Pulmonary vascular disease & thromboembolism
Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism: A Randomized Clinical Trial
Primary result · VTEResult — go to the resultAdjusted difference −0.64% 1-sided 97.5% CI -∞ to 0.21%Authors' conclusion
Among ED patients with suspected PE, the use of the YEARS rule combined with the age-adjusted D-dimer threshold in PERC-positive patients, compared with a conventional diagnostic strategy, did not result in an inferior rate of thromboembolic events.
Study context
- Population
- ED patients with suspected pulmonary embolism (PE): low clinical risk not excluded by PERC, or subjective intermediate clinical risk1,217 (86%) per-protocol
- Participants
- 1,414 patients
- Comparison
- YEARS rule + PERC + age-adjusted D-dimer threshold vs age-adjusted D-dimer threshold alone
- Interventionn = 726
- Controln = 688reference
- Primary endpoint
- Venous thromboembolism (VTE) (noninferiority margin 1.35%)
- Follow-up
- 3 months
Methodological detailscluster-randomized, crossover, noninferiority, 18 emergency departments (EDs) in France and Spain
- Cluster-randomized
- Crossover
- Noninferiority
- 18 EDs in France and Spain
Primary result
VTE
Adjusted difference
−0.64%
1-sided 97.5% CI -∞ to 0.21%
Events by treatment group
Interventionvs Control
adjusted difference −0.64% (1-sided 97.5% CI -∞ to 0.21%)
Non-inferiority margin 1.35 as printed, not drawn
As reported in the abstract
Secondary outcomes
| Outcome | Intervention | Control | Adjusted difference (95% CI) | |
|---|---|---|---|---|
| Chest imaging | 30.4% | 40.0% | −8.7% (−13.8% to −3.5%) | |
| −20−10010Difference (linear scale) |
Median, hours
| Outcome | Intervention | Control | Adjusted difference (hours) (95% CI) | |
|---|---|---|---|---|
| ED length of stay | 6 (IQR 4–8) | 6 (IQR 5–9) | −1.6 (−2.3 to −0.9) | |
| −3−2−101Difference, hours (linear scale) |
Other analysed secondary end points
- Of 6 analysed secondary end points, only chest imaging and ED length of stay differed significantly
Original publication
Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism: A Randomized Clinical Trial. JAMA. Published 7 December 2021. doi:10.
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