Coping strategies in response to peer victimization: Comparing adolescents in the United States and Korea.

We examined cultural specificity in how adolescents' coping strategies in response to peer victimization are associated with adjustment with a sample of 7th-8th graders from the United States (n = 292, 60% female, Mage = 13.6, SD = 0.65) and South Korea (n = 462, 50.2% female, Mage = 13.7, SD = 0.58). Participants read scenarios describing victimization and rated the likelihood of utilizing different coping strategies. US adolescents rated conflict resolution, cognitive distancing, and revenge higher than Korean adolescents, while Korean adolescents endorsed social support seeking more than US adolescents. Social support seeking was positively associated with global self-worth in both countries; however, social support seeking was negatively related to depression and social anxiety only for Korean youth.

Attributions about Peer Victimization in US and Korean Adolescents and Associations with Internalizing Problems.

Although there is cultural variability in how individuals make attributions for their own and others' behaviors, cultural variation in youth's attributions about peer victimization and their relation with internalizing problems has gone unexamined. To address this issue, adolescents from the U.S. (n = 292, 60% female, 79.5% White, Mage = 13.6, SD = 0.65) and Korea (n = 462, 50.2% female, Mage = 13.7, SD = 0.58) reported on their peer victimization, depressive symptoms, social anxiety, self-worth, and rated their attributions to vignettes about peer victimization. Multigroup confirmatory analyses found that Korean and American youth conceptualized characterological self-blame, behavioral self-blame, and externalization of blame similarly. However, Korean youth differentially endorsed each of the three types of attributions, while U.S. adolescents endorsed characterological self-blame and behavioral self-blame at similar levels. Attributions had unique relations with internalizing problems (depression, social anxiety, global self-worth) in each culture. In multigroup SEM analyses, characterological self-blame predicted all internalizing problems for U.S. adolescents, while behavioral self-blame was not uniquely related to internalizing problems. For Korean adolescents, behavioral self-blame significantly predicted all internalizing problems, whereas characterological self-blame predicted global self-worth only. The results suggest that attributions about victimization have different adjustment implications in Korea than in the U.S.

Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial.

BACKGROUND: The risks and benefits of long-term dual antiplatelet therapy remain unclear. METHODS AND RESULTS: This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66-1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42-1.20; P=0.20). CONCLUSIONS: Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versus aspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186146.

Duration of dual antiplatelet therapy after implantation of drug-eluting stents.

BACKGROUND: The potential benefits and risks of the use of dual antiplatelet therapy beyond a 12-month period in patients receiving drug-eluting stents have not been clearly established. METHODS: In two trials, we randomly assigned a total of 2701 patients who had received drug-eluting stents and had been free of major adverse cardiac or cerebrovascular events and major bleeding for a period of at least 12 months to receive clopidogrel plus aspirin or aspirin alone. The primary end point was a composite of myocardial infarction or death from cardiac causes. Data from the two trials were merged for analysis. RESULTS: The median duration of follow-up was 19.2 months. The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy (hazard ratio, 1.65; 95% confidence interval [CI], 0.80 to 3.36; P=0.17). The individual risks of myocardial infarction, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differ significantly between the two groups. However, in the dual-therapy group as compared with the aspirin-alone group, there was a nonsignificant increase in the composite risk of myocardial infarction, stroke, or death from any cause (hazard ratio, 1.73; 95% CI, 0.99 to 3.00; P=0.051) and in the composite risk of myocardial infarction, stroke, or death from cardiac causes (hazard ratio, 1.84; 95% CI, 0.99 to 3.45; P=0.06). CONCLUSIONS: The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes. These findings should be confirmed or refuted through larger, randomized clinical trials with longer-term follow-up. (ClinicalTrials.gov numbers, NCT00484926 and NCT00590174.)

Impact of positive peri-stent vascular remodeling after sirolimus-eluting and paclitaxel-eluting stent implantation on 5-year clinical outcomes: intravascular ultrasound analysis from the Poststent Optimal Stent Expansion Trial multicenter randomized trial.

