PDF: RESCUE BT2
(2023)Objective
To evaluate the efficacy and safety of intravenous tirofiban compared to aspirin in patients with acute ischemic stroke without large or medium-sized vessel occlusion.
Study Summary
• No difference in overall disability or functional independence.
• Symptomatic intracranial hemorrhage occurred only in the tirofiban group.
Intervention
Multicenter, double-blind, double-dummy, randomized trial in China. Patients were assigned to receive either intravenous tirofiban (0.4 µg/kg/min bolus, then 0.1 µg/kg/min infusion for up to 48 hours) or oral aspirin (100 mg daily for 2 days), followed by open-label aspirin for all through 90 days.
Inclusion Criteria
Patients with NIHSS ≥5 and moderate-to-severe limb weakness, without large/medium vessel occlusion, presenting within 24 hours of symptom onset, or showing symptom progression, or early deterioration/no improvement after IVT.
Study Design
Arms: Tirofiban vs. Aspirin
Patients per Arm: Tirofiban: 606; Aspirin: 571
Outcome
• Global outcome (combined functional measures): OR 1.38 (95% CI, 1.07–1.78; P=0.01)
• Symptomatic ICH: 1.0% tirofiban vs. 0% aspirin
• Mortality: 3.8% tirofiban vs. 2.6% aspirin (not significant)
Bottom Line
In patients with acute ischemic stroke without large or medium-sized vessel occlusion, intravenous tirofiban was associated with a greater likelihood of excellent functional outcome at 90 days compared to oral aspirin. However, this was accompanied by a slightly higher incidence of symptomatic intracranial hemorrhage.
Major Points
- RESCUE BT2 was a multicenter, randomized, double-blind, double-dummy trial conducted in China comparing intravenous tirofiban to oral aspirin in patients with acute ischemic stroke without large or medium-sized vessel occlusion.
- The primary endpoint was an excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 or 1.
- Tirofiban significantly improved the rate of excellent outcome versus aspirin (29.1% vs. 22.2%; adjusted risk ratio 1.26; P=0.02).
- The global outcome at 90 days was also improved with tirofiban (adjusted common odds ratio 1.38; P=0.01), but other secondary outcomes were not statistically significant after hierarchical testing.
- Symptomatic intracranial hemorrhage was more frequent in the tirofiban group (1.0% vs. 0%, P=0.03).
Study Design
- Study Type
- Multicenter, double-blind, double-dummy, randomized clinical trial.
- Randomization
- Yes
- Blinding
- Double-blind, double-dummy.
- Sample Size
- 1177
- Follow-up
- 90 days.
- Centers
- 117
- Countries
- China
Primary Outcome
Definition: Excellent outcome (mRS 0–1) at 90 days.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 22.2% (126/567) | 29.1% (176/604) | 1.26 (1.04–1.53) | 0.02 |
Limitations & Criticisms
- Heterogeneous population with four different clinical presentations.
- Only a small subset of patients received IV thrombolysis before enrollment.
- Lower than expected rate of excellent outcomes in both arms may reflect care quality or population differences.
- Follow-up imaging was not mandated unless neurologic deterioration occurred, limiting detection of asymptomatic hemorrhages.
Citation
N Engl J Med 2023;388:2025-36.