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For baseline risks of VTE, we used a prospective cohort study324 that reported a risk for patients with a recurrent unprovoked VTE of 12 per 100 patient-years. Evidence from the included RCTs demonstrates that treating patients with PE at low risk for complications at home, rather than in the hospital, may increase the risk of subsequent PE (RR, 2.95; 95% CI, 0.12-71.85; ARR, 23 more per 1000 patients; 95% CI, 11 fewer to 850 more; low-certainty evidence) and major bleeding (RR, 6.88; 95% CI, 0.36-132.14; ARR, 59 more per 1000 patients; 95% CI, 6 fewer to 1000 more; low-certainty evidence), although CI included significant benefit and harm. 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). These variables typically exhibit a low relative risk for VTE but may be useful in combination with acquired risk factors when considering an individual patient’s risk for recurrence. Remarks: Patients with DVT and/or PE provoked by a transient risk factor typically do not require antithrombotic therapy after completion of primary treatment. However, estimates of the bleeding rate associated with catheter-directed thrombolysis are very imprecise because of the paucity of quality studies and the diversity of methods used. Observational studies suggested a higher level of patient satisfaction with a DOAC and a lower treatment burden than with LMWH or a VKA.273. The diagnosis, risk assessment, and management of pulmonary embolism have evolved with a better understanding of efficient use of diagnostic and therapeutic options. 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. 3.1.2. Thomas L. Ortel, Ignacio Neumann, Walter Ageno, Rebecca Beyth, Nathan P. Clark, Adam Cuker, Barbara A. Hutten, Michael R. Jaff, Veena Manja, Sam Schulman, Caitlin Thurston, Suresh Vedantham, Peter Verhamme, Daniel M. Witt, Ivan D. Florez, Ariel Izcovich, Robby Nieuwlaat, Stephanie Ross, Holger J. Schünemann, Wojtek Wiercioch, Yuan Zhang, Yuqing Zhang; American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. The observational study did adjust for baseline characteristics using propensity scores, but observational studies have a residual selection bias due to unadjusted or unmeasured differences in the groups under comparison. Additionally, 3 observational studies reported mortality and major bleeding at 3 months follow-up, and 1 reported PE at 3 months. The follow-up time ranged from 351 to 365 days. Three analyses showed that the longer course was cost-effective compared with the shorter course of antithrombotic therapy,112,270,271 whereas 1 analysis suggested that a longer course of anticoagulation with warfarin was cost-effective in younger patients and 3 months of anticoagulation was preferred in elderly patients (80-year-old subgroup).272, The panel considered that a longer course of treatment was probably acceptable and feasible. Patients were randomized to receive 20 mg of rivaroxaban or 100 mg of aspirin for 12 months. Treatment of VTE in day-to-day practice poses many challenges to clinicians. Patients in these categories who value rapid resolution of symptoms, are averse to the possibility of PTS, and accept the added risk of major bleeding may prefer thrombolysis. The panel considered home treatment acceptable and feasible in most cases, although economic incentives might favor in-hospital treatment in fee-for-service systems. For patients who sustain a breakthrough thrombotic event while taking a VKA who do not have HIT, there are minimal data available concerning which anticoagulant to select. The longer course of therapy varied from 6 months to 24 months.262 Patients were continuously followed up until the end of the longer course of anticoagulation. The primary objectives for the treatment of deep venous thrombosis (DVT) are to prevent pulmonary embolism (PE), reduce morbidity, and prevent or minimize the risk of developing the postthrombotic syndrome (PTS). Our analysis showed a potential increase in mortality when using a longer course of anticoagulation compared with a shorter course for primary treatment, without statistical significance (RR, 1.38; 95% CI, 0.85-2.23; ARR, 7 more per 1000 patients; 95% CI, 3 fewer to 22 more; moderate-certainty evidence). (This recommendation does not apply to patients who have other conditions We considered that avoidance of PE, DVT, and major bleeding was critical for patients. The panel chair was a hematologist with content expertise, whereas the vice chair was an internist with expertise in guideline development methodology. Also, although no direct evidence was identified, in the context of hemodynamically unstable patients, the potential benefit of thrombolytic therapy on survival would probably result in the intervention being cost-effective. There was no significant impact on the risk of PE in 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) or for a low-risk population268 (ARR, 3 fewer per 1000 patients; 95% CI, 11 fewer to 12 more; moderate-certainty evidence). The investigators reported the incidence of PTS at the end of follow-up using different definitions, including the Villalta criteria. The use of a longer course of anticoagulant therapy may increase the risk of major bleeding (RR, 