BACKGROUND: Positive peri-stent vascular remodeling (PPVR) after drug-eluting stent (DES) implantation is an important mechanism of late-acquired stent malapposition (LASM). METHODS AND RESULTS: A total of 226 patients (sirolimus-eluting stent [SES], n=105; paclitaxel-eluting stent [PES], n=121) from the Poststent Optimal Stent Expansion Trial who underwent a post-intervention and 9-month follow-up intravascular ultrasound were followed clinically for 5 years. PPVR was arbitrarily defined as a >10% increase in the external elastic membrane volume index at follow-up. PPVR and LASM occurred more frequently with SESs than with PESs. The 5-year rate of major adverse cardiac events was lower with SES than with PES (10.7% vs. 23.2%, P=0.002). The late and very late stent thrombosis (ST) rate was similar between the 2 DES types, but it was higher in patients with PPVR than in those without PPVR (8.8% vs. 1.3%, P=0.009) regardless of the DES type. Early discontinuation (<1 year) of dual antiplatelet therapy (DAPT; hazard ratio [HR], 24.14; 95% confidence interval [CI]: 4.90-118.87; P<0.001), PPVR (HR, 14.94; 95%CI: 1.85-120.46; P=0.011), LASM (HR, 8.01; 95%CI: 1.93-33.16; P=0.004), and stent length (HR, 1.14; 95%CI: 0.98-1.32 per mm; P=0.078) were associated with increased risk of late and very late ST. CONCLUSIONS: PPVR and LASM development after DES implantation, along with early discontinuation of DAPT and longer stent length, are important risk factors of late and very late ST.

Impact of intravascular ultrasound guidance on long-term clinical outcomes in patients treated with drug-eluting stent for bifurcation lesions: data from a Korean multicenter bifurcation registry.

BACKGROUND: although intravascular ultrasound (IVUS) has been widely used for complex lesions during coronary intervention, IVUS for stenting at bifurcation lesions has not been sufficiently assessed. The aim of this study was to investigate the impact of IVUS guidance on long-term clinical outcomes during drug-eluting stent (DES) implantation for bifurcation lesions. METHODS: the Korean multicenter bifurcation registry listed 1,668 patients with non-left main de novo bifurcation lesions who underwent DES implantation between January 2004 and June 2006. Using propensity score matching with clinical and angiographic characteristics, 487 patients with IVUS guidance and 487 patients with angiography guidance were selected. The long-term clinical outcomes were compared between the 2 groups. RESULTS: baseline clinical and angiographic characteristics were well matched and showed no significant differences between the 2 groups. Two-stent technique and final kissing ballooning angioplasty were more frequently performed in the IVUS-guided group. Maximal stent diameters at both the main vessel and the side branch were larger in the IVUS-guided group. Periprocedural creatine kinase-MB elevation (>3 times of upper normal limits) was frequently observed in the angiography-guided group. The incidence of death or myocardial infarction was significantly lower in the IVUS-guided group compared to the angiography-guided group (3.8% vs 7.8%, log rank test P = .03, hazard ratio 0.44, 95% CI 0.12-0.96, Cox model P = .04). CONCLUSIONS: intravascular ultrasound guidance during DES implantation at bifurcation lesions may be helpful to improve long-term clinical outcomes by reducing the occurrence of death or myocardial infarction.

Angiographic and intravascular ultrasound follow up of paclitaxel- and sirolimus-eluting stent after poststent high-pressure balloon dilation: from the poststent optimal stent expansion trial.

OBJECTIVES: The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug-eluting stent (DES) and compare paclitaxel-eluting stent (PES) to sirolimus-eluting stent (SES). BACKGROUND: Although poststent high-pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES. METHODS: Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9-month follow-up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in-stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months. RESULTS: At 9-month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm(2) ) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm(2) and 0.21 ± 0.37, P < 0.001 in PES and SES]. CONCLUSIONS: OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high-pressure balloon dilatation.

A warm footbath improves coronary flow reserve in patients with mild-to-moderate coronary artery disease.

BACKGROUNDS: Recent studies have shown that thermal therapy by means of warm waterbaths and sauna has beneficial effects in chronic heart failure. However, a comprehensive investigation of the hemodynamic effects of thermal vasodilation on coronary arteries has not been previously undertaken. In this study, we studied the effect of a warm footbath (WFB) on coronary arteries in patients with coronary artery disease (CAD), as well as any adverse effect. METHODS: We studied 21 patients (33.3% men, mean age 60.8 ± 13.5 years) with CAD. Coronary flow Doppler examination of the left anterior descending coronary artery and coronary flow reserve (CFR) were performed and measured using adenosine before and after a WFB. RESULTS: Systolic and diastolic blood pressure and heart rate did not change with the WFB. Mean velocity of diastolic coronary flow significantly increased (diastolic mean flow velocity: 18.3 ± 7.1 cm/sec initial, 21.5 ± 8.0 cm/sec follow-up, P = 0.002) and CFR significantly improved (1.6 ± 0.4 vs. 2.2 ± 0.5, P < 0.001) after WFB. The WFB was well accepted and no relevant adverse effects were observed. The change of CFR after WFB correlated well with diastolic function (E', r = 0.51, P = 0.031; E/E', r =-0.675, P = 0.002). CONCLUSIONS: A WFB significantly improved CFR without any adverse effects in patients with mild-to-moderate CAD and can be applied with little risk of a coronary artery event if appropriately performed.

