• J A Kline, K E Nordenholz, D M Courtney, C Kabrhel, A E Jones, M T Rondina, D B Diercks, J R Klinger, and J Hernandez.
• Departments of Emergency Medicine and Cellular and Integrative Physiology, Indiana University School of Medicine, Indianapolis, IN, USA.
• J. Thromb. Haemost. 2014 Apr 1;12(4):459-68.

BackgroundAcute pulmonary embolism (PE) can worsen quality of life due to persistent dyspnea or exercise intolerance.ObjectiveTest if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE.MethodsNormotensive patients with PE and right ventricular (RV) strain (by echocardiography or biomarkers) were enrolled from eight hospitals. All patients received low-molecular-weight heparin followed by random assignment to either a single weight-based bolus of tenecteplase or placebo, administered in a double-blinded fashion. The primary composite outcome included: (i) death, circulatory shock, intubation or major bleeding within 5 days or (ii) recurrent PE, poor functional capacity (RV dysfunction with either dyspnea at rest or exercise intolerance) or an SF36(®) Physical Component Summary (PCS) score < 30 at 90-day follow-up.ResultsEighty-three patients were randomized; 40 to tenecteplase and 43 to placebo. The trial was terminated prematurely. Within 5 days, adverse outcomes occurred in three placebo-treated patients (death in one and intubation in two) and one tenecteplase-treated patient (fatal intracranial hemorrhage). At 90 days, adverse outcomes occurred in 13 unique placebo-treated patients and five unique tenecteplase-treated patients Thus, 16 (37%) placebo-treated and six (15%) tenecteplase-treated patients had at least one adverse outcome (exact two-sided P = 0.017).ConclusionsTreatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome.© 2014 International Society on Thrombosis and Haemostasis.

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