First-in-man study of a thinner-strut sirolimus-eluting bioresorbable scaffold (FUTURE-I): Three-year clinical and imaging outcomes.

OBJECTIVES: The FUTURE-I study aimed to assess preliminary safety and effectiveness with the long-term clinical and imaging follow-up for the Firesorb (MicroPort, Shanghai, China), a thinner-strut sirolimus-eluting bioresorbable scaffold (BRS). BACKGROUND: First-generation BRS has been associated with unexpected device-related adverse outcomes at long-term follow-up. METHODS: In this prospective, open-label, first-in-man study, patients with single de novo lesions in native coronary arteries were randomized 2:1 into two cohorts after successful Firesorb implantation: cohort 1 (n = 30) underwent multimodality imaging assessment at 6 and 24 months; and cohort 2 (n = 15) at 12 and 36 months. All patients underwent clinical follow-up at 1, 6, and 12 months and annually up to 5 years. RESULTS: Between January and March 2016, 45 patients were enrolled. At 3-year follow-up, one patient had experienced target lesion failure and none scaffold thrombosis. In-scaffold minimal lumen diameter decreased significantly from 6-month to 2-year (2.53 ± 0.24 mm vs. 2.27 ± 0.37 mm, p = .0003), and only numerically from 1-year to 3-year follow-up (2.48 ± 0.28 mm vs. 2.22 ± 0.13 mm, p = .08). By optical coherence tomography, neointimal strut coverage at 3-year follow-up was 99.8%, and very low rate of late scaffold discontinuity was observed, only in one patient on two cross sections with three malapposed struts. CONCLUSIONS: At 3-year follow-up of the FUTURE-I study, implantation of the thinner-strut Firesorb BRS appeared preliminary feasible and effective in the treatment of patients with noncomplex coronary lesions.

Comparison of two biodegradable-polymer-based sirolimus-eluting stents with varying elution and absorption kinetics in patients with acute myocardial infarction: A subgroup analysis of the PANDA III trial.

BACKGROUND: Implantation of early-generation metallic drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) is associated with poor vessel wall healing. Use of biodegradable polymer (BP) DES might improve safety outcomes; however, the impact of varying drug elution and polymer absorption kinetics of BP-DES on clinical outcomes in the AMI population is unknown. METHODS: This subgroup analysis of the randomized PANDA III trial included 732 patients (366 in each group) presenting with recent (<1 month) AMI. Primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization. Secondary endpoints included a patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization; individual TLF and PoCE components; and definite/probable stent thrombosis (ST). RESULTS: There were no significant differences between-groups in baseline clinical, angiographic, or procedural characteristics other than the proportion of post-dilatation, which was performed more frequently with the BuMA stent (53.9% vs. 44.5%; P = 0.004). After 1 year, compared to Excel SES implantation in patients with AMI, BuMA was associated with similar incidences of TLF and PoCE (5.5% vs. 8.3%, P = 0.14; 8.8% vs. 9.9%, P = 0.61, respectively) but lower incidences of MI (2.5% vs. 6.1%, P = 0.02), target vessel MI (2.2% vs. 5.8%, P = 0.01), and definite/probable ST (0.3% vs. 2.2%, P = 0.04). CONCLUSIONS: BuMA SES, with faster drug elution rate and polymer absorption kinetics, might improve safety outcomes compared to Excel SES in the high-risk AMI population. © 2017 Wiley Periodicals, Inc.

First-in-man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions: clinical, Angiographic, and OCT outcomes of CREDIT-1.

OBJECTIVE: To evaluate the preliminary safety and efficacy of the EXCEL II stent system. BACKGROUND: Although the first biodegradable polymer drug-eluting stent (BP-DES), EXCEL, was launched nearly a decade ago, in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy. METHODS: Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio, the 4-month follow-up group (n = 30) and the 12-month follow-up group (n = 15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI. RESULTS: No MACE, thrombotic events, or target lesion failure was found in the 45 patients during the 12-month follow-up. There was no significant difference (P > 0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either group. At follow-up, the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P < 0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%, P < 0.01). CONCLUSIONS: This first-in-man study demonstrates promising feasibility, safety, and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation.

