Distal DVT can either be treated with anticoagulation, or monitored with close follow-up to detect progression to the proximal veins (above the knee), which requires anticoagulation. Of note, these studies mainly include outpatients with suspected DVT, so the rather low reported rates of extension to proximal veins could reflect the natural history of untreated calf DVT in low-risk patients. Nevertheless, a systematic review published in 2006 reported an estimated rate of extension of 10% (95% CI, 7%-12%) in untreated patients and of 4% (95% CI, 3%-6%) in treated patients.2. For patients with low-risk distal DVT, a short duration of anticoagulants (4-6 weeks) or serial compression ultrasound to screen for progression can be considered. There were similar results for the recurrence of DVT, while there was no clear effect on risk of PE. Further recurrences during the rest of the 3-month observation period occurred in only 4 patients, 3 of whom had an index unprovoked event, suggesting that prolonged full-dose therapeutic treatment might not be necessary for all patients with a calf DVT. In the proximal CUS arm, patients with a normal 2-point CUS underwent qualitative D-dimer testing (SimpliRED, Agen Biomedical, Melbourne, QLD, Australia). Generally, anticoagulation with direct oral anticoagulants (DOACs) – dabigatran, rivaroxaban, apixaban, or edoxaban – is recommended over vitamin K antagonist therapy (usually warfarin), which is in turn recommended over LMWH. The safety of both strategies, therefore, was similar. An interesting approach to assessing the rate of extension of distal DVT to the proximal veins is the use of data arising from diagnostic studies that are based on serial proximal CUS (described in detail in “Various lower-limb venous ultrasound strategies for suspected DVT”). Proximal DVT; Distal DVT - Anticoagulation - Surveillance with serial ultrasound; ASSESSING BLEEDING RISK; ANTICOAGULATION. DVT treatment depends on its anatomical extent: in proximal DVT, thrombus is present in the popliteal or a more proximal vein; in distal DVT, thrombus only occurs … Treatment of VTE Distal DVT caused by a major provoking factor that is no longer present requires OACs There were no reports for overall mortality or PE and major bleeding-related deaths. Our review found a benefit for people with distal DVT treated with anticoagulation therapy with little or no clear difference in major bleeding events, although there was an increase in clinically relevant non-major bleeding when compared with no treatment or placebo. The only randomized placebo-controlled trial included low-risk patients (outpatients without cancer or previous venous thromboembolism [VTE]) and was hampered by limited statistical power. The blood clot can dislodge and travel in the blood, particularly to the pulmonary arteries. Patients with an unlikely probability and negative D-dimer result did not undergo CUS and were left untreated. Nevertheless, evidence suggests that not all calf DVTs deserve therapeutic anticoagulation. Please note that the information contained herein is not to be interpreted as an alternative to medical To date and to our knowledge, only 5 randomized trials have assessed the need for anticoagulant treatment in patients with calf DVT.14,15,46-49 The results of the fifth study,14,15 the only double-blind, randomized, placebo-controlled study in this field, are presented and discussed in detail in “Is it safe not to treat distal DVT in low-risk patients?”, The first study was published >30 years ago by Lagerstedt et al.47 Although the landmark study in the field, it was a small, open-label study with many methodological limitations. The primary efficacy outcome measure was the composite of extension of calf DVT to proximal veins, contralateral proximal DVT, or PE at 6 weeks. However, recurrent VTE were assessed by physical examination and serial isotopic tests, which were later abandoned because of their limited sensitivity. D-dimer seems to have a lower sensitivity and negative predictive value for calf DVT than for proximal DVT. Among all confirmed DVTs, 39% were isolated distal DVTs, which is lower than the pooled estimate of 51% in studies of complete CUS for all patients (Table 2). • The diagnostic performances of venous compression ultrasound are lower for the diagnosis of distal DVT compared to