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BACKGROUND@#A drug-eluting stent (DES) is a highly beneficial medical device used to widen or unblock narrowed blood vessels. However, the drugs released by the implantation of DES may hinder the re-endothelialization process, increasing the risk of late thrombosis. We have developed a tacrolimus-eluting stent (TES) that as acts as a potent antiproliferative and immunosuppressive agent, enhancing endothelial regeneration. In addition, we assessed the safety and efficacy of TES through both in vitro and in vivo tests. @*METHODS@#Tacrolimus and Poly(lactic-co-glycolic acid) (PLGA) were applied to the metal stent using electrospinning equipment. The surface morphology of the stent was examined before and after coating using a scanning electron microscope (SEM) and energy dispersive X-rays (EDX). The drug release test was conducted through high-performance liquid chromatography (HPLC). Cell proliferation and migration assays were performed using smooth muscle cells (SMC).The stent was then inserted into the porcine coronary artery and monitored for a duration of 4 weeks. @*RESULTS@#SEM analysis confirmed that the coating surface was uniform. Furthermore, EDX analysis showed that the surface was coated with both polymer and drug components. The HPCL analysis of TCL at a wavelength of 215 nm revealed that the drug was continuously released over a period of 4 weeks. Smooth muscle cell migration was significantly decreased in the tacrolimus group (54.1% ± 11.90%) compared to the non-treated group (90.1% ± 4.86%). In animal experiments, the stenosis rate was significantly reduced in the TES group (29.6% ± 7.93%) compared to the bare metal stent group (41.3% ± 10.18%). Additionally, the fibrin score was found to be lower in the TES group compared to the group treated with a sirolimus-eluting stent (SES). @*CONCLUSION@#Similar to SES, TES reduces neointimal proliferation in a porcine coronary artery model, specifically decreasing the fibrins score. Therefore, tacrolimus could be considered a promising drug for reducing restenosis and thrombosis.
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There are limited data on outcomes after implantation of everolimus-eluting stents (EES) in East Asian patients with small vessel coronary lesions. A total of 1,600 patients treated with XIENCE EES (Abbott Vascular, CA, USA) were divided into the small vessel group treated with one ≤2.5 mm stent (n=119) and the non-small vessel group treated with one ≥2.75 mm stent (n=933). The primary end point was a patient-oriented composite outcome (POCO), a composite of all-cause death, myocardial infarction (MI), and any repeat revascularization at 12 months. The key secondary end point was a device-oriented composite outcome (DOCO), a composite of cardiovascular death, target-vessel MI, and target lesion revascularization at 12 months. The small vessel group was more often female, hypertensive, less likely to present with ST-elevation MI, and more often treated for the left circumflex artery, whereas the non-small vessel group more often had type B2/C lesions, underwent intravascular ultrasound, and received unfractionated heparin. In the propensity matched cohort, the mean stent diameter was 2.5±0.0 mm and 3.1±0.4 mm in the small and non-small vessel groups, respectively. Propensity-adjusted POCO at 12 months was 6.0% in the small vessel group and 4.3% in the non-small vessel group (p=0.558). There was no significant difference in DOCO at 12 months (small vessel group: 4.3% and non-small vessel group: 1.7%, p=0.270).Outcomes of XIENCE EES for small vessel disease were comparable to those for non-small vessel disease at 12-month clinical follow-up in real-world Korean patients.
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BACKGROUND@#Current polymer-based drug-eluting stents (DESs) have fundamental issues about inflammation and delayed re-endothelializaton of the vessel wall. Substance-P (SP), which plays an important role in inflammation and endothelial cells, has not yet been applied to coronary stents. Therefore, this study compares poly lactic-co-glycolic acid (PLGA)-based everolimus-eluting stents (PLGA-EESs) versus 2-methacryloyloxyethyl phosphorylcholine (MPC)-based SP-eluting stents (MPC-SPs) in in-vitro and in-vivo models. @*METHODS@#The morphology of the stent surface and peptide/drug release kinetics from stents were evaluated. The invitro proliferative effect of SP released from MPC-SP is evaluated using human umbilical vein endothelial cell. Finally, the safety and efficacy of the stent are evaluated after inserting it into a pig’s coronary artery. @*RESULTS@#Similar to PLGA-EES, MPC-SP had a uniform surface morphology with very thin coating layer thickness (2.074 lm). MPC-SP showed sustained drug release of SP for over 2 weeks. Endothelial cell proliferation was significantly increased in groups treated with SP (n = 3) compared with the control (n = 3) and those with everolimus (n = 3) (SP:118.9 ± 7.61% vs. everolimus: 64.3 ± 12.37% vs. the control: 100 ± 6.64%, p < 0.05). In the animal study, the percent stenosis was higher in MPC-SP group (n = 7) compared to PLGA-EES group (n = 7) (MPC-SP: 28.6 ± 10.7% vs. PLGAEES: 16.7 ± 6.3%, p < 0.05). MPC-SP group showed, however, lower inflammation (MPC-SP: 0.3 ± 0.26 vs. PLGAEES: 1.2 ± 0.48, p < 0.05) and fibrin deposition (MPC-SP: 1.0 ± 0.73 vs. PLGA-EES: 1.5 ± 0.59, p < 0.05) around the stent strut. MPC-SP showed more increased expression of cluster of differentiation 31, suggesting enhanced reendothelialization. @*CONCLUSION@#Compared to PLGA-EES, MPC-SP demonstrated more decreased inflammation of the vascular wall and enhanced re-endothelialization and stent coverage. Hence, MPC-SP has the potential therapeutic benefits for the treatment of coronary artery disease by solving limitations of currently available DESs.
