Pulmonary embolism · Thrombolysis in intermediate-risk PE
Pulmonary Embolism Thrombolysis trial
| Design | Randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Single weight-adjusted bolus of tenecteplase plus heparin |
| Control | Placebo plus heparin |
| Population | 1005 patients with intermediate-risk pulmonary embolism: right ventricular dysfunction and a positive troponin, without haemodynamic instability |
| Follow-up | 30 days |
| Primary endpoint | Death or haemodynamic decompensation within 7 days |
| Result | Death or haemodynamic decompensation in 13 of 506 (2.6%) with tenecteplase versus 28 of 499 (5.6%) with placebo — odds ratio 0.44 (95% CI 0.23 to 0.87, p=0.02). Death by day 7 occurred in 6 (1.2%) versus 9 (1.8%), p=0.42. Extracranial bleeding affected 32 (6.3%) versus 6 (1.2%), and haemorrhagic stroke was more common with tenecteplase. |
| Secondary endpoints | All-cause mortality, major extracranial bleeding, haemorrhagic stroke |
In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke.
The trial authors, in the published abstract
The trial that stopped routine thrombolysis for submassive PE. The efficacy signal is real; so is the haemorrhagic stroke. It reframed the question from whether to lyse to how to intervene with less bleeding, which is what the catheter trials such as PEERLESS set out to answer.
Meyer G, Vicaut E, Danays T, et al. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med 2014 Apr 10;370(15):1402-11.