Stroke and tPA

tPA is one of the few drugs shown to be effective in an acute stroke. However, it can have dangerous and life-threatening side effects, which is why physicians are hesitant to administer it. Neurologists don’t really see the big picture – comparing tPA to antibiotics is ridiculous:

“I label this a national tragedy or a national embarrassment,” said Dr. Mark J. Alberts, a neurology professor at the Feinberg School of Medicine at Northwestern University. “I know of no disease that is as common or as serious as stroke and where you basically have one therapy and it’s only used in 3 to 4 percent of patients. That’s like saying you only treat 3 to 4 percent of patients with bacterial pneumonia with antibiotics.”

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  • Avicenna

    Preposterous article that once again wrongfully heralds tPA as a breakthrough.

    The number of people who benefit from tPA each year can be estimated as follows: 700,000 acute strokes each year in the U.S., 88% of them ischemic leaving 616,000 ischemic strokes. A maximum of 2 % get lytic therapy (12,320 patients). Number needed to treat is 9 in order to produce 1 benefical neurological outcome (that would not have occured without therapy). This means that for the maximum 12,320 patients that get tPA annually, only 1,369 patients (0.2 % of all cases of ischemic stroke) will benefit. If I am having a stroke, please do not inject me with tPA.

    These are the realities: Aspirin is more likely to produce a favorable outcome than thrombolytic therapy in ischemic stroke. So after all the fuss about tPA, it seems that the best treatment for patients with ischemic stroke is general critical care support. Just as it should be.

  • Greg P

    “These are the realities: Aspirin is more likely to produce a favorable outcome than thrombolytic therapy in ischemic stroke. So after all the fuss about tPA, it seems that the best treatment for patients with ischemic stroke is general critical care support.”

    This is just wrong-headed thinking. You might as well say that there is no point in tPA for heart attack.

    Down here in the trenches of stroke care and stroke rehabilitation, the power of tPA is profound. The difference between having a stroke so bad you cannot speak a sentence, must walk if at all with a walker from a stroke after which you can carry on a conversation and walk with a cane for steadiness, maybe even be able to drive, is HUGE. To be sure, as we give more tPA it can be harder to precisely know which patients dramatically responded from those who minimally responded, but it is clear that the concern about the dangers is much less than the studies suggest.

    So choose to have no tPA if you will, but let others make their own decision.

  • Avicenna

    Greg, what you said precisely demonstrates the flawed thinking that dominates neurology today. Stroke is not like heart attack and comparing the two is ridiculous. “Brain attack” is an inappropraite term. Let me clarifiy, tPA may be helpful, however, the 3 hour requirement have made the outcomes less than impressive. Plus, what I said about aspirin was not my opinion; it was what the data shows!

  • Anonymous

    Greg P, where is your data?? Yeah, you might be able to cherry pick some data, but on balance it is not impressive.

    In the original NINDS trial it showed a 12% chance of improvement of standard care and a 6% chance of ICH. When extropalated to practice in community settings the data is much les impressive. Most of the improvement in NINDS was from thos treated within 90 minutes. I guess the outcome data would look good if you give it to people who have TIA’s and are getting better anyway. Of course you will kill a few.

    When extrapolated to practice in the community settings the data is even less impressive, although the study writers are quite creative in writing their conclusions.

  • Anonymous

    I am really tired of some of these blowhard neurolgists blathering that everyone, especially ER docs don’t know what they are doing. I work in an urban area of 4 million people. On balance, the NEUROLOGISTS, are also skeptical on the use of TPA. Maybe if Genentech was stuffing their back pocket with a grand or two every time they used it, its use would increase.

    Genentechs advocacy on all levels rivals the snow job we got on WMD for going into IRAQ.. They have also have the John Edwards’s of the world licking ass on it. The bad outcomes of stroke can effectively be used for sympathy to get money.

    I am not closed minded. I understand the data, indications, risks, and benefits. I have given TPA, and will do it in the perfect setting when all the planets are aligned right. I have also killed someone giving TPA as well.