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BACKGROUND@#Biodegradable poly (l-lactic acid) (PLLA), a bio safe polymer with a large elastic modulus, is widely used in biodegradable medical devices. However, because of its poor mechanical properties, a PLLA strut must be made twice as thick as a metal strut for adequate blood vessel support. Therefore, the mechanical properties of a drug-eluting metal-based stents (MBS) and a bioresorbable vascular scaffolds (BVS) were evaluated and their safety and efficacy were examined via a long-term rabbit iliac artery model. @*METHODS@#The surface morphologies of the MBSs and BVSs were investigated via optical and scanning electron microscopy. An everolimus-eluting (EE) BVS or an EE-MBS was implanted into rabbit iliac arteries at a 1.1:1 stent-toartery ratio. Twelve months afterward, stented iliac arteries from each group were analyzed via X-ray angiography, optical coherence tomography (OCT), and histopathologic evaluation. @*RESULTS@#Surface morphology analysis of the EE coating on the MBS confirmed that it was uniform and very thin (4.7 lm). Comparison of the mechanical properties of the EE-MBS and EE-BVS showed that the latter outperformed the former in all aspects (radial force (2.75 vs. 0.162 N/mm), foreshortening (0.24% vs. 1.9%), flexibility (0.52 vs. 0.19 N), and recoil (3.2% vs. 6.3%). At all time points, the percent area restenosis was increased in the EE-BVS group compared to the EE-MBS group. The OCT and histopathological analyses indicate no significant changes in strut thickness. @*CONCLUSION@#BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted.
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Background/Aims@#Rapid percutaneous coronary intervention (PCI) is the cornerstone of treatment for ST-elevation myocardial infarction (STEMI). However, there have been conflicting results regarding the differences in clinical outcomes between on-hours and off-hours presentation in STEMI patients. We aimed to examine the difference in long-term outcomes between off-hours and on-hours PCI in patients with STEMI. @*Methods@#The characteristics and clinical outcomes of 5,364 STEMI patients between November 2011 and June 2015 from the Korea Acute Myocardial Infarction Registry-National Institutes of Health (KAMIR-NIH) registry were analyzed. Patients were divided into two groups: the off-hours group (weekdays from 6:01 PM to 7:59 AM, weekends, and legal holidays) and the on-hours group (weekdays from 8:00 AM to 6:00 PM). Major adverse cardiac and cerebrovascular events (MACCEs) were defined as a composite of allcause mortality, non-fatal myocardial infarction, any revascularization, cerebrovascular accident, and stent thrombosis. The primary endpoint was the occurrence of MACCEs, and all other clinical outcomes were analyzed. @*Results@#A total of 3,119 patients (58.1%) underwent primary PCI due to STEMI during off-hours and 2,245 patients (41.9%) during on-hours. At 36 months, the clinical outcomes of the off-hours group were similar to those of the on-hours group in both the unadjusted and propensity score weighting-adjusted analyses. @*Conclusions@#Our analysis revealed that the long-term outcomes in STEMI patients admitted to hospitals during off-hours were similar to outcomes of those admitted during on-hours.
