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Aims: We compared long-term clinical outcomes between patients treated with Orsiro sirolimus-eluting stent (O-SES) and those treated with durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES)., Methods and Results: The ORIENT trial was a randomized controlled noninferiority trial to compare angiographic outcomes between O-SES and R-ZES. We performed a post hoc analysis of 3-year clinical outcomes and included 372 patients who were prospectively enrolled and randomly assigned to O-SES (n = 250) and R-ZES (n = 122) groups in a 2:1 ratio. The primary endpoint was target lesion failure defined as a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization. At 3 years, target lesion failure occurred in 4.7% and 7.8% of O-SES and R-ZES groups, respectively (hazard ratio, 0.58; 95% confidence intervals, 0.24-1.41; p = .232 by log-rank test). Secondary endpoints including cardiac death, myocardial infarction, and target lesion revascularization showed no significant differences between the groups. Stent thrombosis occurred in two patients in R-ZES group (0.0% vs. 1.6%, p = .040)., Conclusion: This study confirms long-term safety and efficacy of the two stents. We found a trend for lower target lesion failure with O-SES compared to R-ZES, although statistically insignificant., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Background: The association between oxidized low-density lipoprotein (OxLDL) and plaque instability in coronary and carotid artery disease is well established. However, the association between OxLDL and the histologic changes of plaque in peripheral artery disease has not been clearly elucidated. This study aims to investigate the association between plasma OxLDL and histologic plaque instability in patients with peripheral artery disease., Methods: Prospectively obtained plaques from 48 patients who underwent endovascular atherectomy (n = 20), surgical endarterectomy (n = 9), or bypass surgery (n = 19) for treatment of atherosclerotic femoropopliteal artery disease were evaluated for histologic fibrosis, sclerosis, calcification, necrosis, cholesterol cleft, and foamy macrophages using hematoxylin and eosin, oil red O, and immunohistochemical staining. Unstable plaques were defined as plaques that were positive for foamy macrophages and with lipid content of more than 10% of the total plaque area. Plasma OxLDL levels were measured using an enzyme-linked immunosorbent assay (Mercodia AB, Uppsala, Sweden)., Results: Of the 48 patients, 26 (54%) had unstable plaques. The unstable plaque group was younger, had fewer angiographic total occlusions, less calcification, and more CD68-positive and LOX-1-positive cells than the stable plaque group. Plasma OxLDL levels were significantly higher in the unstable plaque group than in the stable plaque group (57.4 ± 13.9 vs. 47.2 ± 13.6 U/L, P = 0.014). Multivariate analysis revealed that plasma OxLDL level, smoking, angiographic nontotal occlusion, and statin nonuse were independent predictors of unstable plaque., Conclusions: Among patients with peripheral artery disease, the histologic instability of femoropopliteal plaque was independently associated with high plasma OxLDL, smoking, nontotal occlusion, and statin nonuse. Further large-scale studies are necessary to evaluate the role of noninvasive OxLDL measurement for predicting plaque instability and future adverse vascular event., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The POST (the effects of postconditioning on myocardial reperfusion in patients with ST-Segment elevation myocardial infarction) study showed that ischemic postconditioning did not improve myocardial reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, it has not been determined whether postconditioning is effective in women. This study sought to evaluate the impact of sex differences on ischemic postconditioning during the primary PCI. We analyzed clinical outcomes at 1 year in the 537 men and 163 women with STEMI, who were randomized to the postconditioning or to the conventional PCI group. Women were older, had higher rates of hypertension, were less likely to be current smokers, and had longer symptom-to-reperfusion time. The rate of major adverse cardiac events (MACE: a composite of death, myocardial infarction, severe heart failure, stent thrombosis, or target vessel revascularization) at 1 year was higher in women compared to men (9.8% vs. 5.4%, p = 0.044). MACE was significantly higher in women compared to men in the postconditioning group (12.2% vs. 5.4%, p = 0.042), but not in the conventional PCI group (7.9% vs. 5.4%, p = 0.391). However, women was not an independent predictor after adjusting baseline risk factors, angiographic and procedural parameters (HR 2.67, 95% CI 0.68-10.5, p = 0.158). Despite women having more adverse clinical characteristics, their prognosis was similar to men in the conventional group. Although women showed a higher rate of the MACE compared to men, women were not an independent predictor in the postconditioning group.

