EuroPCR 2025 | Individual Patient Data Meta-analysis of PROTECTED TAVR and BHF PROTECT-TAVI

Stroke remains a significant complication associated with the various transcatheter aortic valve implantation (TAVI) devices currently in use. The Sentinel cerebral embolic protection (CEP) device could capture embolic debris during TAVI procedures; however, randomized trials have so far failed to show a significant reduction in stroke incidence.

Two major studies were conducted: PROTECTED TAVR (3,000 patients, primarily from the U.S.) and BHF PROTECT-TAVI (7,635 patients from the U.K.), both evaluating stroke occurrence within 72 hours post-TAVI or at hospital discharge. In both trials, a non-significant reduction in neurovascular events was observed (-0.6%, p=0.30 and -0.02%, p=0.94, respectively).

Based on these data, researchers carried out a meta-analysis of individual patient data. A primary analysis assessed stroke incidence (within 72 hours or at discharge) between patients who received CEP and those who did not. A per-protocol analysis was also conducted, including only patients with both CEP filters correctly deployed.

Upon primary analysis, stroke incidence did not show significant differences. However, upon per-protocol analysis, the CEP group showed a lower stroke rate (2.3% vs. 1.7%; P=0.023), though not sustained after adjusting for confounding factors.

Read also: EuroPCR 2025 | Angiography- vs. Physiology-Guided PCI in TAVI Candidates (FAITAVI).

Regarding disabling stroke, the subgroup with proper positioning of both filters showed significantly lower incidence (1.3% vs. 0.8%; P=0.007) at per-protocol analysis.

The authors concluded that there is insufficient evidence to support the routine use of CEP to reduce stroke incidence. They emphasized the need to further identify high-risk subgroups that may benefit from this strategy.

Presented by R. Kharbanda during the Major Late Breaking Trials session, EuroPCR 2025, May 21, Paris, France.