stent struts
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Oddělení klinického sledování společnosti Meril Life Sciences umožňující morfologicky provedenou expanzi, využívá dobře známý anti-proliferant – Sirolimus, který se uvolňuje z biologicky degradabilního kopolymeru do 30 dnů a zajišťuje vysokou integritu potahu a nízkou tloušťku potahu do 2 μm. Výsledný stent demonstruje téměř 100% endotelizaci ve 30denních preklinických modelech a nízkou hodnotu MACE (< 5 %) v klinických studiích u velké skupiny pacientů po uplynutí 1 roku.
BioMimeTM Sirolimus eluting coronary stent comes with a new idea of taking stents towards a biomimicry concept. The stent is built on an ultra-thin strut thickness (65 μm) cobalt chromium stent platform using an intelligent hybrid system of open and closed cells, allowing for a morphology-mediated expansion, while employing a well-known antiproliferant, Sirolimus, that is eluted from a biodegradable copolymer within 30 days and provides high coating integrity and a low coating thickness of up to 2 μm. The resultant stent demonstrates nearly 100% endothelialization in 30-day preclinical models and low MACE rates (< 5%) in clinical trials in a large group of patients after one year.
BACKGROUND: Stent thrombosis (ST) is a serious complication following coronary stenting. Intravascular optical coherence tomography (OCT) may provide insights into mechanistic processes leading to ST. We performed a prospective, multicenter study to evaluate OCT findings in patients with ST. METHODS: Consecutive patients presenting with ST were prospectively enrolled in a registry by using a centralized telephone registration system. After angiographic confirmation of ST, OCT imaging of the culprit vessel was performed with frequency domain OCT. Clinical data were collected according to a standardized protocol. OCT acquisitions were analyzed at a core laboratory. Dominant and contributing findings were adjudicated by an imaging adjudication committee. RESULTS: Two hundred thirty-one patients presenting with ST underwent OCT imaging; 14 (6.1%) had image quality precluding further analysis. Of the remaining patients, 62 (28.6%) and 155 (71.4%) presented with early and late/very late ST, respectively. The underlying stent type was a new-generation drug-eluting stent in 50.3%. Mean reference vessel diameter was 2.9±0.6 mm and mean reference vessel area was 6.8±2.6 mm2. Stent underexpansion (stent expansion index <0.8) was observed in 44.4% of patients. The predicted average probability (95% confidence interval) that any frame had uncovered (or thrombus-covered) struts was 99.3% (96.1-99.9), 96.6% (92.4-98.5), 34.3% (15.0-60.7), and 9.6% (6.2-14.5) and malapposed struts was 21.8% (8.4-45.6), 8.5% (4.6-15.3), 6.7% (2.5-16.3), and 2.0% (1.2-3.3) for acute, subacute, late, and very late ST, respectively. The most common dominant finding adjudicated for acute ST was uncovered struts (66.7% of cases); for subacute ST, the most common dominant finding was uncovered struts (61.7%) and underexpansion (25.5%); for late ST, the most common dominant finding was uncovered struts (33.3%) and severe restenosis (19.1%); and for very late ST, the most common dominant finding was neoatherosclerosis (31.3%) and uncovered struts (20.2%). In patients presenting very late ST, uncovered stent struts were a common dominant finding in drug-eluting stents, and neoatherosclerosis was a common dominant finding in bare metal stents. CONCLUSIONS: In patients with ST, uncovered and malapposed struts were frequently observed with the incidence of both decreasing with longer time intervals between stent implantation and presentation. The most frequent dominant observation varied according to time intervals from index stenting: uncovered struts and underexpansion in acute/subacute ST and neoatherosclerosis and uncovered struts in late/very late ST.
- MeSH
- koronární angioplastika škodlivé účinky trendy MeSH
- koronární trombóza diagnostické zobrazování epidemiologie prevence a kontrola MeSH
- lidé MeSH
- optická koherentní tomografie metody trendy MeSH
- prospektivní studie MeSH
- registrace MeSH
- senioři MeSH
- stenty uvolňující léky škodlivé účinky trendy MeSH
- výzkumná zpráva trendy MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa epidemiologie MeSH
Zavedení koronárních stentů v roce 1986 změnilo praxi intervenční kardiologie od svého vzniku v roce 1977. Další vývoj vedl k metalickým lékovým stentům (DES) se zlepšenými mechanickými vlastnostmi, sníženou tloušťkou tzv. strutu stentu s využitím odbouratelného polymeru či bezpolymerového, abluminálně uvolňovaného léčiva. Nutnost celoživotního ponechání stentu vyvolalo zájem o biologicky odbouratelnou technologii. Tyto biodegradabilní cévní opory, vyrobené z polymerů nebo kovových slitin s lékovým krytím, slouží jako dočasná mechanická opora, která je po ukončení přirozeného hojení cévy degradována a postupně vstřebána. Vývoj této technologie byl pomalý a do klinických studií bylo zařazeno několik typů biologicky odbouratelných stentů. Článek uvádí přehled problematiky včetně rozboru příčin, které vedou k horším klinickým výsledkům ve srovnání s metalickými kovovými stenty s nejistou budoucností.
