Treatment of submassive pulmonary embolism with tenecteplase or placebo: Cardiopulmonary outcomes at 3 months: Multicenter double-blind, placebo-controlled randomized trial

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

Research output: Contribution to journalArticlepeer-review

139 Scopus citations

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 languageEnglish (US)
Pages (from-to)459-468
Number of pages10
JournalJournal of Thrombosis and Haemostasis
Volume12
Issue number4
DOIs
StatePublished - 2014

Keywords

  • Pulmonary embolism
  • Quality of life
  • Randomized controlled trial
  • Thrombolytic therapy
  • Ventricular function, right

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)

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