ROADSTER: Encouraging results for TCAR maintained at 1 year
Transcarotid artery revascularization with a neuroprotection system was associated with a low rate of stroke in patients with carotid artery stenosis, according to 1-year results of the ROADSTER trial.
As Cardiology Today’s Intervention previously reported, transcarotid artery revascularization (TCAR) with a neuroprotection system (Enroute, Silk Road Medical) was associated with lower 30-day stroke and death rates compared with traditional carotid stenting.
For the present analysis, researchers analyzed 165 patients (112 from pivotal phase; 53 from extended-access cohort; mean age, 74 years; 65% men; 80% asymptomatic) with carotid artery stenosis at high risk for endarterectomy.
According to the researchers, high-risk anatomic factors included 11% of patients with contralateral carotid artery occlusion, 1.8% with tandem stenosis greater than 70%, 25% with high cervical carotid artery stenosis, 25.6% with restenosis after carotid endarterectomy, 4.3% with bilateral stenosis requiring treatment and 14.6% with a hostile neck. In addition, some patients had high-risk cardiac factors, including 14% with coronary disease in two or more vessels and a history of angina.
In total, 43.3% of patients had at least one high-risk anatomic factor and 29.9% of patients had at least one high-risk medical factor.
Between 30 days and 1 year, the rate of ipsilateral stroke was 0.6% and the rate of death was 4.2%, although no deaths were attributed to neurologic causes, Mahmoud B. Malas, MD, MHS, FACS, director of the Vascular and Endovascular Research Center at Johns Hopkins University, and colleagues wrote.
Compared with trials of other carotid stent systems, ROADSTER had the lowest rate of stroke between days 31 and 365, as the others ranged from 1.1% (ARCHER 2) to 4.8% (CREATE), the researchers wrote.
“The procedure is safe, at least 1-year durable and well-tolerated by patients,” Malas and colleagues wrote. “Further research is warranted to compare TCAR with other procedures and to evaluate its long-term outcomes.” – by Erik Swain
Disclosures: The study was funded by Silk Road Medical. Malas reports he received proctoring fees from Silk Road Medical. Please see the study for all other authors’ relevant financial disclosures.