1.46; 95% CI, 0.78-2.73; ARR, 6 more per 1000 patients; 95% CI, 3 fewer to 22 more; moderate-certainty evidence). In arriving at this recommendation, the panel acknowledged that the reduced dose of thrombolytic drug used for catheter-directed thrombolysis might confer a safety advantage. Because only catheter-directed thrombolysis is available in the United States, implementing the procedure would probably result in large costs, which, in turn, will probably reduce equity and limit its acceptability and feasibility. For patients with VTE and a major transient risk factor >3 months prior to the VTE or a single minor transient risk factor >2 months prior to the VTE, clinical judgment is essential when considering the contribution of this variable to the initial VTE and the risk of recurrence. Trials included adults with objectively confirmed DVT and/or PE who had been treated with anticoagulants for 6 to 12 months. Panelists then selected outcomes of interest for each question a priori, following an approach described in detail elsewhere.28 In brief, the panel first brainstormed all possible outcomes before rating the relative importance for decision making of each. Follow-up of a randomized study, A comparative randomized trial of heparin versus streptokinase in the treatment of acute proximal venous thrombosis: an interim report of a prospective trial, Early results of thrombolysis vs anticoagulation in iliofemoral venous thrombosis. During this rating process, the panel used definitions of the outcomes (“marker states”) that were developed for these guidelines. The EtD framework is shown online at: https://guidelines.gradepro.org/profile/ADBCBA97-1E09-37C6-B664-D6FD9A489DC3. Risk factors for bleeding with anticoagulant therapy include, but are not limited to, older age, history of prior bleeding, cancer, hepatic and/or renal insufficiency, hypertension, thrombocytopenia, prior stroke, need for antiplatelet therapy, anemia, alcohol abuse, and frequent falls.312 An individual patient’s risk for bleeding will be affected by the severity of the risk factor (eg, degree of thrombocytopenia, location and extent of metastatic cancer), the number of risk factors present, and the presence of additional comorbid conditions. The panel thought that there was no impact on health equity when choosing either intervention. For patients with proximal DVT and significant pre-existing cardiopulmonary disease, When you return home after DVT treatment, your goals are to get better and prevent another blood clot.You’ll need to: Take medications as directed. The recommendation can be adopted as policy in most situations. The use of thrombolytics for patients with PE and hemodynamic compromise may reduce mortality (RR, 0.61; 95% CI, 0.40-0.94; ARR, 58 fewer per 1000 patients; 95% CI, 9 fewer to 90 fewer; low-certainty evidence). For patients with uncomplicated DVT, the ASH guideline panel suggests offering home treatment over hospital treatment (conditional recommendation based on low certainty in the evidence of effects ⨁⨁◯◯). The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. None of the trials were blinded, increasing the possibility of bias. In March 2020, most anticoagulants were off label for the treatment of DVT or PE in people with active cancer. Patients were randomized to receive low-intensity warfarin therapy (target INR, 1.5-1.9) or conventional-intensity warfarin therapy (target INR, 2.0-3.0) after completion of the primary treatment phase of therapy. Patients in these categories who value rapid resolution of symptoms, are averse to the possibility of PTS, and accept the added risk of major bleeding may prefer thrombolysis. The ASH guideline panel provides a conditional recommendation against the routine use of any of these modalities for all patients with VTE but acknowledges the potential utility of 1 (or more) of these approaches for management of individual patients. We explored heterogeneity with the χ2 test and with the I2 statistic. an international normalized ratio (INR) range of 2.0 to 3.0 over a lower INR range In this case, the high mortality of patients with PE and hemodynamic compromise, as well as the potential lifesaving effect of thrombolytics, warranted a strong recommendation. In addition, these patients need to be reevaluated when clinically stable to determine whether they need to continue LMWH or switch to an oral agent. Several studies have demonstrated that primary treatment should continue for a minimum of 3 to 6 months for all patients with VTE.235,236 The recommendations in this section address whether the 3 patient populations described above would benefit from a longer period for primary treatment of the acute thromboembolic event. Policy making will require substantial debate and involvement of various stakeholders. For patients with DVT and/or PE who have completed primary treatment and will continue with a DOAC for secondary prevention, the ASH guideline panel suggests using a standard-dose DOAC or a lower-dose DOAC (conditional recommendation based on moderate certainty in the evidence of effects ⨁⨁⨁○). The PREPIC 2 trial231 included 399 patients with PE and acute deep or superficial vein thrombosis. Guidelines offer 28 recommendations for initial management, secondary