What is the comparison between Retaplase (retaplase) and Alteplase (tissue plasminogen activator, tPA) in the management of acute ischemic stroke?

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Last updated: July 5, 2025View editorial policy

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From the Research

Reteplase is more likely to result in an excellent functional outcome than alteplase for patients with acute ischemic stroke within 4.5 hours of symptom onset, with a risk ratio of 1.13 (95% CI, 1.05 to 1.21; P<0.001 for noninferiority and P = 0.002 for superiority) 1.

Comparison of Reteplase and Alteplase

The comparison between reteplase and alteplase in the management of acute ischemic stroke has been a topic of interest in recent studies.

  • Reteplase is administered as a double bolus of 18 mg, 30 minutes apart, while alteplase is administered as an IV infusion at 0.9 mg/kg (maximum 90 mg) with 10% given as a bolus and the remainder over 60 minutes.
  • The primary efficacy outcome of an excellent functional outcome, defined as a score of 0 or 1 on the modified Rankin scale at 90 days, was higher in the reteplase group (79.5%) compared to the alteplase group (70.4%) 1.
  • However, the incidence of any intracranial hemorrhage at 90 days was higher with reteplase (7.7%) than with alteplase (4.9%), with a risk ratio of 1.59 (95% CI, 1.00 to 2.51) 1.

Safety and Efficacy

The safety and efficacy of reteplase versus alteplase for acute ischemic stroke have been evaluated in several studies.

  • A phase 2 randomized controlled trial found that reteplase was well tolerated in patients with acute ischemic stroke within 4.5 hours of onset, with a similar efficacy profile to alteplase 2.
  • However, the study also found that the incidence of symptomatic intracranial hemorrhage was higher with reteplase (2.4%) than with alteplase (2.0%), although the difference was not statistically significant 1.

Clinical Implications

The clinical implications of the comparison between reteplase and alteplase are significant.

  • Reteplase may be considered as an alternative to alteplase for patients with acute ischemic stroke within 4.5 hours of symptom onset, particularly in cases where alteplase is not available or contraindicated 1.
  • However, clinicians should carefully weigh the benefits and risks of reteplase, including the higher incidence of intracranial hemorrhage, and consider individual patient factors, such as comorbidities and concomitant medications, when making treatment decisions.
  • The results of the study by 1 suggest that reteplase may be a viable option for patients with acute ischemic stroke, but further studies are needed to confirm these findings and establish the long-term safety and efficacy of reteplase in this population.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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