… If the first event carried a high risk for recurrence (eg, was unprovoked), the ASH guideline panel provided a conditional recommendation in support of indefinite antithrombotic therapy for secondary prevention after completion of the primary treatment phase. deep vein thrombosis (DVT) and pulmonary embo-lism (PE), is an important cause of morbidity and ... added as options for VTE prophylaxis and treatment. Pooling all identified trials, we observed a nonsignificant reduction in the risk of PTS (RR, 0.62; 95% CI, 0.38-1.01; ARR, 81 fewer per 1000 patients; 95% CI, 132 fewer to 2 more; very-low certainty evidence). It is possible that newer studies using DOACs could alter the balance of benefits and harms associated with a longer course of therapy. 10 -40% risk of DVT without prophylaxis Most general, gynecologic, or urologic surgery patients High Risk Score 5-8 Thromboprophylaxis with LMWH or UFH, fondaparinux, or warfarin 40 -80% risk of DVT without prophylaxis Hip or knee arthroplasty, major trauma, spinal cord injury Catheter-directed thrombolysis might increase the risk of PTS (RR, 2.59; 95% CI, 1.42-4.74; ARR, 223 more per 1000 patients; 95% CI, 76 more to 369 more; very-low-certainty evidence). Consequently, the investigators observed a nonsignificant reduction in the risk of PE (RR, 0.75; 95% CI, 0.21-2.60; ARR, 6 fewer per 1000 patients; 95% CI, 17 fewer to 35 more; low-certainty evidence) and DVT (RR, 0.64; 95% CI, 0.37-1.12; ARR, 16 fewer per 1000 patients; 95% CI, 28 fewer to 5 more; low-certainty evidence) in the intervention group. This recommendation does not apply to patients who have other conditions that would require hospitalization, have limited or no support at home, and cannot afford medications or have a history of poor adherence. When using a DOAC for indefinite anticoagulation, the risk of DVT was reduced in the study population (RR, 0.15; 95% CI, 0.10-0.23; ARR, 49 fewer per 1000 patients; 95% CI 51 fewer to 44 fewer; high-certainty evidence), as well as for patients with recurrent provoked VTE269,324  (ARR, 26 fewer per 1000 patients; 95% CI, 28 fewer to 24 fewer; high-certainty evidence). This measure assesses the number of patients who received VTE prophylaxis or have documentation why no VTE prophylaxis was given the day of or the day after hospital admission or surgery end date for surgeries that ... eCQMs for 2020 Reporting Period. The risk of recurrent VTE while on anticoagulant therapy with a VKA was 1.6% in a Cochrane meta-analysis.245  Frequent reasons associated with breakthrough thromboembolic events include the underlying condition or disease (eg, cancer, antiphospholipid syndrome, or vasculitis) or inappropriate selection and/or dosing of the anticoagulant (eg, noncompliance, drug-drug interactions, and drug-food interactions).322  An initial assessment of any patient with an apparent breakthrough VTE while on therapeutic anticoagulation includes confirmation of compliance with the therapy being administered and confirmation that the medication and dosing regimen are appropriate for the individual patient. Patients with limb-threatening DVT or at high risk for bleeding and those requiring IV analgesics may benefit from initial treatment in the hospital. The certainty in the evidence was judged very low for all of the relevant outcomes. The certainty in the evidence was judged moderate for mortality, PE, and major bleeding because of imprecision, given that the CI around the absolute estimates likely crossed the thresholds that patients would consider important. The evaluation and management of patients who sustain recurrent thromboembolic events while taking therapeutic anticoagulation constitute an area needing well-designed prospective studies to provide guidance. Before the publication of this guideline, we updated the searches to January 2019 (detailed search strategies are described in Supplement 4). Additionally, panel members were asked to suggest any studies that may have been missed and fulfilled the inclusion criteria for the individual questions. This phase occurs after the patient has completed an initial course of anticoagulant therapy, referred to as primary treatment, at which time the patient will discontinue anticoagulation or continue without a predefined stop date. The Vienna score has been studied more and has showed moderate discrimination (c-statistic, 0.6) and a tendency to underestimate the true risk of VTE. The outcomes were measured in both groups immediately at the end of the longer course of anticoagulation. Other factors, such as renal function, concomitant medications (eg, need for a concomitant drug metabolized through the CYP3A4 enzyme or P-glycoprotein), and the presence of cancer, may also impact DOAC choice. There were significant subgroup effects with different antithrombotic interventions on DVT outcome. Remarks: Factors, such as a requirement for lead-in parenteral anticoagulation, once- vs twice-daily dosing, and out-of-pocket cost may drive the selection of specific DOACs. The recommendations are labeled as “strong” or “conditional” according to the GRADE approach. For patients with DVT and/or PE with stable cardiovascular disease (CVD) who initiate anticoagulation and were previously taking aspirin for cardiovascular risk modification, the ASH guideline panel suggests suspending aspirin over continuing it for the duration of anticoagulation therapy (conditional recommendation based on very low certainty in the evidence of effects ⨁○○○). However, if patients and clinicians decide to stop anticoagulation, the ASH guideline panel suggests against using a longer course of primary anticoagulant therapy (6-12 months). However, they may help to select patients at low risk for complications. Patients were randomized to receive placebo or continue with extended treatment for ≥6 months. In the 4 studies included, quality appraisal identified some overall concern for bias because of the use of data from subgroup analysis. Results from an individual-level meta-analysis, Predicting disease recurrence in patients with previous unprovoked venous thromboembolism: the DASH prediction score, Predicting disease recurrence in patients with previous unprovoked venous thromboembolism: a proposed prediction score (DASH), Clinical prediction guide to predict thrombosis recurrence after a first unprovoked venous thromboembolism. Interventions and Practices Considered: The clinical interventions and practices recommended in this guideline … They may also be used by patients. Adapted from Kearon et al237  and Konstantinides et al238  with permission. ?B3�k�.�$���>��"@=KM�%��4��+HbƉ���g�����g�VP�E�R�X�����C�����Qn�%J�nQ�r#01�>. As with outpatient DVT treatment, social factors, such as limited home support, history of nonadherence, and limited financial resources, would favor the hospital setting for the initial phase of treatment. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update. Rather, the study assessed the effect of anticoagulation in individuals with a high D-dimer level, which is a related question but not the specific question addressed by the panel. Home treatment was associated with a reduction in long-term mortality (RR, 0.72; 95% CI, 0.45-1.15; ARR, 13 fewer per 1000 patients; 95% CI, 25 fewer to 7 more; low-certainty evidence), although this was not statistically significant. For patients with uncomplicated deep vein thrombosis (DVT), the American Society of Hematology (ASH) guideline panel suggests offering home treatment over hospital treatment (conditional recommendation based on low certainty in the evidence of effects ⨁⨁○○). Individuals with significant renal impairment, as indicated by an estimated creatinine clearance <25 mL/min (apixaban) or 30 mL/min (all other DOACs) and patients at high risk for bleeding were excluded. 1, 2. However, as noted above, certain patients with acute DVT might benefit from the addition of thrombolytic therapy, as determined by the severity of symptoms, location and extent of the thrombosis, and/or initial response to anticoagulant therapy. Indefinite antithrombotic therapy also showed a reduced risk for DVT in the study population (RR, 0.20; 95% CI, 0.12-0.34; ARR, 50 fewer per 1000 patients; 95% CI, 56 fewer to 42 fewer; high-certainty evidence), as well as for patients with chronic risk factors at 1 year269,274  (ARR, 45 fewer per 1000 patients; 95% CI, 48 fewer to 41 fewer). Thrombolytics were systemically infused in all of the trials with the exception of 1,190  in which it was administered through a catheter-directed approach. Patient populations and interventions in VTE treatment. Patients with submassive PE should be monitored closely for the development of hemodynamic compromise. Decisions about the optimal antithrombotic strategy for secondary prevention would be similar to those for a first unprovoked VTE (Recommendations 20 to 22). American CHEST guidelines do not recommend use of prophylaxis in isolated lower leg injuries requiring leg immobilization. There is still some controversy over the best practice for prevention of deep vein thrombosis (DVT) during laparoscopic surgery. Of 7 RCTs, allocation was clearly concealed in 3 (unclear in 3 and probably unconcealed in 1 with unspecified opaque envelope), outcome adjudicators were clearly blinded in the 2 largest RCTs (unclear in remaining 5), and missing data were significant in 1 small RCT. We identified 24 systematic reviews62-85  and 12 randomized trials86-97  (n = 28 876). Remarks: Lower-dose DOAC regimens that may be considered for patients who have completed primary treatment and will continue with a DOAC include rivaroxaban, 10 mg daily, or apixaban, 2.5 mg twice daily. Table 2 provides GRADE’s interpretation of strong and conditional recommendations by patients, clinicians, health care policy makers, and researchers. One economic evaluation in a Canadian setting based on a decision tree suggests home treatment as cost effective compared with hospital management.41  The other 4 reports suggest that home management leads to cost savings without compromising outcome effects and safety. We identified 19 systematic reviews239-257  and 13 RCTs88,258,259,261,262,265,267,298,306-310  (n = 8593) to inform this recommendation. We rated down the certainty in the evidence for risk of bias, given that the trial was open label, and for imprecision, because the CIs around the absolute estimates include benefit and harm. Four Markov model analyses of cost-effectiveness for a longer course of anticoagulant therapy vs a shorter course of anticoagulant therapy for VTE treatment were identified. version of the guidelines on June 2, 2020, but sadly he passed away one day later, on June 3, 2020.We will always remember Dr Kearon for his many contributions to the field of Thrombosis and Antithrombotic Treatment, including these guidelines. We did not identify direct evidence of a cost-effectiveness comparison for nonsurgical-provoked DVT/PE. For the baseline risk of major bleeding, we used data from 2 randomized trials on people with VTE; the risk of major bleeding with placebo during an 18-month or 24-month treatment with anticoagulants was as low as 0.5%306  and as high as 1.5% in 18 months.259  The EtD framework is shown online at: https://guidelines.gradepro.org/profile/C151C2DC-8A88-9E05-9D73-2FEB6B917C00. 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