One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial.

Objectives: Transcarotid artery revascularization (TCAR) is a carotid stenting technique that utilizes reversal of cerebral arterial flow to confer cerebral protection. Although carotid endarterectomy (CEA) remains the standard for treatment of symptomatic and asymptomatic carotid stenosis, the search for the optimal minimally invasive option for the high-risk surgical patient continues. The goal of the current study is to evaluate the 1-year safety and efficacy of TCAR in a prospective clinical trial.

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

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.

Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry first 2,001 patients.

Background: Previously, the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE) randomized trial showed that carotid artery stenting (CAS) was not inferior to carotid endarterectomy (CEA) in the treatment of high-surgical risk patients.

Objective: The primary objective of the SAPPHIRE Worldwide Registry is to evaluate 30-day major adverse events (MAE) after CAS performed by physicians with varied experience and utilizing a formal training program. Data will be analyzed on the overall patient population and by high-risk inclusion criteria.

Management of atherosclerotic carotid artery disease: clinical practice guidelines of the Society for Vascular Surgery.

The Society for Vascular Surgery (SVS) appointed a committee of experts to formulate evidence-based clinical guidelines for the management of carotid stenosis. In formulating clinical practice recommendations, the committee used systematic reviews to summarize the best available evidence and the GRADE scheme to grade the strength of recommendations (GRADE 1 for strong recommendations; GRADE 2 for weak recommendations) and rate the quality of evidence (high, moderate, low, and very low quality). In symptomatic and asymptomatic patients with low-grade carotid stenosis (<50% in symptomatic and <60% in asymptomatic patients), we recommend optimal medical therapy rather than revascularization (GRADE 1 recommendation, high quality evidence).

Carotid artery stenting with emboli protection surveillance study: thirty-day results of the CASES-PMS study.

Objective: This study examined whether physicians with varying carotid stent experience would obtain safety and efficacy outcomes as good as those from the pivotal SAPPHIRE trial following participation in a comprehensive carotid stent training program.

Background: This study was performed as a condition of approval study for the PRECISE(R) Nitinol Stent and the ANGIOGUARD XP Emboli Capture Guidewire.

Methods: Patients at high surgical risk who were either symptomatic with >or=50% stenosis or asymptomatic with >or=80% stenosis of the common or internal carotid artery received carotid artery stenting with distal emboli protection using the PRECISE Nitinol Stent and the ANGIOGUARD XP Emboli Capture Guidewire.