Baseline characteristics of the sample.

IntroductionThere 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.MethodThe 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.ResultsA 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.ConclusionWe 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.

引言：目前尚无经过验证的评分工具，可对全严重程度谱系的癌症相关肺栓塞（pulmonary embolism, PE）进行分型。本研究验证了EPIPHANY指数这一全新工具，其可用于预测疑似或意外检出PE的癌症患者的严重并发症风险。
方法：PERSEO研究前瞻性地从西班牙22家医院招募了合并活动性癌症或正在接受抗肿瘤治疗的PE患者。基于EPIPHANY指数风险分层的并发症相对发生频率θ的估计，采用二项检验的贝叶斯替代方法完成。
结果：本研究共纳入900例于2017年10月至2020年1月期间确诊PE的患者。患者15天内严重并发症发生率为11.8%，95%最高密度区间（highest density interval, HDI）为9.8%~14.1%。其中，EPIPHANY指数低危组患者的严重并发症发生率为2.4%（95% HDI：0.8%~4.6%），中危组为5.5%（95% HDI：2.9%~8.7%），高危组为21.0%（95% HDI：17.0%~24.0%）。EPIPHANY指数与不同风险分层患者的总生存期（overall survival, OS）显著相关：低危、中危及高危患者的中位OS分别为16.5个月、14.4个月和4.4个月。相较于其余预测模型，EPIPHANY指数与Hestia标准均展现出更高的阴性预测值与更低的阴性似然比。低/中危组患者6个月出血发生率为6.2%（95% HDI：2.9%~9.5%），高危组为12.7%（95% HDI：10.1%~15.4%），组间差异具有统计学意义（p=0.037）。在门诊患者中，EPIPHANY低/中危组15天内严重并发症发生率为2.1%（95% HDI：0.7%~4.0%），高危组为5.3%（95% HDI：1.7%~11.8%）。
结论：本研究验证了EPIPHANY指数在偶发性或症状性癌症相关PE患者中的应用价值。在缺乏高质量证据的临床场景中，该模型可助力临床决策的标准化。