Boston Scientific (NYSE: BSX) announced that its PROTECTED TAVR clinical trial evaluating its Sentinel System did not meet its primary objective.
Boston Scientific, based in Marlborough, Mass., designed the Sentinel Cerebral Protection System to capture and remove embolic debris resulting from transcatheter aortic valve replacement (TAVR). The goal is to extract the debris before it reaches the brain and potentially causes a stroke. Sentinel provides cerebral embolic protection (CEP) during TAVR.
PROTECTED TAVR evaluated the reduction in periprocedural strokes and neurological outcomes in patients with aortic stenosis treated with either Sentinel during TAVR or TAVR alone. It failed to meet its primary endpoint. The data demonstrated a nonsignificant trend toward a lower rate of stroke in patients treated with the Sentinel device. The study demonstrated a 21% reduction in the relative risk of all strokes over 72 hours or at the time of hospital discharge (2.3% with TAVR and CEP versus 2.9% with TAVR alone).
A secondary analysis demonstrated a statistically significant 60% reduction in the relative risk of disabling stroke over 72 hours or at discharge from hospital in patients treated with Sentinel. (It was 0.5% with TAVR and CEP versus 1.3% with TAVR only).
The company presented data at the 34th Transcatheter Cardiovascular Therapeutics (TCT). Researchers publish results in the New England Journal of Medicineaccording to Boston Scientific.
Still, there are positives to be taken from the Sentinel data
“Data from the PROTECTED TAVR trial provide the medical community with evidence that the device plays an important role in reducing disabling strokes in all patient types in those undergoing TAVR,” said dr. Samir Kapadia, Chairman of the Department of Cardiovascular Medicine Robert and Suzanne Tomsich, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, Cleveland Clinic. “We also found that the rate of vascular complications in this trial was very low whether the device was used or not, underscoring the safety of this technology in TAVR procedures.”
PROTECTED TAVR has enrolled 3,000 patients at more than 50 global sites and all surgical risk levels. Boston Scientific said it was the largest randomized TAVR trial to date. Subgroup analyzes demonstrated consistency across patient subgroups in reduction of disabling strokes with Sentinel.
Past clinical trials have demonstrated the safety and effectiveness of the Sentinel device. It has been shown to capture and remove brain embolic debris in 99% of TAVR cases.
“Because strokes are unpredictable, can occur regardless of an individual’s clinical history, and often have a significant impact on a patient’s quality of life and financial stability, we believe the data appear to demonstrate a consistent effect of CEP technology across all patient populations in the trial – supporting the use of the SENTINEL device as an effective therapy to reduce the risk of the most debilitating form of stroke for patients undergoing TAVR,” said the dr. Ian Meredith, Global CMO, Boston Scientific. “We look forward to additional data on this technology, such as from the PROTECT TAVI trial being recruited into the UKwhich will similarly assess the reduction in TAVR-related strokes using the SENTINEL device.
The analyst’s point of view
BTIG analyst Marie Thibault wrote that following the reading of the trial data, TCT members debated the impact of disabling stroke outcomes. According to Thibault, some said the results should not be ignored, while others saw it as a secondary endpoint in a “negative trial”.
In a public poll, the panel of doctors discussing the results voted 7 to 1 to use Sentinel, she said.
“At this time, we believe the ambiguity of the trial is not likely to change clinical practice, with believers in the device continuing to use it and those who have not yet adopted remaining in the process. ‘gap,” Thibault wrote. “Although PROTECTED TAVR missed its primary target, we believe BSX can drive growth with several new products and expanding market opportunities. Repeat purchase. »