RESCUE BT2 Trial: Tirofiban for Acute Ischemic Stroke

rescue bt2 trial tirofiban

Summary of the RESCUE BT2 Trial: Tirofiban in Acute Ischemic Stroke

Background:

  • Limited research on the effects of tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, in acute ischemic stroke patients without complete occlusion of large or medium-sized vessels.

Methods:

  • Multicenter trial conducted in China.
  • Enrolled patients with ischemic stroke without vessel occlusion, National Institutes of Health Stroke Scale (NIHSS) score of 5 or more, and at least one moderately to severely weak limb.
  • Eligible patients had different clinical presentations: ineligible for thrombolysis or thrombectomy within 24 hours of last known well; stroke symptom progression 24 to 96 hours after onset; early neurological deterioration after thrombolysis; or no improvement after thrombolysis at 4 to 24 hours.
  • Patients randomized to receive intravenous tirofiban (plus oral placebo) or oral aspirin (100 mg/day plus intravenous placebo) for 2 days, followed by oral aspirin until day 90.
  • Primary efficacy endpoint: excellent outcome (modified Rankin scale score of 0 or 1) at 90 days.
  • Secondary endpoints: functional independence at 90 days, quality-of-life score.
  • Primary safety endpoints: death and symptomatic intracranial hemorrhage.

Inclusion criteria:

  1. Aged 18 years or older.
  2. Various presentations of acute ischemic stroke (AIS) within specific timeframes.
  3. NIHSS score of 5 or more, with at least one limb affected.
  4. No visible occlusion of large or medium intracranial vessels on imaging.
  5. Written informed consent obtained.

Results:

  • 606 patients in the tirofiban group and 571 patients in the aspirin group.
  • Majority had small atherosclerotic infarctions.
  • Excellent outcome (mRS score 0 or 1) at 90 days: 29.1% in the tirofiban group vs. 22.2% in the aspirin group (adjusted risk ratio 1.26; 95% CI 1.04-1.53; p=0.02).
  • Secondary endpoints did not consistently align with the primary analysis.
  • Similar mortality rates in both groups.
  • Symptomatic intracranial hemorrhage incidence: 1.0% in tirofiban group vs. 0% in aspirin group.

Conclusions:

  • In this trial involving patients with recent onset or progressing stroke symptoms and nonoccluded large or medium-sized cerebral vessels, intravenous tirofiban showed a greater likelihood of excellent outcomes compared to low-dose aspirin.
  • Incidence of intracranial hemorrhage was low but slightly higher with tirofiban.

Key Takeaways:

  • Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, showed promise in improving outcomes for acute ischemic stroke patients without complete vessel occlusion.
  • Tirofiban was associated with a higher likelihood of excellent outcomes compared to aspirin.
  • Incidence of symptomatic intracranial hemorrhage was low but slightly higher with tirofiban.
  • Further research is needed to validate these findings and determine the optimal treatment approach for this patient population.

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