Fibrinolysis for patients with intermediate-risk pulmonary embolism
Fibrinolysis for patients with intermediate-risk pulmonary embolism. Meyer G et al. N Engl J Med. 2014 Apr 10;370(15):1402-11.
Do normotensive PE patients with signs of RV dysfunction and +troponins benefit from thrombolysis in addition to standard therapy? What are the benefits and consequences of adding tenecteplase to heparin therapy in these intermediate-risk PE patients?
A multicenter, randomized, double-blind, intention-to-treat analysis of 1005 patients with intermediate-risk PE who received either heparin alone or heparin and tenecteplase. Intermediate-risk PE was defined as normotension with CT or ECHO signs of RV dysfunction AND a positive troponin leak.
There was a statistically significant decrease in the primary outcome (7-day mortality or hemodynamic decompensation) and a statistically significant increase in stroke and extracranial bleeding in the tenecteplase group. There was no significant difference in 30 day mortality.
The Takeaway :
The improved primary outcome in the tenecteplase group was due almost entirely to a decreased incidence of hemodynamic decompensation. There was no statistically significant difference in 7-day mortality. Given the increased bleeding risk and lack of mortality benefit at both 7 and 30 days, this study does not support the addition of tenecteplase to heparin treatment in the setting of intermediate-risk PE. However, it is possible that there are other important quality of life differences. Stay tuned for more papers from this study.