The etiology, diagnosis and treatment of venous thromboembolism Kraaijenhagen, R.A.

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1 UvADARE (Digital Academic Repository) The etiology, diagnosis and treatment of venous thromboembolism Kraaijenhagen, R.A. Link to publication Citation for published version (APA): Kraaijenhagen, R. A. (2000). The etiology, diagnosis and treatment of venous thromboembolism General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvADARE is a service provided by the library of the University of Amsterdam ( Download date: 31 Dec 2017

2 Chapter XIII Early discharge strategies following venous thrombosis Harry R. Biiller, Roderik A. Kraaijenhagen and Maria M.W. Koopman From the Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands. Vascular Medicine 3(1): 4750,

3 CHAPTER XIII Abstract Lowmolecularweight heparin therapy is administered subcutaneously, not intravenously. This has made possible the management of selected patients who have acute deep venous thrombosis as outpatients. Others can be treated with an abbreviated several day hospitalisation rather than the conventional 5 or more hospital days needed for administration of continuous intravenous unfractionated heparin. Two large studies, Tasman and a Canadian trial, have demonstrated the efficacy and safety of lowmolecularweight heparin in this setting. Now, the task is to develop guidelines for widespread application of these findings to daily clinical practice. However, successful home treatment will require intensive patients education as well as an extensive infrastructure of supportive nursing and physician services. Careful patient followup will be crucially important. Introduction It is current practice to treat patients with acute venous thrombosis with an initial course of continuous, intravenous unfractionated heparin. Oral anticoagulant therapy is starts concomitantly and continued for at least 3 months 1. Evidence from a series of randomised clinical trials has indicated that the use of unfractionated heparin (UFH) is absolutely necessary in the initial phase of treatment to prevent pulmonary embolism and recurrent venous thrombosis 2, that its dose should be adjusted to prolong the activated partial thromboplastin time into a desired therapeutic range to prevent recurrences 1 and that 5 days of heparin treatment is as effective and safe as 10 days 3 ' 4 (Table 1). Although twicedaily subcutaneous UFH, also in an adjusted dose, has been shown to be as effective and well tolerated as heparin given intravenously, the latter route administration is the most widely used 5. The need for dose adjustments of UFH, regardless of the mode of administration, is based on the large inter and nitreindividual variability of UFH pharmacodynamics and the relatively short halflife. The use of UFH for the treatment of acute deep vein thrombosis Table 1. Unfractionated heparin in the treatment of venous thrombosis. Initial fulldose heparin is absolutely required. Rapidly achieved therapeutic plasma concentrations reduce risk of recurrences. Subcutaneous adjusted dose heparin is equivalent to a continuous intravenous regimen. Shortterm (5 days) heparinization is as effective as longterm (10 days) treatment. 212

4 Early discharge strategies following venous thrombosis Table 2. Advantages of lowmolecularweight heparin compared with unfractionated heparin. Longer plasma halflife. Almost complete bioavailability. Less interaction with endothelial cells, plasma proteins and other blood cells. Reduced risk of osteoporosis and of heparininduced thrombocytopenia. suffers from the limitation that patients need to be admitted to hospital for the intravenous line and the necessary frequent laboratory monitoring and subsequent dose adjustments. Furthermore, the infusion limits patients' mobility and they are exposed to the risks of hospital acquired infections. Finally, this approach increases the treatment costs 6, The depolymerization of UFH yields lowmolecular weight heparins (LMWH) that have advantages over the parent compound. These include: a longer plasma halflife, an almost complete bioavailability after parenteral administration and much less interaction with plasma proteins resulting in a predictable doseresponse relationship 7 ' 8 (Table 2). As a result of these advantages, LMWH can be given subcutaneously, once or twice daily, in a dose that requires adjustment only for bodyweight, thereby obviating the need for laboratory control. Results from at least 13 welldesigned, randomised clinical trials comparing continuous, doseadjusted intravenous UFH with subcutaneous fixed dose LMWH in patients with acute deep vein thrombosis, have shown that this latter approach is at least as safe and effective as the traditional intravenous treatment 9. More recently, these findings have been confirmed in two large studies which also included patients with primary pulmonary embolism All these studies, however, were performed with patients treated entirely in hospital. The simplicity of treatment with LMWH in patients with acute venous thrombosis makes this therapy attractive for use out of hospital. Other inhospital services, such as administration of intravenous chemotherapy, analgesics, antibiotics or parenteral nutrition have been shown to be feasible when given at home. It seems, therefore, a logical development to transfer inhospital treatment of acute venous thrombosis patients with LMWH to treatment at home. The feasibility, efficacy, safety and costeffectiveness of such an approach was recently investigated in two large clinical studies 12,13. The results of these studies, which directly compared inhospital intravenous UFH with fixeddose subcutaneous LMWH home therapy in patients with proven symptomatic deep vein thrombosis, will be discussed in detail. Furthermore, the essential requirements for successful home treatment and the possible disadvantages of this approach will be reviewed. 213

