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. Time frame of the decisions. For baseline risks of VTE, we used a prospective cohort study324 that reported an incidence rate for recurrent VTE of 5.6 per 100 patient-years for patients with a provoked VTE who had discontinued anticoagulation after completion of primary treatment. We identified 1 RCT316 to inform this recommendation. Nederlands Trial Register. Catheter-directed therapy for the treatment of massive pulmonary embolism: systematic review and meta-analysis of modern techniques, Systemic or local thrombolysis in high-risk pulmonary embolism, Systemic thrombolysis increases hemorrhagic stroke risk without survival benefit compared with catheter-directed intervention for the treatment of acute pulmonary embolism, Thrombolysis (catheter directed/systemic) in pulmonary embolism: predictors and etiologies of readmissions, Catheter directed thrombolysis versus systemic thrombolysis for the treatment of pulmonary embolism, Using inferior vena cava filters to prevent pulmonary embolism, Evidence-based evaluation of inferior vena cava filter complications based on filter type, Postthrombotic syndrome in relation to vena cava filter placement: a systematic review, Clinical outcomes of retrievable inferior vena cava filter plus anticoagulation versus anticoagulation alone on high-risk patients: a meta-analysis, The short-term efficacy of vena cava filters for the prevention of pulmonary embolism in patients with venous thromboembolism receiving anticoagulation: meta-analysis of randomized controlled trials, Clinical review: inferior vena cava filters in the age of patient-centered outcomes, Vena caval filters for the prevention of pulmonary embolism. management of venous thromboembolism (VTE), as well as longer-term treatment and secondary
“Treatment of VTE in day-to-day practice poses many challenges to clinicians. ASH vetted and appointed individuals to the guideline panel. Given the lack of evidence of the comparative effectiveness of different DOACs, we were unable to estimate the benefits and harms of specific agents. However, there may be important variability in how individual patients value the risk of thrombosis vs the risk of bleeding. For patients with pulmonary embolism (PE) with a low risk for complications, the ASH guideline panel suggests offering home treatment over hospital treatment (conditional recommendation based on very low certainty in the evidence of effects ⨁○○○). For patients with PE in whom thrombolysis is considered appropriate, the ASH guideline panel suggests using systemic thrombolysis over catheter-directed thrombolysis (conditional recommendation based on very low certainty in the evidence of effects ⨁○○○). model implemented by ASH can be easily updated in the future, adding new recommendations
After completion of the primary treatment phase, subsequent decisions (discussed in Recommendation 19) would determine whether to discontinue anticoagulant therapy or continue indefinitely for secondary prevention of recurrent VTE (Figure 2). that would require hospitalization, have limited or no support at home, and cannot
We estimated an annualized risk for major bleeding of 2.1% assuming a risk for major bleeding close to 0 after anticoagulant discontinuation. Thrombolytics were systemically infused in all of the trials with the exception of 1,190 in which it was catheter directed. 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. Development of these guidelines, including systematic evidence review, was supported by the McMaster University GRADE Centre, a world leader in guideline development. For the baseline risk of major bleeding, we used data from 2 randomized trials on people with VTE, showing that the risk of major bleeding with placebo during 18 or 24 months of follow-up 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/86361A15-ECB8-E636-8A66-7B5713A17FEB. Assuming that 45% of the initial VTE events are PEs and 55% are DVTs,269 we estimated annualized risks of 4.4 and 5.3 per 100 patient-years for PE and DVT recurrence, respectively, for patients with a chronic risk factor. The use of thrombolytics for patients with DVT may reduce the risk of PTS (RR, 0.70; 95% CI, 0.59-0.83; ARR, 169 fewer per 1000 patients; 95% CI, 96 fewer to 231 fewer; low-certainty evidence) without significantly impacting mortality (RR, 0.77; 95% CI, 0.26-2.28; ARR, 0 fewer per 1000 patients; 95% CI, 1 fewer to 1 more; low-certainty evidence), the risk of PE (RR, 1.33; 95% CI, 0.71-2.46; ARR, 5 more per 1000 patients; 95% CI, 4 fewer to 21 more; low-certainty evidence), or the risk of DVT (RR, 0.99; 95% CI, 0.56-1.76; ARR, 1 fewer per 1000 patients; 95% CI, 57 fewer to 99 more; low-certainty