ACT I Study
Published date : 27 April 2010
Article date : 27 April 2010
ACT I is comparing CAS with CEA for the treatment of asymptomatic extracranial carotid atherosclerotic disease. The study is being conducted to demonstrate the non-inferiority of CAS using the Emboshield Embolic Protection System and Emboshield Pro Embolic Protection System (Abbott Vascular) with the Xact-Carotid Stent System to CEA. An update was recently presented at the recent LINC meeting (Leipzig, Germany) by Dr John Laird, Davis, US.
The planned recruitment is 1,858 who will be randomised to a ratio of 3:1 (CAS: CEA). Patients are followed at 24 hours, 30 days, six months and annually up to five years post procedure. A neurological exam performed by an independent neurologist/neurosurgeon or NIHSS certified specialist at pre-enrolment, 24-hours and 30-days post-procedure, six-months and annually up to five years. To date, a total of 980 patients have been randomised.
The primary endpoint is composite death, stroke, myocardial infarction (MI) at 30 days post-procedure, plus ipsilateral stroke from 31 to365 days post-procedure. Secondary endpoints include death and ipsilateral stroke (years two-five years), cranial nerve injury, bleeding, vascular and/or wound complications requiring treatment, complications of general anaesthesia, access artery, renal and airway complications, freedom from clinically-indicated target lesion revascularisation
(TLR) at six and 12 months, acute stent success (residual stenosis <50% by QCA covering an area no longer than original lesion), acute filter success (successful deployment and retrieval of filter in absence of angiographic distal embolization and procedural success (residual stenosis <50% by QCA and freedom from major adverse event at 30 days).
Laird explained, “My prediction from the outcomes of ACT 1 would be low event rates in both groups, with no significant difference between CAS and CEA. This will be due to the use of experienced operators, a lower risk patient group, utilising newer generation devices. However, despite the low event rates, the trial will not convince neurologists that CAS or CEA is indicated for asymptomatic
carotid artery stenosis.”
