Nejvíce citovaný článek - PubMed ID 24419808
Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study 'Prague 19'
BACKGROUND: Bioresorbable scaffold (BRS) Absorb™ 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 Absorb™ 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.
- Klíčová slova
- Bioresorbable scaffold, Long-term follow-up, Optical coherence tomography, Quantitative coronary angiography, STEMI,
- 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
- klinická studie MeSH
- práce podpořená grantem 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
This study assessed the Optical Coherence Tomography (OCT) impact on the coronary flow in ST-elevation myocardial infarction (STEMI) after bioresorbable scaffold implantation. Only few data about OCT use in STEMI are available and coronary flow before and after OCT is not well studied yet. 54 patients with OCT performed at the end of procedure from the Prague 19 trial were selected and coronary flow was evaluated as TIMI frame count (TFC) before and just after OCT. Significant increase in TIMI frame count after OCT [from 9.5 (6.75-12.25) to 11.5 (8-15.25) frames; p = 0.001] and high verapamil administration (18%) was reported. OCT at the end of primary percutaneous coronary intervention with bioresorbable scaffold is a feasible procedure. However, it seems to be associated with flow deterioration.
- Klíčová slova
- Bioabsorbable scaffold, Coronary blood flow, Optical coherence tomography, STEMI,
- MeSH
- časové faktory MeSH
- everolimus farmakologie MeSH
- infarkt myokardu s elevacemi ST úseků diagnóza patofyziologie chirurgie MeSH
- koronární angiografie MeSH
- koronární angioplastika MeSH
- koronární cévy diagnostické zobrazování chirurgie MeSH
- koronární cirkulace fyziologie MeSH
- lidé MeSH
- optická koherentní tomografie metody MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- regionální krevní průtok fyziologie MeSH
- stenty uvolňující léky MeSH
- tkáňové podpůrné struktury * MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- everolimus 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
We briefly and comprehensively present some of the novel findings in the field of revascularization therapy and management of ST-segment-elevation myocardial infarction (STEMI). We highlight the latest evidence-based advancements in the pharmacological and mechanical treatment of patients who presented with STEMI. Since the last updates to the international guidelines (American College of Cardiology/American Heart Association and the European Society of Cardiology) were published in 2011 and 2012, there have been changes and several important studies have presented their final outcomes. We also highlight some controversial approaches as part of the current debates in the cardiology community. In addition, we share our recent experience in the field of biodegradable scaffold stents as a treatment strategy in STEMI.
- MeSH
- antikoagulancia terapeutické užití MeSH
- infarkt myokardu terapie MeSH
- inhibitory agregace trombocytů terapeutické užití MeSH
- lidé MeSH
- revaskularizace myokardu * metody MeSH
- rizikové faktory MeSH
- stenty * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Názvy látek
- antikoagulancia MeSH
- inhibitory agregace trombocytů MeSH