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
• ST Elevation Myocardial Infarction * diagnostic imaging   surgery   MeSH
• Coronary Angiography MeSH
• Percutaneous Coronary Intervention * MeSH
• Humans MeSH
• Prosthesis Design MeSH
• Drug-Eluting Stents * MeSH
• Absorbable Implants MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't 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.

• MeSH
• Time Factors MeSH
• Cytokines metabolism   MeSH
• Adult MeSH
• Everolimus pharmacology   MeSH
• Immunosuppressive Agents pharmacology   MeSH
• ST Elevation Myocardial Infarction diagnosis   immunology   surgery   MeSH
• Coronary Angiography MeSH
• Percutaneous Coronary Intervention instrumentation   methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Immunity, Innate * MeSH
• Prosthesis Design MeSH
• Retrospective Studies MeSH
• Aged MeSH
• Drug-Eluting Stents * MeSH
• Tissue Scaffolds * MeSH
• Absorbable Implants * MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study 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.

• MeSH
• Time Factors MeSH
• Everolimus pharmacology   MeSH
• ST Elevation Myocardial Infarction diagnosis   physiopathology   surgery   MeSH
• Coronary Angiography MeSH
• Percutaneous Coronary Intervention MeSH
• Coronary Vessels diagnostic imaging   surgery   MeSH
• Coronary Circulation physiology   MeSH
• Humans MeSH
• Tomography, Optical Coherence methods   MeSH
• Prospective Studies MeSH
• Prosthesis Design MeSH
• Regional Blood Flow physiology   MeSH
• Drug-Eluting Stents MeSH
• Tissue Scaffolds * MeSH
• Absorbable Implants * MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH

Background: Takotsubo cardiomyopathy (TC) aetiology has not been completely understood yet. One proposed pathogenic mechanism was coronary microvascular dysfunction (MVD). This study compared coronary flow and myocardial perfusion in patients with TC, microvascular angina (MVA), and a control group (CG). Methods: Out of 42 consecutive patients presented to our centre with TC from 2013 to 2017; we retrospectively selected 27 patients. We compared them with a sex- and age-matched group of 27 MVA cases and 27 patients with normal coronary arteries (CG). The flow was evaluated in the three coronary arteries as TIMI flow and TIMI frame count (TFC). Myocardial perfusion was studied with Blush-Score and Quantitative Blush Evaluator (QuBE). Results: TFC, in TC, revealed flow impairment in the three arteries compared to the CG (left anterior descending artery (LAD): 22 ± 8, 15 ± 4; p = 0.001) (right coronary artery: 12 ± 4, 10 ± 3; p = 0,025) (left circumflex: 14 ± 4, CG 11 ± 3; p = 0,006). QuBE showed myocardial perfusion impairment in the LAD territory in TC comparing with both the CG (8,9 (7,2-11,5) versus 11,4 (10-15,7); p = 0,008) and the MVA group (8,9 (7,2-11,5) versus 13,5 (10-16); p = 0,006). Conclusions: Our study confirmed that coronary flow is impaired in TC, reflecting a MVD. Myocardial perfusion defect was detected only in the LAD area.

• MeSH
• Echocardiography methods   MeSH
• Myocardial Infarction physiopathology   MeSH
• Coronary Angiography methods   MeSH
• Coronary Vessels physiopathology   MeSH
• Coronary Circulation physiology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Microvessels physiopathology   MeSH
• Retrospective Studies MeSH
• Blood Flow Velocity physiology   MeSH
• Aged MeSH
• Takotsubo Cardiomyopathy physiopathology   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article 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
• ST Elevation Myocardial Infarction therapy   MeSH
• Coronary Angiography methods   MeSH
• Percutaneous Coronary Intervention * methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Tomography, Optical Coherence methods   MeSH
• Prosthesis Design methods   MeSH
• Aged MeSH
• Drug-Eluting Stents * MeSH
• Tissue Scaffolds MeSH
• Absorbable Implants * MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial 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.

