Introduction There is currently no validated score capable of classifying cancer-associated pulmonary embolism (PE) in its full spectrum of severity. This study has validated the EPIPHANY Index, a new tool to predict serious complications in cancer patients with suspected or unsuspected PE. Method The PERSEO Study prospectively recruited individuals with PE and active cancer or receiving antineoplastic therapy from 22 Spanish hospitals. The estimation of the relative frequency θ of complications based on the EPIPHANY Index categories was made using the Bayesian alternative for the binomial test. Results A total of 900 patients, who were diagnosed with PE between October 2017 and January 2020, were enrolled. The rate of serious complications at 15 days was 11.8%, 95% highest density interval [HDI], 9.8–14.1%. Of the EPIPHANY low-risk patients, 2.4% (95% HDI, 0.8–4.6%) had serious complications, as did 5.5% (95% HDI, 2.9–8.7%) of the moderate-risk participants and 21.0% (95% HDI, 17.0–24.0%) of those with high-risk episodes. The EPIPHANY Index was associated with overall survival (OS) in patients with different risk levels: median OS was 16.5, 14.4, and 4.4 months for those at low, intermediate, and high risk, respectively. Both the EPIPHANY Index and the Hestia criteria exhibited greater negative predictive value and a lower negative likelihood ratio than the remaining models. The incidence of bleeding at 6 months was 6.2% (95% HDI, 2.9–9.5%) in low/moderate-risk vs 12.7% (95% HDI, 10.1–15.4%) in high-risk (p-value = 0.037) episodes. Of the outpatients, serious complications at 15 days were recorded in 2.1% (95% HDI, 0.7–4.0%) of the cases with EPIPHANY low/intermediate-risk vs 5.3% (95% HDI, 1.7–11.8%) in high-risk cases. Conclusion We have validated the EPIPHANY Index in patients with incidental or symptomatic cancer-related PE. This model can contribute to standardize decision-making in a scenario lacking quality evidence.

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12085 Background: EPIPHANY is the first algorithm to predict serious complications in both suspected and unsuspected cancer-associated pulmonary embolism (PE), overcoming limitations of previous models. Methods: PERSEO is a prospective multicenter study. We recruited cancer patients with both incidental and symptomatic PE treated between Oct. 2017 and Dec. 2019. The primary aim was to determine the percentage of serious complications in patients at low predicted risk, with at least 3% accuracy. We also compared the predictive parameters of EPIPHANY with other available scores for prediction 15-day serious complications and 30-day mortality. Results: Cohort includes 831 patients (men, 58.6%; median age, 66 years). Most frequent tumors were lung (27.1%), colorectal (19%) and breast (7.8%). 78.6% had stage IV disease, and 77.6% were receiving antineoplastic treatment. EPIPHANY classified 27%, 24% and 49% of patients as low, medium and high risk, respectively. The rate of 15-day serious complications increased significantly across these prognostic categories: 2.67 (95% CI 0.6 - 4.8), 8.9% (95% CI 0.5 - 12.8), and 25.9% (95% CI 21.7 - 30.2), for low, intermediate, and high risk patients, respectively (p<0.001, linear-by-linear test). In comparison with other validated scores, EPIPHANY has a higher negative predictive value, lower negative likelihood-ratio, and comparable sensitivity (Table). Conclusions: The EPIPHANY index is able to identify a subgroup of patients with cancer-associated pulmonary embolism at very low risk of serious complications or short-term mortality, with potential implications for decision making. [Table: see text]