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Use of a cerebral embolic protection (CEP) device may be effective at capturing debris in patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis, but it did not reduce the risk of stroke in the PROTECTED TAVR trial.
A 3000-patient trial conducted across North America, Europe, and Australia, results of the trial, which were presented at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) 2022 conference, indicate the incidence of stroke within 72 hours did not differ significantly between the CEP group and the control group, but the incidence of disabling stroke was lower among the CEP group.
“In this randomized trial involving patients with aortic stenosis undergoing TAVR, the incidence of procedural complications was similar among those who underwent TAVR with or without CEP,” wrote investigators. “The use of a CEP device during TAVR did not lead to a significantly lower incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR.”
Although uptake of TAVR has ballooned in recent years with more data detailing its safety and efficacy, the risk of stroke remains a concern among patients undergoing TAVR. With embolization of debris linked to increased morbidity and mortality, the US Food and Drug Administration’s approval of Boston Scientific’s Sentinel CEP device was welcomed by many. However, as investigators note in the current study, while the pivotal trial used for approval demonstrated the device captured debris in 99% of patients, the trial was not powered to assess risk of stroke.
With this in mind, the PROTECTED TAVR trial was designed as a prospective, postmarket, multicenter, randomized, controlled trial evaluated the Sentinel CEP device in patients with aortic stenosis undergoing transfemoral TAVR. Randomizing patients in 1:1 ratio to undergo TAVR with CEP or without CEP, the trial enrolled 3000 individuals from 51 centers across North America, Europe, and Australia from February 2020-January 2022. Major exclusion criteria for the study included if the left common carotid or the brachiocephalic artery had greater than 70% diameter stenosis or if the anatomical structure was otherwise incompatible with the placement of the CEP device.
The trial had a primary outcome of interest of stroke within 72 hours after TAVR or before discharge, whichever occurred first. Secondary outcomes of interest included disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury.
The overall study cohort had a mean age of 78.9±7.8 years and a mean STS surgical risk score of 3.4±2.7%. Of the 3000 patients who underwent randomization, 1501 were randomized to the CEP group and 1499 were randomized to the control group without CEP. Investigators pointed out characteristics were vernally similar between the study groups, with the exception of a greater proportion of female patients in the CEP group (42.0% vs 37.8%). Among those randomized to the CEP group, devices were deployed successfully in 94.4% of whom an attempt was made.
Upon analysis, results indicated the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the study group, with rates of 2.3% and 2.9% among the CEP and control groups, respectively (-0.6 percent points [95% CI, -1.7 to 0.5]; P=.30). From their analyses of secondary outcomes of interest, investigators highlighted an apparent decrease in incidence of disabling stroke among those in the CEP group (0.5%) compared to those in the control group (1.3%) (difference, -0.8 [95% CI, -1.5 to -0.1]). Investigators also pointed out there were no significant differences between the study groups for all-cause mortality, acute kidney injury, or a composite outcome of stroke, transient ischemic attack, or delirium.
In an editorial penned by John D. Carroll, MD, of the University of Colorado School of Medicine, and Jeffrey L. Saver, MD, of the David Geffen School of Medicine at UCLA, the pair note their interest in seeing how practicing clinicians, as well as regulatory bodies, react to the results of this study.
“The results from the current trial may change the use of the Sentinel CEP device in practice. Until now, the clinicians who use the device have been influenced by seeing retrieved debris with the expectation of an associated clinical benefit, which has not been confirmed by the primary end-point results of the current trial,” investigators wrote. “Some may continue to use the Sentinel device because of its safety and the suggestion that it prevents disabling strokes. Other clinicians and health care systems could balk at the prospect of adding a major cost to the TAVR procedure without a proven clinical benefit.”
This study, “Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement,” was presented at TCT 2022 and simultaneously published in the New England Journal of Medicine.