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Background/Aims@#Recurrent acute myocardial infarction (AMI) is an adverse cardiac event in patients with a first AMI. The predictors of recurrent AMI after the first AMI in patients who underwent successful percutaneous coronary intervention (PCI) have not been elucidated. @*Methods@#We analyzed the data collected from 9,869 patients (63.2 ± 12.4 years, men:women = 7,446:2,423) who were enrolled in the Korea Acute Myocardial Infarction Registry-National Institute of Health between November 2011 and October 2015, had suffered their first AMI and had received successful PCI during the index hospitalization. Multivariable logistic regression analysis was performed to identify the independent predictors of recurrent AMI following the first AMI. @*Results@#The cumulative incidence of recurrent AMI after successful PCI was 3.6% (359/9,869). According to the multivariable logistic regression analysis, the significant predictive factors for recurrent AMI were diabetes mellitus, renal dysfunction, atypical chest pain, and multivessel disease. @*Conclusions@#In this Korean prospective cohort study, the independent predictors of recurrent AMI after successful PCI for the first AMI were diabetes mellitus, renal dysfunction, atypical chest pain, and multivessel disease.
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Background@#Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION® ) in comparison with a commercial durable polymer everolimus-eluting stent (XIENCE Alpine® ) in a porcine coronary restenosis model. @*Methods@#Twenty-eight coronary arteries from 14 mini-pigs were randomly allocated to TIGEREVOLUTION® stent and XIENCE Alpine® stent groups. The stents were implanted in the coronary artery at a 1.1–1.2:1 stent-to-artery ratio. Eleven stented coronary arteries in each group were finally analyzed using coronary angiography, optical coherence tomography, and histopathologic evaluation 6 months after stenting. @*Results@#Quantitative coronary analysis showed no significant differences in the preprocedural, post-procedural, and 6-month lumen diameters between the groups. In the volumetric analysis of optical coherence tomography at 6 months, no significant differences were observed in stent volume, lumen volume, and percent area stenosis between the groups. There were no significant differences in injury score, inflammation score, or fibrin score between the groups, although the fibrin score was zero in the TIGEREVOLUTION® stent group (0 vs. 0.07 ± 0.11, P = 0.180). @*Conclusion@#Preclinical evaluation, including optical coherence tomographic findings 6 months after stenting, demonstrated that the TIGEREVOLUTION® stent exhibited efficacy and safety comparable with the XIENCE Alpine® stent, supporting the need for further clinical studies on the TIGEREVOLUTION® stent.
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Background/Aims@#High-sensitivity cardiac troponin (hs-TnT) assays detect very low levels of cardiac troponin. This study examined the interval change between initial and subsequent hs-TnT levels and evaluated its ability to predict significant coronary stenosis. @*Methods@#The study analyzed 163 patients who presented with acute coronary syndrome (ACS) and underwent coronary angiography (CAG) between April 2014 and May 2018. The 0 and 3-hour hs-TnT were checked. The patients were subdivided into positive (n = 32) and negative (n = 131) interval change groups. The presence of significant coronary artery stenosis on CAG in the two groups was compared. @*Results@#The positive interval change group was older and had higher 0 and 3-hour hs-TnT and blood glucose levels than the negative interval change group. Significant coronary stenosis was more common in the positive interval change group than in the negative interval change group (68.8% vs. 23.7%, p = 0.001). However, vasospasm was more common in the negative interval change group (6.3% vs. 31.3%, p = 0.003). The positive interval change group had higher rates of bifurcation lesions and received more percutaneous coronary intervention. In multivariate analysis, age, interval change of serial hs-TnT and diabetes mellitus were independent predictors of significant coronary artery stenosis. @*Conclusions@#This study identified a relationship between the serial change in cardiac biomarkers and the presence of significant coronary stenosis in patients with ACS. Serial hs-TnT change was associated with real angiographic stenosis in patients with ACS.
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Purpose@#This study aimed to compare mortality rates after discharge between the patients with non-ST-elevation myocardial infarction (NSTEMI) and those with ST-elevation myocardial infarction (STEMI), and identify each mortality risk factors in these two types of myocardial infarction. @*Materials and Methods@#Between 2011 and 2015, 13105 consecutive patients were enrolled in the Korea Acute Myocardial Infarction-National Institute of Health registry (KAMIR-NIH); 12271 patients with acute myocardial infarction met the inclusion criteria and were further stratified into the STEMI (n=5828) and NSTEMI (n=6443) groups. The occurrence of mortality and cardiac mortality at 3 years were compared between groups, and the factors associated with mortality for NSTEMI and STEMI were evaluated. @*Results@#The comparison between these two groups and long-term follow-up outcomes showed that the cumulative rates of allcause and cardiac mortality were higher in the NSTEMI group than in the STEMI group [all-cause mortality: 10.9% vs. 5.8%; hazards ratio (HR), 0.464; 95% confidence interval (CI), 0.359–0.600, p100 beats/min), no PCI, and low hemoglobin level were identified as the risk factors for 3-year mortality. @*Conclusion@#The NSTEMI group had higher mortality compared to the STEMI group during the 3-year clinical follow-up after discharge. Low LVEF and no PCI were the main risk factors for mortality in the NSTEMI group. In contrast, old age and renal dysfunction were the risk factors for long-term mortality in the STEMI group.