prevention of DVT and PE Among other recommendations, the new guidelines from the American Society of Hematology suggest offering home treatment to low-risk patients with deep venous thrombosis (DVT) or pulmonary embolism (PE). Both of these involved the DVT outcome when using VKAs/LMWH or DOACs. The effect of compression stockings on PTS and DVT observed in the SOX trial was significantly different from the results of unblinded trials, as demonstrated by the tests for interaction. In the randomized trial, only 54 patients were studied, yielding a very wide CI. We considered that avoidance of PE, DVT, and bleeding was critical for patients. The use of a longer course of anticoagulation may increase the risk of major bleeding (RR, 1.46; 95% CI, 0.78-2.73; ARR, 6 more per 1000 patients; 95% CI, 3 fewer to 22 more; moderate-certainty evidence). The guidelines contain 10 chapters that focus on current areas of uncertainty and variation in clinical practice in the management of both deep vein thrombosis and pulmonary embolism.. To develop the new guidelines, ASH partnered with the McMaster University … In this study, participants were randomized to stop anticoagulation or to continue it for up to 18 months. Recusal was used to manage conflicts of interest. Patients with unprovoked VTE, defined as occurring in the absence of any identifiable transient or chronic acquired risk factors, have the highest risk for recurrent VTE if anticoagulation is discontinued after the primary treatment phase. For patients taking aspirin for primary prevention of CVD or for stable coronary artery disease, the ASH guideline panel provides a conditional recommendation in favor of suspending aspirin while taking anticoagulant therapy, based on a very low level of certainty in the evidence. This recommendation does not apply to patients who develop breakthrough VTE in the setting of poor INR control, in whom a DOAC may be a reasonable option. Each EtD table addressed the effects of interventions, resource use (cost effectiveness), values and preferences (relative importance of outcomes), equity, acceptability, and feasibility. Patients were followed for an average of 2.4 years. 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- 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/D9F5564D-D7EE-97A3-8AAB-24FF9D0C32F4. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Although the evidence supporting a reduced risk for bleeding with the use of a DOAC compared with a VKA was of high certainty, the lack of benefit for the VTE outcomes resulted in the conditional recommendation. The Botticelli DVT dose-ranging study, Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism, Einstein-DVT Dose-Ranging Study Investigators, A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study, Oral rivaroxaban for the treatment of symptomatic pulmonary embolism, Apixaban for the treatment of Japanese subjects with acute venous thromboembolism (AMPLIFY-J Study). In populations with a high risk for bleeding, the use of indefinite antithrombotic therapy instead of a defined duration of anticoagulation led to an increase of 18 more bleeding events per 1000 patients (95% CI, 6 more to 35 more; high-certainty evidence). The certainty in the evidence was judged as very low for mortality and major bleeding because of the risk of bias and imprecision. Multidisciplinary PE response teams have recently been implemented at several institutions to expedite rapid assessment and decision-making for these patients207,208 ; however, there has not been a demonstrated improvement in mortality with this approach.208,209 Additional research with clinical outcomes is needed to confirm the role of thrombolytic therapy for patients with PE and hemodynamic compromise, including the optimal strategy for administration of the thrombolytic. If these patients can be safely treated with anticoagulant therapy, however, the ASH guideline panel conditionally recommends against the use of IVC filters, based on the low certainty in the evidence of their effects. Patients were randomized to receive placebo or continue treatment for ≥6 months. The certainty in the evidence was judged as very low for all of the relevant outcomes. 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. It is possible that newer studies using DOACs could alter the balance of benefits and harms associated with a longer course of therapy. In most patients with proximal DVT, the ASH guideline panel suggests anticoagulation therapy alone over thrombolytic therapy in addition to anticoagulation (conditional recommendation based on low certainty in the evidence of effects ⨁⨁○○). DOACs vs LMWH have been compared only in the setting of VTE prophylaxis, which we considered too indirect to make judgments about VTE treatment. For patients with unprovoked DVT and/or PE, the ASH guideline panel suggests against routine use of prognostic scores (recommendation 15), D-dimer testing (recommendation 16), or ultrasound to detect residual vein thrombosis (recommendation 17) to guide the duration of anticoagulation (conditional recommendations based on very low certainty in the evidence of effects ⨁○○○). For patients with breakthrough DVT and/or PE during therapeutic VKA treatment, the ASH