Abstract
BackgroundTreatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection.Methodology/Principal FindingsNine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm2 vs. 12.84±1.38 mm2, p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015).Conclusions/SignificanceMicro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated stent systems, considering final intravascular ultrasound or optical coherence tomography to visualize (and if necessary optimize) stent expansion.
Highlights
The presence of a bifurcation lesion in patients with coronary artery disease (CAD) is a frequent morphology (8.5%)
The proximal stent diameters assessed in human autopsy heart samples were significantly smaller than in porcine heart samples (PD: 3.5460.47 mm human vs. 4.0460.22 mm porcine, p = 0.048) and than those given by the manufacturer (PD: 3.5460.47 mm human vs. 4.03 mm manufacturer, p = 0.014)
The mean stent length assessed in human autopsy heart samples was smaller than in porcine heart samples (L: 16.6661.30 mm human vs. 17.3060.51 mm porcine, p = 0.32) and significantly smaller than that given by the manufacturer (L: 16.6661.30 mm human vs. 18 mm manufacturer, p = 0.015)
Summary
The presence of a bifurcation lesion in patients with coronary artery disease (CAD) is a frequent morphology (8.5%) This incidence was found by a recent study investigating a cohort of 6129 consecutive patients undergoing coronary stent implantation [1]. Drug-eluting stents (DES) have reduced the incidence of revascularization after percutaneous coronary intervention (PCI [2,3]), but in the case of bifurcation lesions, rates for adverse clinical events still remain high. The high rates of restenosis were one of the reasons for the development of dedicated stent systems (DSS) but according to current guidelines for PCI [11], so far there is no recommendation for the use of DSS. The aim of this study was to assess the expansion of the Multi-Link (ML) FrontierTM stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection
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