Anticoagulant therapy in deep venous thrombosis. A randomized controlled study

Nielsen, Hans Kræmmer; Husted, Steen; Krusell, Lars Romer; Fasting, H; Charles, Peder; Hansen, Henning Otte; Nielsen, B. Ostergaard; Petersen, Jørgen B. B.; Bechgaard, P

doi:10.1016/0049-3848(94)90100-7

Cited by 44 publications

(31 citation statements)

References 22 publications

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“…In contrast, Nielsen and colleagues repeated venography after 30 days in 30 fully ambulant patients with symptomatic DVT (three quarters proximal) treated with phenylbutazone alone. 32 Progressive thrombosis in the proximal veins was found in 27% of patients, with additional patients having progression in the calf veins. Ventilation-perfusion lung scanning showed progression in 8% (3 of 39) after 10 days and 3% (1 of 30) at 60 days.…”

Section: Symptomatic Proximal Dvt and Risk Of Pementioning

confidence: 99%

“…During 3 months of follow-up, 1 patient had a confirmed episode of PE, and 8 patients were suspected of having recurrent DVT (no objective testing performed). 32 These 2 studies, together with the high frequency of asymptomatic PE in patients with proximal DVT 24 -28 and the high prevalence of recurrent PE in untreated PE patients, 33 suggest that Ϸ50% of patients with untreated proximal DVT will develop symptomatic PE within 3 months. This risk appears highest at the time of acute DVT, with a subsequent rapid decline over a 3-month period.…”

Section: Symptomatic Proximal Dvt and Risk Of Pementioning

confidence: 99%

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Natural History of Venous Thromboembolism

2003

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Abstract-Most deep vein thromboses (DVTs) start in the calf, and most probably resolve spontaneously. Thrombi that remain confined to the calf rarely cause leg symptoms or symptomatic pulmonary embolism (PE). The probability that calf DVT will extend to involve the proximal veins and subsequently cause PE increases with the severity of the initiating prothrombotic stimulus. Although acute venous thromboembolism (VTE) usually presents with either leg or pulmonary symptoms, most patients have thrombosis at both sites at the time of diagnosis. Proximal DVTs resolve slowly during treatment with anticoagulants, and thrombi remain detectable in half of the patients after a year. Resolution of DVT is less likely in patients with a large initial thrombus or cancer. About 10% of patients with symptomatic DVTs develop severe post-thrombotic syndrome within 5 years, and recurrent ipsilateral DVT increases this risk. About 10% of PEs are rapidly fatal, and an additional 5% cause death later, despite diagnosis and treatment. About 50% of diagnosed PEs are associated with right ventricular dysfunction, which is associated with a Ϸ5-fold greater in-hospital mortality. There is Ϸ50% resolution of PE after 1 month of treatment, and perfusion eventually returns to normal in two thirds of patients. About 5% of treated patients with PE develop pulmonary hypertension as a result of poor resolution. After a course of treatment, the risk of recurrent thrombosis is higher (ie, Ϸ10% per patient-year) in patients without reversible risk factors, in those with cancer, and in those with prothrombotic biochemical abnormalities such as antiphospholipid antibodies and homozygous factor V Leiden.

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Section: Symptomatic Proximal Dvt and Risk Of Pementioning

confidence: 99%

Section: Symptomatic Proximal Dvt and Risk Of Pementioning

confidence: 99%

Natural History of Venous Thromboembolism

2003

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“…On the contrary, a recent study (12) showed no significant difference in progression of PE between anticoagulated and not anticoagulated patients. US, having a negative predictive value of 0.95, should thus be sufficient as a complement to scintigraphy in "intermediate probability" of PE.…”

Section: Resultsmentioning

confidence: 73%

Ultrasound at Scintigraphic “Intermediate Probability of Pulmonary Embolism”

et al. 1996

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For diagnosis of pulmonary embolism (PE), ventilation/perfusion lung scintigraphy is routinely used; approximately one-third of the patients will have the diagnosis "intermediate probability of PE" (inconclusive). In this group only about 33% are found to have pulmonary emboli if examined with pulmonary angiography. To evaluate the diagnostic, therapeutic, and economic consequences of ultrasound of the legs as a complementary diagnostic investigation to "intermediate probability", 72 consecutive patients were investigated with bilateral ultrasound of the proximal deep veins of the legs and pulmonary angiography in a prospective study. Ten patients had PE, of whom 7 had deep venous thrombosis, and 62 had no PE, of whom 2 had deep venous thrombosis. The negative predictive value of ultrasound was 0.95. In view of the importance of adequate treatment and rational use of public health care expenditure, complementary diagnostics should be performed, and ultrasound is an adequate complementary investigation.