• MeSH
• Coated Materials, Biocompatible * MeSH
• Time Factors MeSH
• Everolimus administration & dosage   adverse effects   MeSH
• ST Elevation Myocardial Infarction diagnostic imaging   therapy   MeSH
• Cardiovascular Agents administration & dosage   adverse effects   MeSH
• Coronary Angiography MeSH
• Percutaneous Coronary Intervention adverse effects   instrumentation   MeSH
• Coronary Vessels diagnostic imaging   drug effects   MeSH
• Middle Aged MeSH
• Humans MeSH
• Neointima * MeSH
• Tomography, Optical Coherence MeSH
• Prospective Studies MeSH
• Prosthesis Design MeSH
• Aged MeSH
• Absorbable Implants * MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Study MeSH
• Geographicals
• Czech Republic 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.

• MeSH
• Myocardial Infarction radiography   therapy   MeSH
• Coronary Angiography * MeSH
• Percutaneous Coronary Intervention * MeSH
• Middle Aged MeSH
• Humans MeSH
• Tomography, X-Ray Computed * MeSH
• Prospective Studies MeSH
• Aged MeSH
• Tissue Scaffolds * MeSH
• Absorbable Implants * MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

Koronární stenty jsou již dlouhou dobu rutinně používány při většině perkutánních koronárních intervencí. Hrají důležitou pozitivní roli především v prvních několika měsících. Vývoj stentů, jejichž struktura se po této době začne vstřebávat a po několika letech již není v intervenované tepně přítomna, lze nazvat revolučním krokem. Autoři předkládají přehled současné technologie plně vstřebatelných koronárních stentů a prezentují klinické studie a zkušenosti dostupné v roce 2014. Následuje hypotetická debata mezi příznivcem a odpůrcem této nové technologie, ze které je jasně patrné, že definitivní závěry zatím nelze učinit. Závěrem autoři poskytují svůj osobní názor, velmi povzbudivá je zpráva o dobrém klinickém osudu pacientů po implantaci prvních plně vstřebatelných stentů před více než deseti lety.

Coronary stent is routinely used in majority percutaneous coronary interventions for a long time. They have an important role, especially, in the first months after intervention. We can consider as a breakthrough point the development of stent which has ability to absorb in intervened artery after a few years. The review presents current techniques of fully absorbable coronary stents and also provides clinical trials and experiences available in 2014. The article continues with discussion between supporters and opponents of this new technique, but definitive conclusion can´t be done yet. The authors conclude the review with their own opinion. There are many encouraging data in patients with good clinical outcome after implantation of absorbable stents in more than 10 years follow-up.

• Keywords
• DESolve Nx, BIOSOLVE-I, ABSORB B, ABSORB A, Absorb®, Dreams®, DESolve®,
• MeSH
• Angioplasty, Balloon, Coronary MeSH
• Cardiac Surgical Procedures MeSH
• Clinical Trials as Topic MeSH
• Coronary Angiography MeSH
• Percutaneous Coronary Intervention MeSH
• Coronary Vessels * surgery   MeSH
• Humans MeSH
• Attitude MeSH
• Randomized Controlled Trials as Topic MeSH
• Stents * classification   trends   utilization   MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans 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
• Myocardial Infarction therapy   MeSH
• Platelet Aggregation Inhibitors administration & dosage   MeSH
• Coronary Angiography MeSH
• Humans MeSH
• Tomography, Optical Coherence MeSH
• Prospective Studies MeSH
• Aged MeSH
• Drug-Eluting Stents * MeSH
• Feasibility Studies MeSH
• Tissue Scaffolds * MeSH
• Absorbable Implants MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Controlled Clinical Trial MeSH
• Multicenter Study MeSH
• Research Support, Non-U.S. Gov't MeSH

• MeSH
• Blood Vessel Prosthesis * MeSH
• Myocardial Infarction therapy   MeSH
• Platelet Aggregation Inhibitors therapeutic use   MeSH
• Middle Aged MeSH
• Humans MeSH
• Tissue Scaffolds * MeSH
• Absorbable Implants * MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Publication type
• Journal Article MeSH
• Case Reports MeSH