Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial.

OBJECTIVE: The multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent plus FilterWire EX/EZ Emboli Protection System. BACKGROUND: For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA). METHODS: The trial enrolled 454 high-surgical-risk patients with carotid stenosis by angiography > or = 50% for symptomatic patients and > or = 60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event (MAE, defined as any death, stroke, or myocardial infarction [MI]) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31-365 days) ipsilateral stroke. RESULTS: Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered high-surgical-risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% versus OPC plus delta of 16.1%, P = 0.005). Late ipsilateral stroke was 0.7% and target vessel revascularization at 1 year was 2.4%. CONCLUSIONS: The CABERNET trial demonstrates that CAS with NexStent and FilterWire is noninferior to (equivalent or better than) traditional CEA at 1 year in high-surgical-risk patients based on historical controls.

Cryoplasty for femoropopliteal arterial disease: late angiographic results of initial human experience.

PURPOSE: A new form of angioplasty, called cryoplasty, was developed to improve the late results typically associated with percutaneous transluminal angioplasty. Cryoplasty combines the dilation force of percutaneous transluminal angioplasty with the delivery of cold thermal energy to the vessel wall. This study reports the authors' early clinical experience with cryoplasty in patients with femoropopliteal disease. MATERIALS AND METHODS: Fifteen patients with femoropopliteal arterial lesions were treated with cryoplasty (CryoVascular Systems, Los Gatos, CA). Cryoplasty was performed at 6 atm of pressure and delivered at -10 degrees C for 60 seconds. The ankle-brachial index (ABI) was measured at baseline, 24 hours after cryoplasty, and at 1 and 3 months during follow-up. Repeated angiography was performed at 6 and 18 months to determine short-term and late primary patency. RESULTS: Cryoplasty was technically successful in 93% of patients (< 30% residual stenosis and less then grade C dissection). ABIs at baseline were 0.64 +/- 0.08 and improved the day after cryoplasty to 0.95 +/- 0.09 (P < .05). ABIs were well maintained at 1 and 3 months with measurements of 0.94 +/- 0.09 and 0.92 +/- 0.10, respectively (P < .05 vs baseline). Baseline angiographic diameter stenosis improved significantly immediately following cryoplasty (86% +/- 12% to 16% +/- 3%; P < .05). Angiography at 6 months revealed 0% binary restenosis and insignificant change in residual stenosis from the acute cryoplasty results (16 +/- 3% vs 21 +/- 5%; P = NS). Late angiographic follow-up at 14 months +/- 4 demonstrated primary patency of 83.3%. CONCLUSION: Cryoplasty was able to achieve substantial dilation of femoropopliteal lesions with well-preserved late angiographic patency. Cryoplasty represents a potential advance in the field of endovascular medicine.