A comparison of low-molecular-weight heparin with unfractionated heparin for acute pulmonary embolism. The THESEE Study Group. Tinzaparine ou Heparine Standard: Evaluations dans l'Embolie Pulmonaire

Hôpital Antoine Béclère, Clamart, France.
New England Journal of Medicine (Impact Factor: 55.87). 10/1997; 337(10):663-9. DOI: 10.1056/NEJM199709043371002
Source: PubMed


Low-molecular-weight heparin appears to be at least as effective and safe as standard, unfractionated heparin for the treatment of deep-vein thrombosis, but only limited data are available on the use of low-molecular-weight heparin to treat acute symptomatic pulmonary embolism.
We randomly assigned 612 patients with symptomatic pulmonary embolism who did not require thrombolytic therapy or embolectomy to either subcutaneous low-molecular-weight heparin (tinzaparin) given once daily in a fixed dose or adjusted-dose, intravenous unfractionated heparin. Oral anticoagulant therapy was begun between the first and the third day and was given for at least three months. We compared the treatments at day 8 and day 90 with respect to a combined end point of recurrent thromboembolism, major bleeding, and death.
In the first eight days of treatment, 9 of 308 patients assigned to receive unfractionated heparin (2.9 percent) reached at least one of the end points, as compared,with 9 of 304 patients assigned to low-molecular-weight heparin (3.0 percent; absolute difference, 0.1 percentage point; 95 percent confidence interval, -2.7 to 2.6). By day 90, 22 patients assigned to unfractionated heparin (7.1 percent) and 18 patients assigned to low-molecular-weight heparin (5.9 percent) had reached at least one end point (P=0.54; absolute difference, 1.2 percentage points; 95 percent confidence interval, -2.7 to 5.1). The risk of major bleeding was similar in the two treatment groups throughout the study.
Under the conditions of this study, initial subcutaneous therapy with the low-molecular-weight heparin tinzaparin appeared to be as effective and safe as intravenous unfractionated heparin in patients with acute pulmonary embolism.

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    • "The effectiveness of this regimen has been well described in the short-term treatment of VTE, with the risks of recurrent disease reduced by around 82%. However, this regimen is complex to implement in clinical practice [6–9]. Although they are recommended in current guidelines for the treatment of VTE [5, 10], traditional VTE treatments have numerous limitations. "
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    ABSTRACT: The traditional treatment of venous thromboembolism (VTE) has been use of heparin and vitamin K antagonists (VKA), and although shown to be effective, they have numerous limitations. New oral anticoagulants (NOACs) including direct thrombin (factor IIa) inhibitors (dabigatran) and selective factor Xa inhibitors (rivaroxaban, apixaban and edoxaban) have emerged as promising alternatives with the potential to overcome the limitations of traditional treatments. Clinical trials have been performed with a view to making significant changes to the acute, long-term and extended treatment of VTE. Data are now available on the efficacy and safety, including bleeding rates, of the NOACs in comparison with VKA in the acute treatment and secondary prevention of VTE as well as in comparison with placebo extended VTE treatment. This review compares and contrasts the design and results of the Phase III trials of NOACs in VTE and discusses the implications of the NOACs in terms of treatment strategies in VTE patients. Electronic supplementary material The online version of this article (doi:10.1007/s12325-014-0119-7) contains supplementary material, which is available to authorized users.
    Full-text · Article · May 2014 · Advances in Therapy
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    • "Cependant, une méta-analyse sur les sous-groupes des patients avec EP inclus dans ces études montre que les HBPM sont au moins aussi efficaces et sûres que l'HNF dans le traitement de l'EP [18]. Il n'existe des données spécifiques dans l'EP que pour deux HBPM, la tinzaparine — à partir du seul essai réalisé uniquement avec des patients avec EP [19] — et l'énoxaparine à partir d'une méta-analyse sur données individuelles [20] "
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    ABSTRACT: The initial therapy for patients with pulmonary embolism who are haemodynamically stable relies on antithrombotic treatment. The aim of anticoagulant treatment is to prevent any thrombus extension or recurrence, with revascularization dependent on the fibrinolytic system. Current treatment is biphasic, with parenteral heparin or derivatives (low molecular weight heparins and fondaparinux) followed by oral vitamin K antagonists. Although these treatments are efficient, they suffer from some limitations including parenteral administration and the need for surveillance and monitoring. Use of low molecular weight heparins or fondaparinux is recommended in French guidelines, but unfractionated heparin still has an important role in some specific situations such as severe renal insufficiency, around the time of surgery and where there is a high risk of bleeding. The next generation of anticoagulants will soon be licensed for treatment in pulmonary embolism and may well replace heparin and/or vitamin K antagonists for the majority of patients, although "older" treatments will always be requested in some specific situations.
    Full-text · Article · Feb 2011 · Revue des Maladies Respiratoires
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    • "Nowadays patients with deep vein thrombosis are often treated at home with low molecular weight heparins. Low molecular weight heparins have also been shown to be effective for treating patients diagnosed with pulmonary embolism [8]. This condition is traditionally considered to require hospital admission . "
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    ABSTRACT: The objective of this study is to compare the characteristics, outcomes, and clinical complications of patients with pulmonary embolism (PE) who were treated at home as outpatients versus traditional hospitalization. Prospective study from January 2006 to June 2007. Selected patients diagnosed at the Emergency Department with stable non-massive pulmonary embolism that met standard inclusion criteria of Hospital at Home (HH) were treated at home. Patients that did not meet these criteria were admitted to Conventional Hospitalization (CH). Major and minor bleeding, re-thrombosis, clinical course, unexpected returns to hospital, and need for hospital re-admission in the following 3 months were recorded. 61 patients with PE were included (30 HH and 31 CH). Mean age 66.8 and 66.7 years in HH and CH, respectively. A history of neoplasm was found to be present in 13.3% and 9.7% of HH and CH patients. In the CH group, 19.3% of patients had prior thromboembolic disease. Concomitant DVT was seen in 40% and 29% of HH and CH patient. Pulmonary embolism was bilateral in 30% and 38.7% of HH and CH patients. No major bleeding, re-thrombosis, or death occurred. The home treatment was successfully completed in 100% of the patients. Three patients in the CH group had hospital-acquired infections. Patients with stable non-massive pulmonary embolism may be safely treated under conditions of home hospitalization.
    Preview · Article · Oct 2009 · European Journal of Internal Medicine
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