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
Abstract
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, symptomatic recurrent PE, and major bleeding), adjudicated by an external clinical events committee. Additional outcomes included change in vital signs and core laboratory–assessed pulmonary artery obstruction at 48 hours. RESULTS: A total of 100 patients enrolled across 22 sites were randomized to CAVT (n=47) or anticoagulation alone (n=53). Baseline characteristics were comparable between arms. At 48 hours, mean reduction in RV/LV ratio was greater for CAVT (0.52±0.37) than anticoagulation (0.24±0.40), a difference of 0.27 (95% CI, 0.12–0.43; P <0.001). Refined modified and modified Miller scores exhibited greater changes for CAVT than anticoagulation alone at 48 hours ( P <0.001). Early normalization of vital signs within 48 hours was more frequent after CAVT. The major adverse event rate within 7 days was not different between groups (CAVT, 4.3% versus anticoagulation, 7.5%; P =0.681). Two PE-related deaths occurred in the CAVT arm. CONCLUSIONS: CAVT was superior to anticoagulation alone in reducing RV/LV ratio within 48 hours in patients with intermediate-high risk PE, accompanied by earlier normalization of vital signs and major adverse event rates comparable to those for anticoagulation. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05684796.
Article Details
Authors (117)
Robert A. Lookstein
Department of Inverventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (R.A.L.).
Stavros V. Konstantinides
Suhail Y. Dohad
Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA (S.Y.D.).
John M. Moriarty
Interventional Radiology, David Geffen School of Medicine at UCLA, Los Angeles, CA (J.M.M.).
Sahil A. Parikh
Richard N. Channick
Pulmonary and Critical Care Division, University of California–Los Angeles Health (R.N.C.).
Khanjan H. Nagarsheth
University of Maryland, College Park (K.H.N.).
Rachel P. 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
Cedars Sinai Medical Center, Los Angeles, CA (S.D.).
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
Northern Region Interventional Radiology Service, Auckland City Hospital, Grafton, New Zealand (A.H.).
Yasin Hussain
Elias Iliadis
Frank Italiano
Natalia Jaworska
Kamil Jonas
Kevin Jones
Hussein Kiliddar
Stavros Konstantinides
Grzegorz Kopec
Department of Cardiac and Vascular Diseases, Pulmonary Circulation Center, Jagiellonian University Medical College, Krakow, Poland
Andreas Kramer
Holger Kuehne
Gautam Kumar
Brian Lawler
Marysa Leya
Kevin Liu
Robert Lookstein
Wojciech Magoń
Aziz Marzoug
Yuri Matusov
Braedon McDonald
Department of Critical Care Medicine, Cumming School of Medicine, University of Calgary
Shay McGuinness
Stephen Merrilees
Peter Monteleone
Ascension Texas Cardiovascular, University of Texas Austin Dell School of Medicine, Austin
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
Interventional Cardiology, Baylor University Medical Center, The Heart Hospital, Dallas, TX (Z.R.).
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 Stępniewski
Lucas Struycken
Ranya Sweis
Jordan Tasse
Manoj Thangam
Benjamin Tritle
Michael Troy
Ulku Turba
Jenanan Vairavamurthy
Ilaria Vittoria De Martini
Marcin Waligóra
Ido Weinberg
Massachusetts General Hospital, Harvard Medical School, Boston
Lawrence Whitney
Jason Wong
Gregory Woodhead
Cayce Spencer Workman
Kei Yamada
Maidah Yaqoob
Van Young
Weili Zheng