    The “magic bullet” myth is just that — a myth. These pompous ivory tower neurologists need to pull their head out of their ass and stop disseminating distortions

  • ERMurse

    TPA is only part of the snow job done on the public and medicine, Stroke centers are the rest of the picture. Hospitals have discovered the marketing potential that Stroke Centers (they are assisted by Genentec staff in becoming certified) give them and the protocols that justify the excessive testing and big charges. My hospital is a Stroke Center. When a patient with any kind of neurological symptom (even minor symptoms and time onsets well outside the 3 hour TPA window)a “Stroke Protocol” is called. The patients treatment is on auto pilot and they get their rapid CT scan, full labs including type and cross, Bedside cardiac Echo, Chest Xray, EKG, and Carotid Doppler study, The testing is justified by the patient falling into the “Stroke Protocol”. We give TPA about once a month. The hospital offers “Stroke Fairs” community outreach and advertising that tells anyone with the slightest symptom to rush to the hospital so they can get the “Miracle Clot Busting Drug”. Most of the ER physicians are skeptical but have the choice to follow the protocol or risk their group being removed.

  • Jules

    I am not a clinician, but a data coordinator and department administrator for a Southern California Hospital’s Stroke Program. We have been working the past year, setting up stroke protocols, a Code Stroke Program for ER patients as well as in house patients. I have seen patients who came in with severe right sided weakness and aphasic receive tPA and the next morning, and two days later they are walking in the halls and waving at us. It’s amazing. And while it does not work for every patient- it is amazing when it does.

    I don’t see tPA as a magic answer, as in 18 months, we have seen less than 20 patients who were actually candidates for the drug and there have been a few bad outcomes, a few good outcomes and some that did a small amount if anything at all. Clearly there is need for education, standard order sets and compliance with the Brain Attack Coalition on delivering best care. I see ER physicians and neurologists who are both skeptical and VERY cautious about when we give tPA. But we follow the guidelines and do what we feel is best for the patient.

    I feel very rewarded in my job and I look forward to learning so much more.

    Love your blog, by the way- I just never had anything to add before.

  • Anonymous

    Well Jules:

    re: “I have seen patients who came in with severe right sided weakness and aphasic receive tPA and the next morning, and two days later they are walking in the halls and waving at us. It’s amazing. And while it does not work for every patient- it is amazing when it does.”

    I have also seen a patient have an intracranial hemorrhage and die right after TPA. That was not very amazing. There is a place for TPA but that fact is the lay press is marketing it like the best thing since sliced bread. Simply wrong.

  • 1588d

    Recently there have been many stroke centers that have popped up all over the USA. There has continued to be a significant disagreement between ED physicians and neurologist all over the country as to wheter TPA should be administrered in the 3 hour window or not. Some TPA zealots livelyhood now depend on wheter they give patients TPA in acute ischemic stroke.

    There have also been numerous lawsuits for failure to give TPA, failure to transfer patients to a facility in time to get TPA. Failure to inform the patient and family about the risk of getting TPA. Failure to follow through with the protocol. Failure give TPA in a timely fashion. Failure to get consent to give TPA from patient and family. Once TPA is given and there is bad outcome, ER physicians are being sued because families are stating that they werent’ given a risk benefit check-list of things that could possibly go wrong and what could be expected from receiving the medication. Also there have been lawsuits for administering TPA to a patient with absolute contraindication. There have been suits filed for giving TPA to patients that were improving prior to adminstration (grandpa was moving his arm better just before they administered TPA..he was having a TIA.. and you gave him TPA and TPA is not indicated in TIA.

    Genetech, the company that makes TPA gave the America heart association over 11.4 million dollars…The next thing you know the American heart association was giving TPA their blessing! The implication here is that their blessing was based on money received…not on the evidence.

    What about the evidence???? In 1995, the National Institute of Neurological Disorders and Stroke (NINDS) published the results of a clinical trial that used r-tPA to treat ischemic stroke within 3 hours from symptom onset. This study consisted of 625 patients assigned randomly to placebo or intravenous r-tPA (alteplase). When results were assessed at 3 months, there was an 11% absolute increase in the number of patients with little or no deficits among those receiving alteplase compared with those receiving placebo. There was also a 6% increase in symptomatic intracerebral hemorrhage in those receiving alteplase. In a nutshell out of 100 patients that meet the criteria for administration of TPA(without contraindications), 11 get better, 6 get worse, and for the majority(82%)don’t get better or worse. 1 out of 19 actually die as the result of intracranial hemorrhage.

    Based on this evidence I don’t see how we can continue to “recommend” giving this drug. Clear 89% of the people who get this drug have no change or do worse.

    There are teams of physicians on both sides of the issue who are willing to make their arguments in court. TPA zealots who are making a living off giving TPA with their 6 thousand dollar DRG who are making a profit vs the evidence based realist.

    Good nursing care, early ambulation, swallowing studies ect have shown much more improvement in stroke patients than TPA has ever dreamed.

    Emergency Medicine physicians are being forced to offer patients a dangerous medication that is of questionable benefit based on the evidence.

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