Bioresorbable scaffold implantation in STEMI patients: 5 years imaging subanalysis of PRAGUE-19 study.

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.

Immune-inflammatory response after bioresorbable vascular scaffold implantation in patients with acute myocardial infarction with ST elevation in a long-term perspective.

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.

Takotsubo Cardiomyopathy: One More Angiographic Evidence of Microvascular Dysfunction.

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.

Optical coherence tomography in STEMI with bioresorbable scaffold: possible cause of coronary flow impairment? A sub-study from the Prague 19 trial.

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.

Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update.

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.

Neointimal coverage and late apposition of everolimus-eluting bioresorbable scaffolds implanted in the acute phase of myocardial infarction: OCT data from the PRAGUE-19 study.

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.

One-Year Clinical and Computed Tomography Angiographic Outcomes After Bioresorbable Vascular Scaffold Implantation During Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: The PRAGUE-19 Study.

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.

[Fully absorbable drug eluting coronary stent: where do we stand in 2014?]. / Plne vstrebatelný lékový koronární stent: kde jsme v roce 2014?

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.

Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study 'Prague 19'.

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.

Shock index: a simple clinical parameter for quick mortality risk assessment in acute myocardial infarction.

BACKGROUND: Primary percutaneous coronary intervention (PCI) has become the preferred reperfusion strategy in patients with ST-segment elevation myocardial infarction and cardiogenic shock. Early identification of patients at risk for developing cardiogenic shock allows rapid decision making to determine reperfusion and transportation to a PCI centre. The aim of this analysis was to evaluate shock index (SI) as a marker for patients at risk of cardiogenic shock. METHODS: A total of 644 consecutive patients (73% male) with acute myocardial infarction with ST elevations were analyzed retrospectively. Primary PCI was performed in 92% of patients, and 7% of patients underwent rescue PCI. The SI parameter was defined as the ratio of heart rate to systolic blood pressure at hospital admission. RESULTS: SI (odds ratio [OR], 81.26; 95% confidence interval [CI], 9.76-676.51; P<0.001), age (OR, 1.17; 95% CI, 1.08-1.26; P<0.001), and diabetes (OR, 4.94; 95% CI, 1.44-16.97; P<0.011) were independent predictors of mortality. In the group of patients with SI≥0.8, 20% died, whereas in the group with SI<0.8, 4% of patients died (P<0.01). CONCLUSIONS: The proposed clinical parameter SI correlates with patients' prognosis and could therefore be used as a simple indicator of mortality risk of acute myocardial infarction. The simplicity of this proposed index makes its use accessible in large-scale clinical practices for risk stratification during first contact with patients.

Hemodynamic effects of sildenafil citrate and isosorbide mononitrate in men with coronary artery disease and erectile dysfunction.

INTRODUCTION: Mild hemodynamic effects have been reported with sildenafil citrate therapy. AIM: To compare the hemodynamic effects of sildenafil and isosorbide mononitrate (ISMN) in men with coronary artery disease and erectile dysfunction. METHODS: A total of 31 men aged 35 years or older with coronary artery disease (at least 50% narrowing of the left main stem or at least 70% narrowing of any other coronary artery) and erectile dysfunction (receiving medication for erectile dysfunction or scoring less than 26 out of a maximum score of 30 on the erectile function domain questions of International Index of Erectile Function) were randomized to sildenafil 100 mg (n = 10), ISMN 40 mg (n = 11), or placebo (n = 10) in this single-dose multicenter study. MAIN OUTCOME MEASURES: Hemodynamic parameters were measured at baseline, 1, 2, 4, and 6 hours post dose. RESULTS: Compared with baseline, cardiac index increased slightly with sildenafil (0.29 L/min/m2 at 1 hour) and decreased slightly with placebo (-0.12 L/min/m2 at 4 hours) and ISMN (-0.14 L/min/m2 at 1 hour). The stroke volume index increased from baseline at each time point post dose with sildenafil (4.4 mL/m2 at 2 hours), but decreased with ISMN (-5.8 mL/m2 at 1 hour) and placebo (-2.8 mL/m2 at 4 hours). ISMN reduced mean arterial pressure more than sildenafil did (-22 vs. -10 mm Hg at 2 hours, respectively). Both sildenafil and ISMN increased heart rate (4 vs. 7 beats/minute at 1 hour, respectively) and decreased systemic vascular resistance, but sildenafil produced greater reductions in pulmonary vascular resistance. There were no serious adverse events in the sildenafil group. CONCLUSIONS: Sildenafil 100 mg was well tolerated and induced smaller changes in central and peripheral hemodynamic pressures compared with ISMN 40 mg. Moreover, sildenafil selectively reduced pulmonary resistance, which may have clinical importance in pulmonary hypertension.

One-year coronary bypass graft patency: a randomized comparison between off-pump and on-pump surgery angiographic results of the PRAGUE-4 trial.

BACKGROUND: Off-pump coronary bypass surgery has become a widely used technique during recent years. However, limited data are available with regard to 1-year patency of bypass grafts implanted on the beating heart in unselected consecutive bypass surgery candidates. The aim of this study was to compare 1-year angiographic patency of bypass grafts done on the beating heart (off pump) with those done classically (on pump). METHODS AND RESULTS: The PRAGUE-4 trial randomized 400 consecutive nonselected cardiac surgery candidates into group A (on pump; n=192) and group B (off pump; n=208). One-year follow-up coronary angiography was done in 255 patients. The arterial graft patency after 1 year was 91% in both groups. Saphenous graft patency was 59% (on pump) versus 49% (off pump; P=NS). Saphenous graft patency per patient was lower in the off-pump group: 0.7 patent anastomosis per patient versus 1.1 patent anastomosis in the on-pump group (P<0.01). There were 46% on-pump patients with all grafts patent versus 52% off-pump patients (P=NS). Grafts anastomosed distally to collateralized chronic total occlusions of native coronary arteries remained patent in 100% on the left anterior descending artery compared with 23% on other arteries (P<0.0001). CONCLUSIONS: The patency of arterial coronary bypass grafts done on the beating heart is excellent and equal to grafts done on pump. The off-pump procedure in the unselected patient population results in fewer patent saphenous grafts per patient.