The introduction of coronary stents in 1986 change the practice of interventional cardiology since its inception in 1977. Furtherdevelopment lead to metallic drug eluting stents (DES) with improving mechanical properties, decreasing strut thickness and introducingdegradable polymer or nonpolymer, abluminal drug coating. Leaving metallic support lifelong have generated interesttowards biodegradable technology. These temporary biodegradable vascular supports, made of polymers or metal alloys with a drugcoating, have the potential to scaffold the artery to allow natural healing, and then biodegrade. The development of this technologyhas been slow, several biodegradable stents have entered into clinical trials. This article will review the status of biodegradable stentswith an analysis of the causes that lead to worse clinical outcomes with uncertain future as compared to metallic stents.
- Klíčová slova
- studie ABSORB II, trombóza stentu, vstřebatelné stenty,
- MeSH
- klinická studie jako téma MeSH
- koronární angioplastika * metody využití MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- stenty uvolňující léky * škodlivé účinky trendy MeSH
- stenty * škodlivé účinky trendy MeSH
- trombóza MeSH
- vstřebatelné implantáty škodlivé účinky trendy MeSH
- Check Tag
- lidé MeSH
Intravascular optical coherence tomography (IVOCT) is used to assess stent tissue coverage and malapposition in stent evaluation trials. We developed the OCT Image Visualization and Analysis Toolkit for Stent (OCTivat-Stent), for highly automated analysis of IVOCT pullbacks. Algorithms automatically detected the guidewire, lumen boundary, and stent struts; determined the presence of tissue coverage for each strut; and estimated the stent contour for comparison of stent and lumen area. Strut-level tissue thickness, tissue coverage area, and malapposition area were automatically quantified. The software was used to analyze 292 stent pullbacks. The concordance-correlation-coefficients of automatically measured stent and lumen areas and independent manual measurements were 0.97 and 0.99, respectively. Eleven percent of struts were missed by the software and some artifacts were miscalled as struts giving 1% false-positive strut detection. Eighty-two percent of uncovered struts and 99% of covered struts were labeled correctly, as compared to manual analysis. Using the highly automated software, analysis was harmonized, leading to a reduction of inter-observer variability by 30%. With software assistance, analysis time for a full stent analysis was reduced to less than 30 minutes. Application of this software to stent evaluation trials should enable faster, more reliable analysis with improved statistical power for comparing designs.
- MeSH
- endovaskulární výkony přístrojové vybavení metody MeSH
- lidé MeSH
- optická koherentní tomografie přístrojové vybavení metody MeSH
- senzitivita a specificita MeSH
- software normy MeSH
- stenty škodlivé účinky normy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- hodnotící studie MeSH
- Research Support, N.I.H., Extramural MeSH
Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.
