Mechanical Thrombectomy Versus Anticoagulation Alone in Intermediate-High Risk PE
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Authors: Rachel P. Rosovsky, Stavros V. Konstantinides, Ido Weinberg, Suhail Y. Dohad, Zachary Rosol, Jakub Stępniewski, John M. Moriarty, Sahil A. Parikh, Andrew Holden, Richard N. Channick, Braedon McDonald, Khanjan H. Nagarsheth, Yuri Matusov, Robert A. Lookstein, Ahmed AlBadri, Mohamed Almahmoud, Sameer Arora, Bulent Arslan, Steve Attanasio, Keith Benzuly, Vivian Bishay, Paul Boiteau, Paul Boucher, Brendan Buckley, Michael Campbell, Chad Christopherson, Yashasvi Chugh, Fareed Moses Collado, Frank Corrigan, Michael Cuttica, Shani Dahan, Laura Davidson, Alex Davidovich, David Dexter, Mihaela-Ioana Dregoesc, Tammer El-Aini, Mahir Elder, Fakhir Elmasri, Rukshan Fernando, Aaron Fischman, James Flaherty, Brian Freeze, Oren Friedman, Jennifer Fung, Siddharth Gandhi, Kirema Garcia-Reyes, M. Kurt Gordon, Paul Guichard, Scott Hamilton, Frank Hao, Eric Herget, Yasin Hussain, Elias Iliadis, Frank Italiano, Natalia Jaworska, Kamil Jonas, Kevin Jones, Minhaj Khaja, Hussein Kiliddar, Grzegorz Kopec, Andreas Kramer, Holger Kuehne, Gautam Kumar, Matthew Langston, Brian Lawler, Marysa Leya, Kevin Liu, Wojciech Magon, Aziz Marzoug, Alan Matsumoto, Yuri Matusov, Michael McDaniel, Shay McGuinness, Stephen Merrilees, Bushra Mina, Sanjay Misra, Peter Monteleone, Nicolas Mouawad, Ruben Mylvaganam, Jean Panneton, Ken Parhar, Jong Park, Gaurav Parmar, Jonathan Passeri, Rahul Patel, Marloe Prince, Mona Ranade, Animesh Rathore, Lisa Rauschert, Rehan Riaz, Willie Robinson, Rajesh Sachdeva, Robert Salazar, Daniel Schimmel, Jeffrey Schussler, Matthew Sebastian, Janet Shapiro, Abdul Sheikh, Dan Shilo, Alexander Sidor, Avinash Singh, Geoffrey Southmayd, Jonathan Steinberger, Jakub Stepniewski, Lucas Struycken, Ranya Sweis, Jordan Tasse, Manoj Thangam, Benjamin Tritle, Michael Troy, Ulku Turba, Jenanan Vairavamurthy, Ilaria Vittoria De Martini, Marcin Waligora, Lawrence Whitney, Jason Wong, Gregory Woodhead, Cayce Spencer Workman, Kei Yamada, Maidah Yaqoob, Van Young, Weili Zheng, Robert A. Lookstein
Institutions: Harvard University, Massachusetts General Hospital, Democritus University of Thrace, Johannes Gutenberg University Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Mass General Brigham, Cedars-Sinai Medical Center, Cedars-Sinai Smidt Heart Institute, Baylor University Medical Center, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Jagiellonian University, John Paul II Hospital, University of California, Los Angeles, Columbia University Irving Medical Center, Auckland City Hospital, University of Calgary, Saint Louis University, Icahn School of Medicine at Mount Sinai
Language: English
Subfield: Internal Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,000
Funder: Penumbra
OpenAlex ID: W7220465476