For long-distance travelers at increased risk for VTE, the ACCP recommended 15- to 30-mm Hg below-knee graduated compression stockings, frequent ambulation, calf muscle exercise, or sitting in an aisle seat. For policy makers: policy making will require substantial debate and involvement of various stakeholders. February 2017; DOI: 10.36290/int.2017.002. The panel made a strong recommendation for using pharmacological prophylaxis, although the exact magnitude of the mortality benefit is still in question. In ambulatory population-based cohorts, the estimated 28-day mortality for a first episode of symptomatic VTE is 11%.163. In acutely ill hospitalized medical patients, the ASH guideline panel recommends inpatient VTE prophylaxis with LMWH only, rather than inpatient and extended duration outpatient VTE prophylaxis with DOACs (strong recommendation, moderate certainty in the evidence of effects ⊕⊕⊕◯). For proximal and distal symptomatic DVT, we applied an RR of 0.62 (95% CI, 0.36-1.05), which was the RR for any symptomatic DVT in the studies. Development of these guidelines was wholly funded by ASH, a nonprofit medical specialty society that represents hematologists. The panel rated adverse effects of mechanical prophylaxis, such as risk of falls, ischemia, and limb ulceration, as important, but not critical, for decision making. Four studies utilizing enoxaparin (1 study) or a DOAC (3 studies) for extended prophylaxis reported the effect of extended vs in-hospital–only pharmacological prophylaxis on the development of nonfatal PE, symptomatic proximal DVT, major bleeding, and mortality42,140,141,145 ; 3 studies reported the development of symptomatic distal DVT,42,140,141 and 1 study145 assessed the risk of developing HIT. Future research should address: Tools for quantitative risk assessment for VTE and bleeding in critically ill medical patients; and. 1,2. The EtD framework is shown at https://dbep.gradepro.org/profile/FDD22673-C5BB-8A63-A715-5D225B808EA2. The evidence suggested no important reduction in VTE but increased bleeding with use of LMWH in 1 study. 0000070199 00000 n
Guidelines for prescribing, monitoring and management Oral Anticoagulants Guideline for prescribing, monitoring and management V3 Author: Alice Foster, Dr Dasgupta Approved by MCGT October 2015 Review by: October 2018 1.0 Clinical Guidance Anticoagulants are one of the classes of medicines which frequently cause harm and With a baseline risk of 0.5% for proximal DVT, this translated to an ARR of 1 fewer per 1000 (95% CI, 1 fewer to 2 more per 1000). We identified 1 systematic review evaluating the risk of a symptomatic DVT event within 4 weeks of flights longer than 4 hours. For each guideline question, the McMaster GRADE Centre prepared a GRADE Evidence-to-Decision (EtD) framework, using the GRADEpro Guideline Development Tool (https://gradepro.org).12,13,18 The EtD table summarized the results of systematic reviews of the literature that were updated or performed for these guidelines. ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. People without known VTE risk factors who place a high value on prevention of VTE may choose to use graduated compression stockings. No studies reported on the risk of gastrointestinal bleeding specifically. HIT was probably decreased with LMWH vs UFH, with an RR of 0.42 (95% CI, 0.15-1.18) and an ARR of 3 fewer per 1000 (95% CI, 5 fewer to 1 more per 1000). Of the 3 included studies, 2 of them115,117 assessed the effect of LMWH, whereas 1 study117 assessed the effect of UFH. In people who are at substantially increased VTE risk (eg, recent surgery, history of VTE, postpartum women, active malignancy, or ≥2 risk factors, including combinations of the above with hormone replacement therapy, obesity, or pregnancy), the ASH guideline panel suggests using graduated compression stockings or prophylactic LMWH for long-distance (>4 hours) travel (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). We found 1 systematic review of 9 RCTs that addressed the impact of graduated compression stockings compared with not using stockings in long-distance travelers.165 We did not find additional studies addressing this question. LMWH showed reductions in PE, symptomatic DVT, major bleeding, and HIT compared with UFH, but the estimates were imprecise, with small ARRs (see evidence profile in the online EtD framework). 0000002896 00000 n
For DVT, the RR was 0.87 (95% CI, 0.60-1.25). The panel prioritized clinical questions and outcomes according to their importance for clinicians and adult patients. #### What you need to know Venous thromboembolism includes deep vein thrombosis (DVT) and pulmonary embolism. Rapid diagnosis and treatment of DVT is essential to prevent these complications. The study reported an increase in thrombocytopenia (RR, 4.89; 95% CI, 0.24-98.96), but this increase was very imprecise, and the panel considered thrombocytopenia an important, but not critical, outcome for decision making. The panel assumed that avoidance of death, PE, and DVT was critical or important for decision making to patients. Part C summarizes ASH decisions about which interests were judged to be conflicts. These guidelines are intended to support patients, clinicians, and health care professionals in VTE diagnosis. The mortality RR was 0.89 (95% CI, 0.78-1.02), and ARR was 32 fewer per 1000 (95% CI, from 64 fewer to 6 more per 1000). 0000003603 00000 n
