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Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study.
JAMA. 2014 Mar 19; 311(11):1117-24.JAMA

Abstract

IMPORTANCE

D-dimer measurement is an important step in the diagnostic strategy of clinically suspected acute pulmonary embolism (PE), but its clinical usefulness is limited in elderly patients.

OBJECTIVE

To prospectively validate whether an age-adjusted D-dimer cutoff, defined as age × 10 in patients 50 years or older, is associated with an increased diagnostic yield of D-dimer in elderly patients with suspected PE.

DESIGN, SETTINGS, AND PATIENTS

A multicenter, multinational, prospective management outcome study in 19 centers in Belgium, France, the Netherlands, and Switzerland between January 1, 2010, and February 28, 2013.

INTERVENTIONS

All consecutive outpatients who presented to the emergency department with clinically suspected PE were assessed by a sequential diagnostic strategy based on the clinical probability assessed using either the simplified, revised Geneva score or the 2-level Wells score for PE; highly sensitive D-dimer measurement; and computed tomography pulmonary angiography (CTPA). Patients with a D-dimer value between the conventional cutoff of 500 µg/L and their age-adjusted cutoff did not undergo CTPA and were left untreated and formally followed-up for a 3-month period.

MAIN OUTCOMES AND MEASURES

The primary outcome was the failure rate of the diagnostic strategy, defined as adjudicated thromboembolic events during the 3-month follow-up period among patients not treated with anticoagulants on the basis of a negative age-adjusted D-dimer cutoff result.

RESULTS

Of the 3346 patients with suspected PE included, the prevalence of PE was 19%. Among the 2898 patients with a nonhigh or an unlikely clinical probability, 817 patients (28.2%) had a D-dimer level lower than 500 µg/L (95% CI, 26.6%-29.9%) and 337 patients (11.6%) had a D-dimer between 500 µg/L and their age-adjusted cutoff (95% CI, 10.5%-12.9%). The 3-month failure rate in patients with a D-dimer level higher than 500 µg/L but below the age-adjusted cutoff was 1 of 331 patients (0.3% [95% CI, 0.1%-1.7%]). Among the 766 patients 75 years or older, of whom 673 had a nonhigh clinical probability, using the age-adjusted cutoff instead of the 500 µg/L cutoff increased the proportion of patients in whom PE could be excluded on the basis of D-dimer from 43 of 673 patients (6.4% [95% CI, 4.8%-8.5%) to 200 of 673 patients (29.7% [95% CI, 26.4%-33.3%), without any additional false-negative findings.

CONCLUSIONS AND RELEVANCE

Compared with a fixed D-dimer cutoff of 500 µg/L, the combination of pretest clinical probability assessment with age-adjusted D-dimer cutoff was associated with a larger number of patients in whom PE could be considered ruled out with a low likelihood of subsequent clinical venous thromboembolism.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01134068.

Authors+Show Affiliations

Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland.Department of Vascular Medicine, Amsterdam Medical Center, Amsterdam, the Netherlands.Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.Emergency Department, Centre Hospitalier Universitaire d'Angers, L'Université Nantes Angers Le Mans, Angers, France.Cliniques Universitaires Saint-Luc, Bruxelles, Belgium.Liège University Hospital, Liège, Belgium.Emergency Department, Geneva University Hospital, Geneva, Switzerland.Hôpital Européen Georges-Pompidou, Paris, France.Emergency Department, Brest University Hospital, Brest, France.Centre Hospitalier d'Agen, Agen, France.Centre Hospitalier d'Argenteuil, Argenteuil, France.Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.Centre Hospitalier de Morlaix, Morlaix, France.Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.Department of Internal Medicine, Flevoziekenhuis Hospital, Almere, the Netherlands.Department of Vascular Medicine, Amsterdam Medical Center, Amsterdam, the Netherlands.Rijnstate Hospital, Arnhem, the Netherlands.Maastricht University Medical Center, Maastricht, the Netherlands.Van Weel-Bethesda Hospital, Dirksland, the Netherlands.Amphia Hospital, Breda, the Netherlands.Department of Hematology, Erasmus University Medical Center, Rotterdam, the Netherlands.Department of Internal Medicine, Flevoziekenhuis Hospital, Almere, the Netherlands.Hôpital Européen Georges-Pompidou, Paris, France.Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland.Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.Department of Vascular Medicine, University Medical Center Groningen, Groningen, the Netherlands.Ottawa Health Research Institute, Ottawa, Canada23Centre d'Investigations Cliniques, Université de Brest, Brest, France.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

