Biodegradable vascular scaffold Dotaz Zobrazit nápovědu
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.
- Klíčová slova
- Acute myocardial infarction, Biodegradable stent, Bioresorbable vascular scaffold, Optical coherence tomography, Primary PCI,
- 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
- Názvy látek
- inhibitory agregace trombocytů MeSH
- MeSH
- cévní protézy * MeSH
- infarkt myokardu terapie MeSH
- inhibitory agregace trombocytů terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- tkáňové podpůrné struktury * MeSH
- vstřebatelné implantáty * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
- Názvy látek
- inhibitory agregace trombocytů MeSH
A higher rate of bioresorbable vascular scaffold (BVS) thrombosis has been observed after device implantation compared to implantation of permanent metallic stents in recently published studies. The mechanism of BVS thrombosis is currently under debate. To assess whether the immune-inflammatory response after BVS implantation is a potential trigger of BVS thrombosis. The PRAGUE-19 study was an academic study that enrolled consecutive patients with ST-segment elevation myocardial infarction (STEMI) with the intention to implant a BVS. A laboratory sub-study included 49 patients with an implanted BVS (of which 38 underwent the complete 2-year follow-up) and 52 patients having an implanted permanent metallic stent as the control group (of which 30 underwent the complete 2-year follow-up). Samples for inflammatory markers [high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)] were taken before BVS or stent implantation, on days 1 and 2 after device implantation and at 1 month and 2 years for a clinical control. The primary combined clinical endpoint of the sub-study (death, reinfarction or target vessel revascularization) occurred in 4.08% of the BVS group and 7.69% of the control group (p = 0.442) during the 2-year follow-up period, with overall mortality of 2.04% in the BVS group and 1.92% in the control group (p = 0.966). Definite BVS thrombosis occurred in one patient in the subacute phase; there was no late or very late thrombosis. Two definite stent thromboses were observed in the control group: one in the subacute phase and the other in the late phase. Baseline inflammatory marker levels did not differ between the groups. Lower levels of IL-6 and hs-CRP were observed in the BVS group compared to the control group (12.02 ± 5.94 vs. 15.21 ± 5.33 pg/ml; p < 0.01; 3952.9 ± 1704.75 ng/ml vs. 4507.49 ± 1190.01 ng/ml; p = 0.037, respectively) on days 1 and 2 (12.01 ± 6.31 vs. 13.85 ± 6.01 pg/ml; p = 0.089; 4447.92 ± 1325.31 ng/ml vs. 4637.03 ± 1290.99 ng/ml; p = 0.255, respectively). No differences in IL-6 or hs-CRP were observed after 1 month or 2 years in the clinical control. Levels of TNF-α did not differ between the groups in the early period after BVS or metallic stent implantation, nor during follow-up. The immune-inflammatory response is lower during the early phase after BVS implantation compared to that after metallic stent implantation, but the responses did not differ in the long term.
- Klíčová slova
- Bioresorbable vascular scaffold, Immune–inflammatory reaction, Myocardial infarction, Percutaneous coronary intervention, Thrombosis,
- MeSH
- časové faktory MeSH
- cytokiny metabolismus MeSH
- dospělí MeSH
- everolimus farmakologie MeSH
- imunosupresiva farmakologie MeSH
- infarkt myokardu s elevacemi ST úseků diagnóza imunologie chirurgie MeSH
- koronární angiografie MeSH
- koronární angioplastika přístrojové vybavení metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- přirozená imunita * MeSH
- protézy - design MeSH
- retrospektivní studie MeSH
- senioři MeSH
- stenty uvolňující léky * MeSH
- tkáňové podpůrné struktury * MeSH
- vstřebatelné implantáty * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Názvy látek
- cytokiny MeSH
- everolimus MeSH
- imunosupresiva MeSH
Bioresorbable Vascular Scaffolds (BVS) are polymer-based materials implanted in the coronary arteries in order to treat atherosclerotic lesions, based on the concept that once the lesion has been treated, the material of the implanted stent will undergo a process of gradual resorption that will leave, in several years, the vessel wall smooth, free of any foreign material and with its vasomotion restored. However, after the first enthusiastic reports on the efficacy of BVSs, the recently published trials demonstrated disappointing results regarding long-term patency following BVS implantation, which were mainly attributed to technical deficiencies during the stenting procedure. Intracoronary imaging could play a crucial role for helping the operator to correctly implant a BVS into the coronary artery, as well as providing relevant information in the follow-up period. This review aims to summarize the role of intracoronary imaging in the follow-up of coronary stents, with a particular emphasis on the role of intravascular ultrasound and optical coherence tomography for procedural guidance during stent implantation and also for follow-up of bioabsorbable scaffolds.
