IVT for Minor Stroke
(2024)Objective
Compare intravenous thrombolysis (IVT) with best medical therapy (BMT) in patients with minor ischemic stroke (NIHSS 0–5).
Study Summary
• No significant difference in excellent functional outcome (mRS 0–1 at 90 days) between IVT and BMT
• IVT was associated with a higher risk of symptomatic intracranial hemorrhage compared with BMT
Intervention
Systematic review and meta-analysis of randomized controlled trials and observational studies comparing IVT (intravenous alteplase) versus best medical therapy in minor stroke patients.
Inclusion Criteria
Patients with acute minor ischemic stroke (NIHSS 0–5).
Study Design
Arms: IVT (intravenous alteplase) vs Best Medical Therapy (BMT)
Outcome
• Higher risk of symptomatic intracranial hemorrhage with IVT
• Mortality rates were not significantly different between groups
Bottom Line
Meta-analysis of 20 studies (13,397 patients): IVT with alteplase does NOT improve excellent outcome (mRS 0-1) vs BMT in minor stroke NIHSS ≤5 (82.89% vs 80.90%; OR 1.10; 95% CI 0.89-1.37). IVT substantially increases sICH (1.61% vs 0.12%; OR 7.48; P<0.001) and hemorrhagic transformation (6.56% vs 1.54%; OR 4.73; P<0.001). RCTs alone: OR 0.87 (0.60-1.27). No subgroup showed benefit. Supports BMT (especially DAPT) over alteplase for minor stroke.
Major Points
- No benefit of IVT on mRS 0-1: 82.89% vs 80.90% (OR 1.10; 95% CI 0.89-1.37; P=0.274). RCTs only: OR 0.87 (0.60-1.27).
- 7.5x increased sICH: 1.61% vs 0.12% (OR 7.48; 95% CI 3.55-15.76; P<0.001).
- 4.7x increased hemorrhagic transformation: 6.56% vs 1.54% (OR 4.73; 2.40-9.34; P<0.001).
- Higher early neurological deterioration: 4.81% vs 2.97% (OR 1.81; 1.17-2.80; P=0.007).
- No mortality difference: 0.85% vs 1.05% (OR 0.67; 0.39-1.15).
- No subgroup showed IVT benefit: nondisabling, antiplatelet comparison, LVO exclusion, time window — all consistent.
- DAPT noninferior to IVT per ARAMIS and PRISMS with fewer hemorrhagic complications.
- Largest meta-analysis on topic: 13,397 patients (3 RCTs + 17 observational), 20 studies.
- All sICH definitions consistent: ECASS II OR 7.76, ECASS III OR 4.22, NINDS OR 10.90.
- Knowledge gap: no tenecteplase or urokinase data. TEMPO-2 ongoing.
Study Design
- Study Type
- Systematic review and meta-analysis
- Randomization
- No
- Blinding
- N/A (meta-analysis)
- Sample Size
- 13397
- Follow-up
- 90 days (across included studies)
- Centers
- Multiple (20 studies)
- Countries
- Multiple (China, US, Australia, etc.)
Primary Outcome
Definition: Excellent functional outcome (mRS 0–1 at 90 days)
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| Reference | OR 1.10 (95% CI 0.89–1.37) | - (0.89–1.37) |
Limitations & Criticisms
- Heterogeneity in study designs and patient selection across included studies
- Lack of patient-level data limits ability to adjust for confounders
- Potential publication bias
Citation
Stroke. 2024;55:883–892. DOI: 10.1161/STROKEAHA.123.045495