Positive 30-day results of pivotal, multicentre trial show Wirion embolic filter safe and highly effective

253

The positive 30-day results from 120 patients out of a planned 240 patient cohort at high risk for endarterectomy, who underwent carotid artery stenting using the Wirion embolic protection device (Allium Medical), were published in EuroIntervention and presented at EuroPCR 2015 (19–22 May, Paris, France).

Embolic protection in carotid artery stenting procedures have been shown to reduce the rate of major adverse cardiac and cerebrovascular events associated with the procedure. The 30-day results from this study have shown that the Wirion embolic protection device in carotid artery stenting is safe and highly effective when compared to historical data in a population that includes high-risk patients.

This early European experience from Alberto Cremonesi, Villa Maria Cecilia, Cotignola, Italy, and colleagues, using a novel guidewire-independent distal filter showed that the system is simple to use and highly rated by users. “The ability to cross the lesion over a guidewire of choice and deploy the filter in the exact desired location creates a unique, natural and appealing advantage for all indications,” the authors write in EuroIntervention.

 

At EuroPCR 2015, Bernhard Reimers, Cardiology Department, Mirano Hospital, Mirano, Italy, presented the results.

Earlier in March this year, the company announced the decision to stop recruiting additional patients in view of the successful compliance with all clinical trial objectives at this early stage.

The Wirion embolic protection device is a rapid exchange pre-crimped distal filter system that can be used with any 0.014” guidewire. It is a stent-like system in form and operation. The Wirion system is deployed after a 0.014” guidewire of choice is positioned across the lesion in a standard fashion. Then, the Wirion standalone filter unit can be delivered, positioned and locked anywhere along the guidewire, resulting in smooth crossing of the lesion and optimal protection position along the artery. The Wirion embolic protection device has received the CE mark and is at an advanced stage in the application for US FDA approval.

One hundred and twenty patients who were considered high-risk for surgery were enrolled in the WISE study. The mean age of the cohort was 73.9 years. Fourteen patients were symptomatic and 106 were asymptomatic. The lesions treated had an average stenosis of 84%.

“The 30-day composite primary endpoint of major cardiac and cerebrovascular event (MACCE) was 3.3%, with 0% death. Of these patients, one patient had contralateral stroke and a second patient had type 2 NSTEMI secondary to new untreated anaemia. Both were decided by the clinical event committee as non-procedure-related events. Only two patients (1.7%) experienced procedure-related events. The MACCE rate in the WISE study group was compared with an historical control group of high-surgical-risk patients showing significantly better performance. The device success rate was 99.2% and angiographic success was achieved in 97.5%,” the authors write.