5 CHAPTER XIII Home treatment with lowmolecularweight heparin Anticoagulant treatment for deep vein thrombosis aims to prevent symptomatic pulmonary embolism and recurrent thrombosis in the weeks to months following the initial event. This should be achieved with no excessive risk of bleeding. Consequently, in studies comparing anticoagulant treatment strategies, these outcomes should be the primary endpoints. Because all studies with LMWH therapy in venous thrombosis have been performed in a hospital setting, there is room for legitimate concern that efficacy may be compromised and that patients will become more apprehensive when treated away from a source of direct medical care. Two studies evaluated home treatment with LMWH. In both studies, the first one (the Tasman study) involving various centers in Europe, Australia and New Zealand and the second one based in Canadian centers, consecutive patients with documented, symptomatic, mainly proximal, deep vein thrombosis were randomised to receive either intravenous treatment with UFH in hospital or home treatment with subcutaneous LMWH The patients randomised to LMWH, were, when appropriate, discharged early from hospital or were not admitted at all. In the Tasman study, the changes in quality of life and the use of resources were also assessed. In both trials, patient selection criteria, study design and outcome definitions were comparable. Both studies also used an independent, blinded committee for adjudication of episodes of recurrent venous thromboembolism, major bleeding, as well as all deaths. In the Canadian study, patients were followed for 3 months, while this was 6 months in the Tasman trial. Two different LMWH preparations were used. The baseline clinical characteristics of the two study groups in both trials were comparable, as was the case for the comparison between the studies (Table 3). Although patients with symptoms of possible pulmonary embolism were excluded, Table 3. Baseline clinical characteristics in the Tasman and Canadian studies comparing lowmolecularweight heparin (LMWH) with unfractionated heparin (UFH) in patients with venous thrombosis. Number of patients Mean age ± SD (years) Male sex (%) previous thrombosis (%) Known cancer (%) Recent surgery (%) Tasman LMWH ± study" UFH Canadian LMWH ± study 12 UFH

6 Early discharge strategies following venous thrombosis Table 4. Recurrent venous thromboembolism (VTE), major bleeding and mortality in the Tasman and Canadian studies comparing lowmolecularweight heparin (LMWH) with unfractionated heparin (UFH) in patients with venous thrombosis. Number of patients Recurrent VTE 03 months 36 months All Major bleeding 014 days 1584 days All Mortality 03 months 36 months All Tasman LMWH 202 Number of patients (%) (6.9) (0.5) (6.9) study" UFH (8.6) (2.0) (8.1) Canadian study 12 LMWH UFH (5.3) (2.0) (4.5) 17 17(6.7) 3 0 3(1.2) 17 17(6.7) the clinical characteristics are representative for the usual patient with symptomatic deep vein thrombosis of the leg seen at a primary care diagnostic referral center. As illustrated in Table 4, symptomatic recurrent venous thromboembolism, confirmed by objective tests occurred with a frequency of 6.9% and 5.3% in patients treated with LMWH, compared with 8.6% and 6.7% in patients receiving UFH. It should, however, be noted that the duration of followup in the two studies was different. In boot studies the absolute difference in the rates of recurrence were slightly in favour of LMWH (Tasman study 1.7%: 95% CI ; Canadian study 1.4%: 95% CI ), allowing for the conclusion that this treatment strategy is at least as effective as the intravenous UFH regimen. Major bleeding was uncommon in both studies and also quite comparable between the two treatment regimens (Table 4). As has been noted before, LMWH therapy appears to be associated with a lower overall morality, compared with UFH This is mainly due to a reduction in mortality in those deep vein thrombosis patients with cancer. The validity of this observation and the mechanism for this effect is not certain and should be investigated in an appropriate study. Of the patients with venous thrombosis randomised to LMWH, about onethird to onehalf were treated entirely outside of hospital with either selfinjection or LMWH 215

