Bioresorbable scaffold—the holy grail of percutaneous coronary intervention: fact or myth? (original) (raw)
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Bioresorbable Scaffolds versus Metallic Stents in Routine PCI
The New England journal of medicine, 2017
Background Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice. Methods We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events. Results The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent gro...
Percutaneous Coronary Intervention with Bioresorbable Vascular Scaffolds
International Journal of Cardiovascular Sciences, 2016
Percutaneous coronary intervention (PCI) was the first revolution in interventional cardiology. Coronary stents solved the acute occlusion of the vessel, sealing dissections and preventing negative remodeling. Excessive intimal hyperplasia was reduced with drug-eluting stents (DES) mainly in diabetics, small vessels and long lesions. However, the mechanical effect of stent metal hinders the positive remodeling of the vessel wall, good endothelial function and vascular reactivity. Bioresorbable vascular scaffolds (BVS) provide good initial stability in the vascular structure and complete resorption of the material over time, resulting in better physiological adaptation of the artery. Recent studies show that these devices are safe. Despite some limitations in indication, evidence now offer unique options in the treatment of coronary artery disease (CAD) with the expansion of BVS use in daily practice, which is the reason for this review.
Netherlands Heart Journal, 2015
reinterventions per year. To eliminate this potential late limitation of permanent metallic DES, bioresorbable coronary stents or 'vascular scaffolds' (BVS) have been developed. In a parallel publication in this journal, an overview of the current clinical performance of these scaffolds is presented. As these scaffolds are currently CE marked and commercially available in many countries and as clinical evidence is still limited, recommendations for their general usage are needed to allow successful clinical introduction.
Bioresorbable stents: Is the game over?
International Journal of Cardiology
Bioresorbable scaffolds (BRS) emerged as an alternative to conventional stents with a fundamental idea, to avoid a permanent metallic cage with all its harmful effects on the vessel. The Absorb BVS was the first widely studied device with the promising concept of performing a percutaneous coronary intervention, giving the necessary initial support to maintain vessel integrity and avoid acute vessel thrombosis. After a period, complete resorption of the device without leaving in the vessel any metallic structure would theoretically offer several benefits as the reduction of the inflammatory response and recovering normal vasomotor function, recovering access of jailed side-branches and segments for surgical revascularization, and the reduction of very late stent thrombosis derived from late acquired malapposition. However, cumulative evidence from the different absorb randomized trials (ABSORB II, ABSORB III, ABSORB China, ABSORB Japan) raised significant concerns, due to an elevated rate of scaffold thrombosis, target lesion failure and target vessel failure, when compared to contemporary everolimus drug-eluting stents. Several mechanisms arose explaining scaffold failure; some were strictly related to the device itself, and others related to the operator and the lesion itself. Newer generation BRS are under development targeting the main limitations of the ABSORB BVS, mainly focusing on reducing strut thickness, improving the mechanical structure with faster resorption times, and a better crossing profile. The story of BRS is not over yet, with ongoing refinements in the quest for the ideal stent.
Bioresorbable scaffolds: a new paradigm in percutaneous coronary intervention
BMC Cardiovascular Disorders, 2016
Numerous advances and innovative therapies have been introduced in interventional cardiology over the recent years, since the first introduction of balloon angioplasty, but bioresorbable scaffold is certainly one of the most exciting and attracting one. Despite the fact that the metallic drug-eluting stents have significantly diminished the re-stenosis ratio, they have considerable limitations including the hypersensitivity reaction to the polymer that can cause local inflammation, the risk of neo-atherosclerotic lesion formation which can lead to late stent failure as well as the fact that they may preclude surgical revascularization and distort vessel physiology. Bioresorbable scaffolds overcome these limitations as they have the ability to dissolve after providing temporary scaffolding which safeguards vessel patency. In this article we review the recent developments in the field and provide an overview of the devices and the evidence that support their efficacy in the treatment of CAD. Currently 3 devices are CE marked and in clinical use. Additional 24 companies are developing these kind of coronary devices. Most frequently used material is PLLA followed by magnesium.
