Hemodynamic analysis of a novel bioresorbable scaffold in porcine coronary artery model

BACKGROUND: The shear stress distribution assessment can provide useful insights for the hemodynamic performance of the implanted stent/scaffold. Our aim was to investigate the effect of a novel bioresorbable scaffold, Mirage on local hemodynamics in animal models. METHOD: The main epicardial coronary arteries of 7 healthy mini-pigs were implanted with 11 Mirage Microfiber sirolimus-eluting Bioresorbable Scaffolds (MMSES). Optical coherence tomography (OCT) was performed post scaffold implantation and the obtained images were fused with angiographic data to reconstruct the coronary artery anatomy. Blood flow simulation was performed and Endothelial Shear Stress (ESS) distribution was estimated for each of the 11 scaffolds. ESS data were extracted in each circumferential 5-degree subunit of each cross-section in the scaffolded segment. The generalized linear mixed-effect analysis was implemented for the comparison of ESS in two scaffold groups; 150-mm strut thickness MMSES and 125-mm strut thickness MMSES. RESULTS: ESS was significantly higher in MMSES (150 mm) [0.85(0.49­1.40) Pa], compared to MMSES (125 mm) [0.68(0.35­1.18) Pa]. Both MMSES (150 mm) and MMSES (125 mm) revealed low recirculation zone percentages per luminal surface area [3.17% 6 1.97% in MMSES (150 mm), 2.71% 6 1.32% in MMSES (125 mm)]. CONCLUSION: Thinner strut Mirage scaffolds induced lower shear stress due to the small size vessels treated as compared to the thick strut version of the Mirage which was implanted in relatively bigger size vessels. Vessel size should be taken into account in planning BRS implantation. Small vessels may not get benefit from BRS implantation even with a streamlined strut profile. This pilot study warrants comparative assessment with commercially available bioresorbable scaffolds.

Randomized comparison of absorb bioresorbable vascular scaffold and mirage microfiber sirolimus-eluting scaffold using multimodality imaging

ObjectivesThe primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device.BackgroundThe current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns....

Outcomes After Percutaneous Coronary Intervention or Bypass Surgery in Patients With Unprotected Left Main Disease.

BACKGROUND: Currently available randomized data on the comparison between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) for the treatment of unprotected left main coronary disease (LMD) lacks statistical power due to low numbers of patients enrolled. OBJECTIVES: This study assessed long-term outcomes of PCI and CABG for the treatment of LMD in specific subgroups according to disease anatomic complexity. METHODS: We conducted a pooled analysis of individual patient-level data of the LMD patients included in the PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) and SYNTAX (Synergy Between PCI With TAXUS and Cardiac Surgery) trials. Incidences of major adverse cardiac events were assessed at 5 years follow-up. RESULTS: Study population comprised 1,305 patients. The incidence of major adverse cardiac and cerebrovascular events at 5 years was 28.3% in the PCI group and 23.0% in the CABG group (hazard ratio [HR]: 1.23; 95% confidence interval [CI]: 1.01 to 1.55; p = 0.045). This difference is mainly driven by a higher rate of repeat revascularization associated with PCI (HR: 1.85; 95% CI: 1.38 to 2.47; p < 0.001). The 2 strategies showed similar rates of the safety composite endpoint of death, myocardial infarction, or stroke (p = 0.45). In patients with isolated LM or LM + 1-vessel disease, PCI was associated with a 60% reduction in all-cause mortality (HR: 0.40; 95% CI: 0.20 to 0.83; p = 0.029) and 67% reduction in cardiac mortality (HR: 0.33; 95% CI: 0.12 to 0.88; p = 0.025) when compared with CABG. CONCLUSIONS: In patients with unprotected LMD, CABG, and PCI result in similar rates of the safety composite endpoint of death, myocardial infarction, or stroke. In patients with isolated LM or LM + 1-vessel disease, PCI is associated with lower all-cause and cardiac mortality when compared to CABG.

Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)

BACKGROUND:Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies.METHODS:A total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group...