24643601

Citation

Righini, Marc, et al. "Age-adjusted D-dimer Cutoff Levels to Rule Out Pulmonary Embolism: the ADJUST-PE Study." JAMA, vol. 311, no. 11, 2014, pp. 1117-24.
Righini M, Van Es J, Den Exter PL, et al. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014;311(11):1117-24.
Righini, M., Van Es, J., Den Exter, P. L., Roy, P. M., Verschuren, F., Ghuysen, A., Rutschmann, O. T., Sanchez, O., Jaffrelot, M., Trinh-Duc, A., Le Gall, C., Moustafa, F., Principe, A., Van Houten, A. A., Ten Wolde, M., Douma, R. A., Hazelaar, G., Erkens, P. M., Van Kralingen, K. W., ... Le Gal, G. (2014). Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA, 311(11), 1117-24. https://doi.org/10.1001/jama.2014.2135
Righini M, et al. Age-adjusted D-dimer Cutoff Levels to Rule Out Pulmonary Embolism: the ADJUST-PE Study. JAMA. 2014 Mar 19;311(11):1117-24. PubMed PMID: 24643601.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. AU - Righini,Marc, AU - Van Es,Josien, AU - Den Exter,Paul L, AU - Roy,Pierre-Marie, AU - Verschuren,Franck, AU - Ghuysen,Alexandre, AU - Rutschmann,Olivier T, AU - Sanchez,Olivier, AU - Jaffrelot,Morgan, AU - Trinh-Duc,Albert, AU - Le Gall,Catherine, AU - Moustafa,Farès, AU - Principe,Alessandra, AU - Van Houten,Anja A, AU - Ten Wolde,Marije, AU - Douma,Renée A, AU - Hazelaar,Germa, AU - Erkens,Petra M G, AU - Van Kralingen,Klaas W, AU - Grootenboers,Marco J J H, AU - Durian,Marc F, AU - Cheung,Y Whitney, AU - Meyer,Guy, AU - Bounameaux,Henri, AU - Huisman,Menno V, AU - Kamphuisen,Pieter W, AU - Le Gal,Grégoire, PY - 2014/3/20/entrez PY - 2014/3/20/pubmed PY - 2014/3/25/medline SP - 1117 EP - 24 JF - JAMA JO - JAMA VL - 311 IS - 11 N2 - IMPORTANCE: D-dimer measurement is an important step in the diagnostic strategy of clinically suspected acute pulmonary embolism (PE), but its clinical usefulness is limited in elderly patients. OBJECTIVE: To prospectively validate whether an age-adjusted D-dimer cutoff, defined as age × 10 in patients 50 years or older, is associated with an increased diagnostic yield of D-dimer in elderly patients with suspected PE. DESIGN, SETTINGS, AND PATIENTS: A multicenter, multinational, prospective management outcome study in 19 centers in Belgium, France, the Netherlands, and Switzerland between January 1, 2010, and February 28, 2013. INTERVENTIONS: All consecutive outpatients who presented to the emergency department with clinically suspected PE were assessed by a sequential diagnostic strategy based on the clinical probability assessed using either the simplified, revised Geneva score or the 2-level Wells score for PE; highly sensitive D-dimer measurement; and computed tomography pulmonary angiography (CTPA). Patients with a D-dimer value between the conventional cutoff of 500 µg/L and their age-adjusted cutoff did not undergo CTPA and were left untreated and formally followed-up for a 3-month period. MAIN OUTCOMES AND MEASURES: The primary outcome was the failure rate of the diagnostic strategy, defined as adjudicated thromboembolic events during the 3-month follow-up period among patients not treated with anticoagulants on the basis of a negative age-adjusted D-dimer cutoff result. RESULTS: Of the 3346 patients with suspected PE included, the prevalence of PE was 19%. Among the 2898 patients with a nonhigh or an unlikely clinical probability, 817 patients (28.2%) had a D-dimer level lower than 500 µg/L (95% CI, 26.6%-29.9%) and 337 patients (11.6%) had a D-dimer between 500 µg/L and their age-adjusted cutoff (95% CI, 10.5%-12.9%). The 3-month failure rate in patients with a D-dimer level higher than 500 µg/L but below the age-adjusted cutoff was 1 of 331 patients (0.3% [95% CI, 0.1%-1.7%]). Among the 766 patients 75 years or older, of whom 673 had a nonhigh clinical probability, using the age-adjusted cutoff instead of the 500 µg/L cutoff increased the proportion of patients in whom PE could be excluded on the basis of D-dimer from 43 of 673 patients (6.4% [95% CI, 4.8%-8.5%) to 200 of 673 patients (29.7% [95% CI, 26.4%-33.3%), without any additional false-negative findings. CONCLUSIONS AND RELEVANCE: Compared with a fixed D-dimer cutoff of 500 µg/L, the combination of pretest clinical probability assessment with age-adjusted D-dimer cutoff was associated with a larger number of patients in whom PE could be considered ruled out with a low likelihood of subsequent clinical venous thromboembolism. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01134068. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/24643601/Age_adjusted_D_dimer_cutoff_levels_to_rule_out_pulmonary_embolism:_the_ADJUST_PE_study_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2014.2135 DB - PRIME DP - Unbound Medicine ER -