Párraga Rocío, Real Carlos, Jiménez-Mazuecos Jesús, Vázquez-Álvarez María-Eugenia, Valero Ernesto, Velázquez Maite, Tébar Daniel, Salvatella Neus, Rumiz Eva, Ruiz Quevedo Valeriano, Sabatel-Pérez Fernando, Amat-Santos Ignacio, Lozano Iñigo, Elizondo Irene, Andrés-Morist Abel, Núñez-Gil Iván, Portero Juan J, Gonzalo Nieves, Juárez Fernández Miriam, Viana-Tejedor Ana, Ferrera Carlos, Salinas Pablo
Department of Cardiology, Hospital Universitario Clínico San Carlos, Madrid, Spain.
Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain.
Minerva Cardiol Angiol. 2025 Jun;73(3):304-314. doi: 10.23736/S2724-5683.24.06609-2. Epub 2024 Sep 24.
Pulmonary embolism (PE) treatment is based on risk stratification according to European Society of Cardiology (ESC) guidelines. However, emerging therapies in acute PE may require a more granular risk classification. Therefore, the objective of the present study was to propose a new RIsk claSsification Adapting the SCAI shock stages to right ventricular failure due to acute PE (RISA-PE).
This registry included consecutive intermediate-high risk (IHR) or high-risk (HR)-PE patients selected for catheter-directed interventions (CDI) from 2018 to 2023 in 15 Spanish centers (NCT06348459). Patients were grouped according to RISA-PE classification as A (right ventricular dysfunction and troponin elevation); B (A + serum lactate >2 mmol/L OR shock index ≥1); C (persistent hypotension); D (obstructive shock); and E (cardiac arrest). In-hospital adverse events were assessed to evaluate RISA-PE performance.
A total of 334 patients were included (age 62.1±15.2 years, 55.7% males). The incidence of in-hospital all-cause death was progressively higher with increasing RISA-PE stage (1.2%, 6.4%, 19.0%, 25.6%, and 57.7% for stages A, B, C, D, and E, respectively, P value for linear trend<0.001). However, using the ESC classification, there was an abrupt difference between IHR- and HR-PE patients regarding mortality (4.3% vs. 29.3%, P<0.001). The incidence of in-hospital major bleeding and acute kidney injury followed a similar pattern.
The user-friendly RISA-PE classification may improve the granularity in stratifying PE patients' risk and warrants evaluation in larger studies with different therapeutic approaches in order to detect its utility as a decision-making scale.
肺栓塞（PE）的治疗基于欧洲心脏病学会（ESC）指南进行风险分层。然而，急性PE的新兴疗法可能需要更细致的风险分类。因此，本研究的目的是提出一种新的风险分类方法，即根据急性PE导致的右心室衰竭将SCAI休克阶段进行调整的RISA-PE（急性肺栓塞风险分类）。
该登记研究纳入了2018年至2023年期间在15个西班牙中心因导管导向干预（CDI）而入选的连续中高风险（IHR）或高风险（HR）-PE患者（NCT06348459）。患者根据RISA-PE分类分为A组（右心室功能障碍和肌钙蛋白升高）；B组（A组 + 血清乳酸>2 mmol/L或休克指数≥1）；C组（持续性低血压）；D组（梗阻性休克）；E组（心脏骤停）。评估住院期间的不良事件以评价RISA-PE的性能。
共纳入334例患者（年龄62.1±15.2岁，男性占55.7%）。随着RISA-PE阶段增加，住院全因死亡率逐渐升高（A、B、C、D和E阶段分别为1.2%、6.4%、19.0%、25.6%和57.7%，线性趋势P值<0.001）。然而，使用ESC分类时，IHR-PE和HR-PE患者在死亡率方面存在突然差异（4.3%对29.3%，P<0.001）。住院期间大出血和急性肾损伤的发生率遵循类似模式。
用户友好的RISA-PE分类可能会提高对PE患者风险分层的细致程度，并且有必要在采用不同治疗方法的更大规模研究中进行评估，以检测其作为决策量表的效用。
