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1.
Clin Ther ; 2024 May 03.
Article En | MEDLINE | ID: mdl-38704294

PURPOSE: This study aimed to evaluate the efficacy and tolerability of irbesartan (IRB) and amlodipine (AML) combination therapy in patients with essential hypertension whose blood pressure (BP) was not controlled by IRB monotherapy. METHODS: Two multicenter, randomized, double-blind, placebo-controlled, phase III studies were conducted in Korea (the I-DUO 301 study and the I-DUO 302 study). After a 4-week run-in period with either 150 mg IRB (I-DUO 301 study) or 300 mg IRB (I-DUO 302 study), patients with uncontrolled BP (ie, mean sitting systolic BP [MSSBP] ≥140 mmHg to <180 mmHg and mean sitting diastolic BP <110 mmHg) were randomized to the placebo, AML 5 mg, or AML 10 mg group. A total of 428 participants were enrolled in the 2 I-DUO studies. In the I-DUO 301 study, 271 participants were randomized in a 1:1:1 ratio to receive either IRB/AML 150/5 mg, IRB/AML 150/10 mg, or IRB 150 mg/placebo. In the I-DUO 302 study, 157 participants were randomized in a 1:1 ratio to receive IRB/AML 300/5 mg or IRB 300 mg/placebo. The primary endpoint was the change in MSSBP from baseline to week 8. Tolerability was assessed according to the development of treatment-emergent adverse events (TEAEs) and clinically significant changes in physical examination, laboratory tests, pulse, and 12-lead electrocardiography. FINDINGS: In I-DUO 301, the mean (SD) changes of MSSBP at week 8 from baseline were -14.78 (12.35) mmHg, -21.47 (12.78) mmHg, and -8.61 (12.19) mmHg in the IRB/AML 150/5 mg, IRB/AML 150/10 mg, and IRB 150 mg/placebo groups, respectively. In I-DUO 302, the mean (SD) changes of MSSBP at week 8 from baseline were -13.30 (12.47) mmHg and -7.19 (15.37) mmHg in the IRB/AML 300/5 mg and IRB 300 mg/placebo groups, respectively. In both studies, all combination groups showed a significantly higher reduction in MSSBP than the IRB monotherapy groups (P < 0.001 for both). TEAEs occurred in 10.00%, 10.99%, and 12.22% of participants in the IRB/AML 150/5 mg, IRB/AML 150/10 mg, and IRB 150 mg/placebo groups, respectively, in I-DUO 301 and in 6.33% and 10.67% of participants in the IRB/AML 300/5 mg and IRB 300 mg/placebo groups, respectively, in I-DUO 302, with no significant between-group differences. Overall, there was one serious adverse event throughout I-DUO study. IMPLICATIONS: The combination of IRB and AML has superior antihypertensive effects compared with IRB alone over an 8-week treatment period, with placebo-like tolerability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05476354 (I-DUO 301), NCT05475665 (I-DUO 302).

2.
JACC Cardiovasc Interv ; 17(3): 329-340, 2024 Feb 12.
Article En | MEDLINE | ID: mdl-38355261

BACKGROUND: Distal radial access (DRA) as an alternative access route lacks evidence, despite its recent reputation. OBJECTIVES: The aim of this study was to evaluate the safety and feasibility of DRA on the basis of daily practice. METHODS: The KODRA (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach) trial was a prospective multicenter registry conducted at 14 hospitals between September 2019 and September 2021. The primary endpoints were the success rates of coronary angiography (CAG) and percutaneous coronary intervention (PCI). The secondary endpoints included successful distal radial artery puncture, access-site crossover, access site-related complications, bleeding events, and predictors of puncture failure. RESULTS: A total of 4,977 among 5,712 screened patients were recruited after the exclusion of 735 patients. The primary endpoints, the success rates of CAG and PCI via DRA, were 100% and 98.8%, respectively, among successful punctures of the distal radial artery (94.4%). Access-site crossover occurred in 333 patients (6.7%). The rates of distal radial artery occlusion and radial artery occlusion by palpation were 0.8% (36 of 4,340) and 0.8% (33 of 4,340) at 1-month follow-up. DRA-related bleeding events were observed in 3.3% of patients, without serious hematoma. Multilevel logistic regression analysis identified weak pulse (OR: 9.994; 95% CI: 7.252-13.774) and DRA experience <100 cases (OR: 2.187; 95% CI: 1.383-3.456) as predictors of puncture failure. CONCLUSIONS: In this large-scale prospective multicenter registry, DRA demonstrated high success rates of CAG and PCI, with a high rate of puncture success but low rates of distal radial artery occlusion, radial artery occlusion, bleeding events, and procedure-related complications. Weak pulse and DRA experience <100 cases were predictors of puncture failure. (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach [KODRA]; NCT04080700).


