Thursday, July 02, 2015

EXTEND 1A


Seventy participants who were eligible using "standard criteria" to receive IV rtPA within 4.5 hours of stroke onset were randomized in a PROBE design to receive either IV rtPA only or IV rtPA plus endovascular therapy with a stent retriever.

Groin puncture had to be within 6 hours and endovascular treatment had to be completed within 8 hours after stroke onset.

CT or MRI had to be performed before commencing IV rtPA. Occlusion of the ICA or of M1 or M2 on CT angiography was required. In addition, CT or MRI perfusion imaging had to show (a) mismatch ratio of greater than 1.2, and (b) absolute mismatch volume of greater than 10 mL, and (c) infarct core lesion volume of less than 70mL based on specialized software

Exclusion criteria for coagulopathies as in SWIFT-PRIME

The co-primary outcomes were reperfusion at 24 hours and early neurologic improvement (≥8-point reduction on the NIHSS or a score of 0 or 1 at day 3). The mRS at 90 days was a secondary outcome.
 
Results Interim Analysis:

Trial halted showed that stopping criteria had been met.

Occlusion sites: ICA 31%, MCA 54%

Percentage of ischemic territory that had undergone reperfusion at 24 hours was greater in the endovascular group than in the IV rtPA group.

Outcomes: Endovascular therapy, initiated at a median of 210 (IQR 166-251, IQR) minutes after the onset of stroke, increased early neurologic improvement at 3 days (80% vs. 37%, p=0.002).

More patients achieved functional independence in the endovascular group (mRS 0-2, 71% vs. 40%; p=0.01).

There were no significant differences in rates of death or sICH.

Recanalization to TICI2b/3 was achieved in 86% of patients in the endovascular group at a median of 248 (IQR 204-277) minutes after stroke onset.
 
COMMENT---ENDOVASCULAR THERAPY 'WAS INITIATED' AT 3.5 HOURS
 

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