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“…Only three small methodologically rigorous RCTs of patients with DVTs [17-19] have compared standard anticoagulants with placebos or non-steroidal anti-inflammatory drugs. Combining the data from these trials, 6/66 patients receiving standard heparin and vitamin K inhibitors died and 1/60 unanticoagulated patients died [10].…”

Section: Problems With Anticoagulant Treatment For Vtementioning

confidence: 99%

Diet as prophylaxis and treatment for venous thromboembolism?

Cundiff

Agutter²,

Malone³

et al. 2010

Theor Biol Med Model

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BackgroundBoth prophylaxis and treatment of venous thromboembolism (VTE: deep venous thrombosis (DVT) and pulmonary emboli (PE)) with anticoagulants are associated with significant risks of major and fatal hemorrhage. Anticoagulation treatment of VTE has been the standard of care in the USA since before 1962 when the U.S. Food and Drug Administration began requiring randomized controlled clinical trials (RCTs) showing efficacy, so efficacy trials were never required for FDA approval. In clinical trials of 'high VTE risk' surgical patients before the 1980s, anticoagulant prophylaxis was clearly beneficial (fatal pulmonary emboli (FPE) without anticoagulants = 0.99%, FPE with anticoagulants = 0.31%). However, observational studies and RCTs of 'high VTE risk' surgical patients from the 1980s until 2010 show that FPE deaths without anticoagulants are about one-fourth the rate that occurs during prophylaxis with anticoagulants (FPE without anticoagulants = 0.023%, FPE while receiving anticoagulant prophylaxis = 0.10%). Additionally, an FPE rate of about 0.012% (35/28,400) in patients receiving prophylactic anticoagulants can be attributed to 'rebound hypercoagulation' in the two months after stopping anticoagulants. Alternatives to anticoagulant prophylaxis should be explored.Methods and FindingsThe literature concerning dietary influences on VTE incidence was reviewed. Hypotheses concerning the etiology of VTE were critiqued in relationship to the rationale for dietary versus anticoagulant approaches to prophylaxis and treatment.Epidemiological evidence suggests that a diet with ample fruits and vegetables and little meat may substantially reduce the risk of VTE; vegetarian, vegan, or Mediterranean diets favorably affect serum markers of hemostasis and inflammation. The valve cusp hypoxia hypothesis of DVT/VTE etiology is consistent with the development of VTE being affected directly or indirectly by diet. However, it is less consistent with the rationale of using anticoagulants as VTE prophylaxis. For both prophylaxis and treatment of VTE, we propose RCTs comparing standard anticoagulation with low VTE risk diets, and we discuss the statistical considerations for an example of such a trial.ConclusionsBecause of (a) the risks of biochemical anticoagulation as anti-VTE prophylaxis or treatment, (b) the lack of placebo-controlled efficacy data supporting anticoagulant treatment of VTE, (c) dramatically reduced hospital-acquired FPE incidence in surgical patients without anticoagulant prophylaxis from 1980 - 2010 relative to the 1960s and 1970s, and (d) evidence that VTE incidence and outcomes may be influenced by diet, randomized controlled non-inferiority clinical trials are proposed to compare standard anticoagulant treatment with potentially low VTE risk diets. We call upon the U. S. National Institutes of Health and the U.K. National Institute for Health and Clinical Excellence to design and fund those trials.

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Anticoagulant therapy in deep venous thrombosis. A randomized controlled study

Cited by 44 publications

References 22 publications

Natural History of Venous Thromboembolism

Natural History of Venous Thromboembolism

Ultrasound at Scintigraphic “Intermediate Probability of Pulmonary Embolism”

Diet as prophylaxis and treatment for venous thromboembolism?

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