- Question
- Does routine use of a cerebral embolic protection device during transcatheter aortic-valve implantation (TAVI) reduce the incidence of periprocedural stroke?
- Design
- Randomized, controlled trial (1:1) across 33 centers in the United Kingdom, with 7635 participants assigned to TAVI with or without a cerebral embolic protection device.
- Population
- Patients with aortic stenosis undergoing TAVI.
- Intervention
- TAVI with a cerebral embolic protection device (CEP group), 3815 participants.
- Control
- TAVI without a cerebral embolic protection device (control group), 3820 participants.
- Primary outcome
- Stroke within 72 hours after TAVI or before hospital discharge, if discharge occurred sooner.
- Results
- The primary outcome occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 (2.2%) in the control group (difference, -0.02 percentage points; 95% CI, -0.68 to 0.63; P = 0.94). Disabling stroke occurred in 47 participants (1.2%) with CEP and 53 (1.4%) in the control group.
- Safety
- Death occurred in 0.8% of the CEP group and 0.7% of controls. Access-site complications were similar (8.1% vs. 7.7%). There were 24 serious adverse events in 22 participants (0.6%) with CEP and 13 in 13 participants (0.3%) in the control group.
- Conclusion
- Among patients undergoing TAVI, routine use of cerebral embolic protection did not decrease the incidence of stroke within 72 hours.
- Why it matters
- The trial challenges the routine use of these devices in all patients undergoing TAVI, as no clinical benefit in preventing periprocedural stroke was shown.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026