206 patients with acute ischemic stroke
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PROBE design
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NIHSS ≥ 6
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Intracranial ICA or M1 occlusion by CTA, MRA or DSA.
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Patients who had received IV rtPA were eligible if there was no significant neurological improvement (criteria specified in the protocol) at 30 minutes post initiation of the infusion and vascular imaging at this time confirmed an eligible occlusion.
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Groin puncture had to be possible within 8 hours of stroke onset.
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There were exclusion criteria for coagulopathies. The main exclusion criteria on imaging were ASPECTS <7 on NECT or <6 on DWI-MRI. After the enrollment of 160 patients, the inclusion criteria were modified to include patients up to the age of 85 years (initially 80 years was maximum allowed) with an ASPECTS >8.
•
Only 95% confidence intervals were reported.
•
PROBE design
•
NIHSS ≥ 6
•
Intracranial ICA or M1 occlusion by CTA, MRA or DSA.
•
Patients who had received IV rtPA were eligible if there was no significant neurological improvement (criteria specified in the protocol) at 30 minutes post initiation of the infusion and vascular imaging at this time confirmed an eligible occlusion.
•
Groin puncture had to be possible within 8 hours of stroke onset.
•
There were exclusion criteria for coagulopathies. The main exclusion criteria on imaging were ASPECTS <7 on NECT or <6 on DWI-MRI. After the enrollment of 160 patients, the inclusion criteria were modified to include patients up to the age of 85 years (initially 80 years was maximum allowed) with an ASPECTS >8.
•
Only 95% confidence intervals were reported.
Results:
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The primary outcome analysis showed a common odds ratio of improvement in the distribution of the modified Rankin scale score (shift analysis) favoring endovascular treatment (adjusted odds ratio 1.7, 95% CI 1.05 to 2.8).
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The proportion of patients with a mRS of 0-2 at 90 days was 43.7% in the intervention group and 28.2% in the control group (adjusted odds ratio 2.1, 95% CI 1.1 to 4.0).
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There were no significant differences in death or sICH.
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Ninety-five per cent of those in the endovascular group underwent thrombectomy.
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TICI 2b/3 recanalization was observed in 66% of the endovascular group.
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Across the pre-specified subgroups, there were no significant interactions according to NIHSS score, vessel-occlusion site, baseline ASPECTS score, administration of IV rtPA, age or time of randomization, although for the latter dichotomized at 4.5 hours, the p-value for interaction was 0.9 with the later group doing worse. No data are given for those who underwent groin puncture after 6 hours
•
The primary outcome analysis showed a common odds ratio of improvement in the distribution of the modified Rankin scale score (shift analysis) favoring endovascular treatment (adjusted odds ratio 1.7, 95% CI 1.05 to 2.8).
•
The proportion of patients with a mRS of 0-2 at 90 days was 43.7% in the intervention group and 28.2% in the control group (adjusted odds ratio 2.1, 95% CI 1.1 to 4.0).
•
There were no significant differences in death or sICH.
•
Ninety-five per cent of those in the endovascular group underwent thrombectomy.
•
TICI 2b/3 recanalization was observed in 66% of the endovascular group.
•
Across the pre-specified subgroups, there were no significant interactions according to NIHSS score, vessel-occlusion site, baseline ASPECTS score, administration of IV rtPA, age or time of randomization, although for the latter dichotomized at 4.5 hours, the p-value for interaction was 0.9 with the later group doing worse. No data are given for those who underwent groin puncture after 6 hours
COMMENT-- ALLOWED GROIN PUNCTURE UP TO 8 HOURS BUT DID NOT ANALYZE THAT GROUP, REQUIRED ASPECTS > 7, AGE UP TO 85
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