The ASH panel addressed use of DOACs for inpatient and postdischarge prophylaxis in medical patients using data not available to other guideline groups and recommended against the use of DOACs over other treatments in the hospital. 0000011812 00000 n The guideline panel determined that there is very low certainty in the evidence that there are net desirable consequences from pharmacological prophylaxis compared with mechanical prophylaxis in acutely or critically ill medical patients. The panel felt that applying combined prophylaxis to all patients would mean that the undesirable consequences would likely outweigh the desirable consequences. 0000009376 00000 n 0000008698 00000 n Blood Adv 2018; 2 (22): 3198–3225. Extended duration of pharmacological prophylaxis (LMWH or DOAC) appeared to have no effect on mortality (RR, 1.00; 95% CI, 0.89-1.12; ARR, 0 per 1000; 95% CI, 5 fewer to 5 more per 1000). The panelists received no other payments. Part C summarizes ASH decisions about which interests were judged to be conflicts. Venous thromboembolism (VTE) is the third most common vascular disease. The certainty in these estimated effects was judged as low owing to the risk of bias and imprecision of the estimates. The American College of Physicians issued 2 additional recommendations: for the use of heparin or a related drug, unless patients were at high bleeding risk, and against use of graduated compression stockings. 0000010370 00000 n The ACCP advised not to use prophylaxis in medical patients at low risk of VTE, based on the Padua Prediction Score, or at high risk of bleeding. Framing the question and deciding on important outcomes, Nadroparin for the prevention of venous thromboembolism in nonsurgical patients: a systematic review and meta-analysis, Heparin for the prevention of venous thromboembolism in acutely ill medical patients (excluding stroke and myocardial infarction), Prevention of deep venous thrombosis and pulmonary embolism following stroke: a systematic review of published articles, How complete is the evidence for thromboembolism prophylaxis in general medicine patients? 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. 2 Jul 2017 2017 Thrombosis Canada To … More information on the optimal dosing of parenteral anticoagulation to prevent VTE in acutely or critically ill medical inpatients is needed. In absolute terms and on a population level, graduated compression stockings appeared to have very small and very uncertain effects on VTE, with an RR of 0.10 (95% CI, 0.04-0.25) extrapolated to all VTE events. For PE, the RR could not be calculated, because there were no events in the intervention and control groups. We did not identify any systematic review that addressed this question, but our systematic search for RCTs identified 1 RCT122  in acutely ill medical patients that provided limited evidence for this question. They should never be omitted when recommendations from these guidelines are quoted or translated. wrote the first draft of the manuscript and revised the manuscript based on authors’ suggestions; M.C. The guideline panel used indirect evidence from acutely ill medical patients that evaluated extended outpatient prophylaxis and determined that there is low certainty in the evidence for net health harm from that evidence in medical outpatients with minor provoking factors for VTE. Determination of the acceptable balance between bleeding and thrombosis risk in the context of selecting the optimal thromboprophylaxis in critically ill medical patients. The final guidelines, including recommendations, were reviewed and approved by all members of the panel. In acutely or critically ill medical patients, the ASH guideline panel suggests pharmacological VTE prophylaxis alone over mechanical combined with pharmacological VTE prophylaxis (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). In addition, the panel expressed caution about existing cost-effectiveness analyses that differed in their assumptions and input parameters from that used by the panel in the EtD. 0000050562 00000 n Members of the VTE Guideline Coordination Panel reviewed the disclosures and judged which interests were conflicts and should be managed. 0000031611 00000 n Five of 6 panelists without conflicts voted in favor of a strong recommendation over a conditional recommendation. Other EtD criteria were generally in favor of using LMWH so that the desirable consequences were greater than the undesirable consequences. The panel assumed that avoidance of death, VTE-related death, PE, DVT, and bleeding was critical or important to patients for decision making. sion of DVT on serial imaging for two weeks.8,10,11 Evidence supports outpatient treatment of PE if the risk of nonadherence is low and the patient is clinically It is not clear that patients with prior VTE are particularly susceptible to air travel–related VTE. The EtD framework is shown at https://dbep.gradepro.org/profile/DBB3AAE6-C0E9-1F2D-947D-4ED4A2B15E33. Determination of the acceptable balance between bleeding and thrombosis risk in the context of selecting the optimal VTE prophylaxis in critically ill medical patients, Net health benefit of mechanical prophylaxis in a lower risk medical inpatient population, Utility of outpatient use of mechanical prophylaxis in medical outpatients at risk of VTE, Direct comparisons between graduated compression stockings and pneumatic compression devices in acutely or critically ill medical inpatients, Impact of use of pneumatic compression devices in acutely or critically ill medical inpatients at high bleeding risk or with active bleeding, Better information on bleeding risk in acutely or critically ill medical inpatients to inform decisions about use of mechanical or pharmacological VTE prophylaxis, More direct evidence on combined mechanical and pharmacological prophylaxis compared with mechanical prophylaxis alone via clinical trials on