PDF: TESLA
(2023)Objective
Efficacy of thrombectomy in patients with large core infarcts and good baseline mRS.
Study Summary
Intervention
Thrombectomy vs. medical therapy alone.
Inclusion Criteria
Patients with ICA or M1 occlusion, NIHSS > 6, ASPECTS 2-5, mRS 0-1 within 24h from LKW
Study Design
Arms: Thrombectomy vs. Medical Therapy
Patients per Arm: Not Specified in given information
Outcome
Bottom Line
The TESLA trial was stopped early due to futility, showing no significant difference in functional outcomes between thrombectomy and usual care for patients with large infarcts on noncontrast CT. However, the study was underpowered, and subgroup analysis suggested a potential benefit of thrombectomy for patients with moderate ASPECTS scores.
Major Points
- 300 patients with anterior-circulation, large-vessel occlusion and large infarct on noncontrast CT (ASPECTS 2-5) were randomized within 24 hours of onset.
- The trial was stopped early for futility during the second interim analysis because the probability of thrombectomy being superior to usual care on the primary outcome was 46%.
- The primary outcome was the adjusted common odds ratio (acOR) for the ordinal shift on the modified Rankin Scale (mRS) at 90 days. The acOR was 1.13 (95% CI, 0.77-1.65).
- Functional independence (mRS 0-2) occurred in 19.3% in the thrombectomy group and 15.6% in the usual care group (acOR, 1.34; 95% CI, 0.81-2.22).
- Excellent functional outcome (mRS 0-1) occurred in 12.0% in the thrombectomy group and 9.9% in the usual care group (acOR, 1.25; 95% CI, 0.70-2.24).
- 90-day mortality was 33.6% in the thrombectomy group and 39.7% in the usual care group (acOR, 0.76; 95% CI, 0.50-1.15).
- Symptomatic intracranial hemorrhage occurred in 13.2% in the thrombectomy group and 7.1% in the usual care group (acOR, 2.05; 95% CI, 1.05-3.99).
- Periprocedural complications occurred in 14.8% of the thrombectomy group. Recanalization (mTICI 2b-3) was achieved in 85.3% of the thrombectomy group.
- Subgroup analysis suggested a higher probability of functional independence (mRS 0-2) in patients with ASPECT 4-5 compared to ASPECTS 2-3 in the thrombectomy group.
Study Design
- Study Type
- Open-label, blinded-end point, Bayesian-adaptive randomized trial with interim analyses
- Randomization
- Yes
- Blinding
- Blinded-end point (outcome adjudicators were blinded to treatment assignment).
- Sample Size
- 300
- Follow-up
- 90 days (primary outcome); final follow-up January 25, 2023.
- Centers
- 47
- Countries
- United States
Primary Outcome
Definition: Ordinal shift on the modified Rankin Scale (mRS) at 90 days. The mRS is a 7-point scale, with lower scores indicating less disability.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | - | 1.13 (0.77-1.65) | - |
Limitations & Criticisms
- The trial was stopped early for futility, leading to an underpowered study that was unable to achieve statistical significance for its primary endpoint (ordinal mRS shift at 90 days).
- The trial's non-significant result for overall functional outcome is in contrast to some other large infarct trials, which may be due to differences in patient selection, imaging, or definitions of large infarct.
- The study identified a numerically higher rate of symptomatic intracranial hemorrhage in the thrombectomy group, although the confidence interval was wide.
- The primary efficacy analysis was adjusted using a Bayesian approach, while secondary analyses were performed with frequentist methods and were not adjusted for multiple comparisons.
- The study was open-label, meaning patients and investigators were aware of the treatment assignment, which could introduce bias, though outcome adjudicators were blinded.
- The strict inclusion criteria for ASPECTS scores (2-5) may limit generalizability to patients with larger or smaller infarcts.
- The generalizability may be limited as the study was conducted solely in the US with a specific patient population.
Citation
JAMA. 2024,331(7):573-581. doi:10.1001/jama.2023.27188