Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial
Park K.W.,Seoul National University |
Chae I.-H.,Seoul National University |
Lim D.-S.,Korea University |
Han K.-R.,Kangdong Sacred Heart Hospital |
And 21 more authors.
Journal of the American College of Cardiology | Year: 2011
Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607) © 2011 American College of Cardiology Foundation.
Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study
Gwon H.-C.,Sungkyunkwan University |
Hahn J.-Y.,Sungkyunkwan University |
Park K.W.,Seoul National University |
Song Y.B.,Sungkyunkwan University |
And 22 more authors.
Circulation | Year: 2012
BACKGROUND-: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. METHODS AND RESULTS-: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS-: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607. © 2011 American Heart Association, Inc.
PubMed | Sacred Heart University at Connecticut, Ajou University and Kangnam Sacred Heart Hospital
Type: Journal Article | Journal: Journal of Korean Neurosurgical Society | Year: 2017
The purpose of this study was to investigate the prevalence of and the relevant risk factors for lumbar spondylosis (LS) among middle-aged and elderly rural Korean residents and to explore the association between radiographic LS and lower back pain (LBP) in relation to age and gender.This community-based, cross-sectional study evaluated 1512 subjects with available radiograph. The prevalence of LBP was obtained using a questionnaire and disability resulting from LBP was measured using a validated Korean version of the Oswestry disability index (ODI). In lumbar spine radiographs, vertebral levels from L1/2 to L4/5 were evaluated for the presence of osteophytes and joint-space narrowing (JSN), and Kellgren-Lawrence (KL) grading was applied.Of 4261 subjects aged 40-79 years, data from 1512 subjects were included. The prevalence of radiographic LS indicated by grade 2 osteophytes and JSN were 53.9 and 15.8%, respectively. Seventy-three percent of subjects had KL grade 2 spondylosis and LBP was present in 36.5% of subjects. Although LS was more common among males, the prevalence of LBP was higher among females. Age, male gender and history of hand or knee arthritis were risk factors for LS. LS was significantly associated with LBP mostly among females over 60 years old and correlated with the ODI after adjusting for age and gender.Our study among rural Korean residents revealed a high prevalence of LS and LBP. The association between LS and LBP was observed mostly among females and LS was significantly correlated with the severity of back pain.
Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: Prospective, randomized, double-blind, placebo-controlled, multicenter study
Lee W.K.,Hallym University |
Lee S.H.,Hallym University |
Cho S.T.,Kangnam Sacred Heart Hospital |
Lee Y.S.,Hangang Sacred Heart Hospital |
And 5 more authors.
Journal of Sexual Medicine | Year: 2013
Introduction: There is partial evidence to support the use of phophodiesterase-5 inhibitor (PDE5-I) for the treatment of premature ejaculation (PE). Aim: We compared on-demand dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction (ED). Methods: Our prospective, randomized, double-blind, placebo-controlled, multicenter trial enrolled 118 subjects with lifelong PE without ED. PE was diagnosed using Diagnostic andStatisticalManual ofMentalDisorders, fourth edition, text revision. Patients were divided into two groups: dapoxetine 30mg plus placebo (group A, n=56) and dapoxetine 30mg plus mirodenafil 50mg (group B, n=62). Main Outcome Measures: During 12 weeks, intravaginal ejaculatory latency time (IELT) and the time from foreplay to beginning intercourse (FTIT) with a stopwatch, and Premature Ejaculation Profile (PEP) were measured. Overall sexual act time (OSAT; sum of FTIT and IELT) was calculated. Any treatment-emergent adverse events (TEAEs) were also recorded. Results: Over 12 weeks, IELT, OSAT, and PEP index score significantly improved in group B compared with group A (increased geometric mean IELT in group A and B=3.6 and 6.1 minutes, P=0.026; increased geometric mean OSAT in group A and B=5.5 and 9.9 minutes, P=0.012; increased median PEP index score in group A and B=1.0 and 1.3, P=0.046). However, there was no significant difference between two groups with respect to improvement of FTIT (P=0.147). TEAEs did not differ between groups (all P>0.05), and there was no serious adverse event in any subjects. Conclusions: Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT, OSAT, and PEP index score, and similar TEAEs, compared with that of dapoxetine only. Our results support the suggestion that the PDE5-Is have a potential role in the treatment of PE without ED. © 2013 International Society for Sexual Medicine.
Kim J.-S.,Severance Hospital |
Kim J.,Severance Hospital |
Choi D.,Severance Hospital |
Lee C.J.,Severance Hospital |
And 12 more authors.
