Background: The BEACH trial evaluated the outcomes of carotid artery stent placement with distal emboli protection, using the Carotid Wallstent and the FilterWire EX/EZ(TM), in patients at high surgical risk for carotid endarterectomy (CEA).
Methods: We enrolled 747 patients at high surgical risk for CEA due to prespecified anatomical criteria and/or medical comorbidities. The trial included both symptomatic (>50% carotid artery stenosis) as well as asymptomatic (>80% carotid artery stenosis) high surgical risk patients. Three groups of patients were included in the trial. The Roll-in (R) group (n = 189/747, [25%]) included up to nine patients per site for familiarization of the device and protocol; the Pivotal (P) group (n = 480/747, [65%]) was intended for presentation to the FDA for consideration of device approval; and a Bilateral (B) registry group (n = 78/747, [10%]) was included because of the need to treat patients with bilateral carotid artery disease. In the 480 Pivotal patients, anatomic criteria represented the most frequent high-risk surgical category for enrollment (58.8%), followed by prior CEA (34.2%), multivessel (>or=2) coronary artery disease (21.7%), and contralateral carotid occlusion (18.1%).
Results: The technical success rate for stent deployment and FilterWire EX/EZ deployment and retrieval was 98.2%. The mean postprocedure angiographic diameter stenosis in the Pivotal group was reduced to 10.8%, while the overall procedure success rate (<50% residual diameter stenosis) after stent deployment was 98%. The 30 day composite major adverse event (MAE) rate for the entire cohort of 747 patients (i.e. inclusive of all 3 groups) was 5.8% (all death = 1.5%, all stroke = 4.4%, and all myocardial infarction (MI) = 1.0%). In subgroup analysis, there was no significant difference in the MAE rate between the three groups (P = 5.8%, R = 6.9%, B = 2.6%, P = 0.42).
Conclusion: The similarity in periprocedural event rates for the Pivotal and Roll-in groups suggests a flat learning curve for experienced operators using this carotid stent system. The similarity in event rates for the Bilateral group, when compared with the Roll-in and Pivotal groups, suggests that staged sequential treatment of bilateral stenoses may be performed at the same risk as for unilateral lesions. The 30-day safety of this stent and distal emboli protection system is encouraging and compares favorably with other carotid stent trials in high surgical risk patients.