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Diagnosis and Treatment of Deep Venous Thrombosis and Pulmonary Embolism
Evidence Reports/Technology Assessments, No. 68
Investigators: 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, and Eric B Bass, MD, MPH.
Structured Abstract
Objectives:
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.
Conclusions:
Relatively strong evidence exists to support the efficacy, safety, and cost-effectiveness 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.
Contents
- Preface
- Summary
- 1. Introduction
- 2. Methodology
- 3. Results
- 4. Conclusions
- 5. Future Research
- Q1. What are the efficacy and safety of LMWH compared with UFH for the treatment of DVT?
- Q2. What are the efficacy and safety of LMWH compared with UFH for treatment of PE?
- Q3a. What are the efficacy and safety of outpatient versus inpatient treatment of DVT with LMWH or UFH?
- Q3b. What is the cost-effectiveness of outpatient versus inpatient treatment of DVT with LMWH or UFH?
- Q4. What is the optimal duration of treatment for DVT and PE?
- Q5. How accurate are clinical prediction rules used for the diagnosis of DVT or PE?
- Q6a. What are the test characteristics of ultrasonography for diagnosis of DVT?
- Q6b. Are calf vein thromboses adequately identified with ultrasound?
- Q7. What are the test characteristics of helical CT, MRI, and MRA for diagnosis of PE relative to V/Q scanning and/or standard angiography?
- Q8. What are the test characteristics of D-dimer for diagnosis of VTE?
- Evidence Tables
- Appendixes
- Appendix A. Core Technical Experts and Peer Reviewers
- Appendix B. Priority Journals for Hand Searching
- Appendix C. Literature Search Strategies
- Appendix D. Abstract Review Form for Primary Literature
- Appendix E. Abstract Review Form for Systematic Reviews
- Appendix F. Quality Review Form for Key Questions 3 and 4
- Appendix G. Quality Review Form for Key Questions 5 and 7
- Appendix H. Quality Review Form for Key Questions 3b - costs
- Appendix I. Quality Review Form for Systematic Reviews
- Appendix J: Acronyms and Abbreviations
- Appendix K. Acknowledgments
- References
- Bibliography
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-97-0007. Prepared by: The Johns Hopkins University Evidence-based Practice Center.
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.
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 evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps heath care decisionmakers—patients and clinicians, health system leaders, and policymakers—make more informed decisions and improve the quality of health care services.
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.
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- Guidelines for diagnosis and treatment of deep venous thrombosis and pulmonary embolism.[Methods Mol Med. 2004]Guidelines for diagnosis and treatment of deep venous thrombosis and pulmonary embolism.Abdel-Razeq H, Qari M, Kristensen J, Alizeidah H, Al-Sayegh F, Marashi M, Alzeer A, Al-Amoudi O, Qutub H, Al-Humiadi AA, et al. Methods Mol Med. 2004; 93:267-92.
- Review Controversies in pulmonary embolism and deep venous thrombosis.[Am Fam Physician. 1999]Review Controversies in pulmonary embolism and deep venous thrombosis.Davidson BL. Am Fam Physician. 1999 Nov 1; 60(7):1969-80.
- Review Deep vein thrombosis and pulmonary embolism.[Lancet. 2016]Review Deep vein thrombosis and pulmonary embolism.Di Nisio M, van Es N, Büller HR. Lancet. 2016 Dec 17; 388(10063):3060-3073. Epub 2016 Jun 30.
- Diagnosis and Treatment of Deep Venous Thrombosis and Pulmonary EmbolismDiagnosis and Treatment of Deep Venous Thrombosis and Pulmonary Embolism
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