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

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.

SUBMITTER: Samant S

PROVIDER: S-EPMC8062511 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundData on left main (LM) percutaneous coronary interventions (PCI) have mostly been obtained in studies using drug-eluting stent (DES) platforms without dedicated large-vessel devices and with limited expansion capability.AimsOur study aimed to investigate the safety and efficacy of LM PCI with the latest-generation Resolute Onyx DES.MethodsROLEX (Revascularization Of LEft main with resolute onyX) is a prospective, multicentre study (ClinicalTrials.gov: NCT03316833) enrolling patients with unprotected LM coronary artery disease and a SYNTAX score <33 undergoing PCI with the Resolute Onyx zotarolimus-eluting coronary stent, that includes dedicated extra-large vessel platforms. The primary endpoint (EP) was target lesion failure (TLF): a composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR), at 1 year. All events were adjudicated by an independent clinical event committee. An independent core lab analysed all procedural angiograms.ResultsA total of 450 patients (mean age 71.8 years, SYNTAX score 24.5±7.2, acute coronary syndrome in 53%) were enrolled in 26 centres. Of these, 77% of subjects underwent PCI with a single-stent and 23% with a 2-stent technique (8% double kissing [DK] crush, 6% culotte, 9% T/T and small protrusion [TAP] stenting). Intravascular imaging guidance was used in 45% (42% intravascular ultrasound [IVUS], 3% optical coherence tomography [OCT]). At 1 year, the primary EP incidence was 5.1% (cardiac death 2.7%, TVMI 2.7%, ID-TLR 2.0%). The definite/probable stent thrombosis rate was 1.1%. In a prespecified adjusted subanalysis, the primary EP incidence was significantly lower in patients undergoing IVUS/OCT-guided versus angio-guided PCI (2.0 vs 7.6%; hazard ratio [HR] 0.28, 95% confidence interval [CI]: 0.13-0.58; p<0.001).ConclusionsIn this large, multicentre, prospective registry, LM PCI with the Resolute Onyx DES showed good safety and efficacy at 1 year, particularly when guided by intracoronary imaging.

Project description:AimsPatients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.Methods and resultsABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority < 0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).ConclusionStenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.

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

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