Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease

Abstract

Background and Purpose: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. Methods: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. Results: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. Conclusions: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02536378.

Transient flow reversal combined with sustained embolic prevention in transcervical revascularization of symptomatic and highly-emboligenic carotid stenosis for optimized endovascular lumen reconstruction and improved peri- and post-procedural outcomes

“…8 and Ref. 12) is consistent with (not unexpected) TCAR first-generation opencell stent inability to eliminate post-procedural strokes [10,11,26]. Conversely, the MicroNET-covered stent design shows an effective minimization of post-procedural embolism [29] (that is a measure of the clinical stroke risk [35]) and elimination of post-procedural strokes [15-18, 30, 31], suggesting that the transcervical flow reversal approach to CAS will need to incorporate advances in the carotid stent design that translate into improved periand post-procedural neurologic outcomes.…”

“…Another finding is that this approach, similar to standard TCAR, appears to perform very well technically and clinically with the state-of-theart second-generation carotid stent (MicroNET-covered stent, CGuard). This is important because the use of conventional (first-generation, single-layered) carotid stents in TCAR (that provides an optimal cerebral protection but, nevertheless, the one that is limited to the revascularization procedure) does not protect against post-procedural embolism and strokes [10,11,26,27]. This shortcoming is consistent with the relationship between the first-generation stent plaque prolapse and post-procedural DW-MRI embolism and strokes that are not prevented by a classic single-layer closed-cell design [8,12,[28][29][30].…”

“…In addition to a high-level procedural safety, TCAR minimizes cranial nerve injury associated with carotid surgery [10,11] that is one of the important drawbacks of CEA from the patient's perspective [34]. Overall evidence, inclusive of a significant proportion (≈30-60%) of 30-day strokes occurring with 1 st generation carotid stents post-procedurally in relation to on-going post-procedural plaque embolism [27] (see CREST, CAPTURE, ICSS and other data reviewed recently in Ref.…”

“…Recently, the technique has gained a new momentum with an accumulating data-based realization of its two fundamental advantages: (1) robust cerebral protection by flow reversal is operational against embolism even prior to any endovascular approach to the lesion (i.e., 'protected' lesion crossing), is continuous, and is highly effective throughout the procedure, and (2) avoiding cerebral embolism associated with aortic arch cannulation [3][4][5]9]. Accumulating results from transcarotid artery revascularization (TCAR, using the EnRoute flow reversal system, Silk Road) studies show low stroke/death rates comparable to carotid endarterectomy while maintaining the minimally invasive benefits of carotid stenting [10,11]. The transcervical approach, which circumvents a number of embolic-risk maneuvers inherent to transfemoral carotid stenting, and with its highly effective proximal cerebral protection [9], has a strong potential to become, in surgical hands at least (as the system requires surgical, rather than percutaneous, exposure of the common carotid artery, CCA), the preferred method of carotid artery stenting (CAS) in the near future.…”

Editor's Choice – Early and Late Outcomes after Transcarotid Revascularisation for Internal Carotid Artery Stenosis: A Systematic Review and Meta-Analysis

“…Chang et al 15 Pipinos et al 16 Alexandrescu et al 17 Criado et al 18 Faraglia et al 19 Pinter et al (PROOF) 20 Alvarez et al 21 Ortega et al 22 Kwolek et al (ROADSTER) 23 Alpaslan et al 24 Wang et al 25 Kashyap et al (ROADSTER 2) 32 Lin et al 26 Feldtman et al 27 Palombo et al 28 Schermerhorn et al 29 Christopoulos et al 30 Plessers et al 0.00 (0.00, 0.16) 0.00 (0.00, 0.09) 0.00 (0.00, 0.12) 0.00 (0.00, 0.04) 0.00 (0.00, 0.07) 0.00 (0.00, 0.08) 0.00 (0.00, 0.03) 0.00 (0.00, 0.14) 0.01 (0.00, 0.05) 0.00 (0.00, 0.05) 0.03 (0.00, 0.09) 0.00 (0.00, 0.00) 0.00 (0.00, 0.11) 0.07 (0.00, 0.32) 0.00 (0.00, 0.08) 0.00 (0.00, 0.01) 0.00 (0.00, 0.…”