Bioresorbable scaffold — A magic bullet for the treatment of coronary artery disease?
International Journal of Cardiology, 2016
Today, drug-eluting metal stents are considered the gold standard for interventional treatment of coronary artery disease. While providing inhibition of neointimal hyperplasia, drug-eluting metal stents have many limitations such as the risk of late and very late stent thrombosis, restriction of vascular vasomotion and chronic local inflammatory reaction due to permanent implantation of a 'metallic cage', recognized as a foreign body. Bioresorbable scaffold stents (BRS) are a new solution, which is trying to overcome the limitation of the 'metallic cage'. This structure provides short-term scaffolding of the vessel and then disappears, leaving nothing behind. The purpose of this review is to present the theoretical rationale for the use of BRS and to outline the clinical outcomes associated with their use in terms of data obtained from RCTs, clinical trials, registries and real life use. We have also tried to answer all questions on this intervention based on available data, with a focus on ABSORB BVS (Abbott Vascular, Santa Clara, USA). We consider that this new technology can be the "magic bullet" to treat coronary artery disease.
Bioengineering, 2018
The technology of percutaneous coronary intervention (PCI) is constantly being refined in order to overcome the shortcomings of present day technologies. Even though current generation metallic drug-eluting stents (DES) perform very well in the short-term, concerns still exist about their long-term efficacy. Late clinical complications including late stent thrombosis (ST), restenosis, and neoatherosclerosis still exist and many of these events may be attributed to either the metallic platform and/or the drug and polymer left behind in the arterial wall. To overcome this limitation, the concept of totally bioresorbable vascular scaffolds (BRS) was invented with the idea that by eliminating long-term exposure of the vessel wall to the metal backbone, drug, and polymer, late outcomes would improve. The Absorb-bioabsorbable vascular scaffold (Absorb-BVS) represented the most advanced attempt to make such a device, with thicker struts, greater vessel surface area coverage and less radial...
European Heart Journal
A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device-the Absorb bioresorbable vascular scaffold-has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CEmark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.
Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation, 2015
Percutaneous coronary interventions (PCI) have become a reliable revascularisation option to treat ischaemic coronary artery disease. Drug-eluting stents (DES) are widely used as first choice devices in many procedures due to their established good medium to long term outcomes. These permanent implants, however, do not have any residual function after vascular healing following the PCI. Beyond this initial healing period, metallic stents may induce new problems, resulting in an average rate of 2 % reinterventions per year. To eliminate this potential late limitation of permanent metallic DES, bioresorbable coronary stents or 'vascular scaffolds' (BVS) have been developed. In a parallel publication in this journal, an overview of the current clinical performance of these scaffolds is presented. As these scaffolds are currently CE marked and commercially available in many countries and as clinical evidence is still limited, recommendations for their general usage are needed to...
Advances in Interventional Cardiology, 2014
A b s t r a c t Despite significant advances in design and technology of drug eluting stents (DES) and improved long-term outcome of patients treated with percutaneous coronary intervention, the implantation of metallic stents is associated with some limitations. Multiple stents, covering long coronary segments substantially affect vasomotion, changing the vessel into a rigid tube. Bioresorbable vascular scaffolds (BVS) promise complete bioresorption after 2 to 3 years, vessel lumen enlargement, reduction of the plaque to media ratio, and restoration of vasomotion. Thus BVS seems to be a new, promising, and perhaps even a breakthrough invasive treatment for patients with coronary artery disease. The results of randomised trials and registries confirm the efficacy and safety of the BVS, provided the compliance with the technical aspects of implantation. A key role plays also the selection of patients who could potentially benefit most from the implantation of the BVS. The idea of "leaving nothing behind" after percutaneous coronary interventions is a very exiting concept in modern interventional cardiology. If current technology meets the challenge, major limitations will be overcome, and scaffolds prove to be at least as safe and effective as current DES, than in a long run we will be facing a real breakthrough not only in cardiology, but generally in medicine.