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J Thromb Haemost. 2014 Apr;12(4):459-68. doi: 10.1111/jth.12521.

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

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  • 1Departments of Emergency Medicine and Cellular and Integrative Physiology, Indiana University School of Medicine, Indianapolis, IN, USA.

Abstract

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.

© 2014 International Society on Thrombosis and Haemostasis.

KEYWORDS:

pulmonary embolism; quality of life; randomized controlled trial; thrombolytic therapy; ventricular function, right

PMID:
24484241
[PubMed - indexed for MEDLINE]
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