Adverse events with bioresorbable vascular scaffolds in routine percutaneous coronary interventions: "coup de theatre" or unfinished play?
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ABSTRACT:
SUBMITTER: Cassese S
PROVIDER: S-EPMC5594123 | biostudies-literature | 2017 Aug
REPOSITORIES: biostudies-literature
Publications
Adverse events with bioresorbable vascular scaffolds in routine percutaneous coronary interventions: "coup de théâtre" or unfinished play?
Cassese Salvatore S Husser Oliver O Kastrati Adnan A
Journal of thoracic disease 20170801 8
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Project description:UnlabelledInnovations in drug-eluting stents (DES) have substantially reduced rates of in-segment restenosis and early stent thrombosis, improving clinical outcomes following percutaneous coronary interventions (PCI). However a fixed metallic implant in a vessel wall with restored patency and residual disease remains a precipitating factor for sustained local inflammation, in-stent neo-atherosclerosis and impaired vasomotor function increasing the risk for late complications attributed to late or very late stent thrombosis and late target lesion revascularization (TLR) (late catch-up). The quest for optimal coronary stenting continues by further innovations in stent design and by using biocompatible materials other than cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding, local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics have been recently developed. These devices have been utilized in selected clinical applications so far providing preliminary evidence of safety showing comparable performance with current generation drug-eluting stents (DES). Herein we provide a comprehensive overview of the current status of these technologies, we elaborate on the potential benefits of transient coronary scaffolds over permanent stents in the context of vascular reparation therapy, and we further focus on the evolving challenges these devices have to overcome to compete with current generation DES.Condensed abstract: The quest for optimizing percutaneous coronary interventions continues by iterative innovations in device materials beyond cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding; local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics were recently developed. These devices have been utilized in selected clinical applications providing preliminary evidence of safety showing comparable intermediate term clinical outcomes with current generation drug-eluting stents.
| S-EPMC4355515 | biostudies-literature
Project description: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.
| S-EPMC4751731 | biostudies-literature
Project description:Percutaneous coronary intervention (PCI) has undergone major advances including the evolution in stent technology, from bare metal stents (BMS), to their drug eluting counterparts, to the development of bioresorbable scaffolds (BRS). The primary notion of BRS was to facilitate complete vascular healing and restore normal endothelial function following the resorption of stent scaffold while providing equivalent mechanical properties of a metallic drug eluting stents (DES) in the earlier stages. BRS provide attractive physiologic advancements over the existing DES and have shown promising results in initial clinical studies albeit with small sample sizes. Their use has been primarily restricted to patients recruited in clinical trials with limited real-world applicability. Thus, data from larger randomised control trials is awaited. The major objective of this article is to review the evidence on BRS and identify their clinical applicability in current interventional practice.
| S-EPMC5808659 | biostudies-other
Project description:BackgroundBRS represent a new approach to treating coronary artery disease. Beneficial properties of BRS regarding the restoration of vasomotility after resorption make them attractive devices in CTO revascularization. However, experience in this setting is limited.MethodsWe systematically searched Medline, Scholar, and Scopus for reports of at least 9 patients with CTO undergoing BRS implantation. Patients' and procedural characteristics were summarized. The primary outcome of interest was target lesion revascularization (TLR). Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42017069322).ResultsThirteen reports for a total of 843 lesions with a median follow-up of 12 months (IQR 6-12) were included in the analysis. At short-term, the summary estimate rate of TLR was 2.6% (95% CI: 1 to 4%, I2 = 0%, P = 0.887) while at mid to long-term it was 3.8% (95% CI: 2 to 6%, I2 = 0%, P = 0.803). At long-term follow-up (≥12 months), the summary estimate rate of cardiac death was 1.1% (95% CI: 0 to 2%, I2 = 0%, P = 0.887). The summary estimate rates of scaffold thrombosis and clinical restenosis were respectively 0.9% (95% CI: 0 to 2%, I2 = 0%, P = 0.919) and 1.8% (95% CI: 0 to 4%, I2 = 0%, P = 0.448). Finally, the summary estimate rate of target vessel revascularization was 6.6% (95% CI: 0 to 11%, I2 = 0%, P = 0.04).ConclusionsImplantation of BRS in a population with CTO is feasible, although further longer-term outcome studies are necessary.
