FIBRINOLYSIS FOR PATIENTS WITH INTERMEDIATE-RISK PULMONARY EMBOLISM (PEITHO) (Meyer et al, N Engl J Med 2014; 370 (15): 1402-11)
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This study aimed to establish the role of fibrinolytic therapy in those with intermediate risk pulmonary embolism (i.e. normotensive patients with acute PE & evidence of right ventricular (RV) impairment. RV dysfunction was defined as echo or CT abnormalities & a positive troponin. The primary outcome was combined all-cause mortality or haemodynamic decompensation at day 7. 1005 patients were randomised to unfractionated heparin plus tenecteplase versus unfractionated heparin & placebo. The primary endpoint of death or haemodynamic decompensation within 7 days occurred in 2.6% of the fibrinolysis group versus 5.6% of the placebo group (p 0.02). This difference was driven by haemodynamic decompensation (p 0.002), which included isolated systolic hypertension, which may not be clinically meaningful. There was no difference in mortality between the groups. As expected, major bleeding occurred more often in those assigned to fibrinolysis. Even though those patients at increased risk for major bleeding were excluded, the rate of haemorrhagic stroke in the fibrinolysis group was 10 times higher than the anticoagulation alone group (2% versus 0.2%).
Summary: There is an unfavourable risk: benefit ratio for the use of fibrinolytics in normotensive patients with acute PE & evidence of RV dysfunction.