Via: PR Newswire
ROADSTER pivotal results (presented by Christopher J. Kwolek, MD) In the recent CREST trial, transfemoral carotid artery stenting (CAS) showed an excess periprocedural stroke rate (4.1%) when compared to carotid endarterectomy (CEA) (2.3%), while CEA was shown to carry risks of surgical complications including cranial nerve injury (CNI) (4.8%). ROADSTER is a prospective, multicenter, investigational device exemption study designed to evaluate the safety and effectiveness of a novel hybrid carotid revascularization procedure using the ENROUTE transcarotid neuroprotection system (NPS) (Silk Road Medical, Inc.). The primary endpoint was a composite of any stroke (S), myocardial infarction (MI), or death (D) through 30 days. Symptomatic and asymptomatic patients who were at high risk for complications from CEA were eligible. Between November 2012 and July 2014, 208 patients (67 lead-in, 141 pivotal) were enrolled at 18 hospitals. FDA-approved carotid stent systems, chosen according to site preference, were delivered through the direct carotid access point under high-rate flow reversal afforded by the ENROUTE NPS. Baseline pivotal population characteristics included 26% symptomatic, 35% female, and 47% age 75 or older; 56% of patients had physiologic risk factors, and 69% had anatomic risks. In the intention to treat (ITT) population, the rates for S/D/MI, S/D, and any stroke were 3.5%, 2.8%, and 1.4%, respectively. In a per protocol (PP) analysis (n = 136), the outcomes were 2.9%, 2.2% and 0.7%, respectively. There were no strokes in patients age 75 or older, nor in symptomatic patients. Transient CNI at 30 days was 0.7% and fully resolved. The upper 95% confidence interval of the hierarchical primary endpoint event rate in ROADSTER (3.5%) was statistically significantly less than the objective performance criterion (11%; P = .0047). Notably, the any stroke rate of 1.4% (0.7%, PP) in a high surgical risk population is the lowest to date for CAS and comparable to the periprocedural standard surgical risk CEA arm of CREST (2.3%). The ENROUTE transcarotid NPS appears to be safe and effective for obtaining direct carotid access and preventing embolic events during CAS.
Read More: http://www.prnewswire.com/news-releases/late-breaking-clinical-trial-results-announced-at-viva-14-281541771.html
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