(Leipzig, Germany) January 28, 2020 -- Results from a trial evaluating a novel 3-in-1 carotid stent, post-dilatation balloon, and embolic protection device were presented Tuesday at LINC, offering new insights into the field of carotid artery stenting (CAS).
Micro-emboli and stroke are the Achilles’ heel of CAS, noted Ralf Langhoff, MD (Humboldt University Berlin, Germany), and thus there is great need for technology that can facilitate simple and effective protection from these complications during endovascular intervention. “Long-term data for outcomes and restenosis are absolutely comparable between CAS and carotid endarterectomy (CAE), but still micro-embolic events are more common in the CAS arm of all the landmark trials,” he said.
The 3-in-1 device, Neuroguard IEP (Contego Medical, USA) is comprised of a closed-cell nitinol stent, an angioplasty balloon, and an integrated 40-micron distal protection filter. The technology is a long-overdue logical development that came from years of CAS experience, stressed Dr Langhoff: “Why no one before has built a system that incorporates all the necessary tools for CAS in one single, solid device is – retrospectively – hard to understand.
“You only have to cross the lesion once because everything is on one single delivery device already pre-mounted and ready for release or inflation. In a standard procedure, you would have to cross a stenosis numerous times to finish your CAS procedure, but every crossing of the lesion increases the risk of stroke and may lead to technical complications.”
Closed-cell stents are designed to decrease the risk of early- and procedure-related strokes, but can have the disadvantage of forcing vessels to straighten, commented Dr Langhoff. But the current version of the Neuroguard IEP stent, he added, has a novel closed-cell design that offers optimal flexibility, wall apposition and radial strength, accommodating to given anatomy.
During his presentation, Dr Langhoff walked the audience through the PERFORMANCE I trial – a prospective, multicenter CAS trial to investigate the safety and efficacy of the Neuroguard 3-in-1 stent system in extracranial de novo or post CEA [carotid endarterectomy] carotid artery stenotic lesions in symptomatic and asymptomatic patients. “Last year, we were able to show interim results of the first 60 patients, but today we present 12-month data of the full cohort,” he said.
The primary endpoint for the trial was 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any periprocedural (≤30 days post procedure) death, stroke, or myocardial infarction (MI). A distal primary embolic protection filter was required per the protocol.
“Pre-dilation of the target lesion was at the discretion of the operator, which is probably a crucial point in order to see if, in the future, we could work without a primary, additional filter device. In the PERFORMANCE I trial, 31.7% used a predilatation prior to Neuroguard placement, but it is too early to judge whether this is a trend or whether it is due to safety concerns because, per protocol, every procedure was protected by a primary embolic protection device (such as FilterWire EZ [Boston Scientific], Emboshield NAV6 Embolic Protection System [Abbott], SpiderFX [Medtronic] and one case of a Mo.Ma [Medtronic]).”
PERFORMANCE I was conducted in nine European sites, including 67 patients, 18.3% of whom were symptomatic. The degree of stenosis was >80% (mean) and there were mainly short lesions <2 cm (mean). Almost all lesions were de novo lesions.
Framing the headline results, Dr Langhoff continued: “The overall success rate was 100% with a death and stroke rate of 0%. We faced a single NSTEMI [non ST-elevation myocardial infarction] on day 17, but it was not device-related as adjudicated by the Clinical Endpoint Committee.”
Embolic debris was found in 100% of filters, he went on, and when compared to the distal filter, Neuroguard IEP collected 35.2% more particles (11,132 vs 3,130).
On the back of the impressive zero stroke and death rate in PERFORMANCE I, the PERFORMANCE II trial will be soon rolled out across 42 sites. William Gray (Lankenau Heart Institute, Wynnewood, PA) will be the global principal investigator (PI), with Dr Langhoff as European PI. “It will be of major interest if the Neuroguard IEP can outperform the currently available data in terms of safety in a larger set of patients and centres,” said Dr Langhoff.
Commenting on what these data say of the Neuroguard and its potential, Dr Langhoff said the Neuroguard was very close to being a perfect “fairy-tale” design: “The Neuroguard 3-in-1 device is very close to what interventionists are [dreaming of] for carotid procedures, but there are definitely still some limitations.”
Preparation is a key consideration, for instance: “Preparation of the Neuroguard needs due attention because you have to prepare three devices all at once. It is definitely not rocket science, but you have to carefully follow the instructions for use and get sufficient training to be able to know where to flush, and where to push or pull. The release mechanism is very simple, self-explanatory and straightforward, but most important, very controlled.”
Framing his take-home message on the success and future outlook for Neuroguard, Dr Langhoff concluded: “CEA is a well-established treatment option for a lot of patients in experienced centers. If CAS wants to compete with CEA, it has to minimize the risk of minor strokes. The Neuroguard IEP system has the potential to be a game-changer and show that CAS can be offered on a large scale to patients without any increased risk of stroke – maybe even with a lower risk than CEA – and fewer side effects such as nerve palsy, infection, and bleeding.”