The doctor writes: “In the National Institute of Neurological Disorders and Stroke (NINDS) trial, 12 percent of the group that received tPA had minimal or no disability, compared with the control group, but 6.4 percent of the patients given tPA suffered an intracranial hemorrhage within 36 hours. When that occurred, there was a 45 percent fatality rate. There are virtually no other drugs used in the hospital where the risk-benefit ratio is so close.”
He goes on to say: “Because of these statistics, the American Academy of Emergency Medicine and the Society of Academic Emergency Medicine unequivocally state that tPA is not standard of care.”
He also announces his lack of support for the establishment of a stroke center in his community because this "would result in a vast majority of non-stroke patients not going to the closest hospital, delaying care and inconveniencing families."
I would like to comment on this doctor's position as I feel that it can have a negative impact on the way the public perceives the treatment with tPA, a medicine which for many can make the difference between returning to being completely normal after a stroke, and being bed-bound for life.
Although tPA is often a miracle drug for stroke patients, it poses a great challenge to an already over-worked emergency medical care system. Because of the risk of bleeding, physicians are invariably uncomfortable about giving it to patients, especially in those cases when it is not clear that a person has actually suffered a stroke. And in fact some strokes can be difficult to diagnose. Stroke mimics” for instance are diseases that present with stroke-like symptoms, but are not strokes (the good thing is that these cases are rare). To make things worse, tPA can only be given within three hours of the onset of symptoms because, after that, the risk of bleeding might become even greater.Because of this, we often spend a great portion of these three precious hours making sure that it is OK to treat a given patient. We place great emphasis on finding out the exact time of the onset of symptoms. Frequently, the patient himself cannot say or even write this information for us because the stroke has impaired his language ability. In such cases we are forced to initiate investigations that require phone calls and discussions with family members and friends in order to find the one person who saw the patient the last time he was completely normal. When we find evidence that the symptoms started less than three hours ago, the pressure is on us to perform several tests (blood tests, CAT scans, etc), discuss the risk and benefits of tPA with the patient or his family, to make sure that there are absolutely no contraindications to the treatment, and finally to treat with tPA. All of this within the allowed three hour time period. When the evidence indicates that the last time the patient was noted to be completely normal was more than three hours ago, the fight ends there, and tPA cannot be offered.
Imagine being the physician who is in charge of this patient in a busy emergency room setting while you also have other patients who require close monitoring because they are having heart attacks, dangerous bleeding due to trauma, deadly infections and other calamities that emergency room doctors must deal with every day. This is in fact one challenging job.
But does the challenge mean that tPA should not become standard of care for acute stroke? I hope not. This is precisely why "stroke centers" are being established in communities across the United States under the leadership of government and official stroke agencies such as the Joint Commission and The Brain Attack Coalition. So I do not quite understand this doctor's lack of support of establishing a stroke center in his community. The need for such centers was established long ago and certainly is not some debatable idea. As of January 2009 there are over 1000 stroke centers in the United States and many more are being established as we speak. In a way, achieving stroke center status should be the goal of every hospital in the US, as stroke centers are possibly the only real solution for the safe diagnosis and treatment of acute strokes.
So what is a stroke center? Some people believe that creating a stroke center requires building a whole new center. This is not true. Achieving stroke center status is no more than a certification given to an existing hospital once it has fulfilled certain requisites such as having a CAT scan working around the clock, hiring a neurologist with experience in the diagnosis and treatment of stroke, having a plan in place to triage stroke patients appropriately, and having a team in place to teach EMS personnel, emergency room physicians, and the community at large about stroke (usually a nurse practicioner - Learn more about how a hospital can achieve stroke center status).
I can't see how a stroke center could have a negative impact in a community. And I find it hard to believe that the "vast majority of non-stroke patients" would somehow be diverted away from the nearest hospital. In fact, stroke centers should help shift the pressure and responsibility of diagnosing and treating stroke patients over to people who have been properly trained to do this, thus making the life of already overworked emergency room physicians much easier.
