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

description: <p>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]; <em>P</em>&lt;0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% vs 5.4%; <em>P</em>=0.04) with LBMT vs CDT and less postprocedural ICU utilization (<em>P</em>&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]; <em>P</em>=0.30). At the 24-hour visit, respiratory rate was lower for LBMT patients (18.3&plusmn;3.3 vs 20.1&plusmn;5.1; <em>P</em>&lt;0.001) and fewer had moderate to severe mMRC dyspnea scores (13.5% vs 26.4%; <em>P</em>&lt;0.001), NYHA classifications (16.3% vs 27.4%; <em>P</em>=0.002), and RV dysfunction (42.1% vs 57.9%; <em>P</em>=0.004). RV/LV ratio reduction was similar (0.32&plusmn;0.24 vs 0.30&plusmn;0.26; <em>P</em>=0.55). LBMT patients had shorter total hospital stays (4.5&plusmn;2.8 vs 5.3&plusmn;3.9 overnights; <em>P</em>=0.002) and fewer all-cause readmissions (3.2% vs 7.9%; <em>P</em>=0.03), while 30-day mortality was similar (0.4% vs 0.8%; <em>P</em>=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.</p>