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

Jeffrey 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 journalArticle

120 Citations (Scopus)

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

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Pulmonary Embolism
Randomized Controlled Trials
Placebos
Therapeutics
Intubation
Dyspnea
tenecteplase
Exercise
Right Ventricular Dysfunction
Intracranial Hemorrhages
Low Molecular Weight Heparin
Echocardiography
Shock
Biomarkers
Quality of Life
Hemorrhage
Weights and Measures

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)

Cite this

Treatment of submassive pulmonary embolism with tenecteplase or placebo : Cardiopulmonary outcomes at 3 months: Multicenter double-blind, placebo-controlled randomized trial. / Kline, Jeffrey; Nordenholz, K. E.; Courtney, D. M.; Kabrhel, C.; Jones, A. E.; Rondina, M. T.; Diercks, D. B.; Klinger, J. R.; Hernandez, J.

In: Journal of Thrombosis and Haemostasis, Vol. 12, No. 4, 2014, p. 459-468.

Research output: Contribution to journalArticle

Kline, Jeffrey ; Nordenholz, K. E. ; Courtney, D. M. ; Kabrhel, C. ; Jones, A. E. ; Rondina, M. T. ; Diercks, D. B. ; Klinger, J. R. ; Hernandez, J. / Treatment of submassive pulmonary embolism with tenecteplase or placebo : Cardiopulmonary outcomes at 3 months: Multicenter double-blind, placebo-controlled randomized trial. In: Journal of Thrombosis and Haemostasis. 2014 ; Vol. 12, No. 4. pp. 459-468.
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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{\circledR} 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.",
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T1 - Treatment of submassive pulmonary embolism with tenecteplase or placebo

T2 - Cardiopulmonary outcomes at 3 months: Multicenter double-blind, placebo-controlled randomized trial

AU - Kline, Jeffrey

AU - Nordenholz, K. E.

AU - Courtney, D. M.

AU - Kabrhel, C.

AU - Jones, A. E.

AU - Rondina, M. T.

AU - Diercks, D. B.

AU - Klinger, J. R.

AU - Hernandez, J.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - Pulmonary embolism

KW - Quality of life

KW - Randomized controlled trial

KW - Thrombolytic therapy

KW - Ventricular function, right

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