MODIGLIA-NI
Trial question
What is the effect of a diagnostic strategy using an elevated age-adjusted D-dimer threshold in ED patients with suspected PE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 1414
1414 patients (823 female, 591 male).
Inclusion criteria: adult patients who had a low clinical risk of PE not excluded by the PE rule-out criteria rule or a subjective clinical intermediate risk of PE.
Key exclusion criteria: high or low clinical probability of PE; pregnancy; other obvious cause for chest pain, syncope or dyspnea; concurrent anticoagulation treatment.
Interventions
N=648 modified diagnostic strategy (use of YEARS rule combined with age-adjusted D-dimer testing).
N=623 a conventional diagnostic strategy (test with D-dimer using the age-adjusted threshold level).
Primary outcome
Venous thromboembolism at 3 months
0.15%
0.8%
0.8 %
0.6 %
0.4 %
0.2 %
0.0 %
Modified diagnostic
strategy
A conventional diagnostic
strategy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in VTE at 3 months (0.15% vs. 0.8%; AD -0.64%, 97.5% CI -Infinity to 0.21).
Secondary outcomes
Significant decrease in need of chest imaging (30.4% vs. 40%; AD -8.7%, 95% CI -13.8 to -3.5).
Significant increase in ED median length of stay (6 hours vs. 6 hours; AD 1.6 hours, 95% CI -2.3 to -0.9).
Conclusion
In adult patients who had a low clinical risk of PE not excluded by the PE rule-out criteria rule or a subjective clinical intermediate risk of PE, modified diagnostic strategy was noninferior to a conventional diagnostic strategy with respect to VTE at 3 months.
Reference
Yonathan Freund, Anthony Chauvin, Sonia Jimenez et al. 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. 2021 Dec 7;326(21):2141-2149.
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