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Ischemic Stroke and TPA - Oren Zarif - TPA Stroke

Writer's picture: Oren ZarifOren Zarif

The Lansberg study supports the benefits of tPA therapy in patients with ischemic stroke. It analyzed data from six clinical trials to determine the likelihood of benefit and harm. Researchers concluded that tPA treatment would benefit 16.9 patients while harming just 3.4 patients. These results indicate that while tPA treatment may not be as effective as earlier treatments, it still offers a substantial benefit to patients. This study is expected to inform future decisions about tPA treatment for ischemic stroke.

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In the past, emergency medical teams were hesitant to prescribe tPA to patients with ischemic stroke because it carries a 6-percent risk of hemorrhage. Emergency doctors also want to refer patients to a neurologist, who would be best equipped to decide whether tPA is the best course of treatment. But it's important to note that tPA is only used to treat ischemic stroke. Hemorrhagic strokes cause bleeding in the brain. And tPA would only worsen that bleeding.

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The NINDS played a major role in the development of tPA. The agency funded early studies and conducted pivotal clinical trials of the drug, which led to FDA approval in 1996. The scientists at NINDS recognized the importance of prompt treatment for acute stroke patients, and they pioneered protocols to assess and treat these patients with unprecedented speed. This study has been a valuable resource for stroke research. Its success is a testament to the effectiveness of tPA.

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The Alteplase study showed that tPA was effective in treating coronary artery occlusion in 75% of patients, with relatively limited adverse effects. It was soon approved by the FDA for use in patients with ischemic heart disease. However, these early studies are not sufficient to support the long-term use of tPA. Clinical trials may ultimately need to be conducted to prove the efficacy of this treatment.

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In the first ARGIS trial, argatroban and tPA were combined in a monotherapy protocol. While tPA alone is effective in patients with AIS, the combination of the two therapies was shown to improve outcomes and prevent re-occlusion. In addition, both medications significantly reduced the volume of the lesion and decreased fibrin deposition in the ipsilateral cortical microvasculature.

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The American Stroke Association issued a position statement on tPA. The statement expressed concerns about the risk-benefit ratio. The AHA also stated that eight of every 18 patients who received tPA had recovered within three months, while six of them recovered substantially regardless of treatment. Only 1 patient with tPA developed a symptomatic bleeding complication. As a result, tPA remains the standard treatment for acute stroke.

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In contrast, the study showed that 25% of eligible patients with ischemic stroke did not receive IV tPA therapy. This demonstrates the need to treat patients with acute ischemic stroke as soon as possible. The American Stroke Association strongly recommends that tPA be administered as soon as possible after symptoms begin. The first three hours of treatment are crucial to a patient's survival, and they can be treated with IV TPA within these times.

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One major limitation of the NINDS part II trial is that tPA treatment had only a small impact on the overall mortality rate. Although the effect of tPA on NIHSS score was small, the tPA treatment still had a significant effect on the primary outcome of the trial. Meanwhile, data are also emerging from clinical trials of IV tPA when it is given within three to four hours of symptoms. A Class II meta-analysis of clinical trials using 0.9 mg/kg tPA showed that tPA treatment can benefit patients up to 4.5 hours after the onset of symptoms.

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Moreover, the clinical trial showed that the tPA drug can be beneficial in treating acute ischemic strokes, though it is still underutilized in the treatment of this condition. The NINDS Stroke Study Group's results showed that tPA was associated with a 30% reduction in the risk of recurrent ischemic stroke. However, despite its effectiveness, tPA therapy remains the only drug available for the treatment of acute ischemic stroke.

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The NINDS trial reported that tPA improved 90-day outcomes without increasing mortality. In the trial, a patient who achieved a score of 0 or 1 was considered a successful outcome. This is considered an excellent recovery. A similar study has demonstrated that the treatment improves neurological functions. The primary endpoint of the trial was the proportion of patients with a favorable outcome on the modified Rankin Scale. The study also showed an increased risk of intracerebral hemorrhage.

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