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Background@#Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION® ) in comparison with a commercial durable polymer everolimus-eluting stent (XIENCE Alpine® ) in a porcine coronary restenosis model. @*Methods@#Twenty-eight coronary arteries from 14 mini-pigs were randomly allocated to TIGEREVOLUTION® stent and XIENCE Alpine® stent groups. The stents were implanted in the coronary artery at a 1.1–1.2:1 stent-to-artery ratio. Eleven stented coronary arteries in each group were finally analyzed using coronary angiography, optical coherence tomography, and histopathologic evaluation 6 months after stenting. @*Results@#Quantitative coronary analysis showed no significant differences in the preprocedural, post-procedural, and 6-month lumen diameters between the groups. In the volumetric analysis of optical coherence tomography at 6 months, no significant differences were observed in stent volume, lumen volume, and percent area stenosis between the groups. There were no significant differences in injury score, inflammation score, or fibrin score between the groups, although the fibrin score was zero in the TIGEREVOLUTION® stent group (0 vs. 0.07 ± 0.11, P = 0.180). @*Conclusion@#Preclinical evaluation, including optical coherence tomographic findings 6 months after stenting, demonstrated that the TIGEREVOLUTION® stent exhibited efficacy and safety comparable with the XIENCE Alpine® stent, supporting the need for further clinical studies on the TIGEREVOLUTION® stent.
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Background/Aims@#High-sensitivity cardiac troponin (hs-TnT) assays detect very low levels of cardiac troponin. This study examined the interval change between initial and subsequent hs-TnT levels and evaluated its ability to predict significant coronary stenosis. @*Methods@#The study analyzed 163 patients who presented with acute coronary syndrome (ACS) and underwent coronary angiography (CAG) between April 2014 and May 2018. The 0 and 3-hour hs-TnT were checked. The patients were subdivided into positive (n = 32) and negative (n = 131) interval change groups. The presence of significant coronary artery stenosis on CAG in the two groups was compared. @*Results@#The positive interval change group was older and had higher 0 and 3-hour hs-TnT and blood glucose levels than the negative interval change group. Significant coronary stenosis was more common in the positive interval change group than in the negative interval change group (68.8% vs. 23.7%, p = 0.001). However, vasospasm was more common in the negative interval change group (6.3% vs. 31.3%, p = 0.003). The positive interval change group had higher rates of bifurcation lesions and received more percutaneous coronary intervention. In multivariate analysis, age, interval change of serial hs-TnT and diabetes mellitus were independent predictors of significant coronary artery stenosis. @*Conclusions@#This study identified a relationship between the serial change in cardiac biomarkers and the presence of significant coronary stenosis in patients with ACS. Serial hs-TnT change was associated with real angiographic stenosis in patients with ACS.
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Purpose@#This study aimed to compare mortality rates after discharge between the patients with non-ST-elevation myocardial infarction (NSTEMI) and those with ST-elevation myocardial infarction (STEMI), and identify each mortality risk factors in these two types of myocardial infarction. @*Materials and Methods@#Between 2011 and 2015, 13105 consecutive patients were enrolled in the Korea Acute Myocardial Infarction-National Institute of Health registry (KAMIR-NIH); 12271 patients with acute myocardial infarction met the inclusion criteria and were further stratified into the STEMI (n=5828) and NSTEMI (n=6443) groups. The occurrence of mortality and cardiac mortality at 3 years were compared between groups, and the factors associated with mortality for NSTEMI and STEMI were evaluated. @*Results@#The comparison between these two groups and long-term follow-up outcomes showed that the cumulative rates of allcause and cardiac mortality were higher in the NSTEMI group than in the STEMI group [all-cause mortality: 10.9% vs. 5.8%; hazards ratio (HR), 0.464; 95% confidence interval (CI), 0.359–0.600, p100 beats/min), no PCI, and low hemoglobin level were identified as the risk factors for 3-year mortality. @*Conclusion@#The NSTEMI group had higher mortality compared to the STEMI group during the 3-year clinical follow-up after discharge. Low LVEF and no PCI were the main risk factors for mortality in the NSTEMI group. In contrast, old age and renal dysfunction were the risk factors for long-term mortality in the STEMI group.
