Different D-dimer assays with age-adjusted cutoff to exclude pulmonary embolism: secondary analysis of ADJUST-PE study
Abstract
BACKGROUND
The multicenter prospective ADJUST-PE study proved the safety of an age-adjusted D-dimer (AADD) cutoff to exclude pulmonary embolism (PE).
AIMS
Assess the safety of different D-dimer (DD) assays using AADD in patients included in ADJUST-PE in Geneva compared to the originally used VIDAS D-dimer Exclusion test®.
METHODS
This was a pre-planned secondary analysis. The VIDAS DD Exclusion test® was repeated to ensure reproducible results in thawed samples. Other tests performed were: Innovance DD test®, STA Liatest®, Tina-quant DD®, and the point-of-care LumiraDx test. The main outcome was venous thromboembolic risk (VTE) at initial testing or within 3 months after PE exclusion by a negative DD test using the AADD ("failure rate"). The secondary outcome measure was to compare each assay with VIDAS in the classification of patients as having a negative versus positive AADD result.
RESULTS
602 patients were included, 597 were available for analysis. 14% had PE confirmed at baseline. Failure rates were < 2% for all tests. The risk of a change in classification from positive original VIDAS AADD to negative AADD result was similar to the repeated VIDAS (comparator) for Innovance and LumiraDx, and higher for STA Liatest and Tinaquant. For the two latter assays, 3 and 5 patients with negative AADD had PE, respectively.
CONCLUSION
Innovance and LumiraDx assays had similar safety in excluding PE by AADD compared to VIDAS. STA Liatest and Tinaquant classified a higher proportion…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 602 participants or records.
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