In the first head-to-head comparison of two embolic protection devices used during TAVR, the investigational Emboliner protection catheter performed comparably to the U.S. Food and Drug Administration (FDA)-approved Sentinel cerebral protection system relative to the composite primary endpoint and secondary endpoint of stroke, according to results from the PROTECT H2H trial presented during a Late-Breaking Clinical Trial session at ACC.26 in New Orleans.

The multicenter, open-label, trial conducted at 20 sites across Brazil, Germany and the U.S., randomized 522 patients (mean age, 79 years; 33% women) with severe aortic stenosis undergoing TAVR to either the Emboliner or Sentinel device. The patients were similar across groups at baseline, with a prior stroke in 9%, hypertension in 84% and atrial fibrillation in 25%.

Results at 30 days showed that 4.9% of Emboliner patients vs. 5.0% of Sentinel patients experienced a primary endpoint event, a composite of all-cause death, stroke and acute kidney failure.

The key secondary endpoint of stroke within 30 days occurred in 2% of Emboliner patients and 2.1% of Sentinel patients, “the lowest rates of stroke that have been achieved in a trial of this size,” noted study author, Adam B. Greenbaum, MD, FACC. A similar number of adverse events like bleeding and blood clots was observed in both groups.

The Emboliner device, which is a full-body filter designed to capture TAVR-generated debris, captured three times as many particles larger than 150 microns than the Sentinel device (93 vs. 31) and almost twice as many total particles (1,575 vs. 801), with some as small as 40 microns. However, Greenbaum noted the study was not powered to detect differences in terms of outcomes from debris elsewhere.

The Emboliner also had fewer issues with placement. Operators were able to successfully position the device in 96% of Emboliner patients and 87% of Sentinel patients.

“While the Sentinel is a great advance in the field, it leaves open the question of whether preventing other downstream effects of TAVR-generated debris – for example, in the gut, the legs, the kidneys – could improve patient outcomes,” said Greenbaum. “Any embolic debris during TAVR is neutral at best, potentially harmful, and it would therefore be intuitive that as long as the system is safe and easy to use, the more debris captured, the better.”

Trial limitations included the short follow-up period and low enrollment, which made it impossible to identify whether incidence of kidney failure differed between the two groups.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Hypertension

Keywords: ACC Annual Scientific Session, ACC26, New Orleans, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration, Embolic Protection Devices, Acute Kidney Injury, Aortic Valve Stenosis, Hypertension, Thrombosis, Catheters, Kidney, Stroke