Arterial Occlusive Diseases , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Treatment Outcome , Radial Artery/diagnostic imaging , Coronary Angiography/methods , Hemorrhage/etiology , Arterial Occlusive Diseases/complications , Registries
3.
BMJ ; 383: e075837, 2023 10 18.
Article En | MEDLINE | ID: mdl-37852649

OBJECTIVE: To compare the long term efficacy and safety of rosuvastatin with atorvastatin treatment in adults with coronary artery disease. DESIGN: Randomised, open label, multicentre trial. SETTING: 12 hospitals in South Korea, September 2016 to November 2019. PARTICIPANTS: 4400 adults (age ≥19 years) with coronary artery disease. INTERVENTIONS: Participants were assigned to receive either rosuvastatin (n=2204) or atorvastatin (n=2196) using 2×2 factorial randomisation. MAIN OUTCOME MEASURES: The primary outcome was a three year composite of all cause death, myocardial infarction, stroke, or any coronary revascularisation. Secondary outcomes were safety endpoints: new onset diabetes mellitus; hospital admissions due to heart failure; deep vein thrombosis or pulmonary thromboembolism; endovascular revascularisation for peripheral artery disease; aortic intervention or surgery; end stage kidney disease; discontinuation of study drugs owing to intolerance; cataract surgery; and a composite of laboratory detected abnormalities. RESULTS: 4341 of the 4400 participants (98.7%) completed the trial. Mean daily dose of study drugs was 17.1 mg (standard deviation (SD) 5.2 mg) in the rosuvastatin group and 36.0 (12.8) mg in the atorvastatin group at three years (P<0.001). The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58). The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001). The rosuvastatin group had a higher incidence of new onset diabetes mellitus requiring initiation of antidiabetics (7.2% v 5.3%; hazard ratio 1.39, 95% confidence interval 1.03 to 1.87; P=0.03) and cataract surgery (2.5% v 1.5%; 1.66, 1.07 to 2.58; P=0.02). Other safety endpoints did not differ between the two groups. CONCLUSIONS: In adults with coronary artery disease, rosuvastatin and atorvastatin showed comparable efficacy for the composite outcome of all cause death, myocardial infarction, stroke, or any coronary revascularisation at three years. Rosuvastatin was associated with lower LDL cholesterol levels but a higher risk of new onset diabetes mellitus requiring antidiabetics and cataract surgery compared with atorvastatin. TRIAL REGISTRATION: ClinicalTrials.gov NCT02579499.


Atorvastatin , Coronary Artery Disease , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Rosuvastatin Calcium , Adult , Humans , Young Adult , Atorvastatin/adverse effects , Cataract , Cholesterol, LDL , Coronary Artery Disease/drug therapy , Diabetes Mellitus , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Myocardial Infarction , Rosuvastatin Calcium/adverse effects , Stroke , Treatment Outcome
4.
Catheter Cardiovasc Interv ; 102(6): 1040-1047, 2023 11.
Article En | MEDLINE | ID: mdl-37855180

BACKGROUND: Genoss drug-eluting stent (DES) (Genoss Company Limited) is a new ultrathin sirolimus-eluting stent with an abluminal biodegradable polymer and a cobalt-chromium platform. AIMS: The aim of this study was to evaluate vascular healing and neointimal coverage after implantation of the Genoss DES using optical coherence tomography (OCT) 6 months postimplantation. METHODS: From August 22, 2019 to June 17, 2020, this multicenter, observational, investigator-initiated study enrolled 20 patients who underwent OCT examination 6 months after Genoss DES implantation and provided informed consent. An analyst, blinded to the patients' and procedural information analyzed OCT images at an independent core laboratory. RESULTS: Of the 20 patients, 19 with 27 stents in 21 lesions from 21 vessels were included in the analysis, while one patient withdrew consent and was unwilling to undergo follow-up OCT. OCT analysis was performed 204.4 ± 31.9 days after Genoss DES implantation. A total of 4285 stent struts from 661 cross-sections were analyzed. Strut tissue coverage was observed in 98.7 ± 4.3% of struts, with 0.1 ± 1.2% malapposed struts per lesion. The mean thickness of neointimal hyperplasia (NIH) on the covered struts was 0.12 ± 0.04 mm. CONCLUSIONS: Six months after stent implantation, most Genoss DES struts were covered with a thin layer of NIH that was evenly distributed along the stent length. This pilot study evaluated the outcomes of 6 months dual antiplatelet therapy in the context of ultrathin strut stents, providing insight into developing ethical standards and a scientific foundation for conducting an adequately designed clinical trial.


Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Sirolimus , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Pilot Projects , Treatment Outcome , Prosthesis Design , Time Factors , Stents , Neointima/pathology , Percutaneous Coronary Intervention/adverse effects , Polymers , Tomography, Optical Coherence , Coronary Vessels/diagnostic imaging , Coronary Vessels/pathology
5.
EClinicalMedicine ; 64: 102227, 2023 Oct.
Article En | MEDLINE | ID: mdl-37767195