Most studies on gender difference of the in-hospital outcome of percutaneous coronary intervention (PCI) were performed in the pre-drug-eluting stents (DES) era. This study was performed to investigate whether gender influences the in-hospital outcome of PCI in the DES era.A total of 44,967 PCI procedure between January and December of 2014 from the nationwide PCI registry database in Korea were analyzed. The study population was male predominant (70.2%). We examined the association of gender with unadjusted and adjusted in-hospital mortality and composite events of PCI, including mortality, nonfatal myocardial infarction, stent thrombosis, stroke, urgent repeat PCI and bleeding requiring transfusion.Most of the study patients (91.3%) received DES. The incidence rates of in-hospital mortality (2.95% vs 1.99%, P <.001) and composite events (7.01% vs 5.48%, P <.001) were significantly higher in women compared to men. Unadjusted analyses showed that women had a 1.49 times higher risk of in-hospital mortality and a 1.30 times higher risk of composite events than men (P <.001 for each). After adjustment for potential confounders, female gender was not a risk factor for mortality (P = .258), but the risk of composite events remained 1.20 times higher in women than in men (P = .008).Among patients undergoing PCI in the contemporary DES era, female gender was associated with an increased risk of in-hospital composite events, but not in-hospital mortality. More careful attention should be emphasized to minimize procedure-related risks and to improve prognosis in women undergoing PCI.

Background: This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs)., Methods: This is a prospective, multicenter, open-label, randomized study comparing the use of drug-eluting balloon (DEB) versus second-generation everolimus-eluting stent for the treatment of DES ISR. The primary end point was in-segment late loss at 9-month routine angiographic follow-up., Results: A total of 172 patients were enrolled, and 74 (43.0%) patients underwent the angiographic follow-up. The primary end point was not different between the 2 treatment groups (DEB group 0.15±0.49 mm vs DES group 0.19±0.41 mm, P=.54). The secondary end points of in-segment minimal luminal diameter (MLD) (1.80±0.69 mm vs 2.09±0.46 mm, P=.03), in-stent MLD (1.90±0.71 mm vs 2.29±0.48 mm, P=.005), in-segment percent diameter stenosis (34%±21% vs 26%±15%, P=.05), and in-stent percent diameter stenosis (33%±21% vs 21%±15%, P=.002) were more favorable in the DES group. The composite of death, myocardial infarction, or target lesion revascularization at 1 year was comparable between the 2 groups (DEB group 7.0% vs DES group 4.7%, P=.51)., Conclusions: Treatment of DES ISR using DEB or second-generation DES did not differ in terms of late loss at 9-month angiographic follow-up, whereas DES showed better angiographic results regarding minimal MLD and percent diameter stenosis. Both treatment strategies were safe and effective up to 1year after the procedure., (Copyright © 2017 Elsevier Inc. All rights reserved.)

This study aimed to determine the incidence and the risk factors of hospitalization for variant angina (VA) in Korean patients. Using the National Inpatient Sample (NIS) database, manufactured and released by the Health Insurance Review and Assessment Service (HIRA) in Korea, the incidence of hospitalization and rehospitalization for VA were calculated. The numbers of patients hospitalized for VA were estimated to be 14,362 in 2009, 17,492 in 2010, and 20,592 in 2011. The standardized incidence rates of hospitalization for VA were 31.4% in 2009, 36.5% in 2010, and 41.7% in 2011 (relative increase rate from 2009 to 2011, 33.0%, P for trend < 0.0001). VA patients predominantly belonged to the middle-age group between 40 and 69 years (75.5%), and there were 54.3% male. Based on the hospitalization episodes, the number of rehospitalization was calculated to be 879, 1141, and 1446 patients out of 1867, 2274, and 2677 patients from 2009, 2010, and 2011, respectively. The rates of rehospitalization for VA were 47.1% in 2009, 50.2% in 2010, and 54.0% in 2011 (P for trend < 0.0001). Age was an independent factor associated with rehospitalization for VA. Hospitalization for VA occurred most frequently in fall from 2009 to 2011. In conclusion, hospitalization rates for VA steadily increased from 2009 to 2011 in Korea, and about a half of VA patients was hospitalized more than once a year in 2009 to 2011. Proper health policy and patient education are warranted to control the high rate of hospitalization for VA., Competing Interests: The authors have no funding and conflicts of interest to disclose.

