TY - JOUR
T1 - International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs
AU - Parry, Blair Alden
AU - Chang, Anna Marie
AU - Schellong, Sebastian M.
AU - House, Stacey L.
AU - Fermann, Gregory J.
AU - Deadmon, Erin K.
AU - Giordano, Nicholas J.
AU - Chang, Yuchiao
AU - Cohen, Jason
AU - Robak, Nancy
AU - Singer, Adam J.
AU - Mulrow, Mary
AU - Reibling, Ellen T.
AU - Francis, Samuel
AU - Griffin, S. Michelle
AU - Prochaska, Jürgen H.
AU - Davis, Barbara
AU - McNelis, Patricia
AU - Delgado, Joao
AU - Kümpers, Philipp
AU - Werner, Nikos
AU - Gentile, Nina T.
AU - Zeserson, Eli
AU - Wild, Philipp S.
AU - Limkakeng, Alexander T.
AU - Walters, Elizabeth Lea
AU - LoVecchio, Frank
AU - Theodoro, Daniel
AU - Hollander, Judd E.
AU - Kabrhel, Christopher
N1 - Funding Information:
We performed a cross-sectional, observational study of consecutive ED patients with suspected DVT or PE in 24 centers (18 USA, 6 Europe). All enrolling centers were required to have access to diagnostic testing for VTE on site, including vascular imaging: computed tomography pulmonary angiography (CTPA), ventilation/perfusion (V/Q) scanning, venous ultrasound, or peripheral venography. Centers also were required to have clinical D-dimer testing, approved for the exclusion of VTE, available on site. This study was sponsored by Siemens Healthcare Diagnostics. The sponsor had no role in the analysis or interpretation of the data. The study protocol was approved by each participating institution's institutional review board.
Funding Information:
This work was supported by Siemens Healthcare Diagnostics, Inc (protocol #: SIEM-7205).
PY - 2018/6
Y1 - 2018/6
N2 - Introduction: We sought to determine the test characteristics of an automated INNOVANCE D-dimer assay for the exclusion of pulmonary embolism (PE) and deep venous thrombosis (DVT) in emergency department (ED) patients using standard and age-adjusted cut-offs. Methods: Cross-sectional, international, multicenter study of consecutive patients with suspected DVT or PE in 24 centers (18 USA, 6 Europe). Evaluated patients had low or intermediate Wells PE or DVT scores. For the standard cut-off, a D-dimer result <500 ng/ml was negative. For the age adjusted cut-off, we used the formula: Age (years) ∗ 10. The diagnostic standard was imaging demonstrating PE or DVT within 3 months. We calculated test characteristics using standard methods. We also explored modifications of the age adjustment multiplier. Results: We included 3837 patients and excluded 251. The mean age of patients evaluated for PE (n = 1834) was 48 ± 16 years, with 676 (37%) male, and 1081 (59%) white. The mean age of evaluated for DVT (n = 1752) was 53 ± 16 years, with 710 (41%) male, and 1172 (67%) white. D-dimer test characteristics for PE were: sensitivity 98.0%, specificity 55.4%, negative predictive value (NPV) 99.8%, positive predictive value (PPV) 11.4%, and for DVT were: sensitivity 92.0%, specificity 44.8%, NPV 98.8%, PPV 10.3%. Age adjustment increased specificity (59.6% [PE], 51.1% [DVT]), but increasing the age-adjustment multiplier decreased sensitivity without increasing specificity. Conclusions: INNOVANCE D-dimer is highly sensitive and can exclude PE and DVT in ED patients with low- and intermediate- pre-test probability. Age-adjustment increases specificity, without increasing false negatives.
AB - Introduction: We sought to determine the test characteristics of an automated INNOVANCE D-dimer assay for the exclusion of pulmonary embolism (PE) and deep venous thrombosis (DVT) in emergency department (ED) patients using standard and age-adjusted cut-offs. Methods: Cross-sectional, international, multicenter study of consecutive patients with suspected DVT or PE in 24 centers (18 USA, 6 Europe). Evaluated patients had low or intermediate Wells PE or DVT scores. For the standard cut-off, a D-dimer result <500 ng/ml was negative. For the age adjusted cut-off, we used the formula: Age (years) ∗ 10. The diagnostic standard was imaging demonstrating PE or DVT within 3 months. We calculated test characteristics using standard methods. We also explored modifications of the age adjustment multiplier. Results: We included 3837 patients and excluded 251. The mean age of patients evaluated for PE (n = 1834) was 48 ± 16 years, with 676 (37%) male, and 1081 (59%) white. The mean age of evaluated for DVT (n = 1752) was 53 ± 16 years, with 710 (41%) male, and 1172 (67%) white. D-dimer test characteristics for PE were: sensitivity 98.0%, specificity 55.4%, negative predictive value (NPV) 99.8%, positive predictive value (PPV) 11.4%, and for DVT were: sensitivity 92.0%, specificity 44.8%, NPV 98.8%, PPV 10.3%. Age adjustment increased specificity (59.6% [PE], 51.1% [DVT]), but increasing the age-adjustment multiplier decreased sensitivity without increasing specificity. Conclusions: INNOVANCE D-dimer is highly sensitive and can exclude PE and DVT in ED patients with low- and intermediate- pre-test probability. Age-adjustment increases specificity, without increasing false negatives.
KW - Age-adjustment
KW - D-dimer
KW - Deep vein thrombosis
KW - Emergency department
KW - Pulmonary embolism
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U2 - 10.1016/j.thromres.2018.04.003
DO - 10.1016/j.thromres.2018.04.003
M3 - Article
C2 - 29656169
AN - SCOPUS:85045389159
VL - 166
SP - 63
EP - 70
JO - Thrombosis Research
JF - Thrombosis Research
SN - 0049-3848
ER -