proximal DVT. All these data likely had an impact on the last ACCP recommendations,4,53 which contrary to the recommendations of 2008, now suggest that serial imaging of the deep veins for 2 weeks could be proposed over initial anticoagulation in patients without severe symptoms or risk factors for extension. During 3-mo follow-up in patients left untreated after a normal complete (proximal and distal) CUS. The limited performance of distal venous examination reported in some studies may explain why many centers use only proximal CUS (ie, limited to the popliteal and suprapopliteal veins). Randomised controlled trials comparing different treatments and different treatment periods with placebo or compression therapy are required. © 2016 by The American Society of Hematology. In the nadroparin arm, 1 patient died of metastatic cancer and 1 patient was diagnosed with type II heparin-induced thrombocytopenia. For PE, the Indeed, the rate of extension among studies is highly variable because of high heterogeneity in patient populations, clinical settings, and diagnostic strategies.2,22 Comparison between studies also is limited by disparity in treatment regimens as well as major differences in the follow-up and definition of outcomes (symptomatic extension vs extension diagnosed on systematic testing). A systematic study, Systematic review of the complications following isolated calf deep vein thrombosis, The role of venous ultrasonography in the diagnosis of suspected deep venous thrombosis and pulmonary embolism, Acenocoumarol and heparin compared with acenocoumarol alone in the initial treatment of proximal-vein thrombosis, Systematic review and meta-analysis of the diagnostic accuracy of ultrasonography for deep vein thrombosis, A single complete ultrasound investigation of the venous network for the diagnostic management of patients with a clinically suspected first episode of deep venous thrombosis of the lower limbs, The clinical validity of normal compression ultrasonography in outpatients suspected of having deep venous thrombosis, The Multicentre Italian D-Dimer Ultrasound Study Investigators Group, D-dimer testing as an adjunct to ultrasonography in patients with clinically suspected deep vein thrombosis: prospective cohort study, Simplification of the diagnostic management of suspected deep vein thrombosis, Value of assessment of pretest probability of deep-vein thrombosis in clinical management, Complete compression ultrasonography of the leg veins as a single test for the diagnosis of deep vein thrombosis, Withholding anticoagulation after a negative result on duplex ultrasonography for suspected symptomatic deep venous thrombosis, Deep venous thrombosis: withholding anticoagulation therapy after negative complete lower limb US findings, Outcomes for inpatients with normal findings on whole-leg ultrasonography: a prospective study, Accuracy of complete compression ultrasound in ruling out suspected deep venous thrombosis in the ambulatory setting. Nevertheless, on the basis of this single trial and the absence of other randomized data, the 2008 American College of Chest Physicians (ACCP) consensus recommended to treat all calf DVTs with a 3-month course of anticoagulant treatment (grade 2C).50. Distal DVTs were not searched for in these studies. If negative, then … (1) I find it hard to agree with what was suggested by the American College of Clinical Pharmacy (ACCP) guideline regarding diagnosis and treatment of IDDVT: “If isolated distal DVT is detected on whole-leg US, we suggest serial testing to rule out proximal extension over treatment (Grade 2C)”. In patients with an unprovoked DVT of the leg (isolated distal or proximal) or PE, we recommend treatment with anticoagulation for at least 3 months over treatment of a shorter duration (Grade 1B), and we recommend treatment with anticoagulation for RCTs comparing different treatments and different treatment periods with placebo or compression therapy, are required. Both strategies reported a similar 3-month rate of VTE (0.9% [95% CI, 0.3%-1.8%] for the 2-point proximal CUS and D-dimer arm vs 1.2% [95% CI, 0.5%-2.2%] for the complete single CUS arm). Further randomized studies are needed to define the best therapy for high-risk patients (inpatients, patients with active cancer, or patients with previous VTE) and the optimal dose and duration of treatment. Distal or calf DVT involves the infrapopliteal veins, which are the posterior tibial veins, peroneal veins, anterior tibial veins, and muscular calf veins (soleus or gastrocnemius veins). with isolated distal DVT will be prescribed anticoagulants. 