This study was conducted to investigate the prognostic value of heart block among patients with acute myocardial infarction (AMI) treated with drug-eluting stents. A total of 13,862 patients with AMI, registered in the nation-wide AMI database from January 2005 to June 2013, were analyzed. Second- (Mobitz type I or II) and third-degree atrioventricular block were considered as heart block in this study. Thirty-day major adverse cardiac events (MACE) including all causes of death, recurrent myocardial infarction, and revascularization were evaluated. Percutaneous coronary intervention with implantation of drug-eluting stent was performed in 89.8% of the patients. Heart block occurred in 378 patients (2.7%). Thirty-day MACE occurred in 1,144 patients (8.2%). Patients with heart block showed worse clinical parameters at initial admission, and the presence of heart block was associated with 30-day MACE in univariate analyses. However, the prognostic impact of heart block was not significant after adjustment of potential confounders (p = 0.489). Among patients with heart block, patients with a culprit in the left anterior descending (LAD) coronary artery had worse clinical outcomes than those of patients with a culprit in the left circumflex or right coronary artery. LAD culprit was a significant risk factor for 30-day MACE even after controlling for confounders (odds ratio 5.28, 95% confidence interval 1.22 to 22.81, p = 0.026). In conclusion, despite differences in clinical parameters at the initial admission, heart block was not an independent risk factor for 30-day MACE in adjusted analyses. However, a LAD culprit was an independent risk factor for 30-day MACE among patients with heart block., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background/aims: Most current knowledge regarding amiodarone toxicity derives from clinical trials. This study was performed to investigate the incidence and risk factors of overall adverse effects of amiodarone in real-world practice using a large sample size., Methods: Between January 1, 2000 and March 10, 2012, a total of 930 consecutive patients who had been treated with amiodarone for arrhythmia were reviewed retrospectively. An amiodarone-associated adverse event was considered in cases of discontinuation or drug dose reduction due to an unexpected clinical response., Results: The mean daily dose of amiodarone was 227 ± 126 mg, and the mean duration was 490 ± 812 days. During the mean follow-up duration of 982 ± 1,137 days, a total of 154 patients (16.6%) experienced adverse effects related to amiodarone, the most common being bradycardia or conduction disturbance (9.5%). Major organ toxicities in the thyroid (2.5%), liver (2.2%), eyes (0.6%), and lungs (0.3%) were rare. All patients recovered fully without complications after amiodarone discontinuation or dose reduction. The only independent predictor of adverse effects was the duration of amiodarone treatment (odds ratio, 1.21; 95% confidence interval, 1.03 to 1.41; p = 0.016, per year)., Conclusions: Low-dose amiodarone is well tolerated in a real-world clinical population. Further studies with a prospective design are needed to confirm this finding.

Background: The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease., Methods/design: The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction)., Discussion: The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease., Trial Registration: Clinicaltrials.gov NCT01826552.

Drug interactions (DIs) constitute a serious problem and are considered to contribute to 6-30% of all adverse events (AEs). The use of existing data, including claims data, is expected to be helpful in detecting unknown DIs by complementing conventional spontaneous reporting systems. In the present study, an 'Ω shrinkage measure' was applied to the Korean National Health claims database to test the potential of the claims database as a DI surveillance resource. A well-known DI between non-steroidal anti-inflammatory drugs (NSAIDs) and diuretics was analyzed using the model. International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) codes related to DIs were assigned to the AEs of the DIs: I50, I50.0, I50.1, I50.9, R60, R60.1, R60.9, and J81. An elevated occurrence of AEs versus the expected level was observed using a two-sided 95% lower credibility interval limit above zero, Ω025=0.245, which was the screening limit. The result was consistent with the actual DI between the two drugs. The finding indicates that the claims data have the potential to be used as a DI surveillance resource and that the Ω shrinkage measure may be a promising tool for detecting DIs in claims data., (Copyright © 2013 Elsevier Inc. All rights reserved.)

