Article
Author: CASTELLUCCI, Lana ; Roy, Pierre-Marie ; WANG, Tzu-Fei ; RIVLIN, Leon ; DELLUC, Aurélien ; BLONDON, Marc ; Garnett, Meghan ; NACIUK, Mary ; SCARVELIS, Dimitri ; DAVIS, Phil ; FUMAGALLI, Riccardo ; Le COAT, Anne ; DUFFETT, Lisa ; Le Gal, Grégoire ; Penaloza, Andrea ; CARRIER, Marc ; Moustafa, Fares ; DOUPLAT, Marion ; KAROVITCH, Alan ; YOUATOU TOWO, Pierre ; SIEGAL, Deborah ; GLAUSER, Frédéric ; WELLS, Philip ; JEANNERET, Christina ; Grenot, Marie Chevallier ; Barco, Stefano ; Righini, Marc ; Couturaud, Francis ; LOPEZ, Raphaelle ; Visser, Shaun ; CODE, Cathy ; MOTTE, Serge ; DUPRIEZ, Florence ; PASCU CIOBANU, Andrea ; Tagalakis, Vicky ; Lang, Eddy ; Aujesky, Drahomir ; Thiruganasambandamoorthy, Venkatesh ; Hulme, Jennifer ; FORGIE, Melissa ; Robert-Ebadi, Helia ; Catella, Judith ; KIMPTON, Miriam ; SHAW, Joseph ; Engelberger, Rolf ; Deroche, Claire ; Plumacker, Alain ; Mazzolai, Lucia ; DEXPERT, Jean-Baptiste ; MANCA, Gina ; Ghuysen, Alexandre ; El Kouri, Dominique ; THOMA, Maximilien ; ABSIL, Lara
Importance:The age-adjusted D-dimer cutoff (age × 10 µg/L in patients 50 years or older), safely increases the diagnostic yield of D-dimer in patients with suspected pulmonary embolism but has not been validated in patients with suspected leg deep vein thrombosis (DVT).
Objective:To prospectively validate whether using an age-adjusted D-dimer cutoff allows clinicians to safely rule out DVT.
Design, Setting, and Patients:Multicenter, multinational prospective management outcome study conducted in 27 centers in Belgium, Canada, France, and Switzerland between January 2015 and October 2022 (last follow-up visit, January 30, 2023) and including outpatients presenting to the emergency department with suspected DVT.
Interventions:Patients were assessed by a sequential diagnostic strategy based on the assessment of clinical pretest probability by the Wells score, a highly sensitive D-dimer test, and leg compression ultrasonography. Patients in whom DVT was ruled out were followed up for a 3-month period.
Main Outcome and Measure:The primary outcome was the rate of adjudicated symptomatic venous thromboembolic events during follow-up in patients in whom DVT was ruled out based on a D-dimer value between the conventional cutoff of 500 µg/L and their age-adjusted cutoff.
Results:A total of 3205 patients were included. Median age was 59 years, and 1737 (54%) were female. DVT prevalence was 14%. Among the 2169 patients with a non-high or unlikely clinical probability, 531 (24.5% [95% CI, 22.7%-26.4%]) had a D-dimer level less than 500 µg/L, and 161 additional patients (7.4% [95% CI, 6.4%-8.6%]) had a D-dimer level between 500 µg/L and their age-adjusted cutoff. No failures were identified in patients with a D-dimer level 500 µg/L or greater but below the age-adjusted cutoff (0% [95% CI, 0%-2.3%]). Among patients 75 years or older, using the age-adjusted cutoff instead of the 500-µg/L cutoff increased the proportion of negative D-dimer from 33 of 379 (8.7% [95% CI, 6.3%-12.0%]) to 99 of 379 (26.1% [95% CI, 22.0%-30.8%]), without any false-negative test results.
Conclusions and Relevance:The age-adjusted D-dimer cutoff may safely rule out DVT and was associated with a larger number of patients in whom DVT could be effectively ruled out.
Trial Registration:
ClinicalTrials.gov Identifier:
NCT02384135
.