30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.
BACKGROUND
Carotid endarterectomy is effective in stroke prevention for patients with severe symptomatic carotid-artery stenosis, and carotid-artery stenting has been widely used as alternative treatment. Since equivalence or superiority has not been convincingly shown for either treatment, we aimed to compare the two.


METHODS
1200 patients with symptomatic carotid-artery stenosis were randomly assigned within 180 days of transient ischaemic attack or moderate stroke (modified Rankin scale score of < or =3) carotid-artery stenting (n=605) or carotid endarterectomy (n=595). The primary endpoint of this hospital-based study was ipsilateral ischaemic stroke or death from time of randomisation to 30 days after the procedure. The non-inferiority margin was defined as less than 2.5% on the basis of an expected event rate of 5%. Analyses were on an intention-to-treat basis. This trial is registered at Current Controlled Trials with the international standard randomised controlled trial number ISRCTN57874028.


RESULTS
1183 patients were included in the analysis. The rate of death or ipsilateral ischaemic stroke from randomisation to 30 days after the procedure was 6.84% with carotid-artery stenting and 6.34% with carotid endarterectomy (absolute difference 0.51%, 90% CI -1.89% to 2.91%). The one-sided p value for non-inferiority is 0.09.


CONCLUSIONS
SPACE failed to prove non-inferiority of carotid-artery stenting compared with carotid endarterectomy for the periprocedural complication rate. The results of this trial do not justify the widespread use in the short-term of carotid-artery stenting for treatment of carotid-artery stenoses. Results at 6-24 months are awaited.
Ringleb
P A
PA
Allenberg
J
J
Brückmann
H
H
Eckstein
H-H
HH
Fraedrich
G
G
Hartmann
M
M
Hennerici
M
M
Jansen
O
O
Klein
G
G
Kunze
A
A
Marx
P
P
Niederkorn
K
K
Schmiedt
W
W
Solymosi
L
L
Stingele
R
R
Zeumer
H
H
Hacke
W
W
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D016893:Carotid Stenosis / Q000150:complications / Q000601:surgery / Q000628:therapy*; D016894:Endarterectomy, Carotid; D005260:Female; D006801:Humans; D008297:Male; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000517:prevention & control