Abstract:Isolated distal deep vein thrombosis (IDDVT) is presumed to be more benign than proximal DVT (PDVT) or pulmonary embolism (PE), suggesting a need for different management approaches. This subgroup analysis of the RE-COVERY DVT/PE global, observational study investigated patient characteristics, hospitalization details, and anticoagulant therapy in patients with IDDVT in real-world settings in 34 countries enrolled from January 2016 to May 2017. Data were analyzed descriptively according to the type and locatio… Show more
“… 6 7 However, studies describing clinical practice patterns report that almost all patients with isolated distal DVT receive anticoagulant treatment, with a proportion similar to that of patients with proximal DVT or pulmonary embolism. 8 9 11 12 Furthermore, in a study comparing outcomes among patients with isolated distal DVT stratified by management strategy, recurrence rates were statistically significantly lower in patients receiving anticoagulants than in those managed with surveillance ultrasonography only, and the net clinical benefit, including major bleeding events, clearly favoured anticoagulant treatment. 13 The actual difference between the management of isolated distal DVT and proximal DVT or pulmonary embolism is the duration of treatment, which tends to be shorter, with many patients with isolated distal DVT treated for 4-6 weeks 3 5 14 and fewer patients with isolated distal DVT treated for more than three months compared with patients with proximal DVT.…”
Section: Discussionmentioning
confidence: 99%
“… 13 The actual difference between the management of isolated distal DVT and proximal DVT or pulmonary embolism is the duration of treatment, which tends to be shorter, with many patients with isolated distal DVT treated for 4-6 weeks 3 5 14 and fewer patients with isolated distal DVT treated for more than three months compared with patients with proximal DVT. 8 9 15 …”
Objective
To compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT).
Design
Randomised, double blind, placebo controlled clinical trial.
Setting
28 outpatient clinics specialising in venous thromboembolism.
Participants
402 adults (≥18 years) with symptomatic isolated distal DVT.
Interventions
After receiving standard dose rivaroxaban for six weeks, participants were randomly assigned to receive rivaroxaban 20 mg or placebo once daily for an additional six weeks. Follow-up was for 24 months from study inclusion.
Main outcomes measures
The primary efficacy outcome was recurrent venous thromboembolism during follow-up after randomisation, defined as the composite of progression of isolated distal DVT, recurrent isolated distal DVT, proximal DVT, symptomatic pulmonary embolism, or fatal pulmonary embolism. The primary safety outcome was major bleeding after randomisation until two days from the last dose of rivaroxaban or placebo. An independent committee adjudicated the outcomes.
Results
200 adults were randomised to receive additional rivaroxaban treatment and 202 to receive placebo. Isolated distal DVT was unprovoked in 81 (40%) and 86 (43%) patients, respectively. The primary efficacy outcome occurred in 23 (11%) patients in the rivaroxaban arm and 39 (19%) in the placebo arm (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03, number needed to treat 13, 95% confidence interval 7 to 126). Recurrent isolated distal DVT occurred in 16 (8%) patients in the rivaroxaban arm and 31 (15%) in the placebo arm (P=0.02). Proximal DVT or pulmonary embolism occurred in seven (3%) patients in the rivaroxaban arm and eight (4%) in the placebo arm (P=0.80). No major bleeding events occurred.
Conclusions
Rivaroxaban administered for six additional weeks in patients with isolated distal DVT who had an uneventful six week treatment course reduces the risk of recurrent venous thromboembolism, mainly recurrent isolated distal DVT, over a two year follow-up without increasing the risk of haemorrhage.
Trial registration
EudraCT 2016-000958-36; ClinicalTrials.gov
NCT02722447
.
“… 6 7 However, studies describing clinical practice patterns report that almost all patients with isolated distal DVT receive anticoagulant treatment, with a proportion similar to that of patients with proximal DVT or pulmonary embolism. 8 9 11 12 Furthermore, in a study comparing outcomes among patients with isolated distal DVT stratified by management strategy, recurrence rates were statistically significantly lower in patients receiving anticoagulants than in those managed with surveillance ultrasonography only, and the net clinical benefit, including major bleeding events, clearly favoured anticoagulant treatment. 13 The actual difference between the management of isolated distal DVT and proximal DVT or pulmonary embolism is the duration of treatment, which tends to be shorter, with many patients with isolated distal DVT treated for 4-6 weeks 3 5 14 and fewer patients with isolated distal DVT treated for more than three months compared with patients with proximal DVT.…”
Section: Discussionmentioning
confidence: 99%
“… 13 The actual difference between the management of isolated distal DVT and proximal DVT or pulmonary embolism is the duration of treatment, which tends to be shorter, with many patients with isolated distal DVT treated for 4-6 weeks 3 5 14 and fewer patients with isolated distal DVT treated for more than three months compared with patients with proximal DVT. 8 9 15 …”
Objective
To compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT).