16,23 A meta-analysis by Kearon et al 23 reported a sensitivity of 50% to 75% and specificity of 90% to 95%. Marc Righini, Division of Angiology and Hemostasis, Department of Medical Specialties, Geneva University Hospital and Faculty of Medicine, 4 Rue Gabrielle-Perret-Gentil, CH-1211, Geneva 14, Switzerland; e-mail: marc.righini@hcuge.ch. Despite an open-label design, the study suggested that 6 weeks of treatment are probably enough for distal DVT. There was one death, not related to PE or major bleeding, in the anticoagulation group. Does this patient have deep vein thrombosis? We resolved disagreements by discussion. Ultrasound series report that isolated distal deep vein thrombosis (DVT), also known as calf DVT, represents up to 50% of all lower-limb DVTs and, therefore, is a frequent medical condition. Nevertheless, a meta-analysis showed that all D-dimer assays had a higher sensitivity for proximal than for distal DVT (98% vs 86% for enzyme-linked immunosorbent assay, 94% vs 79% for latex agglutination, 84% vs 64% for whole-blood agglutination).44 Altogether, these data suggest that D-dimer measurements are less sensitive at the distal than at the proximal level and that some patients may have a distal DVT and D-dimer levels below the usual cutoff value of 500 ng/mL. The sensitivity and specificity of CUS for proximal DVT are high (97% and 98%, respectively), 23 and the necessity for treating proximal DVT with anticoagulants is widely accepted. This means that detecting calf DVT actually may be deleterious: It does not reduce the 3-month VTE risk and entails a risk of unnecessary anticoagulant treatment in patients who would have fared well without it. Chest 2012;141 (2 Suppl):e419S-e494S. Art. Low-risk patients with symptomatic distal DVT may benefit more from elastic compression stockings and ultrasound monitoring than from therapeutic anticoagulant treatment. Treatment required if proximal clot extension. There was little to no difference in major bleeding with anticoagulation compared to placebo (RR 0.76, 95% CI 0.13 to 4.62; 4 studies, 480 participants; I2 = 26%; low-certainty evidence). However, other studies have reported much higher sensitivities,42,43 rendering a robust evaluation of D-dimer sensitivity for distal DVT quite difficult. Of note, 23% (65 of 278) of patients with confirmed DVT in the complete single CUS arm were treated with an anticoagulant for a distal DVT without decreasing the 3-month VTE risk. A negative whole-leg ultrasound, however, requires no follow-up imaging, 2 so may be preferred if arranging a follow-up scan is difficult. Low-risk patients (eg, those without active cancer, outpatients, and those without previous VTE) may be better served without therapeutic anticoagulation and should undergo ultrasound surveillance. Major or clinically relevant nonmajor bleeding occurred in 5 of 122 patients (4.1%) in the nadroparin arm and in 0 of 130 patients (0.0%) in the placebo arm (P = .03; risk difference, 4.1%; 95% CI, 0.4%-9.2%) (Table 3). We identified eight randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) reporting on 1239 participants. The guideline does not cover pregnant women. Treatment of Distal DVT Clinical Question. Patients with a proximal DVT on the initial CUS are treated with anticoagulants. Hematology Am Soc Hematol Educ Program 2017; 2017 (1): 231–236. For the comparison anticoagulation versus no anticoagulation or placebo, the reliability of the evidence was high for recurrence of VTE, DVT, and clinically relevant non-major bleeding, and low for PE and major bleeding. Kirkilesis G, Kakkos SK, Bicknell C, Salim S, Kakavia K, Kirkilesis G, Kakkos SK, Bicknell C, Salim S, Kakavia K. Treatment of distal deep vein thrombosis. Implications for simplifying the diagnostic process with compression ultrasound, Diagnostic accuracy of compression ultrasonography for the detection of asymptomatic deep venous thrombosis in medical patients—the TADEUS project, Incidence of venous thromboembolism: a community-based study in Western France. However, robust data from randomized studies