Meyer, GuyGuyMeyerVicaut, EricEricVicautDanays, ThierryThierryDanaysAgnelli, GiancarloGiancarloAgnelliBecattini, CeciliaCeciliaBecattiniBeyer-Westendorf, JanJanBeyer-WestendorfBluhmki, ErichErichBluhmkiBouvaist, HeleneHeleneBouvaistBrenner, BenjaminBenjaminBrennerCouturaud, FrancisFrancisCouturaudDellas, ClaudiaClaudiaDellasEmpen, KlausKlausEmpenFranca, AnaAnaFrancaGaliè, NazzarenoNazzarenoGalièGeibel, AnnetteAnnetteGeibelGoldhaber, Samuel Z.Samuel Z.GoldhaberJimenez, DavidDavidJimenezKozak, MatijaMatijaKozakKupatt, ChristianChristianKupattKucher, NilsNilsKucherLang, Irene M.Irene M.LangLankeit, MareikeMareikeLankeitMeneveau, NicolasNicolasMeneveauPacouret, GerardGerardPacouretPalazzini, MassimilianoMassimilianoPalazziniPetris, AntoniuAntoniuPetrisPruszczyk, PiotrPiotrPruszczykRugolotto, MatteoMatteoRugolottoSalvi, AldoAldoSalviSchellong, SebastianSebastianSchellongSebbane, MustaphaMustaphaSebbaneSobkowicz, BozenaBozenaSobkowiczStefanovic, Branislav S.Branislav S.StefanovicThiele, HolgerHolgerThieleTorbicki, AdamAdamTorbickiVerschuren, FranckFranckVerschurenKonstantinides, Stavros V.Stavros V.Konstantinides2024-10-152024-10-152014-04-10https://boris-portal.unibe.ch/handle/20.500.12422/124728BACKGROUND The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial. METHODS In a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization. RESULTS Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42). CONCLUSIONS In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; ClinicalTrials.gov number, NCT00639743.).en600 - Technology::610 - Medicine & healtharticle10.7892/boris.545332471668110.1056/NEJMoa1302097