Bioresorbable scaffold — A magic bullet for the treatment of coronary artery disease? (original) (raw)
Related papers
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.
Journal of the American College of Cardiology, 2015
The everolimus-eluting bioresorbable vascular scaffold (BVS) is designed to achieve results comparable to metallic drug-eluting stents (DES) at 1 year, with improved long-term outcomes. Whether the 1-year clinical and angiographic results of BVS are non-inferior to current generation DES has not been established. We sought to evaluate the angiographic efficacy and clinical safety and effectiveness of BVS in a randomized trial designed to enable approval of the BVS in China. Eligible patients with 1 or 2 de novo native coronary artery lesions were randomized to BVS or cobalt-chromium everolimus-eluting stents (CoCr-EES) in 1:1 ratio stratified by diabetes and the number of lesions treated. Angiographic and clinical follow-up were planned at 1 year in all patients. The primary endpoint was angiographic in-segment late loss (LL), powered for non-inferiority with a margin of 0.15 mm. A total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES) at 24 sites. Acute clinical device su...
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.
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...
Bioresorbable scaffolds in the treatment of coronary artery disease
Medical Devices: Evidence and Research, 2013
Drug-eluting stents have reduced the risk of in-stent restenosis and have broadened the application in percutaneous coronary intervention in coronary artery disease. However, the concept of using a permanent metallic endovascular device to restore the patency of a stenotic artery has inherited pitfalls, namely the presence of a foreign body within the artery causing vascular inflammation, late complications such as restenosis and stent thrombosis, and impeding the restoration of the physiologic function of the stented segment. Bioresorbable scaffolds (BRS) were introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Currently, several BRSs are available, undergoing evaluation either in clinical trials or in preclinical settings. The aim of this review is to present the new developments in BRS technology, describe the mechanisms involved in the resorption process, and discuss the potential future prospects of this innovative therapy.
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.
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...
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.