Background: The impact of titrated versus fixed intensity statin therapy in patients with coronary artery disease (CAD) and diabetes mellitus (DM) remains to be elucidated. Methods: This was a pre-specified analysis of patients with and without DM from the LODESTAR trial. Patients with CAD were randomly assigned to receive either a treat-to-target strategy with a target LDL-C level of 50-70 mg/dL or a high-intensity statin treatment. Primary outcome was the 3-year composite of all-cause death, myocardial infarction, stroke, or coronary revascularization. Secondary outcomes were safety endpoints. This trial is registered with ClinicalTrials.gov, NCT02579499. Findings: Between September 9, 2016 and November 27, 2019, 4400 patients with CAD were enrolled in the LODESTAR trial. The median age was 65 years (interquartile range, 59-73 years), 3172 (72%) were male, and 1468 (33%) had DM at baseline. There was no significant difference in the occurrence of the primary outcome between the treat-to-target group and high-intensity statin group among patients with DM (10.5% versus 11.1%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69-1.29, p = 0.70) and those without DM (6.9% versus 7.5%, HR 0.93, 95% CI 0.71-1.21, p = 0.58). Among patients without DM, there was a trend towards a lower risk of new-onset DM in the treat-to-target group (8.4% versus 10.4% in the high-intensity statin group, HR 0.79, 95% CI 0.62-1.01; p = 0.06). Interpretation: In patients with CAD, a treat-to-target LDL-C strategy of 50-70 mg/dL as the goal was comparable to high-intensity statin therapy in terms of 3-year clinical efficacy and safety outcomes regardless of the presence of DM. Funding: Sam Jin Pharmaceutical, Seoul, Korea and Chong Kun Dang Pharmaceutical, Seoul, Korea.

6.
Am J Cardiol ; 204: 43-52, 2023 10 01.
Article En | MEDLINE | ID: mdl-37536204

Data regarding the clinical outcomes of older patients after Synergy everolimus-eluting stent (S-EES) implantation are limited. This study investigated the 12-month clinical outcomes of older patients who underwent percutaneous coronary intervention with new-generation drug-eluting stents according to ischemic risks. This prospective multicenter study targeted patients aged ≥75 years who underwent S-EES implantation. The primary and secondary end points included 12-month device-oriented composite end point (DOCE) (cardiovascular death, target vessel myocardial infarction, or target lesion revascularization) and major adverse cardiac and cerebrovascular events (MACCEs; all-cause death, myocardial infarction, target vessel revascularization, stent thrombosis, or stroke), respectively. A stratified analysis was conducted according to high-ischemic risk (HIR), defined as complex coronary intervention (number of stents implanted ≥3, total stented length >60 mm, chronic total occlusion, left main, or bifurcation), diabetes, or chronic kidney disease. In total, 650 enrolled patients aged ≥75 years were categorized into HIR (n = 425) and non-HIR groups (n = 225). In the total population, the 1-year incidence of DOCEs was 2.5%. The rates of DOCEs were not significantly different between the HIR and the non-HIR groups, whereas the MACCE rate was higher in the HIR (9.4%) than the non-HIR group (4.9%, p = 0.035), and the DOCE and MACCE components did not differ significantly in the occurrence between the groups. The independent predictors for the DOCEs or MACCEs included age, anemia, or left ventricular ejection fraction <40%. In conclusion, in older patients, S-EES implantation demonstrated favorable device-related outcomes, regardless of procedural complexity or co-morbidities. However, it requires careful attention because older patients with HIR are associated with worse clinical outcomes.


Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Aged , Humans , Sirolimus/pharmacology , Drug-Eluting Stents/adverse effects , Prospective Studies , Stroke Volume , Treatment Outcome , Risk Factors , Ventricular Function, Left , Myocardial Infarction/etiology , Stents/adverse effects , Percutaneous Coronary Intervention/adverse effects , Registries , Prosthesis Design
7.
J Clin Hypertens (Greenwich) ; 25(9): 828-844, 2023 09.
Article En | MEDLINE | ID: mdl-37584254

The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, or ATV 20 mg /AML 5 mg. The primary endpoint was the efficacy of the RSV 10.20 mg/AML 5 mg via percentage changes in LDL-C after 8 weeks of treatment, compared with the ATV 20 mg /AML 5 mg. There was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 10 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (full analysis set [FAS]: -7.08%, 95% CI: -11.79 to -2.38, p = .0034, per-protocol analysis set [PPS]: -6.97%, 95% CI: -11.76 to -2.19, p = .0046). Also, there was a significant difference in the mean percentage change of LDL-C at 8 weeks between the RSV 20 mg/AML 5 mg and the ATV 20 mg/AML 5 mg (FAS: -10.13%, 95% CI: -15.41 to -4.84, p = .0002, PPS: -10.96%, 95% CI: -15.98 to -5.93, p < .0001). There was no significant difference in the adverse events rates between RSV 10 mg/AML 5 mg, RSV 20 mg/AML 5 mg, and ATV 20 mg/AML 5 mg. In conclusion, while maintaining safety, RSV 10 mg/AML 5 mg and the RSV 20 mg/AML 5 mg more effectively reduced LDL-C compared with the ATV 20 mg /AML 5 mg (Clinical trial: NCT03951207).


