Treatment of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at 3 months: multicenter double‐blind, placebo‐controlled randomized trial

• DOI: 10.1111/jth.12521
• Publication Date: 2014-01-31T17:13:09Z
• Authors: J.A. Kline; K.E. Nordenholz; D.M. Courtney; C. Kabrhel; A.E. Jones; M.T. Rondina; D.B. Diercks; J.R. Klinger; J. Hernandez
• Keywords: Adult; Male; Hemorrhage; Shock; Middle Aged; 3. Good health; 03 medical and health sciences; Dyspnea; Treatment Outcome; 0302 clinical medicine; Double-Blind Method; Fibrinolytic Agents; Tissue Plasminogen Activator; Quality of Life; Tenecteplase; Humans; Female; Prospective Studies; Pulmonary Embolism; Aged; Probability

Acute pulmonary embolism (PE) can worsen quality of life due to persistent dyspnea or exercise intolerance.Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE.Normotensive 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.Eighty-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).Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome.