EBQ:TOPCOAT Trial: Difference between revisions
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| title= Treatment of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at 3 months: multicenter double-blind, placebo-controlled randomized trial. | | title= Treatment of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at 3 months: multicenter double-blind, placebo-controlled randomized trial. | ||
| abbreviation= TOPCOAT | | abbreviation= TOPCOAT | ||
| expansion= | | expansion= Tenecteplase or Placebo: Cardio- pulmonary Outcomes at Three months | ||
| published= 2014 | | published= 2014 | ||
| author= Kline J. et al. | | author= Kline J. et al. | ||
| Line 18: | Line 18: | ||
==Conclusion== | ==Conclusion== | ||
*Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome. | |||
==Major Points== | ==Major Points== | ||
*The adjunctive use of fibrinolysis to treat acute submas- sive pulmonary embolism (PE) remains controversial. The American Heart Association has maintained that for massive pulmonary embolism, thrombolysis with tPA is an effective treatment strategy.<ref>Jaff M. et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830</ref>. This trial addressed thrombolysis in patients who are hemodynamically stable but had moderate PE evidenced on CTA. Commonly, the group termed, sub-massive PE includes patients with elevated troponin, BNP, or RV dysfunction on echocardiogram.. The standard of treatment for the [[Pulmonary_Embolism_(PE)#Submassive|sub-massive PE]] group has been unclear and thrombolysis has not been standard care for treatment, with most of these patients receiving heparin to decrease clot propagation while clot is slowly broken down<ref>Konstantinides S. Association between thrombolytic treatment and the prognosis of hemodynamically stable patients with major pulmonary embolism: results of a multicenter registry. Circulation 1997;96: 882e888</ref> | |||
*The [[EBQ:MOPETT Trial|MOPETT Trial]] and the [[EBQ:PEITHO_Trial|PEITHO Trial]] have suggested there is a possible mortality benefit however the risks of treatment are weighted against the bleeding risks. | |||
*In patients with submassive PE, the use of tenecteplase resulted in a reduction in adverse outcomes based on a complicated composite outcome. However, the only independent variable that reached statistical significance was related to a self assessment of overall health at 90 days. This was simply the patients' response to being asked 'how would you rate your overall health?' (mean was 2.4 vs. 3.3 out of 10). The study was small, under powered and incomplete due to early termination, which limits any conclusions that can be made.<ref>http://www.wessexics.com/The_Bottom_Line/Review/index.php?id=7211101059506312495</ref> | |||
==Study Design== | ==Study Design== | ||
*Multicenter, double-blinded, intention to treat, placebo-controlled, randomized controlled efficacy trial<ref>Kline JA, Hernandez J, Hogg MM, Jones AE, Courtney DM, Kabrhel C, Nordenholz KE, Diercks DB, Rondina MT, Klinger JR. Rationale and methodology for a multicentre randomised tiral of fibrinolysis for pulmonary embolism that includes quality of life outcomes. Emerg Med Australas 2013; 25: 515–26.</ref> | |||
*8 academic centers in the United States | |||
==Population== | ==Population== | ||
===Patient Demographics=== | ===Patient Demographics=== | ||
===Inclusion Criteria=== | ===Inclusion Criteria=== | ||
*Age > 17 years | |||
*PE diagnosed on computed tomographic pulmonary angiography performed within 24 h | |||
*Normal arterial systolic blood pressure with evidence of right ventricular strain | |||
**Hypokinesis on echocardiography | |||
**Elevated troponin I or T using local thresholds (values exceeding the 99 percentile with coefficient of variability < 10%) OR | |||
**Brain natriuretic peptide (BNP) measurement > 90 pg mL�<sup>-1</sup> or NT proBNP > 900 pg mL�<sup>-1</sup> (not more than 6 h prior to CT angiography and not more than 30 h before enrollment). | |||
===Exclusion Criteria=== | ===Exclusion Criteria=== | ||
*Exclusions included systolic hypotension (< 90 mmHg), inability to walk, contraindications to fibrinolysis, and end-stage conditions | |||
==Interventions== | ==Interventions== | ||
| Line 50: | Line 61: | ||
==External Links== | ==External Links== | ||
[http://www.wessexics.com/The_Bottom_Line/Review/index.php?id=7211101059506312495 Wessexics - The Bottom Line] | |||
==Funding== | ==Funding== | ||
Revision as of 21:54, 7 September 2014
incomplete Journal Club Article
Kline J. et al.. "Treatment of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at 3 months: multicenter double-blind, placebo-controlled randomized trial.". J Thromb Haemost. 2014. 12(4):459-468.
