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IV tPA for Acute Ischemic Stroke Patients Aged >80 Years
Quick Takes
- Some providers and regulatory agencies have questioned the safety and effectiveness of IV tPA for acute ischemic stroke patients >80 years of age, often noting that these patients were not well represented in early tPA trials.
- In this pooled analysis of patient-level data from seven randomized controlled trials (RCTs), stroke patients >80 years who were treated with IV tPA had better functional outcomes than those who received placebo.
- Safety outcomes for stroke patients >80 years treated with IV tPA in community-based settings were not worse than the safety outcomes of patients >80 years treated in the seven RCTs.
- Advanced age alone should not be a barrier to treatment with IV tPA, whether in large academic centers or in community hospitals.
Study Questions:
Compared to placebo, is intravenous tissue plasminogen activator (IV tPA) safe and effective when given to acute ischemic stroke patients >80 years of age? And is it safe to use IV tPA in these patients outside of centers participating in randomized controlled trials (RCTs)?
Methods:
The first part of this study was an analysis of individual, patient-level data from seven RCTs of IV tPA versus placebo for acute ischemic stroke. Prespecified outcomes of interest included good stroke outcome (modified Rankin scale score 0-1) at 90 or 180 days; death by 90 days; and symptomatic intracranial hemorrhage (sICH). The second part of this study was an analysis of data from the SITS-UTMOST stroke registry to provide a perspective on the safety of community (“real-life”) usage. All patients included in this registry received IV tPA. Outcomes of interest included death by 90 days and sICH.
Results:
Of 6,035 patients enrolled in the seven RCTs, 1,699 (28.2%) were >80 years. In these patients, IV tPA versus placebo was associated with a higher proportion of good stroke outcome (19.1% vs. 13.1%; p = 0.0109), higher rates of sICH (3.7% vs. 0.4%, p = 0.0002), and no difference in 90-day mortality (29.5% vs. 30.2%; p = 0.8382). In the SITS-UTMOST registry, 2,420 patients were >80 years. Patients >80 years tended to have more severe strokes, as measured by National Institutes of Health stroke scale compared to patients <80 years. The incidence of sICH was 1.4% in patients >80 years (compared to 1.6% in patients ≤80 years and 3.7% in the patients >80 years in the RCTs). The 90-day mortality rate in patients >80 years was 29.0% (compared to 10.9% in patients ≤80 years and 29.5% in the patients >80 years in the RCTs).
Conclusions:
In this pooled analysis of patient-level data from seven RCTs, patients >80 years who were treated with IV tPA had better functional outcomes than those who received placebo. Although a higher rate of sICH was observed in the IV tPA group, no difference in mortality was observed between the IV tPA and placebo groups. Safety outcomes for patients >80 years treated with IV tPA in community-based settings were not worse than the safety outcomes for patients >80 years treated in the seven RCTs.
Perspective:
Not surprisingly, patients >80 years old do worse after acute ischemic stroke compared to patients ≤80 years old. However, patients >80 years do better with IV tPA than without it. Treatment of patients >80 years with IV tPA in community-based settings (compared to clinical trial sites) appears safe. Advanced age alone should not be a barrier to treatment of acute ischemic stroke patients with IV tPA, whether in large academic centers or in community hospitals.
Clinical Topics: Dyslipidemia, Geriatric Cardiology, Prevention, Lipid Metabolism
Keywords: Aged, 80 and over, Brain Ischemia, Geriatrics, Intracranial Hemorrhages, Randomized Controlled Trials as Topic, Secondary Prevention, Stroke, Tissue Plasminogen Activator, Vascular Diseases
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