7 CHAPTER XIII Table 5. Mean duration of initial treatment, hospitalization status and mean duration of hospital stay in the Tasman and Canadian studies comparing lowmolecularweight heparin (LMWH) with unfractionated heparin (UFH) in patients with venous thrombosis. Number of patients Tasman LMWH 202 Duration of initial treatment 6.5 ± 2.2 (days ± SD) Number ol patients (%) Hospitalization during treatment study 13 UFH ±1.8 Canadian study 12 LMWH UFH ± ±1.2 not admitted 72 (35) 120(49) 2(1) discharged after < 48h after > 48h entirely in hospital Mean duration of hospital (days) 44 (22) 36(18) 50 (25) stay (100) administration by family members (Table 5). In the Tasman study, which did not consider the possibility criterion, another 40% of patients were discharged after a brief stay in hospital. In both studies, approximately 25% of patients received their LMWH treatments entirely in hospital. The concern that patients might react negatively to treatment outside the hospital is refuted by the findings of the detailed quality of life assessments in the Tasman study. The indicators of quality of life, including emotional wellbeing and the amount of effort needed to cope with the disease, improved similarly over time in both treatment groups. Treatment with LMWH was associated with less impairment of physical activity and social functioning, indicating that the LMWH therapy allows for more activity and better functioning, without inducing a negative effect on mental wellbeing. The strategy of treating patients at home with LMMWH when feasible led to a 7080% reduction in hospital stay. The mean duration of hospital stay for all LMWH patients was 2.7 and 1.1. days in both studies, compared with 8.1 and 6.5 days for those treated with UFH (Table 5). Even when the savings in costs for the reduced hospital stay is corrected for the increase in costs associated with extra outpatient visits, telephone calls and additional support at home, the LMWH strategy for treatment of venous thrombosis is very costeffective

8 Early discharge strategies following venous thrombosis Requirements for successful home treatment If the results from other studies confirm the feasibility, efficacy and safety of LMWH therapy for venous thrombosis outside a hospital setting, programs should be set up for home treatment. These programs need to be developed by three parties at a regional level and may differ slightly from each other due to the local circumstances. The three parties include: (1) the departments or physicians, currently responsible for the treatment of patients with venous thrombosis; (2) the community facilities and personnel, such as primary care physicians, nurses and laboratories, which will (in part) become responsible for the home treatment program; and (3) patient organisations. Estimates from Canada and Europe have indicated that about 7085% of patients with acute deep vein thrombosis can be treated with LMWH home either after a brief stay in hospital or without being admitted at all 13,16. There are several essential requirements for the success of a home treatment program (Table 6). Guidelines need to be developed to decide whether a patient should be treated in hospital. Clearly, patients with a highrisk for hemorrhagic complications or those with serious comorbid conditions or obvious pulmonary embolism should not enter the home treatment program. Furthermore, patients need to be educated about what venous thrombosis is, its possible complications and which sideeffects are associated with anticoagulant therapy. Patient education material needs to be developed for this purpose. Those patients who do not understand these issues should be treated in hospital. They may, however, be discharged early if they subsequently feel more comfortable with the treatment. For home treatment, two strategies are available: selfinjection (or injection by family members) and nursing support. The great majority of patients prefer selfinjection and are able to do so, but efficient nursing support may be essential for elderly or otherwise incapacitated patients 13 ' 16. If a patient develops complications at home, a 24h service for medical consultation must be available. This could be the local hospital emergency room or the primary care physician. Finally, care outside the hospital increases pressure on community facilities to pro Table 6. Essential requirements for successful home treatment with lowmolecularweight heparin for venous thrombosis. Development of guidelines for selection of patients for home treatment. Availability of patient education brochure. Possibility for homecare services. Around the clock availability of emergency department facilities. Adequate oral anticoagulant therapy control and followup of patients. 217

