August 23, 2016
2 min read

Micromesh stent for CAS shows safety and efficacy, low rates of plaque prolapse

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In patients at various levels of surgical risk undergoing carotid artery stenting, a double-layer micromesh stent appears to be a safe and effective technology, yielding low rates of plaque prolapse and favorable short-term outcomes, according to results of two recent studies published in EuroIntervention.

For one study, Marc Bosiers, MD, from the department of vascular surgery at St. Blasius Hospital, Dendermonde, Belgium, and colleagues conducted the prospective, multinational, single-arm, physician-initiated CLEAR-ROAD study to evaluate safety and efficacy of the carotid artery stenting (CAS) using the Roadsaver stent (Terumo Corp.). The trial enrolled 100 high-risk surgical patients (mean age, 73 years; 70% men; 31% symptomatic) undergoing CAS at nine centers in Belgium, Italy and Germany from July 2015 to February 2016. All patients were scheduled for follow-up evaluations at 30 days, 6 months and 12 months after the index procedure. Each visit entailed carotid duplex ultrasound evaluation, neurological evaluation, medication registration, physical examination and documentation of adverse events.

The primary outcome was the 30-day rate of major adverse events, defined as the cumulative incidence of any death, stroke, or MI after the procedure. The use of embolic protection devices during the procedure was not mandatory; embolic protection devices were used in 58% of cases.

In all cases, successful stent placement was attained. Within the first 30 days after the procedure, one patient had a fatal MI and one patient had a mild ipsilateral stroke. The rate of freedom from major adverse events was 97.9% and the rate of major adverse events was 2.1%. Although a statistical analysis was not feasible, subgroup data indicated no significant differences in the 30-day rates of major adverse events between symptomatic vs. asymptomatic patients, or between embolic protection device use vs. nonuse. Symptomatic patients who were treated without an embolic protection device had a 30-day freedom from major adverse events rate of 94.4%. Asymptomatic patients treated without an embolic protection device achieved a 30-day freedom from major adverse events rate of 100%, according to the results.

The use of the Roadsaver stent can be a valid alternative for the treatment of carotid artery lesions in symptomatic and asymptomatic patients with a high risk for surgery, and could be incorporated into daily practice,” Bosiers and colleagues wrote.

In a second study published in EuroIntervention, Roberto Nerla, MD, from the cardiovascular unit at GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy, and colleagues evaluated 150 consecutive patients (mean age, 74 years; 75% men) with symptomatic or asymptomatic carotid artery stenosis who underwent CAS implantation with the Roadsaver stent from October 2014 to October 2015 at three high-volume interventional cardiology centers in Italy. A subgroup of patients (n = 26; 17.3%) underwent OCT imaging after stent implantation. All patients were scheduled for clinical and duplex ultrasound imaging at baseline, 24 hours and 30 days after the procedure to evaluate stent patency and patency of the external carotid artery.

According to the results, procedural success was attained in all CAS patients (stent diameter, 8.6 ± 0.8 mm; stent length, 25 ± 4.5 mm). No cerebrovascular events occurred in the hospital or at 30-day follow-up. OCT imaging in the patient subgroup revealed a low prevalence of plaque prolapse (n = 2; 7.7%). In both cases, the plaque prolapse was mild, and no further treatment was administered. In Duplex ultrasound imaging conducted before hospital discharge and at 30 days, all patients demonstrated external carotid artery patency.

“The Roadsaver double-mesh carotid stent has recently been introduced into clinical practice,” Nerla and colleagues wrote. “This study represents the largest real-world population receiving CAS with the Roadsaver: Procedural results were good in that they showed stent safety and effectiveness on the lesion independently of the strategy and the specialty-related experience of the operator.” – by Jennifer Byrne

Disclosure: Terumo funded the CLEAR-ROAD study. Some of the researchers from both studies report speaking/consultant fees from Terumo. Please see the full studies for a list of all other researchers’ relevant financial disclosures.