Abstract
Summary: Background: Acute pulmonary embolism (PE) can worsen quality of life due to persistent dyspnea or exercise intolerance. Objective: Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE. Methods: 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. Results: 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). Conclusions: Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome.
Original language | English (US) |
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Pages (from-to) | 459-468 |
Number of pages | 10 |
Journal | Journal of Thrombosis and Haemostasis |
Volume | 12 |
Issue number | 4 |
DOIs | |
State | Published - Apr 2014 |
Keywords
- Pulmonary embolism
- Quality of life
- Randomized controlled trial
- Thrombolytic therapy
- Ventricular function, right
ASJC Scopus subject areas
- Hematology