evidence). All of the meta-analyses were conducted using RevMan (version 5.3 Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). The ASH guidelines also address the question of whether aspirin should be continued or discontinued during anticoagulation in those patients who sustain a VTE while taking aspirin (Recommendation 26). As noted above, 4 panel members believed that this should be a strong recommendation because systemic thrombolysis is not considered appropriate therapy in the United States. The longer course of therapy varied from 6 months to 24 months.262 Patients were followed after the end of the extended anticoagulation treatment. For primary treatment of patients with DVT and/or PE, whether provoked by a transient risk factor (recommendation 12) or by a chronic risk factor (recommendation 13) or unprovoked (recommendation 14), the ASH guideline panel suggests using a shorter course of anticoagulation for primary treatment (3-6 months) over a longer course of anticoagulation for primary treatment (6-12 months) (conditional recommendations based on moderate certainty in the evidence of effects … Our choice of terminology reflects the distinct clinical intention of the 2 phases of VTE management, rather than terms reflecting the relative duration of therapy. thrombolytic therapy. We also identified 5 reports that compared the cost and effectiveness of home treatment and hospital treatment for patients with DVT or for VTE patients, in general. Both of these involved the DVT outcome when using VKAs/LMWH or DOACs. Other variables that may impact the choice of anticoagulant therapy for individual patients include the cost of the DOACs and patient preference for once- or twice-daily dosing. We did not identify a cost-effectiveness comparison for nonsurgical provoked VTE. Acute DVT may be treated in an outpatient setting with LMWH. The words “the guideline panel recommends” are used for strong recommendations and “the guideline panel suggests” are used for conditional recommendations. 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. Among these recommendations, the guideline panel strongly recommended
The certainty in the evidence from observational studies was judged very low for long-term mortality for the same reasons as well as a high degree of inconsistency among the pooled estimates. The certainty in the evidence was judged moderate for mortality, major bleeding, PE, and DVT due to imprecision, given the small number of events in both arms not meeting optimal information size and the fact that the CI around the absolute estimates likely crossed the thresholds that patients would consider important. The majority of patients included in the PREPIC trials did not have significant preexisting cardiopulmonary disease, and no patient had PE with hemodynamic failure. PTS may develop in up to 30% to 50% of patients following the development of a proximal DVT,149,150 and this may be severe in 5% to 10% of patients.3,150 Thrombolytic therapy has been shown to result in a more rapid and complete lysis of thrombus than anticoagulant therapy alone, but relatively few studies have linked radiographic improvements to clinical outcomes. Last guideline approval: September 2020 Guidelines are systematically developed statements to assist patients and providers in choosing appropriate health care for specific clinical conditions. The Thrombosis Canada TM Clinical Guides are: Developed voluntarily by Thrombosis Canada TM … Interpretation of strong and conditional recommendations. The certainty in the evidence was judged low for mortality because of the serious risk of bias and imprecision and moderate for PE and proximal DVT because of the serious risk of bias. It is the standard imaging test to diagnose DVT. Conflicts of interest of all participants were managed according to ASH policies based on recommendations of the Institute of Medicine and Guideline International Network.26,27 At the time of appointment, a majority of the guideline panel, including the chair and the vice chair, had no conflicts of interest, as defined and judged by ASH (ie, no current material interest in any commercial entity with a product that could be affected by the guidelines). A longer course of anticoagulation also showed a potential reduction in the risk of PE in the study population, without statistical significance (RR, 0.66; 95% CI, 0.29-1.51; ARR, 17 fewer per 1000 patients; 95% CI, 35 fewer to 25 more; moderate-certainty evidence), and likely a small reduction in a low-risk population268 (ARR, 11 fewer per 1000 patients; 95% CI, 24 fewer to 17 more; moderate-certainty evidence). However, in certain circumstances, such as when patients are undecided or the balance between risks and benefits is uncertain, clinicians and patients may use prognostic scores, the D-dimer test, or ultrasound assessment for residual thrombosis from an initial DVT to aid in reaching a final decision. Blood Adv. We did not identify any relevant economic evaluation; however, we considered the cost of using ultrasonography or D-dimer as moderate. 