| S-EPMC6419823 | biostudies-literature
Project description:BackgroundEvaluation of recurrent angina after percutaneous coronary interventions is challenging. Since bioresorbable vascular scaffolds (BVS) cause no artefacts in magnetic resonance imaging (MRI) due to their polylactate-based backbone, evaluation of vascular patency by MRI might allow for non-invasive assessment and triage of patients with suspected BVS failure.MethodsPatients with polylactate-based ABSORB-BVS in proximal coronary segments were examined with 3 Tesla MRI directly (baseline) and one year after implantation. For assessment of coronary patency, a high-resolution 3D spoiled gradient echo pulse sequence with fat-saturation, T2-preparation (TE: 40 ms), respiratory and end-diastolic cardiac gating, and a spatial resolution of (1.08 mm)3 was positioned parallel to the course of the vessel for bright blood imaging. In addition, a 3D navigator-gated T2-weighted variable flip angle turbo spin echo (TSE) sequence with dual-inversion recovery black-blood preparation and elliptical k-space coverage was applied with a voxel size of (1.14 mm)3. For quantitative evaluation lumen diameters of the scaffolded areas were measured in reformatted bright and black blood MR angiography data.Results11 patients with implantation of 16 BVS in the proximal coronary segments were included, of which none suffered from major adverse cardiac events during the one year follow up. Vascular patency in all segments implanted with BVS could be reliably assessed by MRI at baseline and after one year, whereas segments with metal stents could not be evaluated due to artefacts. Luminal diameter within the BVS remained constant during the one year period. One patient with atypical angina after BVS implantation was noninvasively evaluated showing a patent vessel, also confirmed by coronary angiography.ConclusionsCoronary MRI allows contrast-agent free and non-invasive assessment of vascular patency after ABSORB-BVS implantation. This approach might be supportive in the triage and improvement of diagnostic workflows in patients with postinterventional angina and scaffold implantation.Trial registrationGerman Register of Clinical Studies DRKS00007456.
| S-EPMC5784929 | biostudies-literature
Project description:Percutaneous coronary intervention, which is safe, effective, and timely, has become an important treatment for coronary artery diseases and has been widely used in clinical practice. However, there are still some problems that urgently need to be solved. Permanent vessel caging through metallic implants not only prevents the process of positive vessel remodeling and the restoration of vascular physiology but also makes the future revascularization of target vessels more difficult. Bioresorbable scaffolds (BRSs) have been developed as a potential solution to avoid the above adverse reactions caused by permanent metallic devices. BRSs provide temporary support to the vessel wall in the short term and then gradually degrade over time to restore the natural state of coronary arteries. Nonetheless, long-term follow-up of large-scale trials has drawn considerable attention to the safety of BRSs, and the significantly increased risk of late scaffold thrombosis (ScT) limits its clinical application. In this review, we summarize the current status and clinical experiences of BRSs to understand the application prospects and limitations of these devices. In addition, we focus on ScT after implantation, as it is currently the primary drawback of BRS. We also analyze the causes of ScT and discuss improvements required to overcome this serious drawback and to move the field forward.