Comparison of the effect of preinterventional arterial remodeling on intimal hyperplasia after implantation of a sirolimus- or paclitaxel-eluting stent.

BACKGROUND: We compared the effect of arterial remodeling on intimal hyperplasia (IH) after the implantation of a sirolimus-eluting stent (SES) and a paclitaxel-eluting stent (PES). METHODS: The study population consisted of patients with positive or intermediate remodeling and negative remodeling. RESULTS: Sixty-nine patients had positive or intermediate remodeling and 107 patients had negative remodeling. At follow-up, late loss was significantly larger (0.58 +/- 0.65 vs. 0.38 +/- 0.55 mm; p = 0.026) in the patients with positive or intermediate remodeling. The IH volume (22.6 +/- 26.2 vs. 12.4 +/- 17.4 mm(3); p = 0.002) and the percent IH (12.9 +/- 14.8 vs. 7.0 +/- 9.6%; p = 0.002) were significantly higher in the patients with positive or intermediate remodeling. Compared to negative remodeling, the IH volume was higher in the PES patients with positive or intermediate remodeling, but this difference was not noted in the SES patients. Multiple-regression analysis revealed that arterial remodeling was a significant independent variable for predicting IH volume in the PES patients (p = 0.018). A positive correlation was found between the remodeling index and the IH volume in the PES patients (r = 0.234, p = 0.028), but not in the SES patients. CONCLUSIONS: This prospective observational intravascular ultrasound study showed that drug-eluting stents may have a different effect on reducing IH accumulation in lesions with preinterventional positive remodeling characteristics which may be related to the different properties of the drug and delivery platform.

The impact of dialysis modality on arterial stiffness in patients with end-stage renal disease.

BACKGROUND: Arterial stiffness determined by brachial-ankle pulse wave velocity (baPWV) has been established as a powerful predictor of cardiovascular mortality in hemodialysis (HD) patients. There are, however, few studies regarding the comparative impact of different renal replacement therapies (RRTs) on PWV. Therefore, we conducted a cross-sectional study to compare arterial wall properties and cardiac function between patients treated with continuous ambulatory peritoneal dialysis (CAPD) and those with HD who were matched for age, dialysis duration, and blood pressure. METHODS: baPWV and transthoracic echocardiography (TTE) were performed in HD patients (n = 23) after 1 h of midweek dialysis session and CAPD patients (n = 26) with empty abdomen after drainage of dialysate. The baseline data were retrospectively reviewed. RESULTS: baPWV was significantly higher in HD patients than in CAPD patients (18.1 +/- 2.8 vs. 16.1 +/- 2.7 m/s, p = 0.015). TTE revealed significantly increased E/E', left atrial volume index (LAVI), and inferior vena cava (IVC) diameter index in HD patients compared with CAPD patients (p < 0.05). In a multivariate regression analysis adjusted for dialysis modality, age, systolic BP, residual glomerular filtration rate, diabetes, and echocardiographic parameters, HD was independently associated with increased baPWV. CONCLUSION: This study showed that HD patients had significantly increased arterial stiffness and severe diastolic dysfunction compared with CAPD patients.

Long-term clinical outcomes and stent thrombosis of sirolimus-eluting versus bare metal stents in patients with end-stage renal disease: results of Korean multicenter angioplasty team (KOMATE) Registry.

