Lauren A. Peruski, DO
The ROADSTER 2 Trial discusses an innovative procedure (transcarotid artery revascularization – TCAR) aimed at treating patients with extracranial internal carotid artery (ICA) disease who are high-risk for current carotid revascularization options, through an assessment of early outcomes. Both symptomatic and asymptomatic patients were selected; symptomatic stenosis was defined as ≥ 50%, while asymptomatic stenosis was defined as ≥ 80%. The procedure uses the ENROUTE transcarotid stent and neuroprotection system, which clamps the proximal ICA and reverses blood flow through an extracorporeal arterial-venous shunt to the femoral vein, as a means of protecting the cerebral circulation from distal embolization during the procedure.
The patients chosen for the trial would otherwise be deemed too high-risk to undergo traditional carotid endarterectomy (CEA), whether due to unfavorable anatomy or significant medical co-morbidities. The 692 patients that comprised the study were a majority (67.8%) male, with comorbid hypertension, hyperlipidemia, and a history of tobacco use.
In the per-protocol population studied, there were 4 ischemic strokes (0.6%), 6 myocardial infarctions (0.9%), and one death within 30 days. The early results of this trial are promising. Compared to data from transfemoral carotid artery stenting (AFCAS) trials, TCAR appears to offer high-risk patients an alternative with seemingly less in-hospital complications (including periprocedural TIA, stroke, or death). Moreover, in comparing TCAR to CEA trials, there does not appear to be a marked difference in early stroke or death between similar patient populations.
While the early results of this trial appear promising, offering an alternative for high-risk patients who are in need of a carotid revascularization procedure, there are a few limitations to consider. When trying to generalize this trial to patients who have had neurological symptoms, specifically stroke or TIA, we should keep in mind that those patients only represented 16% of the population studied. While still high-risk anatomically, a majority of these patients were included with asymptomatic carotid stenosis. Another point to consider is that this trial highlight the early outcomes in these patients, but more long-term data is needed to draw additional conclusions beyond 30 days. Lastly, and most importantly, the data comparing TFCAS and CEA with TCAR was extrapolated, and comparative studies are needed before we can confidently and accurately compare outcomes between these procedures when educating our patients and colleagues.