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Glomerular filtration rate (GFR) is an important indicator of renal failure. However, regarding delta GFR in acute myocardial infarction (AMI) is rare. In this study, it was examined whether the delta GFR had an adverse effect on outcomes in patients with AMI and multivessel disease (MVD). Among 13,105 consecutive patients enrolled in the Korea Acute Myocardial Infarction–National Institute of Health registry, 2619 with AMI and MVD who underwent percutaneous cardiac intervention (PCI) were assigned to the better delta GFR (group I, n=1432 [54.7%]) or worse delta GFR (group II, n=1187 [45.3%]) groups and followed for 3 or more years. The mean age of group I was lower than that of group II (62.64±11.52 years vs. 64.29±11.64 years; p<0.001). On multivariate analysis, delta GFR (hazard ratio, 1.50; 95% confidence interval, 1.05-2.13; p=0.024) was a negative risk factor for adverse cardiac events. Age over 65 years (p< 0.001), history of MI (p=0.008), low hemoglobin (p<0.001), high triglyceride (p=0.008), low high-density lipoprotein cholesterol (p=0.002), and low left ventricular ejection fraction (LVEF) (p<0.001) were prognostic factors for major adverse cardiac events (MACE). In patients with a GFR <60 mL/min/1.73 m2, mortality was increased by 0.9% in the multivessel PCI group and 0.7% in the IRA-only PCI group at the 1-year follow-up. According to the 3-year clinical follow-up analysis, prognosis was better in better delta GFR patients with AMI and MVD who underwent PCI than in worse delta GFR patients.
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The optimal dose of beta blockers after acute myocardial infarction (MI) remains uncertain. We evaluated the effectiveness of low-dose nebivolol, a beta1 blocker and a vasodilator, in patients with acute MI. A total of 625 patients with acute MI from 14 teaching hospitals in Korea were divided into 2 groups according to the dose of nebivolol (nebistol®, Elyson Pharmaceutical Co., Ltd., Seoul, Korea): low-dose group (1.25 mg daily, n=219) and usual- to high-dose group (≥2.5 mg daily, n=406). The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE, composite of death from any cause, non-fatal MI, stroke, repeat revascularization, rehospitalization for unstable angina or heart failure) at 12 months. After adjustment using inverse probability of treatment weighting, the rates of MACCE were not different between the low-dose and the usual- to high-dose groups (2.8% and 3.1%, respectively; hazard ratio: 0.92, 95% confidence interval: 0.38 to 2.24, p=0.860). The low-dose nebivolol group showed higher rates of MI than the usual- to high-dose group (1.2% and 0%, p=0.008). The 2 groups had similar rates of death from any cause (1.1% and 0.3%, p=0.273), stroke (0.4% and 1.1%, p=0.384), repeat PCI (1.2% and 0.8%, p=0.428), rehospitalization for unstable angina (1.2% and 1.0%, p=0.743) and for heart failure (0.6% and 0.7%, p=0.832). In patients with acute MI, the rates of MACCE for low-dose and usual- to high-dose nebivolol were not significantly different at 12-month follow-up.
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In the article cited above, fourth line of the first paragraph in Methods part, page 1085, has an error. Chonbuk National University Hospital should be corrected as “Chonnam National University Hospital.”
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In the article cited above, fourth line of the first paragraph in Methods part, page 1085, has an error. Chonbuk National University Hospital should be corrected as “Chonnam National University Hospital.”
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BACKGROUND/AIMS: This study appraised the long term clinical outcomes of patients treated with percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) disease. There are limited data regarding long-term clinical outcomes after PCI for ULMCA disease. METHODS: From 2001 to 2011, a total of 448 patients who underwent PCI for ULMCA disease and had 2-year clinical follow-up, were analyzed. The study patients were divided into two groups: group I (stable angina pectoris [SAP], n = 60, 48 men, 62 ± 10 years) and group II (acute coronary syndrome [ACS], n = 388, 291 men, 64 ± 10 years). We evaluated clinical and angiographic characteristics and major adverse cardiac events (MACE) during 2-year clinical follow-up. RESULTS: Mean age of studied patients was 64 ± 10 years with 339 male patients. Average stent diameter was 3.6 ± 0.4 mm and stent length was 19.7 ± 6.3 mm. Stent implantation techniques and use of intravascular ultrasound guidance were not different between two groups. In-hospital mortality was 0% in group I and 7% in group II (p = 0.035). One-month mortality was 0% in group I and 7.7% in group II (p = 0.968). Two-year survival rate was 93% in the group I and 88.4% in the group II (p = 0.921). Predictive factors for 2-year MACE were hypertension, Killip class ≥ 3, and use of intra-aortic balloon pump by multivariate analysis. CONCLUSIONS: Although in-hospital mortality rate was higher in ACS than in SAP, clinical outcomes during 2-year clinical follow-up were similar between SAP and ACS after PCI of ULMCA.