Mechanical Thrombectomy Versus Anticoagulation Alone in Intermediate-High Risk PE: Improved Functional 90-Day...

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.

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.

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.

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.

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.

https://clinicaltrials.gov Unique Identifier: NCT05684796.