BACKGROUND: There are still controversies about long-term clinical outcomes of sirolimus-eluting stents (SES) versus bare metal stents (BMS) implantation in patients with end-stage renal diseases (ESRD). OBJECTIVE: To compare long-term outcomes in patients with (ESRD) following SES versus BMS implantation. METHODS: Between March 2003 and July 2005, a total of 54 patients (80 lesions) with ESRD undergoing SES implantation [SES-ESRD] were enrolled and compared with 51 patients (54 lesions) with ESRD receiving BMS during the same periods [BMS-ESRD] in the Korean Multicenter Angioplasty Team Registry. The primary outcome was the composite of death, myocardial infarction (MI), or any stent thrombosis (ST) according to the Academic Research Consortium definition during a 3-year follow-up. RESULTS: The cumulative 3-year rate of composite of death, MI, or ST of the SES-ESRD group (24%) was nearly similar with that of the BMS-ESRD group (24%, P = 1.000). The 3-year rates of death (26% vs. 24%, P = 0.824) or MACE (37% vs. 43%, P = 0.331) in the SES-ESRD did not differ significantly from those in the BMS-ESRD. However, the SES-ESRD showed a sustained lower 3-year TVR rate (9%), compared with BMS-ESRD (24%, P = 0.042). The rate of any ST in SES-ESRD was not significantly higher than that in the BMS-ESRD (17% vs. 14%, P = 0.788). There was no significant difference in the rate of late or very late ST between SES-ESRD (15%) versus BMS-ESRD group (10%, P = 0.557). CONCLUSIONS: SES did not increase the risks for death, MI, or any ST in patients with ESRD during the long-term follow-up, compared with BMS.

Comparison of Resolute zotarolimus-eluting and Xience everolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES VI trial.

BACKGROUND: Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions. METHODS AND RESULTS: This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). CONCLUSION: For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.

Intravascular ultrasound evaluation of optimal drug-eluting stent expansion after poststent balloon dilation using a noncompliant balloon versus a semicompliant balloon (from the Poststent Optimal Stent Expansion Trial [POET]).

The impact of type of balloon such as noncompliant (NC; Quantum) or semicompliant (SC; Maverick(2)) used after stent dilation on optimal stent expansion (OSE) has not been established for drug-eluting stents (DESs). We conducted a prospective multicenter, randomized study to compare NC with SC balloons after stent balloon dilatation. A total of 301 patients (127 men, 83 women, 62 +/- 9 years of age) treated with a DES (sirolimus-eluting stent [SES], n = 152; paclitaxel-eluting stent, n = 149) were included. OSE followed the definition of the Multicenter Ultrasound Stenting in Coronaries (MUSIC) study. The primary end point was the incidence of OSE using intravascular ultrasound according to type of balloon. Baseline characteristics of each group showed no significant differences. OSE in the SC balloon group was achieved at higher rates than the NC balloon group (53 +/- 35%, vs 73 +/- 48%, p = 0.022 in all stents; 25 +/- 33%, vs 36, 48%, p = 0.051 in SESs). However, any differences in the achievement of OSE between the NC and SC balloon groups were not present in paclitaxel-eluting stents. In conclusion, despite postadjuvant balloon inflations with high pressures, underexpansion of the DES was seen commonly. Between the 2 types of balloon for adjuvant dilation after DES implantation, same-size SC balloons could be more useful for obtaining OSE than NC balloons, especially in SESs.

Comparison of sirolimus-eluting stent and paclitaxel-eluting stent for long-term cardiac adverse events in diabetic patients: the Korean Multicenter Angioplasty Team (KOMATE) Registry.

BACKGROUND: There is some controversy on long-term cardiac outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in diabetes mellitus (DM). We compared cardiac adverse events after SES and PES implantation in patients with DM over a period of 3 year. METHODS: A total of 634 patients with DM treated with SES (n = 428) or PES (n = 206) were consecutively enrolled in the KOMATE registry from 2003 to 2004. We assessed major adverse cardiac events (MACEs, cardiovascular death, nonfatal myocardial infarction, ischemia driven target vessel revascularization) and stent thrombosis (ST) according to the definitions set by the Academic Research Consortium. RESULTS: Propensity score (PS) analysis was performed to adjust different baseline characteristics. The mean follow-up duration was 38 +/- 8 month (at least 36 month and up to 53 month). The 3-year MACE rate did not show a significant difference between the two groups [52 (12.1%) in SES vs. 29 (14.1%) in PES, P = 0.496]. The definite and probable ST at 3 year were similar in both SES and PES [12 (2.8%) in SES vs. 7 (3.4%) in PES, P = 0.681]. There were no differences in hazard ratio for MACE and ST between two stents [MACE, crude: 0.844 (0.536-1.330) and adjusted for PS: 0.858 (0.530-1.389); ST, crude: 0.820 (0.323-2.083) and adjusted for PS: 0.960 (0.357-2.587)]. CONCLUSIONS: The present study demonstrated that long-tem cardiac outcomes including ST were not significantly different between SES and PES in patients with DM.