- Klíčová slova
- Coronary stents, bioresorbable, intracoronary imaging, polymer-coated stent, stent struts, vascular scaffold.,
- MeSH
- lidé MeSH
- následné studie MeSH
- protézy - design MeSH
- stenty uvolňující léky * MeSH
- stenty MeSH
- vstřebatelné implantáty * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
The study describes the detailed examination of the effect of ethylene oxide sterilization on electrospun scaffolds constructed from biodegradable polyesters. Different fibrous layers fabricated from polycaprolactone (PCL) and a copolymer consisting of polylactide and polycaprolactone (PLCL) were investigated for the determination of their mechanical properties, degradation rates and interaction with fibroblasts. It was discovered that the sterilization procedure influenced the mechanical properties of the electrospun PLCL copolymer scaffold to the greatest extent. No effect of ethylene oxide sterilization on degradation behavior was observed. However, a delayed fibroblast proliferation rate was noticed with concern to the ethylene oxide sterilized samples compared to the ethanol sterilization of the materials.
- Klíčová slova
- Ethylene oxide sterilization, Nanofibers, Polyesters, Vascular grafts,
- MeSH
- biokompatibilní materiály chemie metabolismus farmakologie MeSH
- buněčné linie MeSH
- cévní protézy MeSH
- ethylenoxid chemie farmakologie MeSH
- mikroskopie elektronová rastrovací MeSH
- modul pružnosti MeSH
- myši MeSH
- nanovlákna chemie MeSH
- pevnost v tahu MeSH
- polyestery chemie metabolismus MeSH
- sterilizace MeSH
- viabilita buněk účinky léků MeSH
- zvířata MeSH
- Check Tag
- myši MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- biokompatibilní materiály MeSH
- ethylenoxid MeSH
- poly(lactide) MeSH Prohlížeč
- polycaprolactone MeSH Prohlížeč
- polyestery 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
- Klíčová slova
- Bioresorbable vascular scaffold, Dual antiplatelet treatment termination, Long-term follow-up, STEMI,
- MeSH
- everolimus aplikace a dávkování MeSH
- infarkt myokardu s elevacemi ST úseků diagnóza mortalita chirurgie MeSH
- koronární angioplastika mortalita trendy MeSH
- lidé MeSH
- míra přežití trendy MeSH
- následné studie MeSH
- pilotní projekty MeSH
- prospektivní studie MeSH
- stenty uvolňující léky * trendy MeSH
- vstřebatelné implantáty * trendy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- dopisy MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
- Názvy látek
- everolimus MeSH
BACKGROUND: Bioresorbable vascular scaffolds (BVS) represent promising new technology, but data on their long-term outcomes in ST-segment-elevation myocardial infarction (STEMI) setting are missing. The aim was to analyze 1-year clinical and computed tomographic angiographic outcomes after BVS implantation in STEMI. METHODS AND RESULTS: PRAGUE-19 is a prospective multicenter single-arm study enrolling consecutive STEMI patients undergoing primary percutaneous coronary intervention (pPCI) with intention-to-implant BVS. A total of 343 STEMI patients were screened during 15 months enrollment period, and 70 patients (mean age 58.6±10.3 and 74% males) fulfilled entry criteria and BVS was successfully implanted in 96% of them. All patients were invited for clinical and computed tomographic angiographic control 1 year after BVS implantation. Restenosis was defined as ≥75% area stenosis within the scaffolded segment. Three events were potentially related to BVS: 1 in-stent restenosis (treated 7 months after pPCI with drug-eluting balloon), 1 stent thrombosis (treated 2 weeks after pPCI by balloon dilatation-this patient stopped all medications after pPCI), and 1 sudden death at home 9 months after pPCI. Four other patients had events definitely unrelated to BVS. Overall, 1-year mortality was 2.9%. Computed tomographic angiography after 1 year was performed in 59 patients. All BVS were widely patent, and binary restenosis rate was 2% (the only restenosis mentioned above). Mean in-scaffold minimal luminal area was 7.8±2.6 mm(2), area stenosis was 20.1±16.3%, minimal luminal diameter was 3.0±0.6 mm, and diameter stenosis was 12.8±11.1%. CONCLUSIONS: BVS implantation in STEMI is feasible and safe and offers excellent 1-year clinical and angiographic outcomes.