JACC: Cardiovascular Interventions | Year: 2010
Objectives: This study sought to determine the efficacy of high-dose atorvastatin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background: Previous randomized trials have demonstrated that statin pre-treatment reduced major adverse cardiac events (MACEs) in patients with stable angina pectoris and acute coronary syndrome. However, no randomized studies have been carried out with STEMI patients in a primary PCI setting. Methods: A total 171 patients with STEMI were randomized to 80-mg atorvastatin (n = 86) or 10-mg atorvastatin (n = 85) arms for pre-treatment before PCI. All patients were prescribed clopidogrel (600 mg) before PCI. After PCI, both groups were treated with atorvastatin (10 mg). The primary end point was 30-day incidence of MACE including death, nonfatal MI, and target vessel revascularization. Secondary end points included corrected thrombolysis in myocardial infarction frame count, myocardial blush grade, and ST-segment resolution at 90 min after PCI. Results: MACE occurred in 5 (5.8%) and 9 (10.6%) patients in the 80-mg and 10-mg atorvastatin pre-treatment arms, respectively (p = 0.26). Corrected thrombolysis in myocardial infarction frame count was lower in the 80-mg atorvastatin arm (26.9 ± 12.3 vs. 34.1 ± 19.0, p = 0.01). Myocardial blush grade and ST-segment resolution were also higher in the 80-mg atorvastatin arm (2.2 ± 0.8 vs. 1.9 ± 0.8, p = 0.02 and 61.8 ± 26.2 vs. 50.6 ± 25.8%, p = 0.01). Conclusions: High-dose atorvastatin pre-treatment before PCI did not show a significant reduction of MACEs compared with low-dose atorvastatin but did show improved immediate coronary flow after primary PCI. High-dose atorvastatin may produce an optimal result for STEMI patients undergoing PCI by improving microvascular myocardial perfusion. (Efficacy of High-Dose AtorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction [STATIN STEMI]; NCT00808717). © 2010 American College of Cardiology Foundation.
Jeong J.,Seoul National University |
Hyun Bae S.,Kangnam Sacred Heart Hospital |
Hyun Bae S.,Seoul National University |
Seo J.-M.,Seoul National University |
And 2 more authors.
Journal of Neural Engineering | Year: 2016
Objective. The aim of this study is to evaluate the long-term reliability of a recently presented liquid crystal polymer (LCP) -based retinal prosthesis in vitro as well as in vivo. Because an all-polymer implant introduces another intrinsic leak type due to gas permeation, for which the traditional helium leak test for metallic packages was not designed to quantify, a new method to investigate its durability is required. Approach. We designed and carried out a series of reliability tests specifically for all-polymer implants by quantitatively investigating moisture ingress through various pathways of the polymer surface, and the polymer-polymer and polymer-metal adhesions. Moisture permeation through the bulk material was estimated by analytic calculation, while water ingress through the adhesively sealed LCP-LCP and LCP-metal interfaces was investigated using the separate parts of an electrode array and a package in an accelerated aging condition. In vivo tests were done in rabbits to examine the long-term biocompatibility and implantation stability by fundus observation and optical coherence tomography (OCT) imaging. Main results. The analytic calculation estimated good barrier properties of the LCP. Samples of the LCP-based electrode array failed after 114 days in 87°C saline as a result of water penetration through the LCP-metal interface. An eye-conformable LCP package survived for 87 days in an accelerated condition at 87°C. The in vivo results confirmed that no adverse effects were observed around the retina 2.5 years after the implantation of the device. Significance. These long-term evaluation results show the potential for the chronic use of LCP-based biomedical implants to provide an alternative to traditional metallic packages. © 2016 IOP Publishing Ltd.
Bae S.H.,Kangnam Sacred Heart Hospital |
Hwang J.S.,Seoul National University |
Yu H.G.,Seoul National University
Retina | Year: 2012
PURPOSE: To document comparative analysis of macular microstructures before and after silicone oil (SO) removal via spectral-domain optical coherence tomography and to assess the retinal changes associated with visual outcome. METHODS: Forty-six eyes that underwent vitrectomy with SO tamponade were included. Ophthalmic examinations were performed before SO removal and at Months 1, 3, and 6 postoperatively including best-corrected visual acuity and spectral-domain optical coherence tomography. The macular microstructures identified by spectral-domain optical coherence tomography were compared before and after SO removal, and tomographic parameters related to visual outcome were analyzed. RESULTS: Under SO tamponade, spectral-domain optical coherence tomography demonstrated macular tomographic findings: epiretinal membrane in 12 eyes (26.1%), cystoid macular edema in 9 (19.6%), undulated inner retina in 8 (17.4%), and submacular fluid in 4 (8.7%). The mean duration of SO tamponade was significantly longer in eyes with macular changes (6.3 ± 4.6 months) than those without changes (5.2 ± 4.4 months) (P = 0.02). A total of 13 eyes had peeling of epiretinal membrane or internal limiting membrane combined with SO removal. After SO removal, most of microstructural changes were resolved. In the eyes with macular epiretinal membrane or cystoid macular edema, final best-corrected visual acuity was significantly improved compared with baseline (P = 0.017, 0.049), which paralleled the decrease of central foveal thickness. Restoration of photoreceptor layer and external limiting membrane was achieved in 2 (4.9%) and 5 eyes (12.5%), and those with continuous photoreceptor layer or external limiting membrane had the better final best-corrected visual acuity. CONCLUSION: Under SO tamponade, macular microstructural changes were identified by spectral-domain optical coherence tomography and were associated with duration of SO tamponade. Most of the microstructural changes were recovered after SO removal, if needed, combined with macular surgery. Anatomic resolution was accompanied by postoperative visual improvement. © Lippincott Williams & Wilkins.