Dyslipidemias , Hypertension , Leukemia, Myeloid, Acute , Humans , Rosuvastatin Calcium/adverse effects , Atorvastatin/adverse effects , Amlodipine/adverse effects , Hypertension/drug therapy , Hypertension/chemically induced , Cholesterol, LDL , Dyslipidemias/drug therapy , Leukemia, Myeloid, Acute/chemically induced , Double-Blind Method , Treatment Outcome
8.
J Clin Hypertens (Greenwich) ; 25(5): 429-439, 2023 05.
Article En | MEDLINE | ID: mdl-37095689

We compared the efficacy and safety of third-standard-dose triple and third-standard-dose dual antihypertensive combination therapies in patients with mild to moderate hypertension. This was a phase II multicenter, randomized, double-blind, parallel-group trial. After a 4-week placebo run-in period, 245 participants were randomized to the third-dose triple combination (ALC group; amlodipine 1.67 mg + losartan potassium 16.67 mg + chlorthalidone 4.17 mg) or third-dose dual combination (AL group; amlodipine 1.67 mg + losartan potassium 16.67 mg, LC group; losartan potassium 16.67 mg + chlorthalidone 4.17 mg, AC group; amlodipine 1.67 mg + chlorthalidone 4.17 mg) therapy groups and followed up for 8 weeks. The mean systolic blood pressure (BP) reduction was -18.3 ± 13.2, -13.0 ± 13.3, -16.3 ± 12.4, and -13.8 ± 13.2 mmHg in the ALC, AL, LC, and AC groups, respectively. The ALC group showed significant systolic BP reduction compared to the AL and AC groups at weeks 4 (P = .010 and P = .018, respectively) and 8 (P = .017 and P = .036, respectively). At week 4, the proportion of systolic BP responders was significantly higher in the ALC group (42.6%) than in the AL (22.0%), LC (23.3%), and AC (27.1%) groups (P = .013, P = .021, and P = .045, respectively). At week 8, the proportion of systolic and diastolic BP responders was significantly higher in the ALC group (59.7%) than in the AL (39.3%) and AC (42.4%) groups (P = .022 and P = .049, respectively) at week 8. Third-standard-dose triple antihypertensive combination therapy demonstrated early effective BP control compared to third-standard-dose dual combination therapies, without increasing adverse drug reactions in patients with mild-to-moderate hypertension.


Hypertension , Hypotension , Humans , Antihypertensive Agents/adverse effects , Losartan , Chlorthalidone , Amlodipine , Blood Pressure , Hypotension/chemically induced , Double-Blind Method , Drug Therapy, Combination , Treatment Outcome
9.
Int J Mol Med ; 51(5)2023 May.
Article En | MEDLINE | ID: mdl-37026512

Atherosclerosis is a progressive chronic inflammatory condition that is the cause of most cardiovascular and cerebrovascular diseases. The transcription factor nuclear factor­κB (NF­κB) regulates a number of genes involved in the inflammatory responses of cells that are critical to atherogenesis, and signal transducer and activator of transcription (STAT)3 is a key transcription factor in immunity and inflammation. Decoy oligodeoxynucleotides (ODNs) bind to sequence­specific transcription factors and limit gene expression by interfering with transcription in vitro and in vivo. The present study aimed to investigate the beneficial functions of STAT3/NF­κB decoy ODNs in liposaccharide (LPS)­induced atherosclerosis in mice. Atherosclerotic injuries of mice were induced via intraperitoneal injection of LPS and the mice were fed an atherogenic diet. Ring­type STAT3/NF­κB decoy ODNs were designed and administered via an injection into the tail vein of the mice. To investigate the effect of STAT3/NF­κB decoy ODNs, electrophoretic mobility shift assay, western blot analysis, histological analysis with hematoxylin and eosin staining, Verhoeff­Van Gieson and Masson's trichrome staining were performed. The results revealed that STAT3/NF­κB decoy ODNs were able to suppress the development of atherosclerosis by attenuating morphological changes and inflammation in atherosclerotic mice aortae, and by reducing pro­inflammatory cytokine secretion through inhibition of the STAT3/NF­κB pathway. In conclusion, the present study provided novel insights into the antiatherogenic molecular mechanism of STAT3/NF­κB decoy ODNs, which may serve as an additional therapeutic intervention to combat atherosclerosis.


Atherosclerosis , NF-kappa B , Animals , Mice , NF-kappa B/metabolism , Lipopolysaccharides , Signal Transduction , Oligodeoxyribonucleotides/pharmacology , Oligodeoxyribonucleotides/therapeutic use , Oligodeoxyribonucleotides/genetics , Inflammation/pathology , Transcription Factors , Atherosclerosis/drug therapy , Atherosclerosis/genetics
10.
JAMA ; 329(13): 1078-1087, 2023 04 04.
Article En | MEDLINE | ID: mdl-36877807