- Klíčová slova
- bioresorbable scaffold, computed tomography, myocardial infarction, restenosis, stent, stent thrombosis,
- MeSH
- infarkt myokardu diagnostické zobrazování terapie MeSH
- koronární angiografie * MeSH
- koronární angioplastika * MeSH
- lidé středního věku MeSH
- lidé MeSH
- počítačová rentgenová tomografie * MeSH
- prospektivní studie MeSH
- senioři MeSH
- tkáňové podpůrné struktury * MeSH
- vstřebatelné implantáty * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
Incomplete stent apposition and uncovered struts are associated with a higher risk of stent thrombosis. No data exist on the process of neointimal coverage and late apposition status of the bioresorbable vascular scaffold (BVS) when implanted in the highly thrombogenic setting of ST-segment elevation acute myocardial infarction (STEMI). The aim of this study was to assess the serial changes in strut apposition and early neointimal coverage of the BVS using optical coherence tomography (OCT) in selected patients enrolled in the PRAGUE-19 study. Intracoronary OCT was performed in 50 patients at the end of primary percutaneous coronary intervention for acute STEMI. Repeated OCT of the implanted BVS was performed in 10 patients. Scaffold area, scaffold mean diameter and incomplete strut apposition (ISA) were compared between baseline and control OCT. Furthermore, strut neointimal coverage was assessed during the control OCT. Mean scaffold area and diameter did not change between the baseline and control OCT (8.59 vs. 9.06 mm(2); p = 0.129 and 3.31 vs. 3.37 mm; p = 0.202, respectively). Differences were observed in ISA between the baseline and control OCT (0.63 vs. 1.47 %; p < 0.05). We observed 83.1 % covered struts in eight patients in whom the control OCT was performed 4-6 weeks after BVS implantation, and 100 % covered struts in two patients 6 months after BVS implantation. Persistent strut apposition and early neointimal coverage were observed after biodegradable vascular scaffold implantation in patients with acute ST-segment elevation myocardial infarction.
- Klíčová slova
- Acute myocardial infarction, Biodegradable vascular scaffold, Late apposition, Neointimal coverage,
- MeSH
- biokompatibilní potahované materiály * MeSH
- časové faktory MeSH
- everolimus aplikace a dávkování škodlivé účinky MeSH
- infarkt myokardu s elevacemi ST úseků diagnostické zobrazování terapie MeSH
- kardiovaskulární látky aplikace a dávkování škodlivé účinky MeSH
- koronární angiografie MeSH
- koronární angioplastika škodlivé účinky přístrojové vybavení MeSH
- koronární cévy diagnostické zobrazování účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- neointima * MeSH
- optická koherentní tomografie MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- senioři 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
- klinická studie MeSH
- Geografické názvy
- Česká republika MeSH
- Názvy látek
- biokompatibilní potahované materiály * MeSH
- everolimus MeSH
- kardiovaskulární látky MeSH
OBJECTIVES: The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation myocardial infarction (STEMI) patients. BACKGROUND: The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients. METHODS: This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated. RESULTS: The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio [HR]: 1.31 [95% confidence interval (CI): 0.48 to 3.52], p = 0.593; vs. 2.8%, HR: 1.15 [95% CI: 0.44 to 2.30], p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 [95% CI: 0.23 to 4.32], p = 0.994; vs. 5.9%, HR: 0.50 [95% CI: 0.13 to 1.88], p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS. CONCLUSIONS: At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings.
- Klíčová slova
- ABSORB, STEMI, everolimus-eluting stent,
- MeSH
- časové faktory MeSH
- databáze faktografické MeSH
- dospělí MeSH
- everolimus MeSH
- infarkt myokardu diagnóza mortalita terapie MeSH
- Kaplanův-Meierův odhad MeSH
- kardiovaskulární látky aplikace a dávkování MeSH
- koronární angioplastika škodlivé účinky přístrojové vybavení mortalita MeSH
- koronární trombóza etiologie MeSH
- kovy * MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- proporcionální rizikové modely MeSH
- protézy - design MeSH
- recidiva MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- sirolimus aplikace a dávkování analogy a deriváty MeSH
- stenty uvolňující léky * MeSH
- tendenční skóre MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- srovnávací studie MeSH
- Názvy látek
- everolimus MeSH
- kardiovaskulární látky MeSH
- kovy * MeSH
- sirolimus MeSH