ANGEL-REBOOT 1-year
(2025)Objective
To compare 1-year outcomes of bailout intracranial angioplasty or stenting (BAOS) versus standard therapy in patients with large vessel occlusion who had unsuccessful recanalization or high-grade residual stenosis after thrombectomy
Study Summary
• BAOS reduced stroke recurrence at 1 year (4% vs 13%, P=0.006)
Intervention
Bailout intracranial angioplasty or stenting after failed thrombectomy
Inclusion Criteria
≥18 years, mRS 0-2 pre-stroke, NIHSS ≥6, anterior or posterior circulation LVO within 24 hours, eTICI 0-2a after 3 thrombectomy attempts OR >70% residual stenosis after 1-3 attempts
Study Design
Arms: BAOS group vs Standard therapy group (continued or terminated thrombectomy)
Patients per Arm: 166 in BAOS group, 160 in standard therapy group (326 total with 1-year follow-up)
Outcome
• Stroke recurrence: 4% (BAOS) vs 13% (standard therapy), HR 0.30 (P=0.006)
• Mortality: 15% (BAOS) vs 17% (standard therapy), HR 0.87 (P=0.61)
Bottom Line
Among Chinese patients with large vessel occlusion with unsuccessful recanalization or high-grade residual stenosis after thrombectomy, BAOS was associated with improved functional outcomes and reduced stroke recurrence at 1 year compared with standard therapy, demonstrating durable long-term benefits beyond the initial 90-day period.
Major Points
- Extended 1-year follow-up of the ANGEL-REBOOT trial involving 326 patients (166 BAOS, 160 standard therapy)
- BAOS significantly improved mRS distribution at 1 year (generalized OR 1.34, 95% CI 1.05-1.73, P=0.02)
- 67% of BAOS patients achieved functional independence (mRS 0-2) at 1 year vs 47% in standard therapy (RR 1.44, P<0.001)
- BAOS reduced stroke recurrence in treated artery: 4% vs 13% (HR 0.30, 95% CI 0.13-0.71, P=0.006)
- Among survivors at 90 days, 44% in BAOS group showed ≥1-point mRS improvement vs 18% in standard therapy
- No difference in 1-year mortality between groups (15% vs 17%, HR 0.87)
- 94% of BAOS patients had underlying ICAD; tirofiban used in 94-98% of patients periprocedu rally
- Post-BAOS, only 6% had ≥70% residual stenosis vs 77% in standard therapy group
- Benefits emerged over time - initial 90-day results showed no difference (common OR 0.86) but 1-year showed significant benefit
Study Design
- Study Type
- Multicenter, open-label, blinded endpoint, randomized controlled trial (PROBE design)
- Randomization
- Yes
- Blinding
- Outcome assessors at 90 days and 1 year were blinded to treatment allocation; treating physicians were not blinded
- Sample Size
- 348
- Follow-up
- 1 year after randomization
- Centers
- 36
- Countries
- China
Primary Outcome
Definition: Distribution of modified Rankin Scale scores at 1 year (ordinal scale 0-6)
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| Median mRS 3 (IQR 1-4) | Median mRS 2 (IQR 0-4) | - (1.05-1.73) | 0.02 |
Limitations & Criticisms
- Open-label design may have introduced differential bias in postacute medical management
- Selection bias possible due to 6% missing 1-year follow-up data (22/348 patients)
- Did not assess cognitive, psychological, or social functioning outcomes
- Adverse event monitoring only up to 90 days; no data on adverse events other than stroke recurrence beyond 90 days
- No information on cause of death beyond 90 days or type/duration of rehabilitation
- Trial conducted exclusively at tertiary hospitals in China; generalizability to other settings uncertain
- No correction for multiple testing; secondary outcomes should be considered exploratory
- Trial not powered to detect differences in treatment effects across subgroups
- Limited number of sICH events (9 total) prevented meaningful comparative analysis at 1 year
- Small sample size in refractory occlusion subgroup (n=19) with wide confidence intervals
- Higher sICH rate in BAOS group at 36 hours (8 vs 1) raises safety concerns despite long-term benefits
Citation
Circulation. 2025;152:00–00. DOI: 10.1161/CIRCULATIONAHA.125.075429