guideline panel suggests using low-molecular-weight heparin (LMWH) over DOAC therapy (conditional recommendation based on very low certainty in the evidence of effects ⨁○○○). For patients with DVT and/or PE, the ASH guideline panel suggests using direct oral anticoagulants (DOACs) over vitamin K antagonists (VKAs) (conditional recommendation based on moderate certainty in the evidence of effects ⨁⨁⨁○). For the baseline risk of major bleeding, we used data from 2 randomized trials on people with VTE, which showed that the risk of major bleeding with placebo during 18 months 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/B4FEBCC9-DEB2-C7FE-9420-79D262F2AB0F. Analysis of RCTs showed that treating patients with PE and a low risk for complications at home, rather than in the hospital, may reduce the risk of mortality at 30 days (RR, 0.33; 95% CI, 0.01-7.98; ARR, 2 fewer per 1000 patients, 95% CI, 2 fewer to 16 more for low-risk PE patients treated in the hospital51 ; low-certainty evidence) and 90 days (RR, 0.98; 95% CI, 0.06-15.58; ARR, 0 fewer per 1000 patients, 95% CI, 7 fewer to 108 more for low-risk PE patients treated in the hospital51 ; low-certainty evidence), although CIs included significant benefit and harm. Both interventions are widely available, and factors such as the route of administration (subcutaneous vs oral), cost, and coverage by health insurance will probably influence patients’ preferences. 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. In this case, the high mortality of patients with PE and hemodynamic compromise, as well as the potential lifesaving effect of thrombolytics, warranted a strong recommendation. Acute DVT may be treated in an outpatient setting with LMWH. Variables that may impact on decision making for the individual patient, particularly the patient with a first event considered high risk for recurrence, might include whether the second event occurred in the same vascular distribution as the first event, the presence (or absence) of an underlying hypercoagulable state, the development of hemorrhagic complications while on anticoagulant therapy, and/or the clinical severity of the second event (eg, massive PE vs popliteal DVT). Clinicians must make decisions on the basis of the clinical presentation of each individual patient, ideally through a shared decision-making process that considers the patient’s values and preferences with respect to the anticipated outcomes of the chosen option. The analysis suggested that an unlimited duration of standard-intensity anticoagulation was always more cost-effective. In the trial evaluating residual vein thrombosis by ultrasonography, participants in the intervention group received anticoagulation for an average of 4 to 5 months longer than did controls. The certainty in the evidence was judged very low for all of the relevant outcomes. However, new evidence may change the recommendations in the future, especially those based on low- or very-low-certainty evidence. Research priorities should focus on the identification of the subsets of patients who would potentially benefit from the use of compression stockings. The ASH guideline panel provided a strong recommendation for VKAs with an INR range of 2.0 to 3.0 over an INR range of 1.5 to 1.9. In the PREPIC 2 trial,231 among the 193 patients who received filters, 5 (2.6%) experienced access site hematoma, 3 (1.6%) experienced filter thrombosis, and 11 (5.7%) experienced retrieval failure for mechanical reasons. Strong recommendations include the use of thrombolytic therapy for patients with PE and hemodynamic compromise, use of an international normalized ratio (INR) range of 2.0 to 3.0 over a lower INR range for patients with VTE who use a vitamin K antagonist (VKA) for secondary prevention, and use of indefinite anticoagulation for patients with recurrent unprovoked VTE. This trial included adults with objectively confirmed DVT and/or PE who had been treated with a DOAC or VKA for 6 to 12 months and had not interrupted therapy for more than 7 days prior to randomization. Remarks: Thrombolysis is reasonable to consider for younger patients with submassive PE at low risk for bleeding. The single published randomized trial that evaluated efficacy was small and did not demonstrate clinical outcome improvements beyond cardiac hemodynamic parameters. In the subgroup analysis performed for DVT when using aspirin, the certainty in the evidence was judged moderate because of imprecision. The same occurred with the risk of DVT. LMWH was used in these reports for home management. The use of a lower-dose DOAC compared with a standard-dose DOAC was associated with a nonsignificant increase in the risk of nonfatal PE (RR, 1.25; 95% CI, 0.54-2.91; ARR, 1 more per 1000 patients; 95% CI, 2 fewer to 10 more; moderate-certainty evidence). There were significant subgroup effects with the different antithrombotic interventions on DVT outcome. The EtD framework is shown online at: https://guidelines.gradepro.org/profile/FFEF27C2-5C33-BB1B-B096-9624FCBB0456. Statements about the underlying values and preferences, as well as qualifying remarks accompanying each recommendation, are its integral parts and serve to facilitate more accurate interpretation. Three analyses