Table 2.

Primary and Secondary Safety End Points.^*

End Point	Endovascular Therapy (N = 434)	Intravenous t-PA Alone (N = 222)	P Value
Death — no. (%)
Within 7 days	52 (12.0)	24 (10.8)	0.57
Within 90 days	83 (19.1)	48 (21.6)	0.52
Intracerebral hemorrhage within 30 hr — no. (%)
Symptomatic	27 (6.2)	13 (5.9)	0.83
Asymptomatic	119 (27.4)	42 (18.9)	0.01
Parenchymal hematoma identified within 30 hr — no./total no. (%)†
Type 2	25/417 (6.0)	13/207 (6.3)	0.90
Type 1	15/417 (3.6)	3/207 (1.4)	0.12
Hemorrhage — no./total no. (%)
Subarachnoid	48/417 (11.5)	12/207 (5.8)	0.02
Intraventricular	27/417 (6.5)	10/207 (4.8)	0.40
Major complication due to nonintracerebral bleeding within 5 days — no. (%)‡	13 (3.0)	5 (2.3)	0.55
Recurrent stroke within 90 days — no. (%)	22 (5.1)	14 (6.3)	0.54
Device or procedural complication — no. (%)‡	70 (16.1)	—

^*Events occurred during specified periods after the administration of intravenous t-PA. P values were obtained with the use of the Cochran–Mantel–Haenszel test. Data for events identified with the use of computed tomography exclude 32 participants for whom a scan was not obtained within 24 hours after initiation of intravenous t-PA or a postbaseline safety scan was not obtained within the defined time window (i.e., participants who died, had care withdrawn at the request of the family, or underwent imaging after the 30-hour window).

^† Parenchymal hematoma type 2 was defined as a dense hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, and type 1 as a hematoma involving 30% or less of the infarcted area.

^‡ Complications included groin hematoma, vessel dissection, vessel perforation, and emboli in a previously uninvolved territory, as identified by the site investigator or as assessed centrally.