9 CHAPTER XIII vide proper anticoagulant therapy and followup of patients for the possible underlying conditions associated with the venous thrombosis. These facilities need to have adequate resources and preparation for this task. Potential disadvantages of home treatment The introduction of LMWH therapy at home constitutes a major step forward in the treatment of patients with deep vein thrombosis. There are, however, several potential hazards. Because the clinical diagnosis is unreliable, the presence of the disease should be confirmed objectively in every patient to avoid unnecessary treatment. Furthermore, an adequate assessment of risk factors to explain the possible cause of thrombosis should be undertaken in each patient. This investigation should include a proper physical examination with subsequent laboratory or imaging tests, if appropriate, for the presence of malignant diseases or thrombophilia 17 ' 18. Finally, adequate control of and compliance with anticoagulant therapy should be guaranteed in the home treatment programs to avoid under and overtreatment. 218

10 Early discharge strategies following venous thrombosis References 1. Ginsberg JS. Management of venous thromboembolism. N Engl J Med 1996; 335: Brandjes DPM, Heijboer H, Büller HR et al. Acenocoumarol and heparin compared with acenocoumarol alone in the initial treatment of proximal vein thrombosis. N Engl J Med 1992; 327: Gallus A, Jackaman J, Tillet J et al. Safety and efficacy of Warfarin started early after submassive venous thrombosis or pulmonary embolism. Lancet 1986; ii: Hull RD, Raskob GE, Rosenbloom D et al. Heparin for 5 days as compared with 10 days in the initial treatment of proximal vein thrombosis. N Engl J Med 1990; 322: Hommes DW, Bura A, Mazzolai L et al. Subcutaneous heparin compared with continuous intravenous heparin administration in the initial treatment of deep vein thrombosis. A metaanalysis. Ann Intern Med 1992; 116: Leape LJ, Brennan TA, Laird NM et al. The nature of adverse events in hospitalised patients: results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324: Hirsh J, Levine MN. Low molecular weight heparin. Blood 1992; 79: Young E, Prins MH, Levine MN, Hirsh J. Heparin binding to plasma proteins. An important mechanism for heparin resistance. Thromb Haemost 1992; 67: Kuijer PMM, Prins MH, Büller HR. Lowmolecularweight heparins treatment of venous thromboembolism. In: Sasahara AA, Loscalzo J eds. Advances in therapeutic agents in thrombosis and thrombolysis. New York: M Dekker Inc., 1997: The Columbus Investigators. Lowmolecularweight heparin in the treatment of patients with venous thromboembolism. N Engl J Med 1997; 337: Simonneau G, Sors H, Charbonnier B et al, on behalf of the THÉSEE Study Group. A comparison of lowmolecularweight heparin with unfractionated heparin for acute pulmonary embolism. N Engl J Med 1997; 337: Levine MN, Gent M, Hirsh J et al. A comparison of lowmolecular weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep vein thrombosis. N Engl J Med 1996; 334: Koopman MMW, Prandoni P, Piovella F et al, on behalf of the TASMAN study 219

11 CHAPTER XIII group. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous lowmolecularweight heparin administered at home. N Engl J Med 1996; 334: Lensing AWA, Prins MH, Davidson BL, Hirsh J. Treatment of deep vein thrombosis with low molecular weight heparins, a metaanalysis. Arch Intern Med 1995; 155: van den Belt AGM, Bossuyt PMM, Prins MH, Gallus AS, Büller HR, on behalf of the Tasman Study Group. Replacing inpatient care by outpatient care in the treatment of deep venous thrombosis. A costminimisation analysis. Thromb Haemost 1998; 79: Wells PS, Kovacs MJ, Forgie MA, Bormanis J, Goudie D, Morrow B, Kovacs J. Outpatient treatmetn of deep venous thrombosis (DVT) with low molecular weight heparin. Blood 1996; 88 (10 suppl 1): 659 (abstract). 17. Heijboer H, Brandjes DPM, Büller HR, Sturk A, ten Cate JW. Deficiencies of coagulationinhibiting and fibrinolytic proteins in outpatients with deepvein thrombosis. N Engl J Med 1990; 323: Prandoni P, Lensing AWA, Büller HR et al, Deepvein thrombosis and the incidence of subsequent symptomatic cancer. N Engl I Med 1992; 327:

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