Benefits/Risks for Fibrinolytic Therapy in Intermediate-Risk PE
Cuts mortality, hemodynamic decompensation; ups risk of intracranial bleeding, stroke
FRIDAY, April 11, 2014 (HealthDay News) -- A single intravenous bolus of tenecteplase reduces early death and hemodynamic decompensation in normotensive patients with intermediate-risk pulmonary embolism, but increases the risk of major hemorrhage and stroke, according to a study published in the April 10 issue of the New England Journal of Medicine.
Guy Meyer, M.D., from the Hôpital Européen Georges Pompidou in Paris, and colleagues randomized 1,005 normotensive patients with intermediate-risk pulmonary embolism due to right ventricular dysfunction and myocardial injury to tenecteplase plus heparin or placebo plus heparin. A composite of death or hemodynamic decompensation (or collapse) within seven days of randomization marked the primary outcome.
The researchers found that death or hemodynamic decompensation occurred in 2.6 percent of the 506 patients in the tenecteplase group versus 5.6 percent of the 499 patients in the placebo group (odds ratio, 0.44; P = 0.02). Death occurred in the first seven days in six patients in the tenecteplase group and nine patients in the placebo group (P = 0.42). Extracranial bleeding occurred in 32 patients in the tenecteplase group and six patients in the placebo group (6.3 versus 1.2 percent; P < 0.001). In the tenecteplase group, 12 patients had a stroke (2.4 percent), of which 10 were hemorrhagic, compared to one patient with hemorrhagic stroke in the control group (P = 0.003).
"In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke," the authors write.
The study was funded in part by a grant from Boehringer Ingelheim.