All studies included acutely ill medical inpatients, with 16 of the trials specifically including stroke patients.68-82 The panel also considered the randomized controlled trial (RCT) by Cohen et al28 that compared fondaparinux against no parenteral anticoagulation and felt that the results were similar enough to include fondaparinux with UFH and LMWH. The panel judged that the cost of pharmacological prophylaxis for this patient group would be moderate, and it could lead to inequity, because not all patient groups would be likely to receive pharmacological prophylaxis as the result of challenges with widespread implementation in nursing homes. This document may also serve as the basis for adaptation by local, regional, or national guideline panels. The panel prioritized symptomatic over asymptomatic VTE, and the latter were included in the trial end points. 0000123556 00000 n
The panel assumed that avoidance of PE, DVT, and bleeding events was critical or important to patients for decision making but that using extended prophylaxis could cause inequity because of concerns about cost and the ability to self-inject. For clinicians: different choices will be appropriate for individual patients, and clinicians must help each patient arrive at a management decision consistent with the patient's values and preferences. The absolute risk reduction in VTE may be higher in high-risk VTE patients, and the benefits may outweigh the harms among patients at increased risk of bleeding. On occasion, a strong recommendation is based on low or very low certainty in the evidence. They may also be used by patients. The panel suggested that future research should address: DOAC use among medical inpatients or for extended prophylaxis after discharge in larger trials assessing symptomatic VTE and bleeding end points, and in more selected patients based on predicted risk of VTE and of bleeding; and, Evaluation of lower-dose DOAC regimens in medical inpatients or for extended use after discharge, to determine whether this might mitigate bleeding risk while preventing VTE.143. The EtD framework is shown at https://dbep.gradepro.org/profile/B7E7908E-FFD0-19C4-862E-16561BEC51FE. 0000007538 00000 n
There are 5 other recent guidelines available on the prevention of VTE in medical patients: the 2011 American College of Physicians guidelines,169 the 2012 American College of Chest Physicians (ACCP) guidelines,170 the 2013 update from the International Union of Angiology (IUA),24 the 2017 update from the Asian Venous Thrombosis Forum,171 and the 2018 National Institute for Health and Care Excellence guidelines.172 The Agency for Healthcare Research and Quality in the United States also provides a guide for implementing effective quality improvement in this area.173 Two major differences between the ASH guidelines and many of the others is the consistent use of systematic reviews and EtDs, which increases transparency, and the use of marker states to estimate the relative importance of key outcomes of treatment to patients. 0000019023 00000 n
PDF | The review article ... 10th edition of the ACCP guidelines for diagnosis and treatment of venous thromboembolism. Studies of pneumatic compression devices compared with graduated compression stockings are needed in acutely or critically ill medical patients with contraindications to pharmacological prophylaxis or those at high bleeding risk. None of the 5 trials reported serious adverse effects of wearing the stockings, but in 1 trial, 4 patients developed varicose vein thrombosis, possibly as a result of the stockings.165 The panel was concerned about potential allergy to the stocking material, but this adverse effect was not reported in the trials. Objective: These evidence-based guidelines are intended to support patients, clinicians, and health care professionals in VTE diagnosis. Question: Should extended-duration pharmacological VTE prophylaxis after discharge (ie, up to 30 or 40 days) vs in-hospital–only pharmacological VTE prophylaxis be used in acutely ill hospitalized medical patients? 0000004341 00000 n