Importance: In patients with coronary artery disease, some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in low-density lipoprotein cholesterol (LDL-C). An alternative approach is to begin with moderate-intensity statins and titrate to a specific LDL-C goal. These alternatives have not been compared head-to-head in a clinical trial involving patients with known coronary artery disease. Objective: To assess whether a treat-to-target strategy is noninferior to a strategy of high-intensity statins for long-term clinical outcomes in patients with coronary artery disease. Design, Setting, and Participants: A randomized, multicenter, noninferiority trial in patients with a coronary disease diagnosis treated at 12 centers in South Korea (enrollment: September 9, 2016, through November 27, 2019; final follow-up: October 26, 2022). Interventions: Patients were randomly assigned to receive either the LDL-C target strategy, with an LDL-C level between 50 and 70 mg/dL as the target, or high-intensity statin treatment, which consisted of rosuvastatin, 20 mg, or atorvastatin, 40 mg. Main Outcomes and Measures: Primary end point was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization with a noninferiority margin of 3.0 percentage points. Results: Among 4400 patients, 4341 patients (98.7%) completed the trial (mean [SD] age, 65.1 [9.9] years; 1228 females [27.9%]). In the treat-to-target group (n = 2200), which had 6449 person-years of follow-up, moderate-intensity and high-intensity dosing were used in 43% and 54%, respectively. The mean (SD) LDL-C level for 3 years was 69.1 (17.8) mg/dL in the treat-to-target group and 68.4 (20.1) mg/dL in the high-intensity statin group (n = 2200) (P = .21, compared with the treat-to-target group). The primary end point occurred in 177 patients (8.1%) in the treat-to-target group and 190 patients (8.7%) in the high-intensity statin group (absolute difference, -0.6 percentage points [upper boundary of the 1-sided 97.5% CI, 1.1 percentage points]; P < .001 for noninferiority). Conclusions and Relevance: Among patients with coronary artery disease, a treat-to-target LDL-C strategy of 50 to 70 mg/dL as the goal was noninferior to a high-intensity statin therapy for the 3-year composite of death, myocardial infarction, stroke, or coronary revascularization. These findings provide additional evidence supporting the suitability of a treat-to-target strategy that may allow a tailored approach with consideration for individual variability in drug response to statin therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT02579499.


Atorvastatin , Cholesterol, LDL , Coronary Artery Disease , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Hyperlipoproteinemias , Rosuvastatin Calcium , Aged , Female , Humans , Cholesterol, LDL/blood , Coronary Artery Disease/blood , Coronary Artery Disease/complications , Coronary Artery Disease/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Myocardial Infarction/etiology , Stroke/etiology , Treatment Outcome , Hyperlipoproteinemias/blood , Hyperlipoproteinemias/complications , Hyperlipoproteinemias/drug therapy , Male , Middle Aged , Rosuvastatin Calcium/administration & dosage , Rosuvastatin Calcium/adverse effects , Rosuvastatin Calcium/therapeutic use , Atorvastatin/administration & dosage , Atorvastatin/adverse effects , Atorvastatin/therapeutic use
11.
Am Heart J ; 259: 58-67, 2023 05.
Article En | MEDLINE | ID: mdl-36754106

BACKGROUND: We aimed to compare clinical outcomes between immediate and staged complete revascularization in primary percutaneous coronary intervention (PCI) for treating ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD). METHODS: A total of 248 patients were enrolled in a prospective, randomized, and multicenter registry. Immediate revascularization was defined as one-time PCI of culprit and non-culprit lesions at the initial procedure. Staged revascularization was defined as PCI of non-culprit lesions at a later date (mean, 4.4 days; interquartile range, 1-11.4), following initial culprit revascularization. The end points were major adverse cardiovascular events (MACE; composite of total death, recurrent myocardial infarction, and revascularization), any individual components of MACE, cardiac death, stent thrombosis, and stroke at 12 months. RESULTS: During a follow-up of 1 year, MACE occurred in 12 patients (11.6%) in the immediate revascularization group and in 8 patients (7.5%) in staged revascularization group (hazard ratio [HR] 1.60, 95% confidence interval [CI] 0.65-3.91). The incidence of total death was numerically higher in the immediate group than in the staged group (9.7% vs 2.8%, HR 3.53, 95% CI 0.97-12.84); There were no significant differences between the 2 groups in risks of any individual component of MACE, cardiac death, stroke, and in-hospital complications, such as need for transfusion, bleeding, acute renal failure, and acute heart failure. This study was prematurely terminated due to halt of production of everolimus-eluting stents (manufactured as PROMUS Element by Boston Scientific, Natick, Massachusetts). CONCLUSIONS: Due to its limited power, no definite conclusion can be drawn regarding complete revascularization strategy from the present study. Further large randomized clinical trials would be warranted to confirm optimal timing of complete revascularization for patients with STEMI and MVD.


