AbstractObjective Evaluate 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 (CEA). TCAR-IEP provides dual neuroprotection and streamlines the procedure by using a novel flow reversal system together with Neuroguard IEP Direct, incorporating a closed-cell nitinol stent, semi-compliant post-dilation balloon, and an integrated 40 μm embolic protection filter mounted on a 70 cm delivery catheter. Methods PERFORMANCE III was a prospective, multicenter, multinational, open-label, non-randomized study. All patients had either de-novo or post-CEA restenotic lesions of the internal carotid artery or carotid bifurcation with ≥ 50% stenosis if symptomatic or ≥ 70% stenosis if asymptomatic. The study primary endpoint was a composite 30-day rate of major adverse events (MAE), defined as the cumulative incidence of all stroke, myocardial infarctions, and death within 30 days of the index procedure. Secondary endpoints included ipsilateral, major and minor strokes, acute success, procedure success, technical success, cranial nerve injury, cardiac death, neurologic death, access site complications and number of patients requiring blood transfusion. Results 146 patients were enrolled in the pivotal cohort. Intent-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 mean diameter stenosis of 82.6%, and 98.6% were moderately to severely calcified. The 30-day rate of MAE was 0.7% (1/145), comprised of one unrelated cardiac death 18 days after the index procedure. There were no strokes or neurological deaths. The upper bound of the 95% CI (3.8%) for the primary endpoint was significantly less than the pre-specified performance goal of 11.0% (pConclusions 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.
Lyden et al. (Fri,) studied this question.