Jaber, Wissam AWissam AJaberGonsalves, Carin FCarin FGonsalvesStortecky, StefanStefanStorteckyHorr, SamuelSamuelHorrPappas, OrestisOrestisPappasGandhi, Ripal TRipal TGandhiPereira, KeithKeithPereiraGiri, JayJayGiriKhandhar, Sameer JSameer JKhandharAmmar, Khawaja AfzalKhawaja AfzalAmmarLasorda, David MDavid MLasordaStegman, BrianBrianStegmanBusch, LucasLucasBuschDexter Ii, David JDavid JDexter IiAzene, Ezana MEzana MAzeneDaga, NikhilNikhilDagaElmasri, FakhirFakhirElmasriKunavarapu, Chandra RChandra RKunavarapuRea, Mark EMark EReaRossi, Joseph SJoseph SRossiCampbell, JosephJosephCampbellLindquist, JonathanJonathanLindquistRaskin, AdamAdamRaskinSmith, Jason CJason CSmithTamlyn, Thomas MThomas MTamlynHernandez, Gabriel AGabriel AHernandezRali, ParthParthRaliSchmidt, Torrey RTorrey RSchmidtBruckel, Jeffrey TJeffrey TBruckelCamacho, Juan CJuan CCamachoLi, JunJunLiSelim, SamySamySelimToma, CatalinCatalinTomaBasra, Sukhdeep SinghSukhdeep SinghBasraBergmark, Brian ABrian ABergmarkKhalsa, BhavrajBhavrajKhalsaZlotnick, David MDavid MZlotnickCastle, JordanJordanCastleO'Connor, David JDavid JO'ConnorGibson, C MichaelC MichaelGibson2024-11-252024-11-252025-02https://boris-portal.unibe.ch/handle/20.500.12422/189390Background 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.en600 - Technology::610 - Medicine & healtharticle10.48620/769753947069810.1161/CIRCULATIONAHA.124.072364