Clinical, functional, and quality of life outcomes through 90 days in the STORM-PE RCT for mechanical thrombectomy with anticoagulation vs anticoagulation alone in acute intermediate-high risk PE patients

Sunday, April 12, 2026

3:09 PM - 3:18 PM ET

Location: 718B

Presenting Author(s)

Robert A. Lookstein, MD

Professor of Radiology and Surgery
Icahn School of Medicine at Mount Sinai, United States

Author/Co-author(s)

SK

Stavros Konstantinides, MD

Center for Thrombosis and Hemostasis
University Medical Center of the Johannes Gutenberg University, Germany
Ido Weinberg, MD

Associate Professor of Medicine
Massachusetts General Hospital / Harvard Medical School, United States
SD

Suhail Y. Dohad, MD, MBBS

Cardiology Specialist
Cedars-Sinai Medical Center, United States
ZR

Zachary Rosol, MD

Medical Director - The Heart Hospital
Texas A&M Health Science Center, United States
GK

Grzgorz Kopec, MD, PhD

Head of the Pulmonary Circulation Centre
agiellonian University Medical College at the St. John Paul II Hospital, Poland
John Moriarty, MD, FSIR (he/him/his)

Professor
UCLA, United States
SP

Sahil Parikh, MD

Director Endovascular Services
Center for Interventional Vascular Surgery, United States
Andrew H. Holden, MD (he/him/his)

Interventional Radiologist
Aukland District Health Board / Auckland Hospital, New Zealand

Purpose: Pulmonary embolism (PE) treatment with mechanical thrombectomy (MT) can rapidly relieve RV overload and may lead to faster normalization of hemodynamics and functional status compared to anticoagulation (AC) alone. STORM-PE is the first RCT to evaluate functional and quality of life (QoL) outcomes through 90 days for MT using computer assisted vacuum thrombectomy (CAVT) with AC vs AC alone for acute intermediate-high risk PE.

Materials and Methods: STORM-PE is an international RCT with 1:1 randomization to CAVT with AC or AC alone.

Eligible adults had acute intermediate-high risk PE (symptoms ≤14 days), with RV/LV ratio ≥1.0 on CTPA and elevated cardiac biomarkers. The primary endpoint was RV/LV ratio changes at 48 (±6) hours, with a secondary safety endpoint of composite MAE ≤7 days. Additional secondary endpoints through 90 days included functional and QoL outcomes, mortality, and PE recurrence.

Results:

Baseline characteristics for 100 patients (22 sites) were comparable between the CAVT (N=47) and AC (N=53) arms and for the 85% who completed follow up. RV/LV ratio reduction at 48 hours was greater in CAVT than AC (0.52 vs 0.24; difference, 0.27 [95% CI, 0.12, 0.43]; P< 0.001), with similar MAE rates ≤7 days (4.3% vs 7.5%, P=0.681). Greater physiological improvements within 48 hours were seen in the CAVT arm for heart rate (P=0.022), supplemental oxygen (P=0.027), and composite NEWS2 score (P=0.034). At 90 days, CAVT arm patients walked significantly farther than AC patients in the 6MWT (479m vs 368m, P=0.003) and completed a greater percentage of their predicted walk distance (94.0% vs. 75.2%, P=0.022). Significantly more CAVT than AC patients had NYHA Class I (97.4% vs 75.6%, P=0.005) at 90 days. From pre-index PE event to discharge, CAVT patients were more likely to shift toward their pre-PE PVFS score (OR 2.2; 95% CI 1.07-4.52; P=0.032). At 90 days, Borg and mMRC dyspnea scores were comparable and improved (P< 0.001) in both arms. From index event, both arms had similar QoL outcome improvement (P< 0.05). There were no differences in all-cause or PE-related mortality or PE recurrence through 90 days. There were no device-related AEs.

Conclusion: STORM-PE demonstrated a superior reduction in RV/LV ratio with CAVT vs AC, with a comparable safety profile and greater physiological improvements. Patients receiving CAVT also had greater improvement in functional outcomes at 90 days. These findings reinforce the role of MT, specifically CAVT, as an effective and safe treatment strategy that leads to rapid recovery and better functional outcomes through 90 days.