Findings from a Cleveland Clinic-led trial show that a Cerebral Embolic Protection (CEP) device reduced the risk of disabling strokes by capturing and removing tiny pieces of calcium and other fragments resulting from transcatheter aortic valve replacement (TAVR) before they can reach the brain.
Findings from the “Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: The PROTECTED TAVR Study” were presented today during a late-breaking clinical science session at the Transcatheter Cardiovascular Therapeutics conference and simultaneously published online in the New England Journal of Medicine.
In the trial, the largest randomized TAVR trial to date, researchers evaluated stroke reduction during or right after the procedure and neurologic outcomes in patients with aortic stenosis treated with either the CEP device to provide cerebral embolic protection during TAVR or TAVR alone. While the data showed a 21% relative risk reduction in strokes at 72 hours or at time of hospital discharge (whichever came first), the overall numbers of stroke were small and the reduction was not statistically significant enough to meet the all-stroke primary endpoint (2.3% with TAVR and CEP vs. 2.9% with TAVR only, P=0.30).
However, a secondary analysis demonstrated a statistically significant 60% relative risk reduction in disabling stroke through 72 hours or time of hospital discharge in patients treated with the CEP device (0.5% with TAVR and CEP vs. 1.3% with TAVR only, P=0.02).
“In the practice of TAVR, an important question for physicians and patients is risk of stroke,” said Samir Kapadia, M.D., chairman of Cardiovascular Medicine at Cleveland Clinic and the study’s lead author. “This trial informs the doctor that the disabling stoke was reduced by the use of the CEP device and the device is safe to use.”
TAVR is an established treatment for patients with aortic stenosis, which is the narrowing of the aortic valve in the heart and can lead to interferences in normal blood flow. TAVR is a minimally invasive procedure in which the aortic valve is replaced with a catheter.
Embolization of debris from the valve can cause a stroke during or right after the procedure, leading to increased injury or death. Stroke continues to be an important complication of TAVR, with 16.7% mortality at 30 days, and remains a top concern for patients.
Although stroke is largely unpredictable, the risk is primarily procedural, with the vast majority resulting from embolic material released at the time of the valve implantation procedure.
In the PROTECTED TAVR trial, a total of 3,000 patients were enrolled and randomized between February 2020 and January 2022 at 51 centers in North America, Europe and Australia, with all patients receiving a neurological exam before and after the procedure.
Disabling stroke occurred in 8 of 1,501 (0.5%) patients in the CEP group and 20 of 1,499 (1.3%) in the control arm. Subgroup analyses demonstrated that the reduction in disabling stroke with the CEP device was consistent across patient subgroups, including age, gender, operative risk, valve type and history of cardiovascular disease.
Vascular complications at the CEP access site were minimal — one patient (0.1%) experienced major bleeding at the radial access site in the wrist during catheter removal.
“This study provides data from the largest randomized CEP trial with a clinical stroke endpoint that is relevant to healthcare providers and patients,” said Dr. Kapadia. “Although stroke risk is decreasing with newer generation devices and is comparable to surgical aortic valve replacement, it remains an important and troubling complication of TAVR.”
The PROTECTED TAVR trial was funded by Boston Scientific. Dr. Kapadia has not been compensated by Boston Scientific Corporation for his work on the PROTECTED TAVR trial.