Journal article
Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study.
- Righini M Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland.
- Van Es J Department of Vascular Medicine, Amsterdam Medical Center, Amsterdam, the Netherlands.
- Den Exter PL Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
- Roy PM Emergency Department, Centre Hospitalier Universitaire d'Angers, L'Université Nantes Angers Le Mans, Angers, France.
- Verschuren F Cliniques Universitaires Saint-Luc, Bruxelles, Belgium.
- Ghuysen A Liège University Hospital, Liège, Belgium.
- Rutschmann OT Emergency Department, Geneva University Hospital, Geneva, Switzerland.
- Sanchez O Hôpital Européen Georges-Pompidou, Paris, France.
- Jaffrelot M Emergency Department, Brest University Hospital, Brest, France.
- Trinh-Duc A Centre Hospitalier d'Agen, Agen, France.
- Le Gall C Centre Hospitalier d'Argenteuil, Argenteuil, France.
- Moustafa F Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.
- Principe A Centre Hospitalier de Morlaix, Morlaix, France.
- Van Houten AA Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.
- Ten Wolde M Department of Internal Medicine, Flevoziekenhuis Hospital, Almere, the Netherlands.
- Douma RA Department of Vascular Medicine, Amsterdam Medical Center, Amsterdam, the Netherlands.
- Hazelaar G Rijnstate Hospital, Arnhem, the Netherlands.
- Erkens PM Maastricht University Medical Center, Maastricht, the Netherlands.
- Van Kralingen KW Van Weel-Bethesda Hospital, Dirksland, the Netherlands.
- Grootenboers MJ Amphia Hospital, Breda, the Netherlands.
- Durian MF Department of Hematology, Erasmus University Medical Center, Rotterdam, the Netherlands.
- Cheung YW Department of Internal Medicine, Flevoziekenhuis Hospital, Almere, the Netherlands.
- Meyer G Hôpital Européen Georges-Pompidou, Paris, France.
- Bounameaux H Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland.
- Huisman MV Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
- Kamphuisen PW Department of Vascular Medicine, University Medical Center Groningen, Groningen, the Netherlands.
- Le Gal G Ottawa Health Research Institute, Ottawa, Canada23Centre d'Investigations Cliniques, Université de Brest, Brest, France.
- 2014-03-20
Published in:
- JAMA. - 2014
Acute Disease
Age Factors
Aged
Angiography
Diagnostic Errors
Emergency Service, Hospital
Europe
Female
Fibrin Fibrinogen Degradation Products
Humans
Male
Outpatients
Prevalence
Probability
Prospective Studies
Pulmonary Embolism
Reference Values
Risk
Sensitivity and Specificity
Venous Thromboembolism
English
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.
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1001/jama.2014.2135
- PMID 24643601
- Persistent URL
- https://folia.unifr.ch/global/documents/182538
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