Safety and efficacy of 6-month versus 12-month dual antiplatelet therapy in patients after implantation of multiple biodegradable polymer-coated sirolimus-eluting coronary stents: Insight from the I-LOVE-IT 2 trial.

OBJECTIVE: This study sought to compare the clinical outcomes of 6-month versus 12-month dual antiplatelet therapy (DAPT) in patients receiving multiple biodegradable polymer-coated sirolimus-eluting stents (BP-SES) implants. BACKGROUND: The clinical outcomes for patients who undergo multiple BP-SES implantation with different DAPT durations are uncertain. METHODS: In the I-LOVE-IT 2 trial, 907 patients treated with multiple BP-SES (total stent number ≥2) were assigned to receive 6-month (n = 440) or 12-month (n = 467) DAPT. The primary endpoint was 12-month target lesion failure (TLF), which is a composite of cardiac death, target vessel myocardial infarction (MI) or clinically indicated target lesion revascularization. The major secondary endpoints were 12-month net adverse clinical events, a composite of all causes of death, MI, stroke, any revascularization and bleeding. RESULTS: The number of stents per patient between the 6-month and 12-month DAPT group was similar (2.4 ± 0.7 vs. 2.4 ± 0.7, P = 0.47). The incidence of 12-month TLF was comparable in the 6-month and 12-month DAPT groups (9.3% vs.7.5%, Log-rank P = 0.33). However, landmark analysis showed that 12-month DAPT, compared to 6-month DAPT, was associated with a significantly lower risk of TLF (4.8% vs. 2.4%, Log-rank P = 0.049) at a cost of a slightly increased risk of all bleeding events (0.5% vs. 1.7%, Log-rank P = 0.07) between 6 and 12 months. CONCLUSIONS: In patients treated with multiple BP-SES, 6- and 12-month DAPT had similar impacts on 12-month clinical outcomes. Additionally, 12-month DAPT might reduce TLF between 6 and 12 months at the cost of a slightly increased risk of all bleeding events. © 2017 Wiley Periodicals, Inc.

Dual-acting biofunctionalised scaffolds for applications in regenerative medicine.

Off the shelf scaffolds for replacing ultra-small diameter vascular grafts are valuable for reconstruction of diseased or damaged vessels. The limitations for such grafts include optimal handling with ready availability of varied lengths of grafts, graft patency with the ability to replace the function of active cellular mechanisms and adequate mechanical properties to maintain physicochemical function. We used a well-established, solvent casting method for potential tissue replacement scaffold fabrication with incorporated bioactive molecules, which we have previously explored to confer haemocompatibility. These grafts were tested in-vivo within the abdominal aorta of 10 Wistar rats and the patency was clinically and echographically evaluated. Haemocompatibility and endothelialisation were assessed on explants. Biofunctionalised scaffolds were also grafted subcutaneously and intraperitoneally to evaluate integration, inflammation and angiogenesis reactions. The potential wider applications of this dual acting scaffold were evaluated for its interactions with human dermal fibroblasts as well as bronchial epithelial cells. Physicochemical property evaluation of the functionalised grafts has clarified the mechanical strength and permeability. This study confirmed the microsurgical suturability of tubular grafts and graft patency of functionalized scaffolds. The study demonstrated the potential of a dual acting biofunctionalised scaffold's use for a wide range of tissue engineering applications where micro-porous, yet impermeable scaffolds are needed.

Analysis of the effect of paclitaxel-eluting stents and paclitaxel-eluting balloon in the treatment of in-stent restenosis.

To compare and analyze the effect and the safety of the paclitaxel-eluting stents and paclitaxel-eluting balloon in the treatment for in-stent rest enosis. 120 cases, who had been undergone percutaneous coronary intervention (PCI) in the Department of Cardiology of Henan Provincial People's Hospital from January 2012 to January 2014 were selected. All the patients were randomly treated with paclitaxel-eluting balloon or paclitaxel-eluting stents. The former were divided into different groups that named group A and the later group B. All the selected patients signed the informed consent on interventional therapy and be given anti-platelet drugs before operating. At the same time, they had routine examination, like chest X-ray, ultrasound, biochemical detection, Myocardial injury markers. (1) The two groups had no significant difference in the general information (P>0.05); (2) The success rate in the two groups reached 100% and (3) All the patients were visited in the 9th, 12th and 24th month to see if any of them was dead. The reexamination results in the 9th month showed that both drug-eluting balloon and drug-eluting stents were safe and effective in treating coronary artery in-stent restenosis. In addition, drug-eluting balloon was more effective than drug-eluting stents to prevent from the in-stent restenosis.

A parotid abscess out of control resulting in craniocervical necrotising fasciitis in the context of diabetes mellitus-a case report and review of the literature.

Background: Necrotising fasciitis is an aggressive life-threatening infective process rarely making an appearance in the head and neck region and its development secondary to parotid abscess is exceptionally rare and scarcely reported in the literature. This case report serves to guide otolaryngologists with respect to its recognition and offers an alternative approach to craniocervical necrotising fasciitis with multiple neck explorations, use of antimicrobial impregnated packing enabling delayed reconstruction with lower morbidity. Case Description: A 76-year-old female with a body mass index of 36.2 kg/m2 and a 30-year history of poorly controlled type 2 diabetes mellitus (HbA1c 91 mmol/moL), presented to the outpatient otolaryngology clinic with right sided parotid mass with minimal erythema, hyperglycaemia (19.2 mmol/L) and no cranial neuropathies. However, the aggressive nature of the parotid abscess triggered by group A streptococcus and Staphylococcus epidermidis led to sepsis and extensive non-odontogenic necrotising fasciitis involving the lateral neck mandating multiple surgical debridement and neck explorations, prolonged intravenous antibiotics with interval definitive reconstruction. A cervicofacial rotational sternocleidomastoid flap was utilised to conceal the defect with patient experiencing a remarkable recovery. The patient's immunosuppressive state from poorly controlled diabetes mellitus and multi-lineage cytopenia is likely to have contributed to a prolonged recovery. Conclusions: This case report highlights the significance of repeat explorations and the need to give time for tissue healing as it unlocks options for reconstruction and reduce overall patient morbidity. Bismuth iodoform paraffin paste packing is a valuable tool with this case demonstrating its use an antiseptic and haemostatic agent in necrotising fasciitis and its ability to create an atmosphere to enable tissue healing minimising need for large-scale reconstructions. The absence of crepitus should not discourage the treating clinician from suspecting necrotising fasciitis of the neck. To limit successive cases, early prevention through aggressive control of predisposing systemic conditions including diabetes mellitus is needed. Moreover, when aggressive infections arise, the clinician should investigate for contributing systemic conditions.

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).