PROTECT
Emboliner vs Sentinel Cerebral Embolic Protection Devices During TAVR (PROTECT H2H)
Presented by Adam Greenbaum — Henry Ford Health
Subspecialty: Valvular
Published in ACC.26 Late-Breaking
Key Result
Emboliner was noninferior to Sentinel for 30-day MACCE during TAVR with the lowest stroke rates in a trial of this size. Emboliner captured 3x more large debris particles.
What did this trial find?
The PROTECT H2H trial compared the investigational Emboliner cerebral embolic protection device vs the FDA-approved Sentinel system during TAVR in 522 patients, finding Emboliner noninferior for 30-day MACCE (4.9% vs 5.0%) with the lowest stroke rates in a trial of this size (2% vs 2.1%) and 3x more large debris capture.
Why does this trial matter?
As a late-breaking presentation at ACC.26, expert commentary and editorial coverage may not yet be widely available or indexed.
Study Design
Multicenter, randomized, controlled, noninferiority trial across 20 sites in 3 countries (N=522)
Clinical Implications
The Emboliner catheter offers comparable clinical outcomes to the current market leader (Sentinel) with superior debris capture, potentially reducing subclinical brain injury during TAVR.
Abstract
The PROTECT H2H trial was a multicenter, randomized trial across 20 sites in Brazil, Germany, and the US comparing the investigational Emboliner protection catheter vs the FDA-approved Sentinel cerebral protection system during TAVR. 522 patients with severe aortic stenosis (mean age 79, 33% women) were enrolled. The primary endpoint (30-day MACCE) demonstrated non-inferiority: 4.9% with Emboliner vs 5.0% with Sentinel. Stroke rates were the lowest achieved in a trial of this size: 2% vs 2.1%. Emboliner captured 3x more particles >150 microns (93 vs 31) and nearly 2x total particles (1,575 vs 801). Device placement success was 96% vs 87%.