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Patient Evidence Summary
Doctor, I have clot in my lungs. Do I need a clot-buster?
In people with pulmonary embolism, anticoagulants are used to prevent the formation of new blood clots while the person's body breaks down the clots slowly over time. Drugs that dissolve blood clots may work faster, but they are not better than anticoagulants at reducing risk of death and they increase the risk of major bleeding. Clot-busting drugs may be recommended for people with larger or more extensive clots.
Study highlights
People who received a fibrinolytic drug plus an anticoagulant did not have a lower risk of death than people who received an anticoagulant alone.
9 more people out of 100 had serious bleeding, and 18 more people out of 1000 bled into their brain while taking a fibrinolytic drug.
Understanding the problem
People with PE have an increased risk of death, but the risk varies from person to person. People with a new PE are usually treated with anticoagulants because they reduce the risk of forming new clots and allow the person's body to naturally break down the clot over time.
Another option is to give a fibrinolytic drug, or "clot-buster", that breaks down the clot. However, fibrinolytic drugs have a higher risk of major bleeding than anticoagulants. In particular, bleeding into the brain is more common with fibrinolytic drugs, and this can lead to symptoms similar to a stroke. For this reason, fibrinolytic drugs are usually reserved for patients who have large clots.
In this study, researchers looked at the benefit and harm of a fibrinolytic drug plus an anticoagulant given to people with moderate-size PE compared with people given anticoagulants alone.
Who? The study included 1006 people who had a moderate-size PE within the past 15 days plus evidence (on imaging or with a blood test) that their heart was working hard to maintain blood flow.
What? The study compared fibrinolytic drug plus anticoagulant with placebo plus anticoagulant.
Fibrinolytic drug plus anticoagulant | vs | Placebo plus anticoagulant |
|---|---|---|
Fibrinolytic drug (Tenecteplase): a clot-buster given by injection into a vein. Heparin: an anticoagulant given by injection into a vein (usual care). | Placebo: a substance administered by vein injection that has no effect on the clot but has the same volume and appearance as Tenecteplase. Heparin: an anticoagulant given by injection into a vein (usual care). |
Fibrinolytic drug plus anticoagulant vs placebo plus anticoagulant in people who have a moderate-size pulmonary embolism plus evidence their heart is working hard
Outcomes at 7 days | Rate of events with fibrinolytic drug | Rate of events with placebo | Results |
|---|---|---|---|
Death from any cause | About 1 out of 100 people | 2 out of 100 people | No difference* |
Low blood pressure requiring urgent treatment | About 2 out of 100 people | 5 out of 100 people | About 3 fewer people out of 100 had low blood pressure requiring urgent treatment while taking the fibrinolytic drug |
Major bleeding | 11 out of 100 people | 2 out of 100 people | About 9 more people out of 100 had major bleeding while taking the fibrinolytic drug |
| Stroke (due to bleeding into brain) | 20 out of 1000 people | About 2 out of 1000 people | About 18 more people out of 1000 had a stroke while taking the fibrinolytic drug |
*Although the rates for the 2 groups look different, the differences were not statistically significant—this means that the difference could simply be due to chance rather than due to the different treatments.
This Evidence Summary is based on the following article:
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. doi: 10.1056/NEJMoa1302097. PubMed
Federico Germini, MD
Federico is a PhD student in the Health Research Methodology program at McMaster University and a CanVECTOR research fellow. He completed his Emergency Medicine residency in Italy and a Masters in Health Research Methodology at McMaster University. His research interests include diagnosis, prognosis, and patient-reported outcomes, mainly applied to pulmonary embolism and hemophilia.
Kerstin De Wit, MBChB, BSc, MSc, MD
Kerstin de Wit works as a Thrombosis physician and an Emergency physician in McMaster Health Sciences, Hamilton. She trained in internal medicine and emergency medicine in the UK and holds both Masters and Doctorate degrees in health research. Her research focuses on diagnosis of pulmonary embolism and prescription of anticoagulation in the emergency department.
Published: Friday, October 11, 2019
Last Updated: Thursday, July 30, 2020
Please note that the information contained herein is not to be interpreted as an alternative to medical advice from a professional healthcare provider. If you have any questions about any medical matter, you should consult your professional healthcare providers, and should never delay seeking medical advice, disregard medical advice or discontinue medication based on information provided here.
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, McMaster University