The absence of coronary artery calcification (CAC) has been used to as an indication to rule out significant coronary artery disease (CAD). However, diagnostic usefulness of 'zero calcium score criteria' as a decision-making strategy to rule out significant CAD as the etiology of acute chest pain has not been studied in depth, especially in Asian ethnicity. We prospectively enrolled 136 Korean patients (58% men, 56 ± 13 years) who presented to the emergency department (ED) with acute chest pain and non-diagnostic ECG. All patients underwent 64-slice CT for calcium scoring and coronary CT angiography (cCTA). We investigated the association of CAC with the presence of ≥50% CAD on cCTA and with a final diagnosis of an acute coronary syndrome (ACS). Ninety-two patients out of 136 (68%) did not show detectable CAC, and 14 out of these 92 without CAC (15%) had ≥50% CAD on cCTA. Sensitivity, specificity, positive predictive value and negative predictive value of zero calcium score criteria for the detection of ≥50% CAD were 0.66 (95% confidence interval, 0.50-0.80), 0.83 (0.74-0.90), 0.64 (0.48-0.77), 0.85 (0.75-0.91), respectively. Patients who had ≥50% CAD without detectable CAC were younger (P = 0.001), and had a higher prevalence of smoking (P = 0.048) as compared to patients with a degree of CAC. Most of the patients with ≥50% CAD of non-calcified plaque were younger than 60 years of age (79%, 11/14), however, 3 of them were older than 60 years of age. Forty-five patients (33%) were subsequently diagnosed as having ACS, and 38% (17/45) of them had no CAC. Zero calcium score did not necessarily guarantee the absence of significant CAD, even in patients older than 60 years, in Asian ethnicity presenting to the ED with chest pain.

Background: Significant microvascular obstruction (MVO) during primary percutaneous coronary intervention (PCI) may suggest severe myocardial damage. The predictive value of N-terminal pro-B-type natriuretic peptide levels (NT-proBNP) for MVO has not been previously evaluated., Hypothesis: The purpose of the study was to determine whether NT-proBNP levels measured upon hospital admission of ST-segment elevation myocardial infarction (STEMI) patients receiving primary PCI have predictive value for MVO., Methods: NT-proBNP levels were obtained upon admission to the emergency department, for 41 acute STEMI patients. Cardiac contrast-enhanced magnetic resonance imaging (CE-MRI) was performed within 4 days after PCI. The optimal cut-off value to predict grade 3 MVO was determined using a receiver operating characteristic (ROC) curve. Multivariate regression analysis was performed to determine predictors for grade 3 MVO., Results: MVO grade correlated with left ventricular ejection fraction (LVEF; r =-0.383, P = 0.013), peak serum creatine kinase MB iso-enzyme (CK-MB; r = 0.470, P = 0.002), and NT-proBNP levels (r = 0.357, P = 0.022). The optimal cut-off value to predict grade 3 MVO was an NT-proBNP level of ≥80 pg/mL. Multivariate regression analysis, including LVEF, peak CK-MB, and an NT-proBNP ≥80 pg/mL revealed that only an NT-proBNP ≥80 pg/mL was an independent factor related to grade 3 MVO., Conclusion: NT-proBNP levels upon hospital admission have a predictive value for MVOs. Further study is needed to determine if protective treatment strategies are warranted in STEMI patients with high NT-proBNP levels at presentation., (©2010, Wiley Periodicals, Inc.)

Recent studies have suggested that percutaneous coronary intervention (PCI) in patients with unprotected left main coronary artery (LMCA) disease renders outcomes comparable to those from coronary artery bypass grafting (CABG). It is necessary to stratify individual patient risk and select the optimal revascularization strategy. We compared the clinical outcomes of patients with unprotected LMCA disease who had undergone PCI with drug-eluting stents or CABG. We identified 462 patients who were treated from January 2003 to December 2006 for unprotected LMCA or LMCA-equivalent disease: 257 had undergone CABG and 205 had undergone PCI with drug-eluting stents. Analyses using propensity scores were performed to minimize the selection bias in the present observational study. After a median follow-up of 33.5 months, no significant difference was found between the CABG and PCI groups in the risk of death (12.1% vs 14.1%, respectively; p = 0.428) or the risk of a composite of death, myocardial infarction, or cerebrovascular accident (17.5% vs 20.0%, respectively; p = 0.434). The rate of major adverse cardiac and cerebrovascular events was significantly lower in the CABG group than in the PCI group (21.8% vs 35.1%, respectively; p = 0.001); the difference was mainly driven by a decrease in the rate of repeat revascularizations (5.1% vs 22.4%; p <0.001). The analyses after propensity score adjustment and matching corroborated the crude group results. In conclusion, PCI with drug-eluting stents showed a safety profile comparable to that of CABG in patients with unprotected LMCA disease. However, the risk of repeat revascularization was significantly greater in the PCI group., (Copyright 2010 Elsevier Inc. All rights reserved.)