Document Type
Article
Publication Date
2-4-2025
Abstract
BACKGROUND: There are a lack of randomized controlled trial data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism.
METHODS: PEERLESS is a prospective, multicenter, randomized controlled trial that enrolled 550 patients with intermediate-risk pulmonary embolism 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 end point was a hierarchal win ratio composite of the following (assessed at the sooner of hospital discharge or 7 days after the procedure): (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) postprocedural intensive care unit admission and length of stay. Assessments at the 24-hour visit included respiratory rate, modified Medical Research Council dyspnea score, New York Heart Association classification, right ventricle/left ventricle ratio reduction, and right ventricular function. End points through 30 days included total hospital stay, all-cause readmission, and all-cause mortality.
RESULTS: The primary end point occurred significantly less frequently with LBMT compared with CDT (win ratio, 5.01 [95% CI, 3.68-6.97]; P<0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% versus 5.4%; P=0.04) with LBMT compared with CDT and less postprocedural intensive care unit use (P<0.001), including admissions (41.6% versus 98.6%) and stays >24 hours (19.3% versus 64.5%). There were no significant differences in mortality, intracranial hemorrhage, or major bleeding between strategies or in a secondary win ratio end point including the first 4 components (win ratio, 1.34 [95% CI, 0.78-2.35]; P=0.30). At the 24-hour visit, respiratory rate was lower for patients treated with LBMT (18.3±3.3 versus 20.1±5.1; P<0.001), and fewer had moderate to severe modified Medical Research Council dyspnea scores (13.5% versus 26.4%; P<0.001), New York Heart Association classifications (16.3% versus 27.4%; P=0.002), and right ventricular dysfunction (42.1% versus 57.9%; P=0.004). Right ventricle/left ventricle ratio reduction was similar (0.32±0.24 versus 0.30±0.26; P=0.55). Patients treated with LBMT had shorter total hospital stays (4.5±2.8 overnights versus 5.3±3.9 overnights; P=0.002) and fewer all-cause readmissions (3.2% versus 7.9%; P=0.03), whereas 30-day mortality was similar (0.4% versus 0.8%; P=0.62).
CONCLUSIONS: PEERLESS met its primary end point in favor of LBMT compared with CDT in treatment of intermediate-risk pulmonary embolism. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural intensive care unit use compared with CDT, with no difference in mortality or bleeding.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05111613.
Recommended Citation
Jaber, Wissam; Gonsalves, Carin; Stortecky, Stefan; Horr, Samuel; Pappas, Orestis; Gandhi, Ripal; Pereira, Keith; Giri, Jay; Khandhar, Sameer; Ammar, Khawaja Afzal; Lasorda, David; Stegman, Brian; Busch, Lucas; Dexter, David; Azene, Ezana; Daga, Nikhil; Elmasri, Fakhir; Kunavarapu, Chandra; Rea, Mark; Rossi, Joseph; Campbell, Joseph; Lindquist, Jonathan; Raskin, Adam; Smith, Jason; Tamlyn, Thomas; Hernandez, Gabriel; Rali, Parth; Schmidt, Torrey; Bruckel, Jeffrey; Camacho, Juan; Li, Jun; Selim, Samy; Toma, Catalin; Basra, Sukhdeep Singh; Bergmark, Brian; Khalsa, Bhavraj; Zlotnick, David; Castle, Jordan; O'Connor, David; and Gibson, C. Michael, "Large-Bore Mechanical Thrombectomy Versus Catheter-Directed Thrombolysis in the Management of Intermediate-Risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial" (2025). Department of Radiology Faculty Papers. Paper 167.
https://jdc.jefferson.edu/radiologyfp/167
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
39470698
Language
Englilsh
Included in
Cardiovascular Diseases Commons, Diagnosis Commons, Health Services Administration Commons, Radiology Commons, Surgical Procedures, Operative Commons, Therapeutics Commons
Comments
This article is the author's final published version in Circulation, Volume 151, Issue 5, February 2025, Pages 260 - 273.
The published version is available at https://doi.org/10.1161/CIRCULATIONAHA.124.072364.
Copyright © 2024 The Authors