STORM-PE: Computer-Assisted Vacuum Thrombectomy Outperforms Anticoagulation, With Robert Lookstein, MD

The STORM-PE trial has proven the superiority of computer-assisted vacuum thrombectomy (CAVT) with anticoagulation (AC) versus AC alone in reducing right-to-left-ventricular (RV/LV) diameter ratio within 48 hours in patients with intermediate to high risk of pulmonary embolism (PE).1

The editorial team at HCPLive sat down with Robert Lookstein, MD, executive vice chairman of the department of diagnostic, molecular, and interventional radiology at the Icahn School of Medicine at Mount Sinai, to discuss the implications of this study and the future of CAVT technology. Lookstein explained the difference between existing models and CAVT, highlighting its potential for improving PE care.

“CAVT was a significant advancement in the field for many reasons,” Lookstein told HCPLive. “First and foremost, it is a relatively smaller size, and it’s less rigid, so the introduction of the catheter causes less strain on the heart. Secondly, the physician performing the procedure doesn’t need to use a syringe to extract the clot; the catheter is attached to a vacuum pump. And then, overarching the entire procedure, is the computer microprocessor that’s built into the catheter, which can sense when the tip of the catheter is touching thrombus instead of just flowing blood or the vessel wall.”

STORM-PE was a prospective, multicenter, randomised, placebo-controlled trial, conducted across 22 locations worldwide. To be included, patients were required to be 18-80 years old, have clinical signs and symptoms of acute PE with a duration ≤14 days, objectively confirmed acute PE based on computed tomographic pulmonary angiography (CTPA), a classification of intermediate high-risk PE as demonstrated by right ventricular dysfunction RV/LV ratio ≥1 on CTPA and elevated cardiac biomarkers, including cardiac troponin, BNP, and/or NT-pro BNP, among other criteria.2

Patients were excluded if they exhibited hemodynamic instability with either cardiac arrest, obstructive shock, or persistent hypotension defined as systolic blood pressure <90 mmHg or an acute drop in systolic blood pressure ≥40 mmHg for >15 minutes, as well as having allergy, hypersensitivity, or heparin-induced thrombocytopenia, a creatinine clearance <45 mL/min, and other criteria.2

The trial ultimately enrolled 100 patients with a mean age of 59.5 +/- 13.22 years in the CAVT arm and 61.2 +/- 14.19 years in the AC arm. Mean time from PE symptom onset to hospital admission was roughly 3 days (interquartile range [IQR] 0-6) in the CAVT arm and 2 days (0-6) in the AC arm (P = 0.889). All patients had elevated cardiac biomarkers, and 59.1% in the CAVT arm and 74.5% in the AC arm had both elevated troponin and BNP or NT-proBNP (P = .128).1

Patients were randomly assigned in a 1:1 ratio to either CAVT (n = 47) or AC (n = 53). For the CAVT arm, access was obtained via the femoral vein (4.3% [2/47] left and 95.7% [45/47] right), and the thrombectomy procedure was technically successful in all patients. Median thrombectomy time was 25 minutes (IQR, 15-41), and median procedure time was 56 minutes (IQR, 42-69).1

At 48 hours, the change in RV/LV ratio was greater for the CAVT arm (0.52 +/- 0.37) than AC (0.24 +/- 0.4), a difference of 0.27 (95% CI, 0.12-0.43; P <.001). Early normalisation of vital signs was also more frequent after CAVT, and the major adverse event rate within 7 days was not different between groups (CAVT 4.3% vs AC 7.5%; P = .681).1

Ultimately, Lookstein and colleagues determined that CAVT was superior to AC alone in reducing RV/LV ratio, as well as accomplishing an earlier normalisation of vital signs and a comparable rate of major adverse events compared to AC.1

“The time that the catheter spent in the patient was incredibly short, arguably the shortest recorded time in the modern cardiovascular era,” Lookstein said. “All trial operators were able to deliver the catheters where the thrombus was located and successfully extract the clot. In other words, the technical success was 100%. There were no complications related to either the insertion or removal of the catheter.”

Editor's Note: Lookstein reports disclosures with Boston Scientific, INARI, Penumbra, Ethicon, Instylla, Imperative Vascular, and others.

References

1. Lookstein RA, Konstantinides SV, Weinberg I, et al. 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. Circulation. Published online November 3, 2025. doi:10.1161/circulationaha.125.077232

2. Penumbra Inc. Comparison of Two Pulmonary Embolism Treatments. ClinicalTrials.gov Identifier: NCT05684796. Updated November 17, 2025. Accessed November 25, 2025. https://clinicaltrials.gov/study/NCT05684796