What does this research mean for the field?

Patient-specific computational simulations accurately reproduce experimental stent testing, demonstrating that the novel 12-peak MEGATRON stent provides superior mechanical performance for left main coronary interventions compared to alternative designs. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

April 22, 2021Open Access

Computational and experimental mechanical performance of a new everolimus-eluting stent purpose-built for left main interventions

Structured PICO

Does the 12-peak MEGATRON stent improve mechanical performance compared to other stent designs in left main coronary artery bifurcation models?

Population

Four patient-specific left main (LM) coronary artery bifurcation geometries (3D reconstructed) and experimental stent models

Intervention

12-peak MEGATRON everolimus-eluting stent deployed computationally and experimentally at 3.5, 4.5, and 5.0 mm diameters

Comparator

9-peak prototype MEGATRON, 10-peak prototype MEGATRON, and SYNERGY everolimus-eluting stents

Outcome

Stent morphometric and biomechanical indices (expansion, scaffolding, vessel prolapse, and radial strength)surrogate

The 12-peak MEGATRON stent demonstrated superior mechanical performance, including greater radial strength and better scaffolding, compared to other designs in computational and experimental left main bifurcation models.

Abstract

Left main (LM) coronary artery bifurcation stenting is a challenging topic due to the distinct anatomy and wall structure of LM. In this work, we investigated computationally and experimentally the mechanical performance of a novel everolimus-eluting stent (SYNERGY MEGATRON) purpose-built for interventions to large proximal coronary segments, including LM. MEGATRON stent has been purposefully designed to sustain its structural integrity at higher expansion diameters and to provide optimal lumen coverage. Four patient-specific LM geometries were 3D reconstructed and stented computationally with finite element analysis in a well-validated computational stent simulation platform under different homogeneous and heterogeneous plaque conditions. Four different everolimus-eluting stent designs (9-peak prototype MEGATRON, 10-peak prototype MEGATRON, 12-peak MEGATRON, and SYNERGY) were deployed computationally in all bifurcation geometries at three different diameters (i.e., 3.5, 4.5, and 5.0 mm). The stent designs were also expanded experimentally from 3.5 to 5.0 mm (blind analysis). Stent morphometric and biomechanical indices were calculated in the computational and experimental studies. In the computational studies the 12-peak MEGATRON exhibited significantly greater expansion, better scaffolding, smaller vessel prolapse, and greater radial strength (expressed as normalized hoop force) than the 9-peak MEGATRON, 10-peak MEGATRON, or SYNERGY (p < 0.05). Larger stent expansion diameters had significantly better radial strength and worse scaffolding than smaller stent diameters (p < 0.001). Computational stenting showed comparable scaffolding and radial strength with experimental stenting. 12-peak MEGATRON exhibited better mechanical performance than the 9-peak MEGATRON, 10-peak MEGATRON, or SYNERGY. Patient-specific computational LM stenting simulations can accurately reproduce experimental stent testing, providing an attractive framework for cost- and time-effective stent research and development.

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