Clot-Busting Stroke Medicine: Mired in Controversy

An ischemic stroke occurs as a result of an obstruction within a blood vessel supplying blood to the brain and accounts for about 87 percent of all strokes, according to the American Stroke Association.

A common treatment used to break up the clots and prevent brain damage has become mired in controversy. The treatment, called tissue plasminogen activator (TPA), demonstrated in a clinical trial that the medicine could break up those blood clots and prevent brain damage. More than 20 years ago TPA was part of a large clinical trial that investigators believed was the answer to the prayers of stroke victims and their families. TPA is the only medicine approved by the U.S. Food and Drug Administration for treating strokes that are caused by blood clots cutting off the supply to the brain. Despite its approval by the FDA, the data has been rejected as flawed by some emergency medicine practitioners, the New York Times reported.

In an interview with the Times Dr. Christopher Lewandowski, the principal trial investigator said they believed the data was so strong there wasn’t much need to explain it. However, as the Times noted, the data has doubters and so far, the doubters have had the stronger voice. In its report, the Times said approximately 30 percent of the 700,000 annual stroke victims in the United States arrive at the hospital in time to benefit from TPA. They often do not receive that medication due to the concerns raised by those concerned about the effects of the medication. Because the clot is not broken up by TPA, the Times said stroke patients can suffer from impaired cognition, paralysis, emotional and behavioral dysfunction or a number of other neurological issues.

TPA has been endorsed by the American Stroke Association and other medical societies for patients who arrive in time for treatment – usually within three hours of the start of a stroke. There is risk, including cerebral hemorrhage, but the Times said in most stroke patients use of TPA prevents brain injury. Additionally, the Times said the number of cerebral hemorrhages in TPA patients has declined over the years.

Those who oppose the use of TPA say the drug is more dangerous than the stroke and can cause brain hemorrhages. Additionally, the skeptics said the research from that trial Lewandowski led is "deeply flawed," the Times reported.

That negative message regarding TPA is being shared across social media and is gaining traction in some medical schools, the Times noted.

Two years ago an article penned in Scientific American highlighted some of the shortcomings of TPA, including the narrow window in which it can be used, as well as the risks of internal bleeding. The article notes that the drug is not as effective against larger blood clots. The article went on to point to other technologies that can break up clots, including a device known as a stent retriever.

Multiple emergency medicine specialists told the Times about the growing skepticism around TPA from across the globe. From the report, it seems that more and more emergency room doctors are informing patients of the risks of the drug, but many are not even telling patients about the drug at all.

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