Design
Randomised, double blind, placebo controlled clinical trial.
Setting
28 outpatient clinics specialising in venous thromboembolism.
Participants
402 adults (≥18 years) with symptomatic isolated distal DVT.
Interventions
After receiving standard dose rivaroxaban for six weeks, participants were randomly assigned to receive rivaroxaban 20 mg or placebo once daily for an additional six weeks. Follow-up was for 24 months from study inclusion.
Main outcomes measures
The primary efficacy outcome was recurrent venous thromboembolism during follow-up after randomisation, defined as the composite of progression of isolated distal DVT, recurrent isolated distal DVT, proximal DVT, symptomatic pulmonary embolism, or fatal pulmonary embolism. The primary safety outcome was major bleeding after randomisation until two days from the last dose of rivaroxaban or placebo. An independent committee adjudicated the outcomes.
Results
200 adults were randomised to receive additional rivaroxaban treatment and 202 to receive placebo. Isolated distal DVT was unprovoked in 81 (40%) and 86 (43%) patients, respectively. The primary efficacy outcome occurred in 23 (11%) patients in the rivaroxaban arm and 39 (19%) in the placebo arm (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03, number needed to treat 13, 95% confidence interval 7 to 126). Recurrent isolated distal DVT occurred in 16 (8%) patients in the rivaroxaban arm and 31 (15%) in the placebo arm (P=0.02). Proximal DVT or pulmonary embolism occurred in seven (3%) patients in the rivaroxaban arm and eight (4%) in the placebo arm (P=0.80). No major bleeding events occurred.
Conclusions
Rivaroxaban administered for six additional weeks in patients with isolated distal DVT who had an uneventful six week treatment course reduces the risk of recurrent venous thromboembolism, mainly recurrent isolated distal DVT, over a two year follow-up without increasing the risk of haemorrhage.
Trial registration
EudraCT 2016-000958-36; ClinicalTrials.gov
NCT02722447
.
“…Theoretically, patients with ICDVT had a lower risk of recurrence than patients with proximal DVT 31 . A recent multicenter and observational study showed that cumulative VTE recurrence was 4.8 times higher in patients with proximal DVT than in patients with distal DVT after 5 years of follow‐up 32 . In addition, bilateral isolated DVT has a worse prognosis, with more frequent recurrence, higher mortality, and a more frequent association with malignant tumors 33 , 34 , 35 , 36 .…”
Isolated calf deep venous thrombosis (ICDVT) includes thrombosis located at the far end of the popliteal vein, such as the anterior tibial vein, posterior tibial vein, fibular vein, and intramuscular vein of the soleus and gastrocnemius. This type of thrombosis has the highest incidence, accounting for approximately half of all deep vein thrombosis (DVT) cases; however, there is no consistent recommendation for ICDVT treatment across countries, and there is also no optimal management strategy. In recent years, increasing evidence has shown that ICDVT can develop into proximal DVT, even causing pulmonary embolism (PE). Therefore, some experts suggest anticoagulant therapy for this type of DVT, while others hold an opposing attitude. Therefore, the treatment strategy for this type of DVT has become a hot and difficult research topic. The purpose of this review is to summarize the characteristics of ICDVT and the effects of different treatment strategies by analyzing recent and important classical works in the literature in an attempt to provide recommendations for the treatment of this most common type of DVT in orthopaedic clinics.
“…Moving on to the adult population, Schellong et al are here reporting data on isolated distal DVT in comparison with proximal DVT from a registry study with 6,095 patients. 10 The investigators found differences in the demography and risk factors between patients with distal DVT compared with proximal DVT and/or PE. There were also differences in location of diagnosis and initial clinical management.…”
Section: Robert Louis Stevenson 1850-1894mentioning
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