Embolic prevention stent system feasible, safe during percutaneous carotid revascularization

In an all-comers population of high-risk patients with carotid stenosis, routine use of a novel dual-layer embolic prevention stent system was safe, effective and not associated with any residual stenosis or postprocedural neurological events during stent healing, according to new data from the PARADIGM study.

PARADIGM was a prospective, non-industry-funded study of 108 patients with carotid stenosis referred by the neurovascular team for carotid revascularization between October 2014 and September 2015. Results were presented by Piotr Musialek, MD, DPhil, from Jagiellonian University Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow, Poland, at EuroPCR and published in EuroIntervention.

According to the researchers, 101 patients (55 symptomatic) aged 51 to 86 years underwent 106 carotid artery stenting procedures with assistance of a neuroprotection device (CGuard MicroNet, InspireMD), and seven patients underwent carotid endarterectomy without use of a neuroprotection device.

Multidisciplinary team

Carotid stenosis treatment decisions were made by a multidisciplinary noninvasive vascular testing committee consisting of a neurologist, interventional angiologist, vascular surgeon and cardiologist. In cases of asymptomatic lesions, intervention was required only in the presence of high stroke risk. Overall, carotid artery stenting was performed proximally in 46% of cases and distally in the rest.

The primary endpoint was a composite of periprocedural death, major or minor stroke and MI, as well as a composite of these endpoints at 30 days, according to the researchers.

In the all-comers carotid artery stenting group, there was a 99.1% rate of neuroprotection device success. No deaths, major stroke or MI were seen at 48 hours and before hospital discharge. One event was determined to be a minor stroke (0.9%). No deterioration by NIH Stroke Scale or modified Rankin Scale score was seen at 48 hours or 30 days in any baseline asymptomatic or symptomatic patient, researchers found.

The mean reference diameter of the internal carotid artery was 4.94 mm and the lesion length was 19.7 mm. The researchers observed a decrease in angiographic diameter stenosis from 83% to 6.7% (P < .001). The nominal 30-mm neuroprotection device had an average in situ length of 29.82 mm, whereas the nominal 40-mm neuroprotection device had an average in situ length of 39.89 mm. This is in keeping with a lack of foreshortening or elongation upon placement in situ, the researchers wrote.

Endovascular route viable

No new neurological events or MIs were observed between hospital discharge and 30-day follow-up. Therefore, the researchers wrote, the 30-day rate of death, major stroke or MI was 0%, whereas the 30-day minor stroke rate was 0.9%. The composite 30-day death/any stroke/MI rate was 0.9%

“This study provides, for the first time, routine clinical evidence that percutaneous carotid stenosis revascularization using a novel dual-layer embolic prevention stent system ... is safe and effective with no residual stenosis ... and with no postprocedural neurological events during stent healing ... in all-comer symptomatic and increased stroke risk asymptomatic patients,” the researchers wrote. “Thus, the endovascular route is viable and, with this new technology, is safe and effective in the everyday clinical practice of carotid revascularization.” – by Jennifer Byrne

References:

Musialek P, et al. Renal and Peripheral Interventions. Presented at: EuroPCR; May 16-19, 2016; Paris.
Musialek P, et al. EuroIntervention. 2016;doi:10.4244/EIJY16M05_02.

Disclosure: Musialek reports participation on the InspireMD advisory board and serving as the co-principal investigator in the CGuard MN-EPS CARENET study.