6/28/23, 11:16 PM MODIGLIA-NI Pathway Feedback Search Clinical Topics Home Studies MODIGLIA NI MODIGLIA NI Disease Pulmonary embolism 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 N = 1414 42.0% male 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) https://web.pathway.md/studies/recO2qaue1vshmOmk 1/2 6/28/23, 11:16 PM MODIGLIA-NI Pathway Primary outcome Venous thromboembolism at 3 months 0.8 % 0.8 0.6 % 0.4 % Difference not exceeding nonferiority margin 0.2 % 0.15 0.0 % Modified diagnostic strategy A conventional diagnostic strategy Difference not exceeding nonferiority 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. Open reference URL https://web.pathway.md/studies/recO2qaue1vshmOmk 2/2