Thirty-day outcomes following transcarotid artery revascularization with integrated embolic protection: The...

We evaluated the safety and effectiveness of transcarotid artery revascularization with integrated embolic protection (TCAR-IEP) among patients at high risk for adverse events during carotid endarterectomy. TCAR-IEP provides dual neuroprotection and streamlines the procedure by using a novel flow reversal system together with the Neuroguard IEP Direct, incorporating a closed-cell nitinol stent, semicompliant postdilation balloon, and an integrated 40-μm embolic protection filter mounted on a 70-cm delivery catheter.

PERFORMANCE III (Direct Access Carotid Artery Stenting Using the Neuroguard IEP System) was a prospective, multicenter, multinational, open-label, nonrandomized study. All patients had either de novo or post-carotid endarterectomy restenotic lesions of the internal carotid artery or carotid bifurcation with ≥50% stenosis if symptomatic or ≥70% stenosis if asymptomatic. The study primary end point was a composite 30-day rate of major adverse events, defined as the cumulative incidence of all strokes, myocardial infarctions, and deaths within 30 days of the index procedure. Secondary end points included ipsilateral, major, and minor strokes; acute, procedural, and technical success; cranial nerve injury; cardiac death; neurological death; access site complications; and number of patients requiring blood transfusion. We enrolled 146 patients in the pivotal cohort. The intention-to-treat analysis included all 146 evaluable patients (mean age, 70.5 years; 21.2% symptomatic; 39.7% diabetic), with one patient lost to follow-up at 30 days. Lesions were predominantly de novo, with a mean diameter of stenosis of 82.6%; 98.6% were moderately to severely calcified.

The 30-day rate of major adverse events was 0.7% (1/145), composed of one unrelated cardiac death 18 days after the index procedure. There were no strokes or neurological deaths. The upper bound of the 95% confidence interval (3.8%) for the primary end point was significantly less than the prespecified performance goal of 11.0% (P < .001), thereby meeting the study's objective. Technical success was achieved in 99.3% of patients, with no cranial nerve injuries, stent thromboses, or blood transfusions. The mean flow reversal time was 7.4 ± 3.5 minutes.

PERFORMANCE III results demonstrate high technical success and zero strokes, neurological deaths, or cranial nerve injuries. These outcomes highlight the potential of dual neuroprotection, utilizing TCAR-IEP, to enhance patient safety with carotid stenting.