Thrombolysis (alone) for intermediate risk PE improves haemodynamics but not survival, at the cost of extra stroke and bleeding

Thrombolysis in the non critically ill patient with PE causes 5% increased risk of bleeding and 2% increased risk of stroke, but doesn't significantly improve survival (which is not really surprising as only 2-3% die by 30 days). It does, however, make some haemodynamic numbers look better on the way!

Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism

Guy Meyer, M.D., Eric Vicaut, M.D., Thierry Danays, M.D., et al.,

N Engl J Med 2014; 370:1402-1411April 10, 2014DOI: 10.1056/NEJMoa1302097

Background

The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial.

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Methods

In a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization.

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Results

Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42).

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Conclusions

In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; ClinicalTrials.gov number, NCT00639743.)

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