Intermediate-Risk Patients with PE Should Receive Thrombolytics Only If They Decompensate

April 9, 2014

Intermediate-Risk Patients with PE Should Receive Thrombolytics Only If They Decompensate

  1. Ali S. Raja, MD, MBA, MPH, FACEP

Primary thrombolysis did not improve mortality but did increase major hemorrhage and stroke in patients with intermediate-risk pulmonary embolism.

  1. Ali S. Raja, MD, MBA, MPH, FACEP

Administration of thrombolytic therapy for acute pulmonary embolism (PE) requires weighing the substantial risk of hemorrhage against the potential benefits, mainly improved hemodynamics and reduced mortality. For patients in shock with clear evidence of PE (high risk), the benefits seem to outweigh the risks, but for hemodynamically stable patients with evidence of right ventricular dysfunction and elevated troponin levels (intermediate risk), the evidence has been less clear. To determine the safety and efficacy of thrombolytic therapy in intermediate-risk patients, researchers in France performed a multicenter, randomized, double-blind trial comparing tenecteplase plus heparin with placebo plus heparin in 1005 hemodynamically stable patients with PE, right ventricular dysfunction on ultrasound or computed tomography, and troponin elevation.

Mortality was similar in the tenecteplase and placebo groups at 7 days (1.2% and 1.8%) and 30 days (2.4% and 3.2%). The tenecteplase group had higher rates of both intracranial bleeding (2.0% vs. 0.2%) and extracranial bleeding (6.3% vs. 1.2%). However, significantly more patients in the placebo group had hemodynamic decompensation and needed rescue thrombolysis during their admission (5.0% vs. 1.6%).


Given the risk for hemorrhage, primary thrombolysis should not be given to hemodynamically stable patients with intermediate-risk pulmonary embolism. However, intermediate-risk patients can decompensate and should be closely monitored in case they need rescue thrombolysis or mechanical embolectomy during hospitalization. These results are similar to those of earlier smaller trials and reinforce current practice (NEJM Journal Watch Gen Med Oct 18 2002, NEJM Journal Watch Hosp Med Feb 11 2008, NEJM Journal Watch Emerg Med Dec 12 2008).

Editor Disclosures at Time of Publication

  • Disclosures for Ali S. Raja, MD, MBA, MPH, FACEP at time of publication Consultant / Advisory board Diagnotion, LLC Speaker's bureau Airway Management Education Center Grant / research support NHLBI; Brigham and Women’s Hospital Eleanor and Miles Shore Award; Harvard Medical School Milton Foundation; DHHS/CMS; NIBIB Editorial boards Western Journal of Emergency Medicine Leadership positions in professional societies Society for Academic Emergency Medicine; Brigham and Women’s Physician Organization


Reader Comments (3)

Barbara Brush CNS-BC, CNS, MSN, RN Other Healthcare Professional, Orthopedics, Miami Valley Hospital

Helpful addition to our collection to determine protocols

GABRIELE KRUTISCH Physician, Cardiology

A longer follow-up period would be of interest - 1 - 3 months - to see, if there is a difference in the clinical status of the two groups.
Patients in the fibrinolysis-group maybe have less symptoms in daily life.

VJERAN NIKOLIC HEITZLER Physician, Cardiology, University hospital, Zagreb

Something is missing.When did the autors start the the thrombolytic therapy ? 3, 6,12 or more then 24 hour's after onset the symptoms.

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