| S-EPMC7733966 | biostudies-literature
Project description:ObjectiveRecanalization with balloon angioplasty and/or self-expanding stents (SES) has become the endovascular treatment of choice for symptomatic femoropopliteal occlusive disease. These strategies generate suboptimal clinical results, however, because they fail to expand the artery fully and ineffectively prevent recoil, neointimal hyperplasia, and restenosis. Balloon-expandable stents, given their greater radial force and rigid structure, represent a more effective treatment strategy, but only short lengths can be implanted safely in arteries that deform and bend with skeletal motion. The purpose of this preclinical experiment was to test the hypothesis that simultaneous implantation of a series of short, resorbable, balloon-expandable, paclitaxel-eluting scaffolds would prevent neointimal hyperplasia and stenosis compared with SES in an animal model of percutaneous femoropopliteal intervention.MethodsWe extruded 6 × 60 mm Efemoral Vascular Scaffold Systems (EVSS) from copolymers of poly-L-lactic acid, coated with paclitaxel 3 μg/mm2, crimped onto a single delivery balloon, and implanted percutaneously into the iliofemoral arteries of eight Yucatan mini-swine. We implanted 7- to 8-mm × 60 mm SES into the contralateral experimental arteries. The animals were serially imaged with contrast angiography and optical coherence tomography after 30, 90, 180, 365, and 730 days. The primary end point of this study was neointimal morphometry over time. Secondary end points included acute deformation and angiographic and optical coherence tomography-derived measurements of chronic vascular response.ResultsOver the 2-year study period, one SES was found to be completely occluded at 90 days; all EVSS were widely patent at all time points. Arteries treated with SES exhibited profound neointimal hyperplasia with in-stent stenosis. In contrast, arteries treated with EVSS exhibited only modest vascular responses and minimal stenosis. After 2 years, the mean neointimal thickness (0.45 ± 0.12 vs 1.31 ± 0.91 mm; P < .05) and area (8.41 ± 3.35 vs 21.86 ± 7.37 mm2; P < .05) were significantly decreased after EVSS implantation. By 2 years, all scaffolds in all EVSS-treated arteries had resorbed fully.ConclusionsIn this preclinical animal model of peripheral endovascular intervention, the EVSS decreased neointimal hyperplasia and stenosis significantly compared with SES, then dissolved completely between the first and second years after implantation.
| S-EPMC10403740 | biostudies-literature
Project description:This review focuses on the clinical and biological features of the bioresorbable scaffolds in interventional cardiology highlighting scientific achievements and challenges of the transient scaffolding with Absorb BVS. Special attention is granted to the vascular biology pathways which, involved in the resorption of scaffold, artery remodeling and mechanisms of Glagovian atheroregression setting the stage for subsequent clinical applications. Twenty five years ago Glagov described the phenomenon of limited external elastic membrane enlargement in response to an increase in plaque burden. We believe this threshold becomes the target for development of strategies that reverse atherosclerosis, and particularly transient scaffolding has a potential to be a tool to ultimately conquer atherosclerosis.
| S-EPMC4807720 | biostudies-literature
Project description:The limitations of the first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have been demonstrated in several randomized controlled trials. Little data are available regarding the outcomes of patients receiving hybrid stenting with both BVS and drug-eluting stents (DES). Of 3144 patients prospectively enrolled in the GABI-Registry, 435 (age 62 ± 10, 19% females, 970 lesions) received at least one BVS and one metal stent (hybrid group). These patients were compared with the remaining 2709 (3308 lesions) who received BVS-only. Patients who had received hybrid stenting had more frequently a history of cardiovascular disease and revascularization (p < 0.05), had less frequently single-vessel disease (p < 0.0001), and the lesions treated in these patients were longer (p < 0.0001) and more frequently complex. Accordingly, the incidence of periprocedural myocardial infarction (p < 0.05) and that of cardiovascular death, target vessel and lesion failure and any PCI at 24 months was lower in the BVS-only group (all p < 0.05). The 24-months rate of definite and probable scaffold thrombosis was 2.7% in the hybrid group and 2.8% in the BVS-only group, that of stent thrombosis in the hybrid group was 1.86%. In multivariable analysis, only implantation in bifurcation lesions emerged as a predictor of device thrombosis, while the device type was not associated with this outcome (p = 0.21). The higher incidence of events in patients receiving hybrid stenting reflects the higher complexity of the lesions in these patients; in patients treated with a hybrid strategy, the type of device implanted did not influence patients´ outcomes.
| S-EPMC6617525 | biostudies-literature
Project description: Not available
| S-EPMC5440260 | biostudies-literature