Efficacy and safety profiles of a new S(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, noninferiority clinical trial.

BACKGROUND: "Chiral switching" from an existing racemate to a pure enantiomeric compound is a popular theme in drug development, especially when the enantiomer is found to have better efficacy and safety profiles. Amlodipine is a racemic mixture, composed of the S(-)-enantiomer, which is the pharmacologically active isomer, and the R(+)-enantiomer, which is 1000-fold less active. S(-)-amlodipine nicotinate, a chirally switched form of amlodipine nicotinate, has been developed and found to be bioequivalent to amlodipine besylate in Phase I clinical trials in Korea. OBJECTIVE: The aim of this study was to compare the efficacy and safety profiles of S(-)-amlodipine nicotinate with those of amlodipine besylate in adult Korean patients with mild to moderate hypertension (diastolic blood pressure [DBP] >or=90 mm Hg and or=90 and or=90 mm Hg). The primary end point was noninferiority of the difference in mean SiDBP from baseline to week 8 for S(-)-amlodipine nicotinate compared with amlodipine besylate. Secondary end points were as follows: (1) noninferiority of the difference in mean sitting systolic blood pressure (SiSBP) from baseline to week 8 between the study groups; and (2) SiDBP response rate (defined as the proportion of patients whose SiDBP was <90 mm Hg or whose SiDBP reduction was >or=10 mm Hg from baseline) after the 8-week treatment. Also, the incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs) were reported. Severe AEs/ADRs were defined as those associated with any of the following: death; an event associated with a high risk of mortality; an event requiring hospitalization; or development of a permanent disability or congenital malformation. RESULTS: One hundred fifty-seven patients were assessed for inclusion in the study. Of these, 124 patients were randomly allocated to receive S(-)-amlodipine nicotinate (42 men, 21 women; mean [SD] age, 52.4 [10.3] years [range, 23-70 years]; weight, 67.7 [10.8] kg [range, 44-92 kg]) or amlodipine besylate (45 men, 16 women; mean [SD] age, 54.5 [10.0] years [range, 30-73]; weight, 68.9 [9.8] kg [range, 49-95 kg]). One hundred sixteen patients completed the study, but 11 patients (8.9%) were dropped from the per-protocol analysis due to violations; therefore, 105 patients were included in the modified intent-to-treat population analysis (S[-]-amlodipine nicotinate, 55 patients; amlodipine besylate, 50 patients). There were no significant between-group differences in the baseline characteristics. Baseline mean (SD) SiSBP and SiDBP were 142.6 (11.3) and 94.9 (4.8) mm Hg in the S(-)-amlodipine nicotinate group, and 141.8 (8.3) and 96.1 (4.9) mm Hg in the amlodipine besylate group. Mean (SD) changes in SiSBP were 17.6 (11.2) mm Hg in the S(-)-amlodipine nicotinate group and 18.6 (12.3) mm Hg in the amlodipine besylate group. The SiDBP response rates were 92.7% in the S(-)-amlodipine nicotinate group and 88.0% in the amlodipine besylate group. There were no significant between-group differences in the prevalence of AEs and ADRs. In the S(-)-amlodipine nicotinate group, 15 patients (23.8%) reported a total of 28 AEs, and 19 patients (31.1%) reported a total of 27 AEs in the amlodipine besylate group. Six patients (9.5%) in the S(-)-amlodipine nicotinate group and 7 patients (11.4%) in the amlodipine besylate group experienced a total of 19 ADRs (11 and 8, respectively). The most common ADRs were liver enzyme elevation (3/63 [4.8%]) in the S(-)-amlodipine nicotinate group and facial flushing (3/61 [4.9%]) in the amlodipine besylate group. No cases of severe AEs or ADRs were reported in either group. CONCLUSIONS: The reduction of SiDBP after 8 weeks of treatment with S(-)-amlodipine nicotinate was noninferior compared with that of racemic amlodipine besylate in these adult Korean patients with mild to moderate hypertension. The SiDBP response rate and the reduction of SiSBP after 8 weeks of treatment with S(-)-amlodipine nicotinate were not significantly different from those with racemic amlodipine besylate. Both treatments were generally well tolerated.