are scarce. Only patients with abnormal D-dimer levels underwent the repeat CUS at 1 week. Altogether, these studies question the necessity to treat all calf DVT with therapeutic anticoagulation. The 2016 CHEST Guidelines for Antithrombotic Therapy for VTE Disease support home treatment of low-risk PE (Grade 2B) and DVT (Grade 1B) in clinically stable patients with good cardiopulmonary reserve, good social support with ready access to medical care, 1 and who are expected to be compliant with follow-up. There was no clear difference in major bleeding events (RR 3.42, 95% CI 0.36 to 32.35; 2 studies, 389 participants; I2 = 0%; low-certainty evidence) or clinically relevant non-major bleeding events (RR 1.76, 95% CI 0.90 to 3.42; 2 studies, 389 participants; I2 = 1%; low-certainty evidence) between three months or more of treatment and six weeks of treatment. During the 3-month follow-up, no patient in the warfarin arm had a recurrent VTE, whereas 19 of 28 who did not receive warfarin had recurrent VTE. As a result, significant variation exists in diagnostic and therapeutic practices across centers.1,5-8 In some centers, both the proximal veins and the calf veins are imaged in all patients with suspected DVT, and patients diagnosed with isolated calf DVT are treated with anticoagulant therapy.9 Other centers rely on serial imaging of the proximal veins only and, thus, do not diagnose or treat calf DVT.10 In the latter strategy, in case of a negative proximal ultrasound, the test often is repeated 1 week later to rule out extension of a calf DVT to the proximal veins. The reported rate of PE ranged from 0% to 5.8% with a mean rate of 1.4%. Groupe d’Etude de la Thrombose de Bretagne Occidentale, Deep venous thrombosis and the risk of pulmonary embolism. DVT/PE Duration of Treatment (Recommendations from the America College of Chest Physicians 2016 Update on Antithrombotic Therapy for VTE ) Provoked Unprovoked -associated Proximal DVT or PE Isolated-distal DVT Proximal DVT or PE -distal Provoked by surgery Provoked by non-surgical transient risk factor See page 2 3 months (1B) Low or Moderate Reprinted from Cogo et al78 with permission. The prevalence appears to be increasing, particularly because of an increased use of indwelling central venous catheters.1,2Proximal UEDVT Choice may also depend on individual physician or patient preference or recommendations in local guidelines. A systematic review of management outcome studies, The anticoagulation of calf thrombosis (ACT) project: results from the randomized controlled external pilot trial, Need for long-term anticoagulant treatment in symptomatic calf-vein thrombosis, Investigators of the “Durée Optimale du Traitement AntiVitamines K” (DOTAVK) Study, Comparison of 3 and 6 months of oral anticoagulant therapy after a first episode of proximal deep vein thrombosis or pulmonary embolism and comparison of 6 and 12 weeks of therapy after isolated calf deep vein thrombosis, Therapy of isolated calf muscle vein thrombosis: a randomized, controlled study, Evolution of untreated calf deep-vein thrombosis in high risk symptomatic outpatients: the blind, prospective CALTHRO study, Isolated distal deep vein thrombosis: efficacy and safety of a protocol of treatment, Antithrombotic therapy for VTE disease: CHEST Guideline and Expert Panel Report [published correction appears in Chest. The small number of participants in this meta-analysis and strength of evidence prompts a call for more research regarding the treatment of distal DVT. If one considers each study individually, the 3-month thromboembolic risk in patients with a negative proximal CUS is low because it was <1%.10,27-30 Even if serial proximal CUS is safe, its main limitation is the need for a second ultrasound examination, which is cumbersome and costly and has a very low yield, because it reveals a proximal DVT in only 1% to 5.7% of patients. There was an increase in clinically relevant non-major bleeding events in the group treated with anticoagulants (RR 3.34, 95% CI 1.07 to 10.46; 2 studies, 322 participants; I2 = 0%; high-certainty evidence). Unlike proximal DVT and pulmonary embolism, which have been studied extensively and for which management is well standardized, much less is known about the optimal management of isolated calf DVT. 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