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

作者：R. Lookstein, Stavros Konstantinides, Ido Weinberg, Suhail Dohad, Zachary Rosol, Grzegorz Kopeć, John M. Moriarty, Sahil A. Parikh, Andrew Holden, Richard N. Channick, Braedon McDonald, Khanjan Nagarsheth, Kei Yamada, Rachel Rosovsky, Ahmed AlBadri, Mohamed Almahmoud, Sameer Arora, Bulent Arslan, Steve Attanasio, Keith Benzuly, Vivian Bishay, Paul Boiteau, Paul Boucher, Brendan Buckley, Michael Campbell, Richard Channick, Chad Christopherson, Yashasvi Chugh, Fareed Moses Collado, Frank Corrigan, Michael Cuttica, Laura Davidson, Alex Davidovich, David Dexter, Suhail Dohad, 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, Frank Hao, Eric Herget, Andrew Holden, Yasin Hussain, Elias Iliadis, Frank Italiano, Natalia Jaworska, Kamil Jonas, Kevin Jones, Hussein Kiliddar, Stavros Konstantinides, Grzegorz Kopeć, Andreas Kramer, Holger Kuehne, Gautam Kumar, Brian Lawler, Marysa Leya, Kevin Liu, Robert Lookstein, Wojciech Magon, Aziz Marzoug, Yuri Matusov, Braedon McDonald, Shay McGuinness, Stephen Merrilees, Peter Monteleone, John Moriarty, Nicolas Mouawad, Ruben Mylvaganam, Khanjan Nagarsheth, Jean Panneton, Ken Parhar, Sahil Parikh, Jong Park, Rahul Patel, Marloe Prince, Mona Ranade, Animesh Rathore, Lisa Rauschert, Rehan Riaz, Willie Robinson, Zachary Rosol, Rachel Rosovsky, 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, Ido Weinberg, Lawrence Whitney, Jason Wong, Gregory Woodhead, Cayce Spencer Workman, Kei Yamada, Maidah Yaqoob, Van Young, Weili Zheng · 发表于：Circulation · 年份：2025 · DOI：10.1161/circulationaha.125.077232 · 被引用次数：46 · 研究领域：Venous Thromboembolism Diagnosis and Management、Atrial Fibrillation Management and Outcomes、Trauma, Hemostasis, Coagulopathy, Resuscitation

BACKGROUND: Patients with intermediate-high risk pulmonary embolism (PE) have an elevated right ventricular (RV) to left ventricular (LV) diameter ratio and are at risk of early clinical decompensation and mortality. Reperfusion therapy aims to rapidly relieve acute RV pressure overload and to normalize hemodynamics. STORM-PE (A Prospective, Multicenter, Randomized Controlled Trial Evaluating Anticoagulation Alone Versus Anticoagulation Plus Mechanical Aspiration With the Indigo Aspiration System for the Treatment of Intermediate-High Risk Acute Pulmonary Embolism) is the first reported randomized controlled trial to test the efficacy and to evaluate the safety of mechanical thrombectomy, specifically computer-assisted vacuum thrombectomy (CAVT) with anticoagulation compared to anticoagulation alone. METHODS: STORM-PE is an international randomized controlled trial with 1:1 randomization to CAVT with anticoagulation or anticoagulation alone. Eligible adults had acute-onset (symptoms ≤14 days), intermediate-high risk PE and were normotensive, with an RV/LV ratio ≥1.0 on computed tomographic pulmonary angiography and elevated cardiac biomarkers. The primary end-point analysis tested for a difference between groups for the change in RV/LV ratio at 48 hours, assessed by a blinded independent imaging core laboratory. Secondary end points included major adverse events within 7 days (a composite of clinical deterioration necessitating rescue therapy, PE-related mortality, symptomati...