For new reviews, risk for bias was assessed at the health outcome level using the Cochrane Collaboration’s risk for bias tool for randomized trials or nonrandomized studies. The guideline panel determined that there is very low certainty in the balance between desirable and undesirable health effects of combined mechanical and pharmacological prophylaxis compared with mechanical prophylaxis alone in acutely or critically ill medical patients. M.C. Proper use of graduated compression stockings might require support in the elderly and people with disabilities, but stockings on a population level were considered probably feasible. VTE in hospitalized and nonhospitalized medical patients and long-distance travelers confers an important disease burden and can be fatal. With a baseline risk of 0.4%, the ARR for PE was 1 fewer per 1000 (95% CI, from 2 fewer to 2 more per 1000). In 2014, in response to long-standing member interest, ASH initiated an effort to develop evidence-based clinical practice guidelines for hematology that meet the highest standards of development, rigor and trustworthiness. Several VTE risk factors (eg, cancer, plaster casts, hormone replacement therapy, oral contraceptives, and pregnancy) multiplicatively increase the risk of air travel–related VTE.162 For example, pregnant women who traveled by air had an odds ratio (OR) for VTE of 14.3 (95% CI, 1.7-121.0) compared with an OR of 4.3 (95%, 0.9-19.8) associated with pregnancy alone.164 Women who traveled by air while using oral contraceptives had an 8.2-fold (95% CI, 2.3-28.7) elevated risk for VTE compared with nontravelers who were not on contraceptives, whereas the risk with oral contraceptives alone was increased 2.5-fold (95% CI, 0.9-7.0).162. Overall, the certainty in these estimated effects was very low owing to very serious imprecision and serious indirectness of the estimates (see evidence profile and online EtD framework). The ACCP and the ASH panel considered long-distance travelers and advised against prophylaxis for persons without risk factors. trailer
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A myth-busters review using the patient safety net database, Rivaroxaban for thromboprophylaxis in acutely ill medical patients, Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients, Venous thromboembolism in older adults: A community-based study, The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. 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. The recommendation is supported by credible research or other convincing judgments that make additional research unlikely to alter the recommendation. These guidelines are not intended to serve or be construed as a standard of care. 0000017198 00000 n
The panel followed best practices for guideline development recommended by the Institute of Medicine and the Guidelines International Network (GIN).8-11 The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach12-18 to assess the certainty in the evidence and formulate recommendations. For at-risk medical or critically ill patients, LMWH, UFH twice daily or thrice daily, and fondaparinux were all recommended, with selection among these based on patient preference, compliance, and local factors related to formularies. The panel included hematologists, internists, other physicians, and a pharmacist who all had clinical and research expertise on the guideline topic; methodologists with expertise in evidence appraisal and guideline development; and 1 patient representative. Supplement 3 provides the complete “Disclosure of Interest” forms of researchers who contributed to these guidelines. 0000007147 00000 n
Guidelines aim to present all the relevant evidence on a particular clinical issue in order to help physicians to weigh the benefits and risks of a particular diagnostic or therapeutic procedure. In the 3 included trials, use of a DOAC compared with LMWH led to an increased risk for major bleeding (RR, 1.70; 95% CI, 1.02-2.82; ARI, 2 or 8 more hemorrhages per 1000 for 2 representative baseline risks of bleeding [low and high]). We defined acutely ill medical patients as patients hospitalized for a medical illness. VTE prophylaxis was administered by provider choice from among several medications and with or without concomitant compression stockings.36, Overall VTE hazard ratio (HR), 32 (95% CI, 4.1-251), VTE HR with prophylaxis, 0.13 (95% CI, 0.04-0.4), Incidence of major or clinically relevant nonmajor bleeding with prophylaxis = 1.6% (95% CI, 0.5-4.6). The guideline panel also explicitly took into account the extent of resource use associated with alternative management options. 0000027796 00000 n
The full-text version of this article contains a data supplement. Blood Adv 2018; 2 (22): 3198–3225. Compare combined mechanical and pharmacological prophylaxis with mechanical prophylaxis alone utilizing comparative effectiveness research studies. We did not address whether twice or thrice daily unfractionated heparin should be used when unfractionated heparin is chosen, because we did not develop a guideline question for this, there are little data, and there are no recent data. In acutely or critically ill medical patients, the ASH guideline panel suggests using mechanical alone over mechanical combined with pharmacological VTE prophylaxis (conditional recommendation, very low certainty in the evidence of effects ⊕◯◯◯). Decisions may be constrained by the realities of a specific clinical setting and local resources, including, but not limited to, institutional policies, time limitations, and availability of treatments. 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