Han S.,Catholic University of Korea |
Kim J.,Catholic University of Korea |
Yim H.,Hallym University |
Hur J.,Hallym University |
And 6 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2013
The pharmacokinetic (PK) property of fluconazole might be significantly altered in major burn patients by medical interventions and physiologic changes.In this study, our aims were to investigate fluconazole PK in burn patients using a population approach and to recommend the optimal fluconazole regimen based upon the predicted therapeutic outcome.At steady state, blood samples for PK analysis were obtained from 60 burn patients receiving between 100 and ̃400 mg fluconazole daily.A mixed-effect modeling was performed and the therapeutic outcome of antifungal therapy was predicted for 10,000 virtual patients using NONMEM (version 7.2).MIC values were sampled from the MIC distribution at the study site.An area under the free drug concentration-time curve (fAUC)/MIC measurement of >25 h was used as the criterion for therapeutic success.When the same dose was given, the plasma concentration of fluconazole was predicted to be lower in burn patients compared to the nonburn population because of the large PK parameter (clearance, volume of distribution) estimates and continuous renal replacement therapy (CRRT).This tendency was particularly predominant when the patients were within 30 postburn days.Based upon our findings, 400 mg/day fluconazole is recommended to obtain therapeutic successes in major burn patients.Copyright © 2013, American Society for Microbiology.All Rights Reserved.
Kim J.-K.,Hallym University |
Choi S.R.,Kangnam Sacred Heart Hospital |
Choi S.R.,Hallym University |
Choi M.J.,Chuncheon Sacred Heart Hospital |
And 8 more authors.
Clinical Nutrition | Year: 2014
Background & aims: We investigated the prevalence of sarcopenia in elderly patients with end-stage renal disease (ESRD) and its relationship with various markers of nutrition, cognitive function, depressive symptoms, inflammation and β2-microglobulin. Methods: A cross-sectional study was conducted with 95 patients having ESRD aged over 50 years. Sarcopenia was defined as a decline in both muscle mass and strength. Results: The mean age was 63.9±10.0 years; 56.8% were men and 52.6% had diabetes. Sarcopenia was highly prevalent in elderly patients with ESRD (37.0% in men and 29.3% in women). Subjective Global Assessment (SGA), inflammatory markers and β2-microglobulin levels were significantly associated with sarcopenia, even after adjustment for age, gender, diabetes, and body mass index. Additionally, patients with depressive symptoms showed a higher risk of sarcopenia relative to those without depressive symptoms (odds ratio, OR=6.87, 95% confidence interval, CI=2.06-22.96) and sarcopenia was more likely to be present in patients with mild cognitive dysfunction (OR=6.35, 95% CI=1.62-34.96). Conclusions: Sarcopenia is highly prevalent in elderly patients with ESRD and is closely associated with SGA, inflammatory markers, β2-microglobulin, depression and cognitive dysfunction. © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism.
Lim J.W.,Hallym University |
Kim H.K.,Kangnam Sacred Heart Hospital |
Cho D.Y.,Kangnam Sacred Heart Hospital
Clinical and Experimental Ophthalmology | Year: 2011
Background: To determine the effect on macular function of removal of the internal limiting membrane (ILM) during epiretinal membrane surgery. Design: Prospective, interventional study. Participants: Twenty-two eyes of 22 patients with idiopathic epiretinal membranes undergoing surgery. Methods: Histologic analysis of the ILM specimens were classified based on amount of retinal tissue fragments attached to the removed ILM. The ophthalmic examinations were assessed prospectively. Main Outcome Measures: The visual acuity, optical coherence tomography, and multifocal electroretinography at baseline, 1 and 3 months after surgery. Results: The visual acuity at baseline, 1 and 3 months after surgery were not different between the small and large retinal debris groups. On multifocal electroretinography, there was no significant difference in response of the N1 amplitude, N1 latency, and P1 amplitude between the small and large retinal debris groups at baseline, and 1 and 3 months after surgery. However, compared to the small debris group, the P1 latencies in the foveal areas were delayed in the large debris group at 1 and 3 months (P=0.020, P=0.047, respectively). The central retinal thickness was significantly reduced in the large debris group, while the status of the photoreceptor line was not different based on optical coherence tomography between the small and large debris groups 3 months after surgery (P=0.047). Conclusion: Large amounts of retinal debris attached to the removed ILM did not affect visual acuity. However, the ultrastructural findings of Muller cell damage might be related to subtle macular dysfunction on multifocal electroretinography after surgery. © 2010 The Authors. Clinical and Experimental Ophthalmology © 2010 Royal Australian and New Zealand College of Ophthalmologists.