Vascular/Cirurgia Vascular/Circulação - Dímero-D para a exclusão de Trombose Venosa Aguda e Embolismo Pulmonar
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Vascular/Cirurgia Vascular/Circulação

Dímero-D para a exclusão de Trombose Venosa Aguda e Embolismo Pulmonar

06/07/2004

Uma revisão sistemática

Apesar da extensa literatura, o papel diagnóstico do dímero-D para trombose venosa profunda (TVP) ou embolismo pulmonar (EP) permanece obscuro, repercutindo em múltiplos estudos sobre o dímero-D com diferentes sensibilidades e variabilidade. Este estudo, recentemente publicado no Annals of Internal Medicine, teve como objetivo revisar sistematicamente os estudos sobre dímero-D que avaliaram sensibilidade, especificidade, razão de verossimilhança e variabilidade.

Estudos em todas as línguas foram identificados por buscas no PubMed de 1983 a janeiro de 2003 e EMBASE de 1988 a janeiro de 2003. Foram selecionados estudos em perspectiva que compararam o dímero-D com um padrão de referência. Os estudos de alta qualidade metodológica foram incluídos nas análises primárias; a análise de sensibilidade incluiu estudos adicionais mais fracos. Foram coletados dados sobre o método para dímero-D utilizado, o valor de corte e se os pacientes tinham suspeita de TVP ou EP.

Para TVP, o ensaio ELISA e ELISA rápido quantitativo dominaram a ordem de classificação para estes valores: sensibilidade de 0,96 (intervalo de confiança [IC] de 95%: 0,91 a 1,00) e razão de verossimilhança negativa de 0,12 (IC: 0,04 a 0,33); e sensibilidade de 0,96 (IC: 0,90 a 1,00) e razão de verossimilhança negativa de 0,09 (IC: 0,02 a 0,41), respectivamente. Para EP, o ELISA e ELISA rápido quantitativo também dominaram a ordem de classificação para estes valores: sensibilidade de 0,95 (IC: 0,85 a 1,00) e razão de verossimilhança negativa de 0,13 (IC: 0,03 a 0,58); e sensibilidade de 0,95 (IC: 0,83 a 1,00) e razão de verossimilhança negativa de 0,13 (IC: 0,02 a 0,84), respectivamente.

O ELISA e ELISA rápido quantitativo apresentaram razões de verossimilhança negativas que permitiram uma alta segurança na exclusão de TVP ou EP. Os valores de verossimilhança positivos (geralmente de 1,5 a 2,5), não aumentam muito a certeza de diagnóstico. As análises de sensibilidade não afetam estes achados. Embora muitos estudos avaliaram múltiplos métodos para dímero-D, os achados são baseados basicamente em comparações indiretas das características de desempenho do teste através dos estudos, o que foi considerado pelos autores como uma limitação do trabalho.

Os autores concluíram que os ELISAs em geral dominam a classificação comparativa entre os métodos para dímero-D para sensibilidade e razão de verossimilhança negativa, e que, por excluir embolismo pulmonar ou trombose venosa profunda, um resultado negativo no ELISA rápido quantitativo é tão útil diagnosticamente quanto uma varredura usual de pulmão ou achado negativo na ultra-sonografia dúplex.

D-Dimer for the Exclusion of Acute Venous Thrombosis and Pulmonary Embolism - Annals of Internal Medicine 2004; 140(8): 589-602.


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ARTICLE

D-Dimer for the Exclusion of Acute Venous Thrombosis and Pulmonary Embolism

A Systematic Review

Paul D. Stein, MD; Russell D. Hull, MBBS, MSc; Kalpesh C. Patel, MBBS; Ronald E. Olson, PhD; William A. Ghali, MD, MPH; Rollin Brant, PhD; Rita K. Biel, BSc; Vinay Bharadia, MSc; and Neeraj K. Kalra, MD

20 April 2004 | Volume 140 Issue 8 | Pages 589-602

Background: Despite extensive literature, the diagnostic role of D-dimer for deep venous thrombosis (DVT) or pulmonary embolism (PE) remains unclear, reflecting multiple D-dimer assays and concerns about differing sensitivities and variability.

Purpose: To systematically review trials that assessed sensitivity, specificity, likelihood ratios, and variability among D-dimer assays.

Data Sources: Studies in all languages were identified by searching PubMed from 1983 to January 2003 and EMBASE from 1988 to January 2003.

Study Selection: The researchers selected prospective studies that compared D-dimer with a reference standard. Studies of high methodologic quality were included in the primary analyses; sensitivity analysis included additional weaker studies.

Data Extraction: Two authors collected data on study-level factors: D-dimer assay used, cutoff value, and whether patients had suspected DVT or PE.

