Rapid Responses to:

NEWS: Ray Moynihan Drug maker’s PR firm is force behind blood clot awareness campaign BMJ 2008; 336: 1460-a-1461-a [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

DVT prophylaxis will prevent 5000 Australians from dieing of PE. Really?

David R Cole   (24 July 2008)

Thromboprophylaxis in medical inpatients and DoH guidance

Shoaib Faruqi, Alyn H Morice   (2 March 2009)

DVT prophylaxis will prevent 5000 Australians from dieing of PE. Really? 24 July 2008
David R Cole, Consultant General Physician Christchurch Hospital, Christchurch, New Zealand Send response to journal: Re: DVT prophylaxis will prevent 5000 Australians from dieing of PE. Really?	Where did the figure of 5000 preventable deaths per year from venous thromboembolism in Australia come from? It is commonly estimated that 1-2% of pulmonary embolism cases proves fatal. This implies that there are 250,000 - 500,000 cases of preventable pulmonary embolism occuring per year in Australia, which has a total population of 20 million. And where did the cost benefit analysis come from? Was it an independent analysis looking at clinically significant proven preventable end-points (mortality and morbidity)? Or rather industry sponsored extrapolation of industry sponsored trials involving surrogate endpoints of uncertain significance? Dare I suggest this is industry created paranoia of epidemic proportion? Competing interests: None declared
Thromboprophylaxis in medical inpatients and DoH guidance 2 March 2009
Shoaib Faruqi, Specialist Registrar Department of Cardiovascular and Respiratory Studies, Castle Hill Hospital, Cottingham, HU16 5JQ, UK, Alyn H Morice Send response to journal: Re: Thromboprophylaxis in medical inpatients and DoH guidance	We read with interest the article by Ray Moynihan.[1 ]We do not support the “routine” use of thromboprophylaxis in hospitalized medical patients. The justification of the impact of thromboprophylaxis on mortality and cost benefit in Australia were questioned.[2] There seems to be a similar support for thromboprophylaxis for hospitalized medical patients in the UK as well, which we think lacks a robust evidence base. We read with interest the guidance from the department of health (DoH) on the prevention of venous thrombo-embolism (VTE) in hospitalized patients[3] and their subsequent guidance on risk assessment.[4] The role for thromboprophylaxis in surgical patients is very well established and with an excellent evidence base. However we fail to understand the DoH’s enthusiasm for thromboprophylaxis in virtually all patients hospitalized with a “medical” complaint. The DoH guidance states that “VTE caused in excess of 25,000 potentially preventable deaths per annum in UK”, which would be a very compelling argument for thromboprophylaxis in medical patients provided, as in surgical patients, it resulted in decrease in mortality. However this is not the case. None of the randomized controlled trials looking at thromboprophylaxis in medical patients have shown significant reduction in mortality. An adequately powered, prospective, randomized, double blind study looking specifically at mortality failed to show a reduction.[5] There are several recent meta-analyses on the role of thromboprophylaxis in medical patients and they all failed to show a reduction in overall mortality.[6,7,8] In fact the meta-analysis even casts doubt as to the efficacy of thromboprophylaxis in preventing soft end points such as symptomatic VTE, both DVT and PE. In medical patients what is needed is an appropriate risk assessment tool, which we do not think the recent DoH guidance provides. For example an age of >60 years alone without any other risk factor lacks robust evidence as a recommendation. Similarly the presence of a chronic disease or a BMI >30kg/m2 are by themselves not very persuasive indications for thromboprophylaxis. Under the guidance the vast majority of medical inpatients are likely to meet at least one of the “high thrombosis risk” factors and merit thromboprophylaxis. In fact multiple risk factors were needed for inclusion in all the recent large medical thromboprophylaxis studies.[9,10,11] There are medical, nursing and patient costs which need to be considered. Bruising and pain at injection sites are not uncommon. Clinically significant bleeding and heparin induced thrombocytopenia can be life threatening. Thromboprophylaxis in some hospitalized medical patients maybe justified but the broad brush recommended by the DoH is not supported by the data. There is an urgent need to develop a validated risk stratification model to identify those patients who may benefit. References 1. Moynihan R. Drug maker's PR firm is force behind blood clot awareness campaign. BMJ. 2008 Jun 28;336(7659):1460-1. 2. Cole RD. DVT prophylaxis will prevent 5000 Australians from dieing of PE. Really? (Rapid response to : Moynihan R. Drug maker's PR firm is force behind blood clot awareness campaign. BMJ. 2008 Jun 28;336(7659):1460-1.) http://www.bmj.com/cgi/eletters/336/7659/1460-a#199271 3.http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_073957 4.http://www.dh.gov.uk/en/Publichealth/Healthprotection/Bloodsafety/VenousThromboembolismVTE/index.htm 5. Mahé I, Bergmann JF, d'Azémar P, Vaissie JJ, Caulin C. Lack of effect of a low-molecular-weight heparin (nadroparin) on mortality in bedridden medical in-patients: a prospective randomised double-blind study. Eur J Clin Pharmacol. 2005;61(5-6):347-51. 6. Själander A, Jansson JH, Bergqvist D, Eriksson H, Carlberg B, Svensson P. Efficacy and safety of anticoagulant prophylaxis to prevent venous thromboembolism in acutely ill medical inpatients: a meta-analysis. J Intern Med. 2008;263(1):52-60. 7. Kanaan AO, Silva MA, Donovan JL, Roy T, Al-Homsi AS. Meta- analysis of venous thromboembolism prophylaxis in medically Ill patients. Clin Ther. 2007;29(11):2395-405. 8. Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta- analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007;146(4):278-88. 9. Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006;332(7537):325-9. 10. Leizorovicz A, Cohen AT, Turpie AG, Olsson CG, Vaitkus PT, Goldhaber SZ; PREVENT Medical Thromboprophylaxis Study Group. Randomized, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation. 2004;110(7):874-9. 11. Samama MM, Cohen AT, Darmon JY, Desjardins L, Eldor A, Janbon C, Leizorovicz A, Nguyen H, Olsson CG, Turpie AG, Weisslinger N. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group. N Engl J Med. 1999;341(11):793-800. Competing interests: None declared