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<p>Evidence Report/Technology AssessmentNumber 68</p> <p>Diagnosis and Treatment of Deep Venous Thrombosis and Pulmonary Embolism</p> <p>Agen cy for H ealthca re Resea rch an d Qu ality</p> <p>This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. Endorsement by the Agency for Healthcare Research and Quality (AHRQ) or the U.S. Department of Health and Human Services (DHHS) of such derivative products may not be stated or implied. AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidencebased information on health care outcomes; quality; and cost, use, and access. The information helps heath care decisionmakerspatients and clinicians, health system leaders, and policymakersmake more informed decisions and improve the quality of health care services.</p> <p>Evidence Report/Technology AssessmentNumber 68</p> <p>Diagnosis and Treatment of Deep Venous Thrombosis and Pulmonary Embolism</p> <p>Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 2101 East Jefferson Street Rockville, MD 20852 http://www.ahrq.gov Contract No. 290-97-0007 Prepared by: The Johns Hopkins University Evidence-based Practice Center Jodi B. Segal, MD, MPH John Eng, MD Mollie W. Jenckes, MHSc, BSN Leonardo J. Tamariz, MD, MPH Dennis T. Bolger, MD, MPH Jerry A. Krishnan, MD Michael B. Streiff, MD Kirk A. Harris, BA Carolyn J. Feuerstein Eric B. Bass, MD, MPH Investigators</p> <p>AHRQ Publication No. 03-E016 March 2003</p> <p>ISBN: 1-58763-079-6 ISSN: 1530-4396</p> <p>PrefaceThe Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome written comments on this evidence report. They may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852.</p> <p>Carolyn Clancy, M.D. Director Agency for Healthcare Research and Quality</p> <p>Robert Graham, M.D. Director, Center for Practice and Technology Assessment Agency for Healthcare Research and Quality</p> <p>The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.</p> <p>iii</p> <p>Structured AbstractObjectives. Venous thromboembolism (VTE), thrombosis in the venous vasculature, causes considerable morbidity and mortality, and diagnosis and treatment are challenging. In this report we sought to summarize evidence on the following questions: 1) What are the efficacy and safety of low molecular weight heparin (LMWH) compared to unfractionated heparin (UFH) for treatment of deep venous thrombosis (DVT)? 2) What are the efficacy and safety of LMWH compared to UFH for treatment of pulmonary embolism (PE)? 3) What are the efficacy, safety, and cost-effectiveness of outpatient versus inpatient treatment of DVT with LMWH or UFH? 4) What is the optimal duration of treatment for DVT and PE? 5) How accurate are clinical prediction rules used for the diagnosis of DVT or PE? 6) What are the test characteristics of ultrasonography for diagnosis of DVT? 7) What are the test characteristics of helical computerized tomography (CT), magnetic resonance imaging (MRI), and magnetic resonance angiography (MRA) for diagnosis of PE? 8) What are the test characteristics of D-dimer for diagnosis of VTE? Search Strategy. The Johns Hopkins University Evidence-based Practice Center (EPC) team searched electronic databases for literature from January 1966 to April 2002. The team identified additional articles by hand-searching relevant journals and reference lists, and by querying experts. Selection Criteria. Paired investigators reviewed the abstracts of identified citations to select original studies and systematic reviews that addressed the questions, reported on human subjects, and were written in English. Each question had additional eligibility criteria. Data Collection and Analysis. Paired reviewers assessed the quality of each eligible study and abstracted data. Main Results. The search identified 64 original studies and 29 systematic reviews that addressed the questions. Results were as follows: 1) The evidence indicated that LMWH was more efficacious than UFH in reducing thrombus extension and recurrence in patients with DVT, with less risk of major bleeding and death. 2) Evidence was limited but supported the efficacy and safety of LMWH for the treatment of PE. 3) LMWH for outpatient treatment of DVT was safe and effective in carefully selected patients. LMWH was either cost-saving or cost-effective compared with inpatient treatment with UFH. 4) The evidence indicated that the optimal duration of oral anticoagulation after a first DVT is between three and six months. A longer duration may be necessary for patients with thrombophilic risk factors or PE. 5) Clinical prediction rules had high negative predictive values for excluding DVT, and moderately high predictive values for excluding PE. 6) Ultrasonography had high sensitivity and specificity for diagnosing proximal DVT, but was less accurate for diagnosis of calf vein thrombosis. 7) Helical CT was fairly sensitive and had high specificity for detecting PE. MRA was accurate in detecting PE of the lobar and segmental branches of pulmonary arteries. 8) The literature was too varied to make conclusions about the accuracy and role of D-dimer for diagnosis or exclusion of VTE. v</p> <p>Conclusions. Relatively strong evidence exists to support the efficacy, safety, and costeffectiveness of LMWH for treatment of DVT, as an inpatient or outpatient therapy. Moderate evidence exists to define the optimal duration of oral anticoagulation for patients with DVT. Less evidence exists regarding duration of treatment for PE. Strong evidence indicates that ultrasonography is accurate for diagnosing proximal DVT, while moderate evidence exists to support a role for clinical prediction rules for diagnosis of DVT or PE, and for helical CT or MRA for diagnosis of PE.</p> <p>This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Suggested Citation: Segal JB, Eng J, Jenckes MW, et al. Diagnosis and Treatment of Deep Venous Thrombosis and Pulmonary Embolism. Evidence Report/Technology Assessment Number 68. (Prepared by Johns Hopkins University Evidence-based Practice Center under Contract No. 290-97-0007.) AHRQ Publication No. 03-E016. Rockville, MD: Agency for Healthcare Research and Quality. March 2003.