The use of mechanical thrombectomy, specifically computer-assisted vacuum thrombectomy (CAVT) using the 16Fr Lightning Flash system (Penumbra), with anticoagulation achieves superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high-risk pulmonary embolism (PE). This is according to data presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference (25–28 October, San Francisco, USA) from the STORM-PE randomised controlled trial (RCT).
“These findings mark a pivotal step in advancing care for PE, providing the strongest evidence to date that advanced therapy with CAVT can rapidly and safely improve recovery of the right heart compared to conventional anticoagulation therapy,” said presenter and co-global principal investigator Robert Lookstein (Icahn School of Medicine at Mount Sinai, New York, USA) in a press release announcing the results. “STORM-PE supports the role of CAVT as a more effective therapeutic option for intermediate-high-risk patients and will evolve the paradigm of care by delivering rapid relief with a comparable safety profile to anticoagulation alone.”
The trial enrolled 100 patients across 22 international sites. Patients treated with CAVT demonstrated a greater reduction in right-to-left ventricular (RV/LV) diameter ratio within 48 hours (mean reduction 0.52 vs. 0.24; p<0.001) and nearly 80% of patients had positive treatment effect with CAVT, which was significantly greater than the patients who received anticoagulation alone (78.3% vs. 51.9%; p=0.011), reflecting rapid haemodynamic recovery.
“What’s particularly compelling is that a significantly greater portion of patients treated with CAVT achieved normalisation of RV/LV ratio within 48 hours—a critical indicator of right heart recovery—without an increase in complications,” said Rachel Rosovsky (Massachusetts General Hospital and Harvard Medical School, Boston, USA), co-global principal investigator. “These findings represent a meaningful advancement in optimising early interventions in patients with intermediate-high-risk PE, and we look forward to exploring how changes in RV/LV ratio correlate with other clinical and functional outcomes.”
The rate of major adverse events (MAE) within seven days—including a composite of PE-related mortality, recurrent PE, clinical deterioration requiring rescue therapy, and major bleeding—was comparable between groups (4.3% [2/47] with CAVT vs. 7.5% [4/53] with anticoagulation alone).
“For the first time, we have prospective, level-one evidence demonstrating that CAVT with anticoagulation is superior to anticoagulation alone,” said James F Benenati, chief medical officer at Penumbra. “Combined with Penumbra’s strong prospective data from STRIKE-PE, this randomised evidence from the STORM-PE trial will play a critical role in advancing PE care and supporting the inclusion of CAVT in future treatment guidelines.”
Additional results from the STORM-PE trial are set to be presented at the upcoming VEINS (Venous Endovascular Interventional Strategies) and VIVA (Vascular InterVentional Advances) conference (1–5 November, Las Vegas, USA).