Coronary Artery Disease , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Stroke , Humans , Coronary Artery Disease/complications , Coronary Artery Disease/surgery , ST Elevation Myocardial Infarction/therapy , Percutaneous Coronary Intervention/methods , Prospective Studies , Risk Factors , Treatment Outcome , Stroke/etiology , Death , Myocardial Revascularization
12.
Adv Mater ; 35(12): e2209128, 2023 Mar.
Article En | MEDLINE | ID: mdl-36625665

The galvanostatic lithiation/sodiation voltage profiles of hard carbon anodes are simple, with a sloping drop followed by a plateau. However, a precise understanding of the corresponding redox sites and storage mechanisms is still elusive, which hinders further development in commercial applications. Here, a comprehensive comparison of the lithium- and sodium-ion storage behaviors of hard carbon is conducted, yielding the following key findings: 1) the sloping voltage section is presented by the lithium-ion intercalation in the graphitic lattices of hard carbons, whereas it mainly arises from the chemisorption of sodium ions on their inner surfaces constituting closed pores, even if the graphitic lattices are unoccupied; 2) the redox sites for the plateau capacities are the same as those for the closed pores regardless of the alkali ions; 3) the sodiation plateau capacities are mostly determined by the volume of the available closed pore, whereas the lithiation plateau capacities are primarily affected by the intercalation propensity; and 4) the intercalation preference and the plateau capacity have an inverse correlation. These findings from extensive characterizations and theoretical investigations provide a relatively clear elucidation of the electrochemical footprint of hard carbon anodes in relation to the redox mechanisms and storage sites for lithium and sodium ions, thereby providing a more rational design strategy for constructing better hard carbon anodes.

13.
Angiology ; 74(5): 417-426, 2023 05.
Article En | MEDLINE | ID: mdl-36047931

A significant mismatch between proximal and distal reference lumen diameters of the target lesion may pose challenges during percutaneous coronary intervention (PCI) and therefore influence the outcomes. We investigated total 1706 lesions underwent IVUS guided percutaneous coronary intervention, that were divided into 2 groups, including 411 lesions in Mismatch group and 1295 lesions in Non-Mismatch group. After propensity score matching, 397 lesions in each group were selected for final data set. The analysis showed that Mismatch group PCI required more frequently use of post-stenting optimization (79.6% vs 53.9%, P < .001) using higher max pressure (19.5 ± 3.9 vs 16.7 ± 3.7 atm, P < .001). Besides, Mismatch group also encountered more PCI major complications (7.8% vs 4.0%, P = .024) and lower procedure success rate (91.4% vs 95.5%, P = .022). On final angiogram, Mismatch group had smaller minimum lumen diameter (2.62 ± .45 vs 2.90 ± .57 mm, P < .001) and lower angiographic success rate (93.2% vs 96.7%, P = .023). On final IVUS, Mismatch group had higher rate of incomplete stent apposition and stent edge dissection (6.3% vs 3.0%, P = .029 and 2.5% vs .5%, P = .021, respectively). In conclusion, reference mismatch posed significant challenging during PCI that led to unfavorable procedural outcomes. These impacts may translate into long-term clinical implications that need to be addressed in future studies.


Coronary Artery Disease , Percutaneous Coronary Intervention , Humans , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Coronary Angiography/methods , Treatment Outcome , Ultrasonography, Interventional/methods
14.
Anal Bioanal Chem ; 414(10): 3257-3265, 2022 Apr.
Article En | MEDLINE | ID: mdl-35029693

During the recent several decades, lateral flow immunoassay (LFIA) constructed with gold nanoparticle (AuNP) has been widely utilized to conveniently detect target analyte. However, AuNP-based LFIA has limitations, such as limited detection sensitivity and quantification capability. Herein, to overcome these constraints, we have developed cerium oxide nanoparticle (nanoceria)-based LFIA for C-reactive protein (CRP) detection in human serum samples. It was fabricated with nanoceria, a notable nanozyme that shows an oxidase activity to quickly oxidize organic substrate, such as 3,3',5,5'-tetramethylbenzidine (TMB), to produce colored product without any oxidizing agent (e.g., hydrogen peroxide), which is advantageous for realizing point-of-care testing (POCT) applications. By employing human blood serum spiked with CRP, the nanoceria-based LFIA showed two blue-colored lines on the test and control region within 3 min via TMB oxidation, by the captured nanoceria through antigen-antibody interaction. The produced blue-colored lines were distinguished by naked eyes and quantitated with real images acquired by a conventional smartphone with the ImageJ software. With this strategy, target CRP was specifically determined down to 117 ng mL-1 with high detection precisions yielding coefficient of variation of 9.8-11.3% and recovery of 90.7-103.2% using human blood serum samples. This investigation demonstrates the potential of oxidase-like nanoceria for developing LFIA, which is particularly useful in instrumentation-free POCT environments.


Colorimetry , Metal Nanoparticles , C-Reactive Protein , Cerium , Gold , Humans , Hydrogen Peroxide , Immunoassay
15.
Materials (Basel) ; 14(24)2021 Dec 08.
Article En | MEDLINE | ID: mdl-34947117

Sodium ion batteries (SIBs) have drawn interest as a lithium ion battery (LIB) alternative owing to their low price and low deposits. To commercialize SIBs similar to how LIBs already have been, it is necessary to develop improved anode materials that have high stability and capacity to operate over many and long cycles. This paper reports the development of homogeneous Sb2S3 nanorods (Sb2S3 NRs) on reduced graphene oxide (Sb2S3 NRs @rGO) as anode materials for SIBs. Based on this work, Sb2S3 NRs show a discharge capacity of 564.42 mAh/g at 100 mA/g current density after 100 cycles. In developing a composite with reduced graphene oxide, Sb2S3 NRs@rGO present better cycling performance with a discharge capacity of 769.05 mAh/g at the same condition. This achievement justifies the importance of developing Sb2S3 NRs and Sb2S3 NRs@rGO for SIBs.

