Large-bore Mechanical Thrombectomy Versus Catheter-directed Thrombolysis in the Management of Intermediate-risk Pulmonary Embolism: Primary Results of the PEERLESS Randomized Controlled Trial
Authors: Wissam A. Jaber, Carin F. Gonsalves, Stefan Stortecky, Samuel Horr, Orestis Pappas, Ripal T. Gandhi, Keith Pereira, Jay Giri, Sameer J. Khandhar, Khawaja Afzal Ammar, David M. Lasorda, Brian Stegman, Lucas Busch, David J. Dexter II, Ezana M. Azene, Nikhil Daga, Fakhir Elmasri, Chandra R. Kunavarapu, Mark E. Rea, Joseph S. Rossi, Joseph Campbell, Jonathan Lindquist, Adam Raskin, Jason C. Smith, Thomas M. Tamlyn, Gabriel A. Hernandez, Parth Rali, Torrey R. Schmidt, Jeffrey T. Bruckel, Juan C. Camacho, Jun Li, Samy Selim, Catalin Toma, Sukhdeep Singh Basra, Brian A. Bergmark, Bhavraj Khalsa, David M. Zlotnick, Jordan Castle, David J. O'Connor, C. Michael Gibson
Journal: Circulation (2024)

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 &lt;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 &lt;0.001), including admissions (41.6% vs 98.6%) and stays &gt;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 &lt;0.001) and fewer had moderate to severe mMRC dyspnea scores (13.5% vs 26.4%; P &lt;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.