, et al. Sequential intrapulmonary and systemic activation of coagulation and fibrinolysis during and after total hip replacement surgery. Thromb Res. 1993;70:451-8. 
  22. Bajaj SP, Joist JH. New insights into how blood clots: implications for the use of APTT and PT as coagulation screening tests and in monitoring of anticoagulation therapy. Semin Thromb Haemost. 1999;25:407-18.
  23. McNally MA, Mollan RAB. Total hip replacement, lower limb blood flow and venous thrombogenesis. J Bone Joint Surg. 1993;75-B:640-4. 
  24. Dahl OE, Andreassen G, Aspelin T, et al. Prolonged thromboprophylaxis following hip replacement surgery – Results of a double-blind, prospective, randomised, placebo-controlled study with dalteparin (Fragmin®). Thromb Haemost. 1997;77:26-31.
  25. Rosendaal FR. Risk factors in venous thrombotic disease. Thromb Haemost. 1999;82:610-9.
  26. Samama CM, Rosencher N, Kleine E, et al. Observational study of dabigatran etexilate 150mg in patients with moderate renal impairment undergoing elective total hip or knee replacement. Thromb Res. 2016 Jul;143:103-10.