Randomized comparison of carbon ion-implanted stent versus bare metal stent in coronary artery disease: the Asian Pacific Multicenter Arthos Stent Study (PASS) trial.

BACKGROUND: Heavy metal ions can cause allergic and inflammatory reactions that might be associated with in-stent restenosis. This randomized multicenter clinical study was designed to determine if carbon ion-implanted stents reduce luminal late loss by blocking heavy metal ion diffusion into the surrounding tissue. METHODS: A total of 225 patients with 230 native coronary lesions were randomly assigned to receive either a carbon ion-implanted Arthos Inert stent (group 1, n = 113) or a bare metal Arthos stent (group 2, n = 117). The primary endpoint was in-stent luminal late loss at 6-month angiographic follow-up, and the secondary endpoints were the 6-month angiographic restenosis rate and the occurrence of the major adverse cardiac events (MACE) including death, nonfatal myocardial infarction, and target lesion revascularization at 12 months. RESULTS: The baseline characteristics were similar in the 2 groups. In-hospital events did not occur in any patients. Angiographic follow-up at 6 months was obtained in 184 lesions (80%). At follow-up, the luminal late loss was similar in the 2 groups (0.91 +/- 0.77 mm in group 1 vs 0.88 +/- 0.80 mm in group 2, P = .79), and the angiographic restenosis rates were 11.0% in group 1 and 16.1% in group 2 (P = .31). The occurrence rates of MACE at 12 months were 9.1% in group 1 and 10.4% in group 2 (P = .73). CONCLUSIONS: The initial and long-term outcomes of the carbon ion-implanted stent were excellent. However, it did not improve long-term outcomes vs the bare metal stent.

Randomized Comparisons Between Different Stenting Approaches for Bifurcation Coronary Lesions With or Without Side Branch Stenosis.

OBJECTIVES: This study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions. BACKGROUND: The optimal bifurcation stenting technique needs to be evaluated. METHODS: The trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non-left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis. RESULTS: Between the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p=0.064), comprising 15.1% versus 3.7% for the main branch (p=0.004) and 2.8% versus 5.6% for the SB (p=0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p=0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p=0.44), comprising 5.2% versus 4.8% for the main branch (p=0.90) and 3.9% versus 8.3% for the SB (p=0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p=0.84). CONCLUSIONS: Angiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non-left main bifurcation lesions once the procedure was performed successfully.

Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial.

BACKGROUND: Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease. METHODS AND RESULTS: This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinum chromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94). CONCLUSIONS: BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186120.

Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study.

BACKGROUND: Fixed-dose combination drugs may enhance blood pressure (BP) goal attainment through complementary effects and reduced side effects, which leads to better compliance. OBJECTIVE: This study aimed to evaluate the efficacy and safety profiles of once-daily combination amlodipine/losartan versus losartan. METHODS: This was an 8-week, double-blind, multicenter, randomized phase III study conducted in outpatient hospital clinics. Korean patients with essential hypertension inadequately controlled on losartan 100 mg were administered amlodipine/losartan 5 mg/100 mg combination versus losartan 100 mg. The main outcome measures were changes in sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP) and BP response rate from baseline values, which were assessed after 4 and 8 weeks of treatment. Safety and tolerability were also assessed. RESULTS: At week 8, both groups achieved significant reductions from baseline in DBP (11.7 ± 7.0 and 3.2 ± 7.9 mmHg), which was significantly greater in the amlodipine/losartan 5 mg/100 mg combination (n = 70) group (p < 0.0001). Additionally, the amlodipine/losartan 5 mg/100 mg combination group achieved significantly greater reductions in SBP at week 8 and in SBP and DBP at week 4 compared with the losartan 100 mg (n = 72) group (all p < 0.0001). Response rates were significantly higher in the amlodipine/losartan 5 mg/100 mg group versus the losartan 100 mg group (81.4% vs 63.9% at week 4, p < 0.0192; 90.0% vs 66.7% at week 8, p < 0.001). Both treatments were generally well tolerated. CONCLUSION: Switching to a fixed-dose combination therapy of amlodipine/losartan 5 mg/100 mg was associated with significantly greater reductions in BP and superior achievement of BP goals compared with a maintenance dose of losartan 100 mg in Korean patients with essential hypertension inadequately controlled on losartan 100 mg. CLINICAL TRIAL REGISTRATION: Registered at Clinicaltrials.gov as NCT00940680.