16.
Nat Commun ; 12(1): 4334, 2021 Jul 15.
Article En | MEDLINE | ID: mdl-34267194

Structural and morphological control of crystalline nanoparticles is crucial in the field of heterogeneous catalysis and the development of "reaction specific" catalysts. To achieve this, colloidal chemistry methods are combined with ab initio calculations in order to define the reaction parameters, which drive chemical reactions to the desired crystal nucleation and growth path. Key in this procedure is the experimental verification of the predicted crystal facets and their corresponding electronic structure, which in case of nanostructured materials becomes extremely difficult. Here, by employing 31P solid-state nuclear magnetic resonance aided by advanced density functional theory calculations to obtain and assign the Knight shifts, we succeed in determining the crystal and electronic structure of the terminating surfaces of ultrafine Ni2P nanoparticles at atomic scale resolution. Our work highlights the potential of ssNMR nanocrystallography as a unique tool in the emerging field of facet-engineered nanocatalysts.

17.
JACC Cardiovasc Interv ; 14(8): 892-906, 2021 04 26.
Article En | MEDLINE | ID: mdl-33888235

Among patients undergoing percutaneous coronary procedures, transradial access, compared with transfemoral access, is associated with a reduced risk for complications including mortality, especially in higher risk patients. However, transradial access is limited by radial artery occlusion (RAO) that despite being mostly asymptomatic because of the extensive anastomoses between the forearm arteries restricts future use of the same radial artery. Distal radial access (DRA) in the anatomic snuffbox or on the dorsum of the hand has recently gained global popularity as an alternative access route for vascular procedures. A strong anatomic and physiological rationale yields potential for significantly reduced risk for RAO and positive impact on procedural outcome for better patient care. Indeed, currently published studies buttress very low rates of RAO after DRA, hence supporting its development. The authors provide an analysis of the foundation of DRA, provide historical background, and offer a critical review of its current status and future directions. Also, given the limited evidence currently available to properly perform DRA in the real world, consensus opinion on what is considered optimal practice is also presented to supplement this document and enhance the implementation of DRA while minimizing its complications.


Percutaneous Coronary Intervention , Radial Artery , Consensus , Humans , Percutaneous Coronary Intervention/adverse effects , Radial Artery/diagnostic imaging , Republic of Korea , Treatment Outcome
18.
J Korean Med Sci ; 36(2): e15, 2021 Jan 11.
Article En | MEDLINE | ID: mdl-33429474

BACKGROUND: Data regarding the association between preexisting cardiovascular risk factors (CVRFs) and cardiovascular diseases (CVDs) and the outcomes of patients requiring hospitalization for coronavirus disease 2019 (COVID-19) are limited. Therefore, the aim of this study was to investigate the impact of preexisting CVRFs or CVDs on the outcomes of patients with COVID-19 hospitalized in a Korean healthcare system. METHODS: Patients with COVID-19 admitted to 10 hospitals in Daegu Metropolitan City, Korea, were examined. All sequentially hospitalized patients between February 15, 2020, and April 24, 2020, were enrolled in this study. All patients were confirmed to have COVID-19 based on the positive results on the polymerase chain reaction testing of nasopharyngeal samples. Clinical outcomes during hospitalization, such as requiring intensive care and invasive mechanical ventilation (MV) and death, were evaluated. Moreover, data on baseline comorbidities such as a history of diabetes, hypertension, dyslipidemia, current smoking, heart failure, coronary artery disease, cerebrovascular accidents, and other chronic cardiac diseases were obtained. RESULTS: Of all the patients enrolled, 954 (42.0%) had preexisting CVRFs or CVDs. Among the CVRFs, the most common were hypertension (28.8%) and diabetes mellitus (17.0%). The prevalence rates of preexisting CVRFs or CVDs increased with age (P < 0.001). The number of patients requiring intensive care (P < 0.001) and invasive MV (P < 0.001) increased with age. The in-hospital death rate increased with age (P < 0.001). Patients requiring intensive care (5.3% vs. 1.6%; P < 0.001) and invasive MV (4.3% vs. 1.7%; P < 0.001) were significantly greater in patients with preexisting CVRFs or CVDs. In-hospital mortality (12.9% vs. 3.1%; P < 0.001) was significantly higher in patients with preexisting CVRFs or CVDs. Among the CVRFs, diabetes mellitus and hypertension were associated with increased requirement of intensive care and invasive MV and in-hospital death. Among the known CVDs, coronary artery disease and congestive heart failure were associated with invasive MV and in-hospital death. In multivariate analysis, preexisting CVRFs or CVDs (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.07-3.01; P = 0.027) were independent predictors of in-hospital death after adjusting for confounding variables. Among individual preexisting CVRF or CVD components, diabetes mellitus (OR, 2.43; 95% CI, 1.51-3.90; P < 0.001) and congestive heart failure (OR, 2.43; 95% CI, 1.06-5.87; P = 0.049) were independent predictors of in-hospital death. CONCLUSION: Based on the findings of this study, the patients with confirmed COVID-19 with preexisting CVRFs or CVDs had worse clinical outcomes. Caution is required in dealing with these patients at triage.


