Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents:final five-year results of the AIDA randomised clinical trial

Background: Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years – the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce. Aims: This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group. Methods: AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT. Results: Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86). Conclusions: The excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards

Bioresorbable scaffolds for the treatment of coronary artery disease: current status and future perspective

Bioresorbable scaffolds represent a novel approach in the treatment of coronary artery disease which allows for vessel wall support without leaving a permanent foreign body in the coronary artery. This technology has the potential to reduce some of the shortcomings of current standard treatment with metallic drug-eluting stents, such as late in-stent restenosis, impaired vasomotion of the stented segment and hindrance of surgical revascularizations. Currently, several bioresorbable scaffolds are available and undergoing clinical or preclinical evaluation. This review will present the current status of development of bioresorbable scaffolds, describe the degradation/resorption process of each device and the clinical data available to dat

The future of BRS in bifurcations

Bioresorbable scaffolds (BRS) provide a new tool for percutaneous treatment of coronary stenosis. Initially, relatively simple coronary artery lesions were treated with this novel technology; nowadays, we have gained more experience with a wide variety of lesions, including bifurcation lesions. Data are limited in terms of the use of BRS in coronary bifurcation lesions, although it has been demonstrated that over time the bioresorbable struts are replaced by a tissue bridge resembling a "neo-carina". Furthermore, data are emerging about the endothelial shear stress (ESS) alterations and blood flow patterns after scaffold implantation. It is likely that ESS and blood flow determinations will guide correct future bifurcation techniques. In the future, BRS with thinner struts and more resistant to fracture are likely to improve bifurcation treatment with BR

An Assessment of Government Capacity Building to Restrict the Marketing of Unhealthy Food and Non-Alcoholic Beverage Products to Children in the Region of the Americas

The Pan American Health Organization (PAHO) Strategic Plan 2020–2025 committed to reduce children’s consumption of energy-dense nutrient-poor food and beverage products high in fat, sugar and salt (HFSS) and promote healthy eating patterns to reduce malnutrition in all forms. This paper describes the capacity-building needs in PAHO’s Member States to restrict the marketing of HFSS food and beverages to children. We asked Ministries of Health officials or national institutes/departmental representatives (n = 35) to complete a 28-item web-based survey (January to July 2020). Capacity-building needs were assessed using an adapted version of the World Health Organization’s government capacity-building framework with three modules: public health infrastructure, policies and information systems. Notable achievements for the PAHO’s Plan of Action were identified. State representatives reported strong infrastructure and information systems; however, policy improvements are needed to increase comprehensive national responses. These include using a constitutional health and human rights approach within the policies, policies that document conflict of interest from non-state actors, and strengthening regulatory oversight for digital media platforms. These findings provide baseline data and we suggest priorities for further action to strengthen national governments’ capacity-building and to accelerate the development, implementation, and monitoring systems to restrict the marketing of HFSS food and non-alcoholic beverages to children in the region of the Americas

Evaluation of the MiStent sustained sirolimus eluting biodegradable polymer coated stent for the treatment of coronary artery disease: does uniform sustained abluminal drug release result in earlier strut coverage and better safety profile?

Treatment of coronary artery disease has made strides over the last decades. Development of drug eluting stents (DES), coated with a polymer layer and an anti-proliferative drug to reduce neointimal hyperplasia, has reduced the incidence of in-stent-restenosis relative to treatment with bare metal stents. Patients treated with first generation DES more likely suffer from (very) late events which can be cause by the permanent presence of a polymer. Therefore second generation DES with more biocompatible coatings, and third generation DES, with very thin struts coated with biodegradable polymers, were developed. Areas covered: The MiStent SES is one of these third generation DES and is designed to limit the duration of polymer exposure, optimize coronary vessel healing and more precisely and consistently control drug elution to improve safety and clinical outcomes. This review provides a detailed description of the technique behind the MiStent SES, and describes the pre-clinical and clinical trials conducted with this device to date. Expert commentary: Recent clinical trials have shown non-inferiority of very thin strut biodegradable polymer coated DES compared to durable polymer coated DES, whilst maintaining an excellent safety profile. Longer follow-up, to see the real potential benefits of these devices, is mandatory howeve

First-in-Man Trial of SiO2 Inert-Coated Bare Metal Stent System in Native Coronary Stenosis - The AXETIS FIM Trial -

Background: A novel bare metal stent with an SiO2 coating was developed to prevent excessive neointimal hyperplasia by inertization of the metallic stent surface. The efficacy of the device was demonstrated in a preclinical model. The aim of this first-in-man trial was to assess the safety and feasibility of the new device. Methods and Results: This prospective non-randomized single-arm trial was designed to enroll 35 patients with a de novo coronary lesion. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at the baseline procedure and at the 6-month follow-up. Stent implantation was performed with OCT guidance according to optimal stent implantation criteria. The trial was terminated upon the advice of the data safety monitoring board after enrolling 14 patients due to the high incidence of re-intervention. Optimal OCT implantation criteria were achieved in only 8.3% of lesions. At 6 months, angiographic in-stent late lumen loss as the primary endpoint was 0.77 +/- 0.44 mm, and binary restenosis occurred in 33.3% of lesions. At the 6-month OCT, neointimal volume obstruction was 32.8 +/- 15.6% with a neointimal thickness of 237 +/- 117 mu m. At 12 months, the device-oriented composite endpoint (defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization rate) was 33.3%. Conclusions: In contrast with the preclinical study, the Axetis stent did not efficiently suppress neointimal hyperplasia in humans in this tria