CANCARE RESEARCH
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Mechanical Thrombectomy Versus Anticoagulation Alone in Intermediate-High Risk PE: Improved Functional 90-Day Outcomes in STORM-PE RCT.
Clinical takeaway Thrombectomy was associated with better measured functional recovery at 90 days in this randomized trial. Incomplete testing and secondary-endpoint status temper interpretation; mortality benefit and equivalent safety were not established.
Summary & abstract
Study summary
STORM-PE randomized 100 patients with acute intermediate-high risk pulmonary embolism to computer-assisted vacuum thrombectomy plus anticoagulation or anticoagulation alone; this report evaluates 90-day secondary outcomes. Six-minute walk distance was greater with thrombectomy (478.7 ± 159.5 versus 368.0 ± 127.8 m; P = 0.003), although only approximately two-thirds completed testing. NYHA class I was more frequent with thrombectomy (97.4% versus 75.6%; P = 0.005). Dyspnea and quality-of-life scores were comparable, and no between-group differences were reported in all-cause mortality, PE-related mortality, or symptomatic PE recurrence through 90 days.
Study limitation: Functional outcomes were secondary endpoints, and only approximately two-thirds completed walk testing, creating potential follow-up bias.
Published abstract
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.
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