Multi-parameter design of triply periodic minimal surface scaffolds: from geometry optimization to biomechanical simulation.

This study introduces a multi-parameter design methodology to create triply periodic minimal surface (TPMS) scaffolds with predefined geometric characteristics. The level-set constant and unit cell lengths are systematically correlated with targeted porosity and minimum pore sizes. Network and sheet scaffolds featuring diamond, gyroid, and primitive level-set structures are generated. Three radially graded schemes are applied to each of the six scaffold type, accommodating radial variations in porosity and pore sizes. Computer simulations are conducted to assess the biomechanical performance of 18 scaffold models. Results disclose that diamond and gyroid scaffolds exhibit more expansive design ranges than primitive counterparts. While primitive scaffolds display the highest Young's modulus and permeability, their lower yield strength and mesenchymal stem cell (MSC) adhesion render them unsuitable for bone scaffolds. Gyroid scaffolds demonstrate superior mechanical and permeability performances, albeit with slightly lower MSC adhesion than diamond scaffolds. Sheet scaffolds, characterized by more uniform material distribution, exhibit superior mechanical performance in various directions, despite slightly lower permeability. The higher specific surface area of sheet scaffolds contributes to elevated MSC adhesion. The stimulus factor analysis also revealed the superior differentiation potential of sheet scaffolds over network ones. The diamond sheet type demonstrated the optimal differentiation. Introducing radial gradations enhances axial mechanical performance at the expense of radial mechanical performance. Radially decreasing porosity displays the highest permeability, MSC adhesion, and differentiation capability, aligning with the structural characteristics of human bones. This study underscores the crucial need to balance diverse biomechanical properties of TPMS scaffolds for bone tissue engineering.

Distribution of microplastics in different tissues of major commercial catches in different functional areas of the South Yellow Sea.

The microplastic (MP) pollution in different tissues of six commercial catches, including (Miichthys miiuy, Eleutheronema tetradactylum, Collichthys lucidus, Mugil cephalus, Portunus trituberculatus and Exopalaemon carinicauda) in Haizhou Bay (nori farming area), Yancheng offshore (wind power construction area) and the Nantong marine ranch area of the South Yellow Sea was investigated. MPs are ubiquitous in commercial catches; the average abundance of MPs is 5.19 ± 3.64 items/individual. There are significant differences in the level of MP pollution in commercial catches among functional sea areas. The level of MP pollution in commercial catches in Haizhou Bay and Yancheng offshore is higher than that in the Nantong marine ranch areas. This difference may be related to intense anthropogenic activities such as engineering construction and mariculture. In addition to the presence in digestive tract, MPs in the skin and gills of fish and in the gills of shrimp and crabs cannot be ignored. The main shape, color and material of MPs are fiber, black-gray and celluloid (CP), respectively. Since commercial catches are consumed by humans, the potential risks of MPs in these catches to human health and marine ecology are of concern.

Loading of microplastics by two related macroalgae in a sea area where gold and green tides occur simultaneously.

Macroalgae are important components of offshore ecosystems and can also cause algal blooms. Microplastics (MPs) have been found in macroalgae and exhibit interactions during algal blooms. Ulva prolifera and Sargassum horneri are common algae in the Yellow Sea in China and are also the major macroalgae that cause green and gold tides. However, the loading of MPs by S. horneri along the coast of China has not been investigated, and the loading characteristics of MPs by two related macroalgae in a sea area where gold and green tides occur simultaneously have not been reported. Because U. prolifera and S. horneri occur simultaneously in the Yellow Sea, we investigated the characteristics of MPs in U. prolifera and S. horneri at 9 stations in the Yellow Sea located along the migration paths of green and gold tides. It was found that U. prolifera exhibited a higher abundance of MPs (0.065 ± 0.047 items/g-1 fresh weight) and ratio of the MP abundance in macroalgae to that in seawater (Rm/Rs = 97.33) than S. horneri (0.016 ± 0.016 items/g-1 fresh weight, Rm/Rs = 24.56). Moreover, the MPs in U. prolifera showed increased diversity in shape, color and material than those in S. horneri, and the particle sizes in the former were also smaller. Fast-growing biomass, slender branches, hollow air sacs and soft epidermis may allow U. prolifera to load more MPs. However, these mechanisms have not been fully established and merit further study. The relationship between severe algal blooms and MP pollution should be considered.

