New Data on Thrombolysis and Stroke - Oren Zarif - TPA Stroke

Despite all of the new data on tPA and stroke, the majority of patients do not reach a hospital quickly enough to receive tPA therapy. This results in a therapeutic window of just three hours. Furthermore, while 27% of patients who arrive at the hospital within three hours receive the treatment, another 31% do not receive it because the symptoms were too mild or were rapidly improving. Despite the new findings, doctors at Stanford are confident enough to offer the drug to patients off-label.

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The researchers looked at a total of 532 patients in a retrospective review, spanning three years. They found that patients who received tPA within 60 minutes of stroke onset exhibited better health outcomes. They also found that administering tPA during head CT scans shortened OTT. This could help reduce delays in stroke care, as patients would be seen sooner. The research also found that tPA is safe and may reduce the occurrence of ischemic stroke.

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There is also a potential for routine delivery of thrombolysis, but this has not been achieved at the same rate as achieving high delivery rates. Another major limiting factor is late presentation for treatment. The results of the study indicate that the health system has a large role to play in improving access to this treatment. However, no agreed-upon benchmark for tPA delivery in clinical practice has been established. But despite these shortcomings, significant improvements have been demonstrated.

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While tPA has been approved for acute ischemic stroke since the late 1990s, the neurology community has not endorsed its use. There have been accusations of conflict of interest and imbalances between the treatment and control groups. There have also been allegations of a conflict of interest in a recent study sponsored by the National Institute of Neurological Disorders and Stroke (NINDS).

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The HASTE project, a prospective cohort study of stroke patients, demonstrated substantial improvements in the DTN time and quality. The STAT stroke protocol implemented by the HASTE team includes pre-notifying the stroke team that a patient is arriving. The STAT stroke protocol includes pre-notification of EMS stretchers and transport to a CT scanner, and immediate administration of tPA after arrival. Among 350 patients, the STAT protocol showed an overall decrease of 32% in DTN time.

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A case series of clinical experience with tPA provides additional data on safety and effectiveness of this thrombolytic therapy. Additionally, a meta-analysis of 15 published open-label trials using tPA has demonstrated that tPA may lead to HT or ICH in patients who were not previously at risk for such diseases. Further, the safety of tPA has been shown to decrease after a period of delayed tPA administration.

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Further, tPA has been studied since the early 1980s. The first human trials of tPA were conducted in animals and a small number of patients. However, these studies did not show any significant changes in the death rate in tPA-treated stroke patients. Researchers have also been able to clone genes and directly express proteins in cell cultures. Genentech began producing recombinant tPA in sufficient quantities to allow for future commercialization.

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Newer clinical investigations suggest the potential for improved tPA therapy. For example, the recent research on diffusion-/perfusion-weighted imaging (DWI/FLAIR) mismatch and perfusion-/diffusion-weighted imaging (PWI/DWI) have important implications in patient selection. Furthermore, the ECASS III phase III trial evaluated tPA for three to four hours after ischemic onset, suggesting that thrombolytic agents improve clinical outcomes.

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Despite the benefits of tPA for ischemic stroke patients, physicians who fail to use the drug are at risk for a malpractice lawsuit. A recent systematic review of malpractice lawsuits and thrombolytic therapies for ischemic stroke patients does not address this issue. However, the research on this topic has been highly positive. If more physicians would follow the guidelines, the risk of medical malpractice lawsuits might be minimal. This is especially true when physicians provide high-quality care to stroke patients and follow the guidelines for tPA.

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Despite the potential benefits of tPA therapy, researchers continue to seek ways to differentiate between exogenous tPA and its thrombolytic effects in the brain. Moreover, tPA treatment can enhance the development of a vascular injury, increase BBB permeability, and upregulate MMP-9. In addition, this drug promotes the infiltration of leukocytes and activates microglia.