Data Synthesis: For DVT, the enzyme-linked immunosorbent assay (ELISA) and quantitative rapid ELISA dominate the rank order for these values: sensitivity, 0.96 (95% confidence limit [CL], 0.91 to 1.00), and negative likelihood ratio, 0.12 (CL, 0.04 to 0.33); and sensitivity, 0.96 (CL, 0.90 to 1.00), and negative likelihood ratio, 0.09 (CL, 0.02 to 0.41), respectively. For PE, the ELISA and quantitative rapid ELISA also dominate the rank order for these values: sensitivity, 0.95 (CL, 0.85 to 1.00), and negative likelihood ratio, 0.13 (CL, 0.03 to 0.58); and sensitivity, 0.95 (CL, 0.83 to 1.00), and negative likelihood ratio, 0.13 (CL, 0.02 to 0.84), respectively. The ELISA and quantitative rapid ELISA have negative likelihood ratios that yield a high certainty for excluding DVT or PE. The positive likelihood values, which are in the general range of 1.5 to 2.5, do not greatly increase the certainty of diagnosis. Sensitivity analyses do not affect these findings.

Limitations: Although many studies evaluated multiple D-dimer assays, findings are based largely on indirect comparisons of test performance characteristics across studies.

Conclusion: The ELISAs in general dominate the comparative ranking among the D-dimer assays for sensitivity and negative likelihood ratio. For excluding PE or DVT, a negative result on quantitative rapid ELISA is as diagnostically useful as a normal lung scan or negative duplex ultrasonography finding.


Editors' Notes

Editors' Notes

Context

  • Clinicians may not know which D-dimer assay is best for diagnosing deep venous thrombosis (DVT) or pulmonary embolism (PE).

Contribution

  • This meta-analysis summarizes data from 78 prospective studies that compared results of different D-dimer assays with findings of objective tests (for example, compression ultrasonography, venography, lung scanning) in patients with suspected DVT or PE. Enzyme-linked immunosorbent assays (ELISAs) had the best sensitivity (about 95%) and negative likelihood ratios (about 0.1) for excluding DVT and PE. None of the assays had positive likelihood values that greatly increased the certainty of diagnosis.

Implications

  • Negative ELISA results are strong evidence against DVT or PE.

–The Editors

 

Author and Article Information

From Saint Joseph Mercy-Oakland, Pontiac, Michigan; Wayne State University, Detroit, Michigan; University of Calgary, Calgary, Alberta, Canada; and Oakland University, Rochester, Michigan.

Acknowledgments: The authors thank Natasha Burke, BSc, Adrian Jorgenson, BSc, and Jeanne Sheldon, BA, University of Calgary, for their assistance in preparing the manuscript and Trupti Patel, BS, for her help in analyzing the data.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Paul D. Stein, MD, Saint Joseph Mercy-Oakland, 44555 Woodward Avenue, Suite 107, Pontiac, MI 48341; e-mail, steinp@trinity-health.org.

Current Author Addresses: Dr. Stein: Saint Joseph Mercy-Oakland, 44555 Woodward Avenue, Suite 107, Pontiac, MI 48341.

Dr. Hull and Ms. Biel: Thrombosis Research Unit, University of Calgary, 601 South Tower, Foothills Hospital, 1403 29 Street Northwest, Calgary, Alberta T2N 2T9, Canada.

Dr. Patel: 712 Indian Creek Drive, Wilkes Park, PA 18702.

Dr. Olson: Office of the Vice Provost for Research and Graduate Studies, Oakland University, 520 O'Dowd Hall, Rochester, MI 48309-4401.

Dr. Ghali: University of Calgary, 3330 Hospital Drive Northwest, Calgary, Alberta T2N 4N1, Canada.

Dr. Brant: University of Calgary, 3310 Hospital Drive Northwest, Calgary, Alberta T2N 1N4, Canada.

Mr. Bharadia: University of Victoria, Cornett Building A238, 3800 Finnerty Road (Ring Road), Victoria, British Columbia V8P 5C2, Canada.

Dr. Kalra: Detroit Medical Center, Wayne State University, 4201 St. Antoine Street, Detroit, MI 48201.

Author Contributions: Conception and design: P.D. Stein, R.D. Hull, V. Bharadia.

Analysis and interpretation of the data: P.D. Stein, R.D. Hull, R.E. Olson, W.A. Ghali, R. Brant, R.K. Biel, V. Bharadia, N.K. Kalra.

Drafting of the article: P.D. Stein, R.D. Hull, R.E. Olson, R. Brant, R.K. Biel, V. Bharadia.

Critical revision of the article for important intellectual content: P.D. Stein, R.D. Hull, R.E. Olson, W.A. Ghali, R. Brant, V. Bharadia.

Final approval of the article: P.D. Stein, R.D. Hull, W.A. Ghali.

Provision of study materials or patients: P.D. Stein, R.D. Hull, V. Bharadia.

Statistical expertise: P.D. Stein, R.D. Hull, R.E. Olson, W.A. Ghali, R. Brant.

Obtaining of funding: P.D. Stein, R.D. Hull.

Administrative, technical, or logistic support: P.D. Stein, R.D. Hull, R.K. Biel, V. Bharadia.

Collection and assembly of the data: P.D. Stein, R.D. Hull, K.C. Patel, R.K. Biel, V. Bharadia, N.K. Kalra.


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