showed that the extended strategy was cost-effective compared with limited antithrombotic therapy,112,270,271 whereas 1 analysis suggested that longer initial conventional-intensity anticoagulation with warfarin was cost-effective in younger patients and 3 months of anticoagulation was preferred in elderly patients (80-year-old subgroup).272 The panel considered that cost-effectiveness varies with patients, any risk factor(s) contributing to the increased risk of recurrent VTE, and the specific anticoagulant used. The use of either clinical probability adjusted or age adjusted D-dimer interpretation has led to … These guidelines are primarily intended to help clinicians make decisions about treatment alternatives. These trials reported the effect of antithrombotic therapy on mortality, VTE, and major bleeding. ASH staff supported panel appointments and coordinated meetings but had no role in choosing the guideline questions or determining the recommendations. in the hospital, the authors noted.). 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. Among these recommendations, the guideline panel strongly recommended We observed a nonsignificant mortality increase for patients randomized to receive IVC filters (RR, 1.12; 95% CI, 0.83-1.60; ARR, 9 more per 1000 patients; 95% CI, 10 fewer to 36 more; low-certainty evidence). The guideline does not cover pregnant women. An observational study suggested a higher level of patient satisfaction with a DOAC and a lower treatment burden than with LMWH or a VKA.273. The EtD framework is shown online at: https://guidelines.gradepro.org/profile/B7293C21-767F-B3F8-8BB2-A4E5173CDAC3. Therefore, special tests that can look for clots in the veins or in the lungs (imaging tests) are needed to diagnose DVT or PE. Participants were randomized to DOACs or to an initial treatment with LMWH (5-10 days) with dose-adjusted warfarin (INR range, 2.0-3.0). One Markov model272 compared an unlimited duration of conventional-intensity anticoagulation (INR range, 2.0-3.0) vs low-intensity anticoagulation (INR range, 1.5-2.0) with warfarin. Also, in the trial randomizing individuals with high D-dimer levels to continue or to stop anticoagulation, extended anticoagulation was associated with a higher risk for bleeding (RR, 3.49; 95% CI, 0.14-84.76; ARR, 24 more per 1000 patients; 95% CI, 8 fewer to 813 more; very-low-certainty evidence). 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. 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. However, when we considered only the trials with a low risk for bias, this potential benefit was not observed (RR, 1.01; 95% CI, 0.76-1.33). Thrombolytic therapy can be an appropriate intervention in selected patients with PE, as described in Recommendations 6 and 7, and can be administered systemically or using a catheter-directed approach. For patients with DVT and/or PE who have completed primary treatment and will continue VKA therapy as secondary prevention, the ASH guideline panel recommends using an INR range of 2.0 to 3.0 over a lower INR range (eg, 1.5-1.9) (strong recommendation based on moderate certainty in the evidence of effects ⨁⨁⨁○). The risk for recurrent VTE is low following completion of a course of anticoagulant therapy as primary treatment for patients who sustain a thromboembolism in the setting of a transient risk factor.268 Transient risk factors may be surgical or nonsurgical events (eg, hospitalization for an acute illness, estrogen therapy, or pregnancy), and, by definition, they resolve or can be discontinued (Table 3). Both of these were on the outcome when using VKA, LMWH, or DOAC. We developed our recommendations using the principles outlined by the Institute of Medicine and Guideline International Network.25-27 An article detailing the methods used to develop these guidelines has been published.360. The PESI1 and simplified PESI2 have been most widely validated. Our analysis showed a potential decrease in mortality when using indefinite antithrombotic therapy compared to a defined duration of anticoagulation, but without statistical significance (RR, 0.75; 95% CI, 0.49-1.13; ARR, 4 fewer per 1000 patients; 95% CI, 8 fewer to 2 more; moderate-certainty evidence). Some panelists disclosed new interests or relationships during the development process, but the balance of the majority was maintained. As documented above, although thrombolytic therapy may reduce mortality for patients with PE and hemodynamic compromise, it is also associated with an increased risk for major bleeding and intracranial bleeding. Introduction-GRADE evidence profiles and summary of findings tables, GRADE: an emerging consensus on rating quality of evidence and strength of recommendations, GRADE Guidelines: 16. Indefinite antithrombotic therapy also reduced the risk of DVT for patients with recurrent provoked VTE at 1 year269,324 (ARR, 25 fewer per 1000 patients; 95% CI, 27 fewer to 20 fewer). Additional factors that may be useful for evaluation of the individual patient would include whether a transient risk factor was also present prior to the event and whether the patient has comorbid conditions that may predispose toward an increased risk for bleeding complications.
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