Methods
We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary endpoint was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Inactivating stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access point, and acute kidney injury were also assessed. A professional neurologist examined all patients at baseline and after TAVR.
Results
A total of 3000 patients in North America, Europe and Australia were randomized. 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge was not significantly different between the CEP group and the control group (2.3% vs 2.9%; difference, -0.6 percentage points; 95% confidence interval , -1.7 to 0.5; P =0.30). Disabling stroke occurred in 0.5% of patients in the CEP group and in 1.3% of patients in the control group. There were no significant differences between the CEP group and the control group in the proportion of patients who died (0.5% vs. 0.3%). had stroke, transient ischemic attack or delirium (3.1% vs 3.7%). or had acute kidney injury (0.5% vs 0.5%). One patient (0.1%) had a vascular complication at the CEP access point.
conclusions
Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP had no significant effect on the incidence of perioperative stroke, but based on the 95% confidence interval around this effect, the results may not exclude a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.)
