中高危肺栓塞（PE）中机械取栓与单纯抗凝治疗的比较：STORM-PE随机对照试验中90天功能结局改善。
完整摘要 · 中文译文
背景：高达50%的肺栓塞（PE）存活者存在长期功能受限和生活质量（QoL）下降。再灌注策略可快速缓解右心室（RV）功能障碍并预防临床恶化或血流动力学崩溃；然而，这些方法从未在以患者为中心结局的随机试验中与单纯抗凝治疗进行过评估。 目的：本研究旨在评估在急性中高危PE患者中，与单纯抗凝治疗相比，机械血栓切除术联合抗凝治疗能否在90天内改善功能性、生活质量及安全性结局。 方法：STORM-PE研究纳入100例PE患者，在22个国际中心按1：1随机分配至计算机辅助真空血栓切除术（CAVT）联合抗凝治疗组或单纯抗凝治疗组，以48小时右心室与左心室（RV/LV）比值变化为主要终点。次要终点包括7天内主要不良事件、功能和生活质量结局、死亡率以及90天内症状性PE复发。 结果：所有患者从随机化至末次随访就诊的中位时间为91.0天[Q1-Q3：80.5-100.0]。90天时，66.0%（31/47）的CAVT患者和64.2%（34/53）的抗凝治疗患者完成了6分钟步行试验。与单纯抗凝治疗相比，CAVT组表现出更长的6分钟步行距离（478.7 ± 159.5 m vs 368.0 ± 127.8 m，P = 0.003）。90天时，CAVT组中NYHA功能I级患者多于抗凝治疗组（97.4% [37/38] vs 75.6% [34/45]，P = 0.005）。呼吸困难和生活质量评分相当 组间差异，两组在全因死亡率、肺栓塞相关死亡率及90天内症状性肺栓塞复发方面均无差异。 结论：在STORM-PE研究中，与单纯抗凝相比，抗凝联合计算机辅助真空血栓切除术（CAVT）在90天时功能结局改善，且安全性发生率相当。该试验支持将CAVT作为中高危肺栓塞有效且安全的再灌注策略。 临床试验注册：https://clinicaltrials.gov 唯一标识符：NCT05684796。
完整摘要 · 英文原文
BACKGROUND: Up to 50% of pulmonary embolism (PE) survivors experience long-term functional limitations and reduced quality of life (QoL). Reperfusion strategies can rapidly relieve right-ventricular (RV) dysfunction and prevent clinical deterioration or hemodynamic collapse; however, these approaches have never been evaluated in a randomized trial against anticoagulation alone using patient-centered outcomes. OBJECTIVES: This study sought to evaluate whether mechanical thrombectomy with anticoagulation improves functional, QoL, and safety outcomes compared with anticoagulation alone in patients with acute intermediate-high risk PE over 90 days. METHODS: STORM-PE enrolled 100 PE patients randomized 1:1 to computer-assisted vacuum thrombectomy (CAVT) with anticoagulation or anticoagulation alone across 22 international sites, with RV-to-left-ventricular (RV/LV) ratio change at 48 hours as the primary endpoint. Secondary endpoints included major adverse events within 7 days, functional and QoL outcomes, mortality, and symptomatic PE recurrence through 90 days. RESULTS: For all patients, median time from randomization to last follow-up visit was 91.0 days [Q1-Q3: 80.5-100.0]. At 90 days, 66.0% (31/47) of CAVT and 64.2% (34/53) of anticoagulation patients completed the 6-min walk test. The CAVT arm exhibited a longer 6-min walk distance compared with anticoagulation alone (478.7 ± 159.5 m vs 368.0 ± 127.8 m, P = 0.003). More CAVT than anticoagulation patients were NYHA functional class I (97.4% [37/38] vs 75.6% [34/45], P = 0.005) at 90 days. Dyspnea and QoL scores were comparable between groups, with no differences between arms for all-cause mortality, PE-related mortality, and symptomatic PE recurrence within 90 days. CONCLUSIONS: In STORM-PE, CAVT with anticoagulation resulted in improved functional outcomes at 90 days compared with anticoagulation alone, with equivalent safety rates. This trial supports CAVT as an effective and safe reperfusion strategy for intermediate-high risk PE. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov Unique Identifier: NCT05684796.