A Randomized Trial Comparing the NeoVas Sirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents.

OBJECTIVES: The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents. BACKGROUND: BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating. METHODS: Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients. RESULTS: The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; pnoninferiority < 0.0001; psuperiority = 0.36). Clinical outcomes at 1 year were similar in the 2 groups, as were the rates of recurrent angina (27.9% vs. 32.1%; p = 0.26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs. 96.2%; p < 0.001), less strut malapposition (0% vs. 0.6%; p <0.001), and a smaller minimal lumen area (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001) with NeoVas compared with CoCr-EES respectively, with nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs. 0.91 ± 0.06; p = 0.07). CONCLUSIONS: The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).

Comparison of long-term in-stent vascular response between abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent: 3-year OCT follow-up from the TARGET I trial.

The study sought to compare long-term optical coherence tomography (OCT)-based in-stent vascular response between the abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) and the durable polymer everolimus-eluting stent (EES) in the TARGET I trial. The TARGET I trial was a prospective, multicenter, randomized clinical trial which enrolled 458 patients with single de novo lesions treated by abluminal groove-filled biodegradable polymer SES and EES. A subset of 43 patients underwent angiography and OCT examinations at 3 years. All OCT images were analyzed at 0.4 mm intervals. A similar increase in angiographic late lumen loss was observed in SES and EES (from 0.05 ± 0.05 vs. 0.05 ± 0.05 mm [p = 0.84] at 9 months to 0.25 ± 0.37 vs. 0.26 ± 0.19 mm [p = 0.99] at 3 years, respectively), without significant differences at 3 years in mean neointimal thickness of stent struts (SES: 0.13 ± 0.02 mm vs. EES: 0.13 ± 0.02 mm, p = 0.80); mean percentage of covered struts (SES: 99.2 % vs. EES: 99.3 %, p = 0.53), or malapposed strut rates (SES: 0.08 % vs. EES: 0.06 %, p = 0.15). The OCT-based in-stent vascular response evaluation found similar vascular healing for the two studied devices, indicating that the luminal loss in EES from 9 months to 3 years cannot be imputed on its coated biocompatible polymer.

Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial.

AIMS: To compare stent strut coverage using optical coherence tomography (OCT) at three-month follow-up between a PLGA-polymer with electro-grafting base layer sirolimus-eluting stent (SES) (BuMA) and a PLA-polymer SES (EXCEL). METHODS AND RESULTS: This prospective, single-centre, non-inferiority randomised BuMA-OCT trial enrolled patients with de novo coronary artery lesions, treated with either the BuMA or the EXCEL stent. The study primary endpoint was OCT-evaluated stent strut coverage at three months. Secondary endpoints were neointimal thickness of stent struts, and incomplete stent apposition evaluated with OCT. A total of 80 patients were randomly assigned to receive the BuMA (n=40) or the EXCEL (n=40) stent. In OCT follow-up (achieved in 86.3% of cases: BuMA, n=33; EXCEL, n=36), the percentage of stent strut coverage was significantly higher in the BuMA vs. the EXCEL group (strut level: 94.2% vs. 90.0%, p<0.01; p(non-inferiority)<0.0001; p(superiority) <0.0001), while the proportion of malapposed struts (strut level: 1.28% vs. 1.80%, p=0.51) and the mean neointimal thickness (strut level: 0.07±0.03 mm vs. 0.06±0.02 mm, p=0.31) were similar. Rates of myocardial infarction (periprocedural non-Q-wave, 7.5% vs. 7.5%, p=1.00) and target lesion failure (7.5% vs. 7.5%, p=1.00) were similar between groups, with no cardiac death or stent thrombosis. CONCLUSIONS: In the BuMA-OCT randomised trial, the novel BuMA PLGA-polymer with electro-grafting base layer SES was superior to the EXCEL PLA-polymer SES in the primary endpoint of stent strut coverage at three-month follow-up.