Carotid endarterectomy or stenting or best medical treatment alone for moderate-to-severe asymptomatic carotid artery stenosis. SPACE-2

OBJECTIVES	To compare best medical therapy (BMT) vs. carotid endarterectomy (CEA) or carotid artery stenting (CAS) for treatment of asymptomatic carotid artery stenosis.
STUDY	Randomized, multicenter, open-label, phase 3 trial at 36 study centers in Austria, Germany, and Switzerland. An amendment was made to change the design to two trials with two arms, ratio 1:1 in both trials CEA plus BMT vs BMT alone (SPACE-2a), and CAS plus BMT vs BMT (SPACE-2b).
POPULATION	Patients 50–85 years of age with asymptomatic carotid artery stenosis of the distal common carotid artery or the extracranial internal carotid artery of at least 70% according to European Carotid Surgery Trial (ECST) criteria, or equivalent to at least 50–99% according to North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria, using ultrasound criteria.
ENDPOINTS	The primary safety endpoint was any stroke or death from any cause within 30 days after CEA or CAS. The primary efficacy endpoint was the cumulative incidence of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days, or any ipsilateral ischemic stroke within 5 years of follow-up, after treatment with CEA or CAS or after randomization to BMT.

Carotid endarterectomy or stenting or best medical treatment alone for moderate-to-severe asymptomatic carotid artery stenosis: 5-year results of a multicenter, randomized controlled trial. SPACE-2