COVID-19/complications , COVID-19/mortality , Diabetes Mellitus/mortality , Hypertension/mortality , Aged , COVID-19/pathology , Cardiovascular Diseases/complications , Cardiovascular Diseases/mortality , Cardiovascular Diseases/pathology , Comorbidity , Critical Care/statistics & numerical data , Diabetes Mellitus/pathology , Female , Heart Disease Risk Factors , Hospital Mortality , Humans , Hypertension/pathology , Male , Middle Aged , Prognosis , Republic of Korea , SARS-CoV-2
19.
Circ J ; 85(6): 817-825, 2021 05 25.
Article En | MEDLINE | ID: mdl-33431720

BACKGROUND: The benefits and risks of prolonged dual antiplatelet therapy (DAPT) have not been studied extensively across a broad spectrum of acute coronary syndromes. In this study we investigated whether treatment effects of prolonged DAPT were consistent in patients presenting with ST-segment elevation myocardial infarction (STEMI) vs. non-STEMI (NSTEMI).Methods and Results:As a post hoc analysis of the SMART-DATE trial, effects of ≥12 vs. 6 months DAPT were compared among 1,023 patients presenting with STEMI and 853 NSTEMI patients. The primary outcome was a composite of recurrent myocardial infarction (MI) or stent thrombosis at 18 months after the index procedure. Compared with the 6-month DAPT group, the rate of the composite endpoint was significantly lower in the ≥12-month DAPT group (1.2% vs. 3.8%; hazard ratio [HR] 0.31, 95% confidence interval [CI] 0.12-0.77; P=0.012). The treatment effect of ≥12- vs. 6-month DAPT on the composite endpoint was consistent among NSTEMI patients (0.2% vs. 1.2%, respectively; HR 0.20, 95% CI 0.02-1.70; P=0.140; Pinteraction=0.718). In addition, ≥12-month DAPT increased Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding among both STEMI (4.4% vs. 2.0%; HR 2.18, 95% CI 1.03-4.60; P=0.041) and NSTEMI (5.1% vs. 2.2%; HR 2.37, 95% CI 1.08-5.17; P=0.031; Pinteraction=0.885) patients. CONCLUSIONS: Compared with 6-month DAPT, ≥12-month DAPT reduced recurrent MI or stent thrombosis regardless of the type of MI at presentation.


Non-ST Elevated Myocardial Infarction , Drug Therapy, Combination , Humans , Non-ST Elevated Myocardial Infarction/drug therapy , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/adverse effects , ST Elevation Myocardial Infarction/drug therapy , Treatment Outcome
20.
EuroIntervention ; 17(5): e411-e417, 2021 Aug 06.
Article En | MEDLINE | ID: mdl-33136005

BACKGROUND: Data on direct comparison between various drug-eluting stents with short duration dual antiplatelet therapy (DAPT) are limited, especially in patients with acute coronary syndrome (ACS). AIMS: We sought to compare biodegradable polymer biolimus-eluting stents (BP-BES) with durable polymer everolimus-eluting (DP-EES) and zotarolimus-eluting stents (DP-ZES) in patients with ACS according to different durations of DAPT. METHODS: In the SMART-DATE trial, 2,712 patients with ACS underwent randomisation for allocation of DAPT (6 months [n=1,357] or 12 months or longer [n=1,355]) and type of stent (BP-BES [n=901]), DP-EES [n=904], or DP-ZES [n=907]). The primary endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. RESULTS: At 18 months, the primary endpoint was attained by 2.6% with BP-BES, 2.0% with DP-EES, and 2.1% with DP-ZES (HR 1.29, 95% CI: 0.70-2.39, p=0.42 for BP-BES vs DP-EES and HR 1.23, 95% CI: 0.67-2.26, p=0.50 for BP-BES vs DP-ZES). The treatment effect of BP-BES for the primary endpoint was consistent among patients receiving 6-month DAPT as well as those receiving 12-month or longer DAPT (BP-BES vs. DP-EES, pinteraction=0.48 and BP-BES vs DP-ZES, pinteraction=0.87). After excluding 179 patients (101 in the BP-BES group) who did not receive allocated DES, the per-protocol analysis showed similar results. CONCLUSIONS: The risk of a composite of cardiac death, myocardial infarction, or stent thrombosis was not significantly different between patients receiving BP-BES versus DP-EES or DP-ZES across a short or prolonged duration of DAPT after ACS.


Acute Coronary Syndrome , Percutaneous Coronary Intervention , Absorbable Implants , Acute Coronary Syndrome/drug therapy , Humans , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Stents , Treatment Outcome
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