Table 4.

Adverse events by randomisation assignment

	Interventional therapy (n=114)		Medical management (n=109)		p value
	Number of events	Rate per patient-year	Number of events	Rate per patient-year
Stroke*
All	45	0·144	12	0·039	<0·0001
Haemorrhagic	33	0·106	8	0·026	··
Ischaemic	12	0·038	4	0·013	··
Focal deficit†
All	14	0·045	1	0·003	0·0008
Persistent	4	0·013	1	0·003	··
Reversible	10	0·032	0	0	··
Seizure
All	50	0·160	40	0·131	0·34
Focal (simple, complex)	30	0·096	14	0·045	··
Generalised	16	0·051	19	0·062	··
Not classified	4	0·013	7	0·023	··
Headache
All	65	0·208	59	0·193	0·67
Migraine (with or without aura)	15	0·048	28	0·091	··
Tension-type (episodic, chronic)	30	0·096	29	0·094	··
Unclassified, other	21	0·067	15	0·049	··
Contrast reaction	1	0·003	0	0	0·31
Catheter adherence	1	0·003	0	0	0·31
Infection	2	0·003	0	0	0·15

Data are number of events.

^*Including recurrent stroke.

^†Neurological deficit unrelated to stroke.