Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial.

Reperfusion therapy aims to rapidly relieve acute RV pressure overload and to normalize hemodynamics.

再灌注治疗的目标是迅速缓解急性右心室压力过载，并使血流动力学恢复正常。

STORM-PE (A Prospective, Multicenter, Randomized Controlled TrialEvaluating Anticoagulation Alone Versus Anticoagulation Plus Mechanical Aspiration With the Indigo Aspiration System for the Treatment of Intermediate-High Risk Acute Pulmonary Embolism) is the first reported randomized controlled trialto test the efficacy and to evaluate the safety of mechanical thrombectomy, specifically computer-assisted vacuum thrombectomy (CAVT) with anticoagulation compared to anticoagulation alone.

STORM-PE（一项前瞻性、多中心、随机对照试验，评估单独抗凝治疗与抗凝联合使用Indigo吸取系统进行机械吸取治疗中高风险急性肺栓塞的疗效和安全性）是首个报告的随机对照试验，旨在测试机械血栓切除术（特别是计算机辅助真空血栓切除术（CAVT））与单独抗凝治疗相比的疗效，并评估其安全性。

Methods

STORM-PE is an international randomized controlled trialwith 1:1 randomization to CAVT with anticoagulation or anticoagulation alone.

STORM-PE 是一项国际随机对照试验，采用1:1随机分配，比较CAVT联合抗凝治疗与单独抗凝治疗的效果。

Eligible adults had acute-onset (symptoms ≤14 days), intermediate-high risk PE and were normotensive, with an RV/LV ratio ≥1.0 on computed tomographic pulmonary angiography and elevated cardiac biomarkers.

符合条件的成年人患有急性起病（症状≤14天）、中高风险的肺栓塞，并且血压正常，CT肺动脉造影显示RV/LV比值≥1.0，心脏生物标志物升高。

The primary end-point analysis tested for a difference between groups for the change in RV/LV ratio at 48 hours, assessed by a blinded independent imaging core laboratory.

主要终点分析测试了两组在48小时时RV/LV比值变化的差异，由一名盲法独立影像核心实验室评估。

Secondary end points included major adverse events within 7 days (a composite of clinical deterioration necessitating rescue therapy, PE-related mortality, symptomatic recurrent PE, and major bleeding), adjudicated by an external clinical events committee.

次要终点包括7天内发生的重大不良事件（包括需要救援治疗的临床恶化、与肺栓塞相关的死亡、有症状的肺栓塞复发和主要出血事件的复合结果），由外部临床事件委员会进行裁定。

Additional outcomes included change in vital signs and core laboratory-assessed pulmonary artery obstruction at 48 hours.

额外的结局指标包括48小时时生命体征的变化和核心实验室评估的肺动脉阻塞情况。

Results

A total of 100 patients enrolled across 22 sites were randomized to CAVT (n=47) or anticoagulation alone (n=53).

共有100名患者在22个研究地点入组，被随机分配至CAVT组(n=47)或仅抗凝治疗组(n=53)。

Baseline characteristics were comparable between arms.

两组患者的基线特征具有可比性。

At 48 hours, mean reduction in RV/LV ratio was greater for CAVT (0.52±0.37) than anticoagulation (0.24±0.40), a difference of 0.27 (95% CI, 0.12-0.43; P<0.001).

在48小时时，CAVT组的右心室/左心室(RV/LV)比率平均降低0.52±0.37，而抗凝治疗组为0.24±0.40，两者差异为0.27 (95% 置信区间, 0.12-0.43; P<0.001)。

Refined modified and modified Miller scores exhibited greater changes for CAVT than anticoagulation alone at 48 hours (P<0.001).

在48小时时，精化的改良评分和改良Miller评分显示，CAVT组的变化大于单独抗凝治疗组 (P<0.001)。

Early normalization of vital signs within 48 hours was more frequent after CAVT.

在48小时内早期恢复正常生命体征在CAVT后更为常见。

The major adverse eventrate within 7 days was not different between groups (CAVT, 4.3% versus anticoagulation, 7.5%; P=0.681).

7天内主要不良事件的发生率在两组之间没有差异（CAVT组为4.3%，抗凝组为7.5%；P=0.681）。

Two PE-related deaths occurred in the CAVT arm.

在CAVT组中发生了两例与肺栓塞相关的死亡事件。

Conclusions

CAVT was superior to anticoagulation alone in reducing RV/LV ratio within 48 hours in patients with intermediate-high risk PE, accompanied by earlier normalization of vital signs and major adverse eventrates comparable to those for anticoagulation.

在中高风险肺栓塞患者中，CAVT在48小时内降低右心室/左心室比率方面优于单独抗凝治疗，同时伴随着生命体征的更早正常化，主要不良事件的发生率与抗凝治疗相当。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05684796.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT05684796.