</p> <p>vi</p> <p>Agency for Healthcare Research and Quality</p> <p>Evidence Report/Technology AssessmentNumber 68</p> <p>Diagnosis and Treatment of Deep Venous Thrombosis and Pulmonary EmbolismSummary</p> <p>OverviewVenous thromboembolism (VTE) refers to all forms of pathologic thrombosis occurring on the venous side of the circulation, the most common of which is deep venous thrombosis (DVT) of the lower extremities. The most life-threatening manifestation of VTE is embolization of venous thrombi to the pulmonary circulation pulmonary embolism (PE). The occurrence of VTE is generally triggered by a confluence of environmental and constitutional risk factors. VTE and its complications are a common cause of morbidity and mortality in the United States. Researchers have estimated that the average annual incidence of isolated DVT is 50 per 100,000 people and for PE, with or without DVT, the incidence is 70 per 100,000. Others estimate the incidence as being higher and suggest that 450,000 cases of DVT (350,000 cases of non-fatal PE, and 250,000 cases of fatal PE) may occur annually in the United States. The reference standard for VTE diagnosis remains clot visualization with contrast venography or pulmonary angiography. However, the invasiveness and the risks of these modalities have led to a steady increase in the use of noninvasive or minimally invasive VTE testing. All of these tests are optimally used after clinical examination and estimation of the pre-test likelihood of disease. When VTE has been diagnosed, acute management usually involves anticoagulation with intravenous unfractionated heparin (UFH), or more recently, subcutaneous low molecular weight heparin (LMWH), to prevent further clot formation and allow endogenous thrombolysis to proceed. Thrombolytic therapy with intravenous</p> <p>tissue plasminogen activator, urokinase, or streptokinase typically has been reserved for patients with life threatening pulmonary embolism. Once adequate anticoagulation is achieved with heparin, patients switch to oral anticoagulants (e.g., warfarin) for months to years to decrease the risk of recurrent VTE. Although anticoagulants are effective in treating VTE, they are also associated with an increased risk of serious bleeding complications.</p> <p>Reporting the EvidenceWith recent technological advances in diagnosis of VTE and the availability of new pharmacological therapies, a number of questions require careful evaluation of the evidence to guide clinical practice and policy-making. This report addresses the following questions regarding the diagnosis and treatment of VTE. Treatment 1. What are the efficacy and safety of LMWH compared with UFH for the treatment of DVT? The main outcomes of interest were death, recurrent VTE, and bleeding complications. 2. What are the efficacy and safety of LMWH compared with UFH for treatment of PE? The outcomes of interest were the same as for question 1. 3a. What are the efficacy and safety of outpatient versus inpatient treatment of DVT with LMWH or UFH? The clinical outcomes of interest were the same as for question 1.</p> <p>U . S . D E PA R T M E N T O F H E A LT H A N D H U M A N S E R V I C E S P u b l i c H e a l t h S e r v i c e</p> <p>3b. What is the cost-effectiveness of outpatient versus inpatient treatment of DVT with LMWH or UFH? The outcomes of interest included all costs to society in addition to the above mentioned clinical outcomes. 4. What is the optimal duration of treatment for DVT and PE in patients without known thrombophilic disorders and in patients with thrombophilic disorders? The main outcomes of interest again were death, recurrent VTE, and bleeding complications. Diagnosis 5. How accurate are clinical prediction rules used for the diagnosis of DVT or PE? The review focused on prediction rules that were based on at least two of the following types of clinical information: medical history, physical examination, and blood tests. 6a. What are the test characteristics of ultrasonography for diagnosis of DVT? The review focused on the sensitivity, specificity, and predictive values of ultrasonography. 6b. Are calf vein thromboses adequately identified with ultrasound? The review for this question also focused on the sensitivity, specificity, and predictive values of ultrasonography. 7a. What are the test characteristics of helical computed tomography (CT) for diagnosis of PE relative to ventilation/perfusion (V/Q) scanning or standard angiography? 7b. What are the test characteristics of magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) for diagnosis of PE relative to V/Q scanning and/or standard angiography? The review focused on the sensitivity, specificity, and predictive values of these radiologic tests (7a and 7b). 8. What are the test characteristics of D-dimer for diagnosis of VTE? The review focused on the sensitivity, specificity, and predictive values of this blood test.</p> <p>methodology, an allied health professional, and representatives of private and governmental payers. Literature Search The EPC team searched several literature indexing systems to identify articles relevant to the review. These included MEDLINE, MICROMEDEX, the Cochrane Controlled Trials Register, and the Cochrane Database of Systematic Reviews. To ensure a comprehensive literature search and identification of all relevant articles, the EPC team also examined the reference lists from articles identified through the electronic searching, queried the technical experts, and reviewed the table of contents of recent issues of relevant journals. Two members of the EPC team independently reviewed the abstracts identified by the search to exclude those that did not meet the eligibility criteria. Primary studies were eligible if they addressed one of the key questions, included original human data, were not limited to prevention of VTE, were not case reports, and were written in the English language. Reviews were eligible for inclusion in the report if they used a systematic approach to searching and synthesizing the literature on one of the key questions. Individual key questions had additional exclusion criteria. When two reviewers agreed that an abstract was not eligible, it was excluded from further review. The EPC team discovered that the primary literature had been systematically reviewed in some detail for questions 1, 2, 6a, 6b, 7a, and 8. To avoid replication of earlier work, team members systematically reviewed the reviews on these questions. They extracted the results of the reviews and reported the aggregate effect measures. For questions 3a, 3b, 4, 5, an...</p>