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Background <p>The optimal dosing of alteplase for acute ischemic stroke remains debated, particularly regarding the balance between efficacy and bleeding risks. This study compared outcomes between standard-dose (0.9&#xa0;mg/kg) and low-dose (&lt; 0.85&#xa0;mg/kg) alteplase in an Iranian cohort.</p> Methods <p>In this retrospective cohort study, 328 patients with acute ischemic stroke treated at Boo-Ali Sina Hospital (2016–2023) were analyzed. Participants were divided into standard-dose (<i>n</i> = 177) and low-dose (<i>n</i> = 151) groups. Primary outcomes included functional independence (modified Rankin Scale [mRS] 0–2 at 3 months) and symptomatic intracranial hemorrhage (sICH). Secondary outcomes comprised mortality and hemorrhagic complications. Multivariable logistic regression adjusted for age, NIHSS score, and comorbidities.</p> Results <p>The low-dose group had significantly lower rates of sICH (5.29% vs. 13.55%, <i>p</i> = 0.01), fatal bleeding (1.98% vs. 7.90%, <i>p</i> = 0.03), and in-hospital mortality (8.6% vs. 15.81%, <i>p</i> = 0.01). Parenchymal hemorrhage-1 occurred exclusively with standard dosing (15.9% vs. 0%). Three-month functional outcomes were comparable (mRS 0–2: 53.6% vs. 46.9%, <i>p</i> = 0.22). Adjusted analyses confirmed reduced odds of any ICH (OR 0.34, 95% CI 0.18–0.64) and fatal ICH (OR 0.23, 95% CI 0.06–0.83) with low-dose therapy.</p> Conclusion <p>Low-dose alteplase was associated with fewer hemorrhagic complications and lower mortality while maintaining comparable functional outcomes to standard dosing. These findings support its potential as a safer alternative, particularly in resource-limited settings where cost and drug availability pose challenges. Randomized trials are needed to validate these results.</p>

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Low-dose vs. standard-dose alteplase for acute ischemic stroke: a retrospective cohort study of safety and efficacy in an Iranian population

  • 期刊论文

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  • 发表日期：

    2025年9月29日

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  • Fatemeh Rahimi,
  • Ashraf Zarvani,
  • Farzad Fayedeh,
  • Athena Sharifi-Razavi

摘要

Background

The optimal dosing of alteplase for acute ischemic stroke remains debated, particularly regarding the balance between efficacy and bleeding risks. This study compared outcomes between standard-dose (0.9 mg/kg) and low-dose (< 0.85 mg/kg) alteplase in an Iranian cohort.

Methods

In this retrospective cohort study, 328 patients with acute ischemic stroke treated at Boo-Ali Sina Hospital (2016–2023) were analyzed. Participants were divided into standard-dose (n = 177) and low-dose (n = 151) groups. Primary outcomes included functional independence (modified Rankin Scale [mRS] 0–2 at 3 months) and symptomatic intracranial hemorrhage (sICH). Secondary outcomes comprised mortality and hemorrhagic complications. Multivariable logistic regression adjusted for age, NIHSS score, and comorbidities.

Results

The low-dose group had significantly lower rates of sICH (5.29% vs. 13.55%, p = 0.01), fatal bleeding (1.98% vs. 7.90%, p = 0.03), and in-hospital mortality (8.6% vs. 15.81%, p = 0.01). Parenchymal hemorrhage-1 occurred exclusively with standard dosing (15.9% vs. 0%). Three-month functional outcomes were comparable (mRS 0–2: 53.6% vs. 46.9%, p = 0.22). Adjusted analyses confirmed reduced odds of any ICH (OR 0.34, 95% CI 0.18–0.64) and fatal ICH (OR 0.23, 95% CI 0.06–0.83) with low-dose therapy.

Conclusion

Low-dose alteplase was associated with fewer hemorrhagic complications and lower mortality while maintaining comparable functional outcomes to standard dosing. These findings support its potential as a safer alternative, particularly in resource-limited settings where cost and drug availability pose challenges. Randomized trials are needed to validate these results.