International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs.

Parry, Blair Alden

Chang, Anna Marie

Schellong, Sebastian M

House, Stacey L

Fermann, Gregory J

Deadmon, Erin K

Giordano, Nicholas J

Chang, Yuchiao

Cohen, Jason

Robak, Nancy

Singer, Adam J

Mulrow, Mary

Reibling, Ellen T

Francis, Samuel

Griffin, S Michelle

Prochaska, Jürgen H

Davis, Barbara

McNelis, Patricia

Delgado, Joao

Kümpers, Philipp

Werner, Nikos

Gentile, Nina T

Zeserson, Eli

Wild, Philipp S

Limkakeng, Alexander T

Walters, Elizabeth Lea

LoVecchio, Frank

Theodoro, Daniel

Hollander, Judd E

Kabrhel, Christopher

2018-05-08T00:21:57Z

2018-05-08T00:21:57Z

2018-04-05

2018-05-08T00:21:56Z

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.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.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.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.

S0049-3848(18)30301-3

0049-3848

1879-2472

https://hdl.handle.net/10161/16697

eng

Elsevier BV

Thrombosis research

10.1016/j.thromres.2018.04.003

Age-adjustment

D-dimer

Deep vein thrombosis

Emergency department

Pulmonary embolism

International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs.

Journal article

Limkakeng, Alexander T|0000-0002-9822-5595

School of Medicine

Duke

Surgery, Emergency Medicine

Surgery

Clinical Science Departments

Published

166