Large-bore mechanical thrombectomy versus catheter-directed thrombolysis in the management of intermediate-risk pulmonary embolism: Primary results of the PEERLESS randomized controlled trial

Wissam A. Jaber, Emory University Hospital, Atlanta, GA.
Carin F. Gonsalves, Thomas Jefferson University Hospitals, Philadelphia, PA.
Stefan Stortecky, Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Samuel Horr, Centennial Medical Center, Nashville, TN.
Orestis Pappas, Allegheny Health Network, Erie, PA.
Ripal T. Gandhi, Miami Cardiac and Vascular Institute, Baptist Health South Florida, Miami, FL.
Keith Pereira, Saint Louis University, St. Louis, MO.
Jay Giri, Cardiovascular Medicine Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
Sameer J. Khandhar, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
Khawaja Afzal Ammar, Advocate Health - MidwestFollow
David M. Lasorda, Allegheny General Hospital, Allegheny Health Network, Pittsburgh, PA.
Brian Stegman, CentraCare Heart and Vascular Center, St. Cloud, MN.
Lucas Busch, Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Düsseldorf, Düsseldorf, Germany.
David J. Dexter Ii, Sentara Healthcare, Macon & Joan Brock Virginia Health Sciences at Old Dominion University, Norfolk, VA.
Ezana M. Azene, Emplify Health, La Crosse, WI.
Nikhil Daga, Huntington Hospital, Pasadena, CA.
Fakhir Elmasri, Lakeland Vascular Institute, Lakeland, FL.
Chandra R. Kunavarapu, Methodist Heart and Lung Institute, San Antonio, TX.
Mark E. Rea, Summa Health System, Akron, OH.
Joseph S. Rossi, University of North Carolina, Chapel Hill, NC.
Joseph Campbell, OhioHealth Riverside Methodist Hospital, Columbus, OH.
Jonathan Lindquist, University of Colorado Anschutz Medical Campus, Aurora, CO.
Adam Raskin, Mercy Heart Institute, Cincinnati OH.
Jason C. Smith, Loma Linda University Health, Loma Linda, CA.
Thomas M. Tamlyn, Heart and Vascular Institute of Wisconsin, Ascension St. Elizabeth Hospital, Appleton, WI.
Gabriel A. Hernandez, University of Mississippi Medical Center, Jackson, MS.
Parth Rali, Temple University Hospital, Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Philadelphia, PA.
Torrey R. Schmidt, University of Pittsburgh Medical Center, Harrisburg, PA.
Jeffrey T. Bruckel, University of Rochester Medical Center, Rochester, NY.
Juan C. Camacho, Department of Clinical Sciences, Florida State University, Sarasota, FL.
et al

Affiliations

Advocate Aurora St. Luke's Medical Center

Abstract

Background:There is a lack of randomized controlled trial (RCT) data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism (PE).

Methods:PEERLESS is a prospective, multicenter, RCT that enrolled 550 intermediate-risk PE patients with right ventricular dilatation and additional clinical risk factors randomized 1:1 to treatment with large-bore mechanical thrombectomy (LBMT) or catheter-directed thrombolysis (CDT). The primary endpoint was a hierarchal win ratio (WR) composite of the following: 1) all-cause mortality, 2) intracranial hemorrhage, 3) major bleeding, 4) clinical deterioration and/or escalation to bailout, and 5) postprocedural intensive care unit (ICU) admission and length of stay, assessed at the sooner of hospital discharge or 7 days post-procedure. Assessments at the 24-hour visit included respiratory rate, mMRC dyspnea score, NYHA classification, right ventricle (RV)/left ventricle (LV) ratio reduction, and RV function. Endpoints through 30 days included total hospital stay, all-cause readmission, and all-cause mortality.

Results:The primary endpoint occurred significantly less frequently with LBMT vs CDT (WR 5.01 [95% CI: 3.68-6.97]; P<0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% vs 5.4%; P=0.04) with LBMT vs CDT and less postprocedural ICU utilization (P<0.001), including admissions (41.6% vs 98.6%) and stays >24 hours (19.3% vs 64.5%). There was no significant difference in mortality, intracranial hemorrhage, or major bleeding between strategies, nor in a secondary WR endpoint including the first 4 components (WR 1.34 [95% CI: 0.78-2.35]; P=0.30). At the 24-hour visit, respiratory rate was lower for LBMT patients (18.3±3.3 vs 20.1±5.1; P<0.001) and fewer had moderate to severe mMRC dyspnea scores (13.5% vs 26.4%; P<0.001), NYHA classifications (16.3% vs 27.4%; P=0.002), and RV dysfunction (42.1% vs 57.9%; P=0.004). RV/LV ratio reduction was similar (0.32±0.24 vs 0.30±0.26; P=0.55). LBMT patients had shorter total hospital stays (4.5±2.8 vs 5.3±3.9 overnights; P=0.002) and fewer all-cause readmissions (3.2% vs 7.9%; P=0.03), while 30-day mortality was similar (0.4% vs 0.8%; P=0.62).

Conclusions:PEERLESS met its primary endpoint in favor of LBMT vs CDT in treatment of intermediate-risk PE. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural ICU utilization compared with CDT, with no difference in mortality or bleeding.

Type

Article

PubMed ID

39470698

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