PubMed PDF
PubMed PDF
Clinical Question
Does thrombolysis of submissive PE with tenecteplase increases the probability of a favorable composite outcome of death, circulatory shock, intubation, major bleeding in 5 days, recurrent PE, functional capacity or a Physical component summary at 90 day followup.
Conclusion
- Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome.
Major Points
- The adjunctive use of fibrinolysis to treat acute submas- sive pulmonary embolism (PE) remains controversial. The American Heart Association has maintained that for massive pulmonary embolism, thrombolysis with tPA is an effective treatment strategy.[1]. This trial addressed thrombolysis in patients who are hemodynamically stable but had moderate PE evidenced on CTA. Commonly, the group termed, sub-massive PE includes patients with elevated troponin, BNP, or RV dysfunction on echocardiogram.. The standard of treatment for the sub-massive PE group has been unclear and thrombolysis has not been standard care for treatment, with most of these patients receiving heparin to decrease clot propagation while clot is slowly broken down[2]
- The MOPETT Trial and the PEITHO Trial have suggested there is a possible mortality benefit however the risks of treatment are weighted against the bleeding risks.
- In patients with submassive PE, the use of tenecteplase resulted in a reduction in adverse outcomes based on a complicated composite outcome. However, the only independent variable that reached statistical significance was related to a self assessment of overall health at 90 days. This was simply the patients' response to being asked 'how would you rate your overall health?' (mean was 2.4 vs. 3.3 out of 10). The study was small, under powered and incomplete due to early termination, which limits any conclusions that can be made.[3]
Study Design
- Multicenter, double-blinded, intention to treat, placebo-controlled, randomized controlled efficacy trial[4]
- 8 academic centers in the United States
Population
Patient Demographics
Inclusion Criteria
- Age > 17 years
- PE diagnosed on computed tomographic pulmonary angiography performed within 24 h
- Normal arterial systolic blood pressure with evidence of right ventricular strain
- Hypokinesis on echocardiography
- Elevated troponin I or T using local thresholds (values exceeding the 99 percentile with coefficient of variability < 10%) OR
- Brain natriuretic peptide (BNP) measurement > 90 pg mL�-1 or NT proBNP > 900 pg mL�-1 (not more than 6 h prior to CT angiography and not more than 30 h before enrollment).
Exclusion Criteria
- Exclusions included systolic hypotension (< 90 mmHg), inability to walk, contraindications to fibrinolysis, and end-stage conditions
Interventions
Outcomes
Primary Outcome
Secondary Outcomes
Subgroup analysis
Criticisms & Further Discussion
External Links
Funding
Sources
- ↑ Jaff M. et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830
- ↑ Konstantinides S. Association between thrombolytic treatment and the prognosis of hemodynamically stable patients with major pulmonary embolism: results of a multicenter registry. Circulation 1997;96: 882e888
- ↑ http://www.wessexics.com/The_Bottom_Line/Review/index.php?id=7211101059506312495
- ↑ Kline JA, Hernandez J, Hogg MM, Jones AE, Courtney DM, Kabrhel C, Nordenholz KE, Diercks DB, Rondina MT, Klinger JR. Rationale and methodology for a multicentre randomised tiral of fibrinolysis for pulmonary embolism that includes quality of life outcomes. Emerg Med Australas 2013; 25: 515–26.