- MeSH
- akutní koronární syndrom diagnóza mortalita chirurgie MeSH
- antibakteriální látky terapeutické užití MeSH
- cévy - implantace protéz metody MeSH
- diabetes mellitus epidemiologie MeSH
- infarkt myokardu bez ST elevací komplikace epidemiologie MeSH
- infarkt myokardu s elevacemi ST úseků komplikace epidemiologie MeSH
- koronární angioplastika přístrojové vybavení MeSH
- lékařská praxe - způsoby provádění normy MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen diagnóza mortalita chirurgie MeSH
- okluze cévního štěpu epidemiologie MeSH
- polymery MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- senioři MeSH
- sirolimus terapeutické užití MeSH
- stenty uvolňující léky škodlivé účinky trendy MeSH
- vstřebatelné implantáty škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- pozorovací studie MeSH
BACKGROUND: Bioresorbable scaffold (BRS) AbsorbTM clinical use has been stopped due to higher rate of device thrombosis. Scaffold struts persist longer than 2 years in the vessel wall. Second generation devices are being developed. This study evaluates long-term invasive imaging in STEMI patients. METHODS: PRAGUE-19 study is an academic study enrolling consecutive STEMI patients with intention to implant AbsorbTM BRS. A total of 83 STEMI patients between December 2012 and March 2014 fulfilled entry criteria. Coronary angiography and optical coherence tomography at 5 year follow-up was performed in 25 patients. RESULTS: Primary combined clinical endpoint (death, myocardial infarction or target vessel revascularization) occurred in 12.6% during the five-year follow-up with overall mortality 6.3%. Definite scaffold thrombosis occurred in 2 patients in the early phase after BRS implantation. Quantitative coronary angiography after 5 years demonstrated low late lumen loss of 0.11 ± 0.35 mm with binary restenosis rate of 0%. Optical coherence tomography demonstrated complete resorption of scaffold struts and mean lumen diameter of 3.25 ± 0.30 and 3.22 ± 0.49 (P = 0.73) at baseline and after 5 years, respectively. Three patients developed small coronary artery aneurysm in the treated segment. CONCLUSION: Invasive imaging results 5 years after BRS implantation in STEMI showed complete resorption of scaffold struts and stable lumen vessel diameter. Trial registration ISRCTN43696201 (retrospectivelly registred, June 7th, 2019). https://www.isrctn.com/ISRCTN43696201.
- MeSH
- infarkt myokardu s elevacemi ST úseků * diagnostické zobrazování chirurgie MeSH
- koronární angiografie MeSH
- koronární angioplastika * MeSH
- lidé MeSH
- protézy - design MeSH
- stenty uvolňující léky * MeSH
- vstřebatelné implantáty MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
BACKGROUND: Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. METHODS: The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. RESULTS: The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). CONCLUSIONS: The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.
- Publikační typ
- časopisecké články MeSH
AIMS: Early clinical results after implantation of bioresorbable vascular scaffolds (BVS) in ST-elevation myocardial infarction (STEMI) are encouraging, but long-term data are missing. This study evaluates long-term outcome in STEMI patients with implanted BVS. METHODS AND RESULTS: The PRAGUE-19 study is an academic study enrolling consecutive STEMI patients with the intention to implant BVS. A total of 580 STEMI patients were screened between December 2012 and March 2015; 117 patients fulfilled entry criteria and BVS was successfully implanted in 114 (97%) of them. The primary combined clinical endpoint (death, reinfarction or target vessel revascularisation) occurred in 11.5% during the mean follow-up period of 730±275 days with overall mortality of 4.4%. Definite scaffold thrombosis occurred in two patients in the early phase after BVS implantation; there was no late thrombosis. Quantitative coronary angiography (10 patients) at three years demonstrated late lumen loss of 0.2±0.33 mm and optical coherence tomography showed minimal lumen area of 5.3±1.37 mm2 and neointimal hyperplasia area of 2.9±0.48 mm2. BVS struts were still visible at three years and 99.4% of them were well apposed and covered. CONCLUSIONS: Encouraging clinical and imaging results after BVS implantation in STEMI patients persist during long-term follow-up.
- MeSH
- infarkt myokardu s elevacemi ST úseků terapie MeSH
- koronární angiografie metody MeSH
- koronární angioplastika * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- optická koherentní tomografie metody MeSH
- protézy - design metody MeSH
- senioři MeSH
- stenty uvolňující léky * MeSH
- tkáňové podpůrné struktury MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
AIMS: Bioresorbable vascular scaffolds (BVSs) have been studied in chronic coronary artery disease, but not in acute ST-segment elevation myocardial infarction (STEMI). This prospective multicentre study analysed the feasibility and safety of BVS implantation during primary percutaneous coronary intervention (p-PCI) in STEMI. METHODS AND RESULTS: Bioresorbable vascular scaffold implantation became the default strategy for all consecutive STEMI patients between 15 December 2012 and 30 August 2013. A total of 142 patients underwent p-PCI; 41 of them (28.9%) fulfilled the inclusion/exclusion criteria for BVS implantation. The BVS device success was 98%, thrombolysis in myocardial infarction 3 flow was restored in 95% of patients, and acute scaffold recoil was 9.7%. An optical coherence tomography (OCT) substudy (21 patients) demonstrated excellent procedural results with only a 1.1% rate of scaffold strut malapposition. Edge dissections were present in a 38% of patients, but were small and clinically silent. Reference vessel diameter measured by quantitative coronary angiography was significantly lower than that measured by OCT by 0.29 (±0.56) mm, P = 0.028. Clinical outcomes were compared between BVS group and Control group; the latter was formed by patients who had implanted metallic stent and were in Killip Class I or II. Combined clinical endpoint was defined as death, myocardial infarction, or target vessel revascularization. Event-free survival was the same in both groups; 95% for BVS and 93% for Control group, P = 0.674. CONCLUSION: Bioresorbable vascular scaffold implantation in acute STEMI is feasible and safe. The procedural results evaluated by angiography and OCT are excellent. The early clinical results are encouraging.