2: Clinical practice guidelines, GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. Similar outcomes were seen for the risk of PE for the study population (RR, 0.84; 95% CI, 0.43-1.66; ARR, 13 fewer per 1000 patients; 95% CI, 47 fewer to 55 more), as well as for a low-risk population274 (ARR, 7 fewer per 1000 patients; 95% CI, 25 fewer to 29 more; moderate-certainty evidence). The online EtD framework is available here: https://guidelines.gradepro.org/profile/4D133D47-A600-EC68-85E9-5221E45B47F9. When using a DOAC for a longer course of anticoagulation, the risk of DVT was reduced in the study population (RR, 0.21; 95% CI, 0.11-0.41; ARR, 62 fewer per 1000 patients; 95% CI, 70 fewer to 46 fewer; moderate-certainty evidence), as well as in the low-risk population274 (ARR, 42 fewer per 1000 patients; 95% CI, 47 fewer to 31 fewer; moderate-certainty evidence). Trials included adults with objectively confirmed DVT and/or PE who had been treated with anticoagulants for ≥3 months without recurrence, referred to as the “study population” below. Several studies have demonstrated that patients with PE who are at low risk for complications can be effectively and safely treated at home; however, the quality of evidence in support of this recommendation is of very low certainty, making this a conditional recommendation. The use of warfarin with an INR range lower than 2.0 to 3.0 may increase the risk of DVT (RR, 3.25; 95% CI, 1.07-9.87; ARR, 24 more per 1000 patients; 95% CI, 1 more to 96 more; moderate-certainty evidence) and may increase the risk of nonfatal PE (RR, 5.0; 95% CI, 0.24-103.79; ARR could not be estimated; moderate-certainty evidence), although without statistical significance. For patients with PE with low risk for complications, the ASH guideline panel suggests offering home treatment over hospital treatment (conditional recommendation based on very low certainty in the evidence of effects ⨁○○○). As noted above, in the case of prognostic scores, at the time of our systematic review, we did not find any trial assessing their impact in patient-important outcomes, and the evidence regarding their discrimination ability and their validation was limited. In populations with a low risk for bleeding,98 the use of a longer course of anticoagulation instead of a shorter course may lead to an increase of 10 more bleeding events per 1000 patients (95% CI, 5 fewer to 36 more; moderate-certainty evidence). Remarks: For guidance on selection of antithrombotic therapy after completion of primary treatment, see Recommendation 20. Supplement 2 provides the complete “Disclosure of Interests” forms of all panel members. Trials included adults with objectively confirmed DVT and/or PE who had been treated with anticoagulants for ≥3 months without recurrence. Are direct oral anticoagulants equally effective in reducing deep vein thrombosis and pulmonary embolism? Anticoagulation period in idiopathic venous thromboembolism. The panel agreed on recommendations (including direction and strength), remarks, and qualifications by consensus or, in rare instances, by voting (an 80% majority was required for a strong recommendation) based on the balance of all desirable and undesirable consequences. These patients are considered to be at a higher risk for recurrent thromboembolism if anticoagulant therapy is discontinued. For patients with recurrent unprovoked VTE at 1 year,269,324 indefinite antithrombotic therapy also reduced the risk of DVT (ARR, 53 fewer per 1000 patients; 95% CI, 58 fewer to 44 fewer). 2014;43(6):477], Editor's Choice - efficacy and safety of the new oral anticoagulants dabigatran, rivaroxaban, apixaban, and edoxaban in the treatment and secondary prevention of venous thromboembolism: a systematic review and meta-analysis of phase III trials, Indirect treatment comparison of new oral anticoagulants for the treatment of acute venous thromboembolism, New oral anticoagulants for the treatment of acute venous thromboembolism: are they safer than vitamin K antagonists? The PREPIC230 trial included 400 patients with proximal DVT with or without concomitant PE. 2020 Oct 13;4(19):4693-4738. doi: 10.1182/bloodadvances.2020001830. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC) The number of events in the trials was very small, which led to wide CIs around the absolute estimates. 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