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Bioresorbable scaffolds: a new paradigm in percutaneous coronary intervention.

ABSTRACT: 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.

SUBMITTER: Tenekecioglu E

PROVIDER: S-EPMC4751731 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Bioresorbable scaffolds: a new paradigm in percutaneous coronary intervention.

Tenekecioglu Erhan E Farooq Vasim V Bourantas Christos V CV Silva Rafael Cavalcante RC Onuma Yoshinobu Y Yılmaz Mustafa M Serruys Patrick W PW

BMC cardiovascular disorders 20160212

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 n ...[more]

PMID: 26868826

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Project description:UNLABELLED:Innovations 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.

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.

Project description:BACKGROUND:Diabetes is among the strongest predictors of outcome after coronary artery stenting and the incidence of negative outcomes is still high in this specific group. Data of long-term outcomes comparing diabetic patients with non-diabetic patients treated with bioresorbable scaffolds are still incomplete. This work evaluates the long-term outcomes after implantation of a coronary bioresorbable scaffold (BRS) in diabetic patients compared to non-diabetics. METHODS:Patients who received at least one Absorb BRS in the time of May 2012 to December 2014 were enrolled into this single-center registry. Quantitative coronary angiography (QCA) was performed. RESULTS:Six hundred fifty seven patients including 138 patients (21%, mean age 65?±?11, 78% male) with diabetes were enrolled. Patients in the diabetic group were significantly older, were more likely to suffer from hypertension and hyperlipidemia and had more often a prior stroke or TIA as well as a reduced renal function (all P?<?0.05). The initial stenosis was less severe in the diabetic group (74.8% vs. 79.6%, P?=?0.036), but the residual stenosis after BRS implantation exceeded that of the control group (16.7% vs. 13.8%, P?=?0.006). History of diabetes had no impact on the incidence of events within one year after BRS implantation. Beyond 1 year, diabetic patients had a higher incidence of cardiovascular death (6.9 vs. 1.4%, HR:5.37 [1.33-21.71], P?=?0.001), scaffold restenosis (17.6 vs. 7.8%, HR:3.56 [1.40-9.05], P?<?0.0001) and target lesion revascularization (P?=?0.016). These results were confirmed in the propensity score analysis. In both diabetics and non-diabetics, there was a strong association (HR:18.6 [4.7-73.3]) between the risk of restenosis and the technique used at implantation; in contrast, the impact of vessel size was more manifest in non-diabetics than in diabetic patients, and an increased risk of restenosis was demonstrated for both large and small vessels. CONCLUSION:As for metal stents, beyond one year after implantation, diabetes was associated with an increased incidence of scaffold restenosis and related outcomes. This negative impact of diabetes was reset when an optimal implantation technique was used.

Project description:Despite the widespread use of percutaneous coronary intervention (PCI), the appropriateness of these procedures in contemporary practice is unknown.To assess the appropriateness of PCI in the United States.Multicenter, prospective study of patients within the National Cardiovascular Data Registry undergoing PCI between July 1, 2009, and September 30, 2010, at 1091 US hospitals. The appropriateness of PCI was adjudicated using the appropriate use criteria for coronary revascularization. Results were stratified by whether the procedure was performed for an acute (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina with high-risk features) or nonacute indication.Proportion of acute and nonacute PCIs classified as appropriate, uncertain, or inappropriate; extent of hospital-level variation in inappropriate procedures.Of 500,154 PCIs, 355,417 (71.1%) were for acute indications (ST-segment elevation myocardial infarction, 103,245 [20.6%]; non-ST-segment elevation myocardial infarction, 105,708 [21.1%]; high-risk unstable angina, 146,464 [29.3%]), and 144,737 (28.9%) for nonacute indications. For acute indications, 350,469 PCIs (98.6%) were classified as appropriate, 1055 (0.3%) as uncertain, and 3893 (1.1%) as inappropriate. For nonacute indications, 72,911 PCIs (50.4%) were classified as appropriate, 54,988 (38.0%) as uncertain, and 16,838 (11.6%) as inappropriate. The majority of inappropriate PCIs for nonacute indications were performed in patients with no angina (53.8%), low-risk ischemia on noninvasive stress testing (71.6%), or suboptimal (?1 medication) antianginal therapy (95.8%). Furthermore, although variation in the proportion of inappropriate PCI across hospitals was minimal for acute procedures, there was substantial hospital variation for nonacute procedures (median hospital rate for inappropriate PCI, 10.8%; interquartile range, 6.0%-16.7%).In this large contemporary US cohort, nearly all acute PCIs were classified as appropriate. For nonacute indications, however, 12% were classified as inappropriate, with substantial variation across hospitals.

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Bioresorbable scaffolds: a new paradigm in percutaneous coronary intervention.

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Bioresorbable scaffolds: a new paradigm in percutaneous coronary intervention.

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