- MeSH
- infarkt myokardu terapie MeSH
- inhibitory agregace trombocytů aplikace a dávkování MeSH
- koronární angiografie MeSH
- lidé MeSH
- optická koherentní tomografie MeSH
- prospektivní studie MeSH
- senioři MeSH
- stenty uvolňující léky * MeSH
- studie proveditelnosti MeSH
- tkáňové podpůrné struktury * MeSH
- vstřebatelné implantáty MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky kontrolované MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
TIPS (transjugulární portosystémový zkrat) je zákrok z oboru intervenční radiologie sloužící ke snížení portální hypertenze. Krev je odvedena z vena portae přes vena hepatica do vena cava inferior. Drenáž se realizuje pomocí necévní formace, tj. kanálem proraženým v jatemím parenchymu (shunt). Na základě studia vlastní sestavy 38 pitvaných pripadů se založeným TIPS (25 mužů a 13 žen, ve věku 22-81 let) byly sledovány histologické změny (maturace) ve stěně arteficiálně vytvořeného krevního kanálu v játrech. Průběh maturace lze rozdělit do tří etap, a to akutní, charakterizovanou pritomností alterativhich změn hlavně na jatemím parenchymu v okolí shuntu; druhou etapou je fáze změn reparačnich (subakutní fáze) s převahou úklidu buněčného detritu jatemích buněk a organizace zbytků fibrínu. Ve třetí fázi (chronické) převažují změny konsolidační v podobě vytváření tzv. neointimy a obrovskobuněčné reakce kolem drátů stentu. V uzlech jatemích buněk vystavených tlaku pružných drátů stentu byl nalezen, u tri pří'padů Z nejčasnějších období, zvláštní dosud nepopsaný fenomén kompresivní fusiformní remodelace hepatocytů. Neointima se chová jako netrombogenní struktura, čímž přispívá k udržení průchodnosti shuntu. Podle histologický určeného stupně maturace ve stěně shuntu lze usuzovat na dobu, po kterou je spojka instalována. TIPS představuje dlouhodobě fungující náhradní komunikaci mezi portálním a systémovým řečištěm. Na rozdíl od dobře rekonstruovatelné formální patogeneze histologických změn jsou problémy kauzální patogeneze, zejména pokud jde o neointimu, středem zsymu pracovišť bazálního výzkumu.
An interventional radiological procedure TIPS (transjugular portosystemic shunt) assists in the decrease of portal hypertension. Portal blood is conducted via the hepatic vein into the lower vena cava. Blood drainage is performed via non-vascidar formation, i.e. by the channel created within the liver parenchyma (shunt). Histological changes (maturation) within the wall of an artificially formed blood conducting chaimel were studied on the base of examination of the set of 38 autopsy cases with the placed TIPS (25 males and 13 females, ages ranging from 22-81 years). Maturation course can be divided into three periods. The first stage is characterised by the presence of alterative changes mainly within the liver parenchyma surrounding the shunt. Reparative changes pass through the second stage with the predominance of liver ceU debris removal and organisation of fibrin remnants. Consolidation changes dominate the third stage with the development of so-called neointima and giant-ceU reaction aroimd the stent stmts. In three cases of the acute period of stent placement a new, so far not described specific phenomenon of compressive fusiform hepatocellular remodelation was found within the nodules of hepatocytes exposed to the pressure of resilient stent struts. Neointima is a non-thrombogenous structure participating on the shunt patency. It IS possible to judge approximately the time of stent placement according to the histologically estimated level of shunt wall maturation. TIPS is a long-lasting supplement conduit between the portal and systemic blood circulation. Contrary to the easily reconstruable formal pathogenesis of histological changes, the problems of causal pathogenesis of the neointima challenge mainly the interest of laboratories involved in basic science.
