Fibrinolysis for patients with intermediate-risk PE

The use of fibrinolysis for normotensive patients with an intermediate risk of death after acute pulmonary embolism (PE) remains a controversial topic. The PIETHO trial (N Engl J Med 2014;370:1402–11) was a multicentre, double-blind trial, in which 1006 patients with acute PE and evidence of right ventricular dysfunction on echocardiography or CT, as well as positive cardiac troponin test, were randomly assigned to initial treatment with tenecteplase plus heparin, or placebo plus heparin. The primary outcome of death or haemodynamic compromise within 7 days of randomisation occurred in 13 of 506 patients (2.6%) in the fibrinolysis group and 28 of 499 patients (5.6%) in the placebo group (p=0.02). Haemodynamic compromise occurred in 25 of 499 patients (5%) in the placebo group. Major bleeding occurred more often in the fibrinolysis group, with 2% of developing haemorrhagic stroke compared to 0.2% of the placebo group. The rate of death from any cause during the first 7 days was low for both groups. …