efficacy, harms, and adherence to the intervention, particularly in high-risk medical inpatients in whom the balance of potential benefits vs harms might be more favorable than among lower-risk patients, Obtain patient preferences for mechanical or pharmacological prophylaxis in the hospital setting by studying feasibility, equity, and acceptability, Determine current utilization rate of combined mechanical and pharmacological prophylaxis in practice among acutely or critically ill medical inpatients, Provide more direct evidence on combined mechanical and pharmacological prophylaxis compared with mechanical prophylaxis alone via clinical trials on efficacy, harms and adherence to the intervention, particularly in high-risk medical inpatients in whom the balance of potential benefits vs harms might be more favorable than among lower-risk patients, Comparative effectiveness research on combined mechanical and pharmacological prophylaxis compared with mechanical prophylaxis alone in acutely or critically ill medical inpatients, Conduct trials of combined mechanical and pharmacological prophylaxis compared with pharmacological prophylaxis alone among very high risk patient groups, A systematic review of observational studies and a large comparative RCT are needed to increase the evidence available comparing pneumatic compression devices with graduated compression stockings in acutely or critically ill medical patients, Studies of pneumatic compression devices compared with graduated compression stockings in acutely or critically ill medical patients with contraindications to pharmacological prophylaxis or those at high bleeding risk, Study DOAC use among medical inpatients or for extended prophylaxis after discharge in larger trials assessing symptomatic VTE and bleeding end points in more selected patients based on predicted risk of VTE and of bleeding, Evaluation of lower-dose DOAC regimens in acutely ill medical inpatients or for extended use after discharge, to determine whether this might mitigate bleeding risk while preventing VTE, Trials of pharmacological or nonpharmacological interventions in selected high-risk medical patients at discharge, Studies that evaluate dose adjustments or lower doses of anticoagulants that might maximize benefit while minimizing harm when used for extended treatment to prevent VTE after hospital discharge among acutely or critically ill medical inpatients, Studies on identification of high-risk subgroups of chronically ill medical patients who could benefit from VTE prophylaxis, with consideration given to those who are immobilized, Studies of low-dose anticoagulant approaches, including use of DOACs or aspirin in chronically ill medical patients, Research on current clinical practices for VTE prevention and patient preferences for VTE prevention in chronically ill medical inpatients or nursing home residents, Development of risk-assessment methods to determine absolute risk of VTE in outpatients with minor provoking VTE risk factors, Trials of interventions (pharmacological or nonpharmacological) in a high-risk population of outpatients with minor provoking VTE risk factors, Risk-assessment methods to define travelers at sufficiently high VTE risk to warrant VTE prophylaxis intervention, Large pragmatic trials of interventions to prevent VTE in travelers, particularly those at high VTE risk, Evidence on effectiveness and safety of DOACs to prevent VTE in travelers at risk of VTE. Conflicts of interest of all participants were managed according to ASH policies based on recommendations of the Institute of Medicine45  and GIN.11  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). 0000059740 00000 n People without known VTE risk factors who place a high value on prevention of VTE may choose to use graduated compression stockings. The same RR was used for distal DVT, resulting in an ARR of 0 fewer per 1000 (95% CI, 1 fewer to 20 more per 1000) for a low-risk population and 0 fewer per 1000 (95% CI, 4 fewer to 61 more per 1000) for a high-risk population. Based on the modeling of low- and high-risk populations, the ARR for proximal DVT was 0 fewer per 1000 (95% CI, 0 fewer to 5 more per 1000) and 0 fewer per 1000 (95% CI, 1 fewer to 15 more per 1000), respectively. Seven studies reported the effect of mechanical prophylaxis vs pharmacological prophylaxis on risk of mortality.122,124-129  Seven studies reported the effect of mechanical prophylaxis vs pharmacological prophylaxis on development of symptomatic PE.121,122,124-127,129  Three studies reported the effect of mechanical prophylaxis vs pharmacological prophylaxis on development of symptomatic DVT.121,126,127  Seven studies reported the effect of mechanical prophylaxis vs pharmacological prophylaxis on risk of major bleeding.121,124-128,130  The EtD framework is shown at https://dbep.gradepro.org/profile/95794127-BD67-D33B-BCDA-3FF49A76A6F2. Sixteen RCTs reported on major bleeding (RR, 1.48; 95% CI, 0.81-2.71; ARR, 3 more per 1000; 95% CI, from 1 fewer to 12 more per 1000). Part D describes new interests disclosed by individuals after appointment. EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study, Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial, Rivaroxaban for thromboprophylaxis after hospitalization for medical illness, Can home prophylaxis for venous thromboembolism reduce mortality rates in patients with chronic obstructive pulmonary disease? In acutely ill medical patients, the ASH guideline panel suggests using UFH, LMWH, or fondaparinux rather than no parenteral anticoagulant (conditional recommendation, low certainty in the evidence of effects ⊕⊕◯◯). Study118 assessed the risk of major bleeding, and major bleeding because trials did not consider studies addressing as! Air travel–related VTE of graduated compression stockings and the corresponding recommendations and nonfinancial.! 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