In patients undergoing carotid artery stenting, the use of the ENROUTE transcarotid neuroprotective system appears to be safe and effective in preventing periprocedural stroke, according to results from the ROADSTER trial.
In the prospective, single-arm, multicenter clinical trial, researchers evaluated 208 patients (67 included as lead-in cases; 141 in the pivotal phase) enrolled at 18 study sites between November 2012 and July 2014. Eligible participants were at increased risk for undergoing carotid endarterectomy and had asymptomatic stenosis of at least 70% or symptomatic stenosis of at least 50% as measured by duplex ultrasound imaging, magnetic resonance angiography, CT angiography or catheter angiography.
The primary endpoint was a composite of all stroke, MI and death at 30 days after carotid artery stenting. Secondary endpoints included: cranial nerve injury; 30-day stroke, death, stroke/death and MI; acute device, technical and procedural success; and complications at the access site. Under the study protocol, each investigator was allocated a lead-in phase of up to five patients to gain familiarity with the ENROUTE transcarotid neuroprotective system (Silk Road Medical) before the pivotal phase. Patients in the pivotal phase included 26% symptomatic patients and 75% asymptomatic patients. An independent clinical events committee adjudicated all major adverse events.
According to the results, the device yielded a 99% acute device and technical success rate (140 of 141). Hierarchical analysis revealed rates of study outcomes in the pivotal cohort as follows: all-stroke, 1.4% (2 of 141); stroke and death, 2.8% (4 of 141); and stroke, death and MI, 3.5% (5 of 141).
With regard to local complications, the researchers observed one cranial nerve injury (0.7%) to the recurrent branch of the tenth nerve causing hoarseness. This fully resolved at 6 months. Additionally, there were eight arterial dissections, five of which did not require treatment. None of these dissections extended to the carotid bifurcation.
“Transcarotid stenting with dynamic flow reversal produced excellent results when applied by surgical teams with little or no prior experience using this technique before the lead-in phase,” the researchers wrote. “The overall stroke rate of 1.4% in patients at high surgical risk is the lowest reported to date for any prior clinical trial of [carotid artery stenting], and is comparable with the [carotid endarterectomy] limb of CREST in standard-risk patients.” – by Jennifer Byrne
Disclosure: The study was sponsored by Silk Road Medical, and most researchers report a financial relationship with Silk Road Medical. See the full study for a list of all of the authors’ relevant financial disclosures.