European Studies Evaluate Carotid Artery Stenting Devices
August 23, 2016—Two studies of carotid artery stenting were published online in EuroIntervention. Marc Bosiers, MD, et al reported findings from the CLEAR-ROAD study (2016;12:e671–e676). Eugenio Stabile, MD, et al evaluated the impact on the outcome of different types of carotid stents in the European Registry of Carotid Artery Stenting (2016;12:e265–e270).
As summarized in EuroIntervention, CLEAR-ROAD evaluated the dual-layer micromesh Roadsaver carotid stent (Terumo Europe). The prospective, multinational, single-arm, physician-initiated study is designed evaluate the Roadsaver in 100 nonconsecutive patients at high risk for carotid endarterectomy requiring revascularization. Patients were enrolled at nine centers in Belgium, Italy, and Germany.
The investigators reported the primary endpoint, which is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction (MI). In the study, the use of embolic protection devices (EPDs) was not mandatory; 31% of the patients were symptomatic, and in 58% of the patients, EPDs were used. Technical success was achieved in all cases.
The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). Although no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, nor regarding EPD use.
The CLEAR-ROAD investigators concluded that the Roadsaver carotid stent shows promising results and that it is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.
In the second study published in EuroIntervention, the investigators evaluated clinical outcomes according to different carotid stent designs among 1,604 patients in the ERCAS population who underwent neuroprotected CAS. They noted that conflicting data exist on the impact on the outcome of the use of different stent types during CAS.
The investigators advised that all types of commercially available carotid stents were used. Open-cell design stents were classified according to free cell area into < 7.5 mm2 or > 7.5 mm2. A total of 713 closed-cell, 456 hybrid-cell, 238 < 7.5 mm2 open-cell, and 197 > 7.5 mm2 open-cell stents were implanted.
Overall, the 30-day stroke and death rate was 1.37%. At 30 days, 19 strokes occurred (1.18%): eight in the group of patients treated with a closed-cell (1.12%), two in those with a hybrid-cell (0.44%), three in those with a < 7.5 mm2 open-cell (1.26%), and six in those treated with a > 7.5 mm2 open-cell stent (3.05%) (P = .045).
These data suggest that, in the setting of neuroprotected CAS performed in high-volume centers by properly trained operators, the use of an open-cell design stent with a free cell area > 7.5 mm2 may be associated with an increased 30-day stroke risk, concluded the investigators in EuroIntervention.