What about the risks of tPA? In spite of some rather controversial opinions by some emergency room professionals, the benefits of this treatment have been clearly shown by the NINDS and other trials. These trials have been discussed by stroke experts worldwide for longer than a decade. Their results have been analyzed, tested, and re-tested and today tPA enjoys worldwide acceptance (several major European trials have now confirmed the benefits of tPA and it is slowly becoming the standard of stroke care in most advanced nations across the globe).
So why tPA? Let me discuss some of the relevant numbers shown by the NINDS trials.
In the NINDS trials, symptomatic hemorrhage, (defined as bleeding associated with clinical deterioration) was measured at 36 hours. Six percent of people treated with tPA in the first study and 7% in the second had this unfortunate side effect. By contrast, people who were not treated with tPA had hemorrhage rates of 0% and 1% in the first and second trial, respectively. So does this mean that acute stroke patients who are not treated with tPA do better? Not at all. In fact, in spite of having a lesser chance of bleeding, stroke patients not treated with tPA have an increased risk of ending disabled. After treatment with tPA 42.7% of patients achieved an excellent outcome by comparison with 26.6% of untreated patients.
Note that the outcome measured by the stroke trials is excellent outcome and not just some statistical increase in the degree of improvement after stroke. When the numbers are tabulated there is roughly a 13% to 15% absolute increase in excellent outcome in patients treated with tPA. In other words, the study was designed to only compare the number of people who were completely cured, or nearly completely cured of their stroke after treatment with tPA. Because of this design, treatment with tPA very often represents a choice between becoming completely cured from a disabling stroke, or to remain disabled, often permanently. So does the risk of treatment outweigh the risk of hemorrhage? You betcha! This is why most people opt to get treated with tPA in spite of the 6.4% chance of bleeding in the brain.
Furthermore, in spite of the increased risk of bleeding after treatment with tPA, the NINDS trials demonstrated decreased, not increased mortality in patients treated with tPA. This was true in both the first and the second NINDS trials. Seventeen percent of those treated with tPA died (this includes those who bleed as a result of treatment) vs 21% of those not treated with tPA. Thus, in spite of the alarming (though accurate) numbers provided in this doctor's opinion piece, the public should know the rest of the story. The risk of death is actually greater in stroke patients NOT treated with tPA.
For most people who are familiar with the tPA literature, giving (or even receiving) tPA is a no-brainer. The positive results of the above and many other confirmatory studies are simply too clear. My personal feeling is that the issue that has prevented certain emergency room physicians from fully accepting tPA as the standard of care is whether or not they can give it safely, in a monitored setting, without the need to attend to other similarly important emergencies.
Again, this issue can be improved when a hospital achieves stroke center status and strokes are diagnosed and treated under the supervision of neurologists or vascular neurologists who can diagnose, treat and manage stroke patients and their possible complications.
My last reaction to this doctor's piece is to a segment where he writes: "In addition, it is not the use of tPA, an expensive piece of equipment like the Merci Retriever, neuro-radiologist, neurologists or neurosurgeons that have been shown to improve the survival in the vast majority of stroke patients. Rather it's comprehensive nursing care. Protocols that focus on avoiding infections. Such as: early ambulation, aspiration precautions, avoiding foley catheters, and early speech and physical therapy".
This is a gross misrepresentation of the truth. Though all the things he cites in this segment have been shown to increase the survival of stroke patients, it is irresponsible to imply that tPA, neurologists, neurosurgeons, the MERCI device and other modern treatments of stroke have not been shown to improve stroke outcomes. They have. I just went over the NINDS trials which show that tPA clearly improves stroke outcomes. Similar studies have shown the efficacy of neurologists and the MERCI device. What is even more irresponsible is to imply that the treatment of stroke is comprehensive care and physical therapy. This is equivalent to regressing towards the dark ages of stroke treatment.