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Objective: Rotational atherectomy (RA) and newly developed second-generation drug-eluting stent (DES) support the strategy of longer stent deployment in comparison to short stent implantations in the past. However, studies analyzing the outcome of patients who received long stent implantation following RA are few in number. The present study compared the clinical outcomes of patients with the coronary arterial disease (CAD) who underwent RA with long stent implantation using first- and second-generation DES.Methods: A retrospective cohort study was performed at the single center from March 2003 to October 2019. Eighty-seven patients with CAD who underwent RA with ≥32 mm long stent implantation were enrolled in the study and divided into two groups according to the type of DES. As a primary endpoint, the cumulative 2-year incidence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), target vessel revascularization, and stent thrombosis (ST) was compared by DES type. Adjusted interaction between the type of stent and clinical variables was estimated to determine the predictor variables of MACE.Results: The second-generation DES group was associated with a shorter procedure duration and more common usage of intravascular ultrasound in procedural characteristics. In the second-generation DES group, a trend toward a lower rate of MI and ST existed. All-cause mortality and cardiovascular mortality were not significantly different. When combined with MACE, we could identify a significant reduction in the second-generation DES group.Conclusion: In comparison to the first-generation DES group, the second-generation DES group was associated with a lower rate of MACE for 2 years in patients who underwent RA with long stent implantation.

Because of paucity of published data, we evaluated the 2-year major clinical outcomes between early invasive (EI) and delayed invasive (DI) strategies according to the stage of chronic kidney disease (CKD) in patients with non-ST-segment elevation myocardial infarction (NSTEMI), who underwent a successful newer-generation drug-eluting stent (DES) implantation.A total of 8241 NSTEMI patients were recruited from the Korea Acute Myocardial Infarction Registry (KAMIR). Based on baseline estimated glomerular filtration rate (eGFR; ≥90, 60-89, 30-59, and30 mL/min/1.73 mAfter multivariable-adjusted and propensity score-adjusted analyses, the cumulative incidence of MACE (group A, p = 0.139 and p = 0.103, respectively; group B, p = 0.968 and p = 0.608, respectively; group C, p = 0.111 and p = 0.196, respectively; group D, p = 0.882 and p = 0.571, respectively), all-cause death, re-MI, and any repeat revascularization was similar between the EI and DI groups in the 4 different renal function groups.In the era of newer-generation DES, EI and DI strategies showed comparable major clinical outcomes in patients with NSTEMI and CKD during a 2-year follow-up period. However, to confirm these results, further randomized, large-scale, long-term follow-up studies are needed.

Recently, the number of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) has reduced, whereas increased mortality was reported. A plausible explanation for increased mortality was prehospital delay because of patients' reticence of their symptoms.The purpose of this study was to investigate the association between prehospital delay and clinical outcomes in patients with NSTEMI METHODS: Among 13,104 patients from the Korea-Acute-Myocardial-Infarction-Registry-National Institutes of Health, the authors evaluated 6,544 patients with NSTEMI. Study patients were categorized into 2 groups according to symptom-to-door (StD) time (24 or ≥24 hours). The primary outcome was 3-year all-cause mortality, and the secondary outcome was 3-year composite of all-cause mortality, recurrent MI, and hospitalization for heart failure.Overall, 1,827 (27.9%) patients were classified into the StD time ≥24 hours group. The StD time ≥24 hours group had higher all-cause mortality (17.0% vs 10.5%; P 0.001) and incidence of secondary outcomes (23.3% vs 15.7%; P 0.001) than the StD time 24 hours group. The higher all-cause mortality in the StD time ≥24 hours group was observed consistently in the subgroup analysis regarding age, sex, atypical chest pain, dyspnea, Q-wave in electrocardiogram, use of emergency medical services, hypertension, diabetes mellitus, chronic kidney disease, left ventricle dysfunction, TIMI (Thrombolysis In Myocardial Infarction) flow, and the GRACE risk score. In the multivariable analysis, independent predictors of prehospital delay were the elderly, women, nonspecific symptoms such as atypical chest pain or dyspnea, diabetes, and no use of emergency medical services.Prehospital delay is associated with an increased risk of 3-year all-cause mortality in patients with NSTEMI. (iCReaT Study No. C110016).

Background: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. Methods: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. Results: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P =0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P =0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. Conclusions: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Background Successful percutaneous coronary intervention (PCI) of the occluded infarct-related artery (IRA) in latecomers may improve long-term survival mainly by reducing left ventricular remodeling. It is not clear whether inhibition of renin–angiotensin system (RAS) brings additional better clinical outcomes in this specific population subset. Methods Between January 2008 and June 2013, 669 latecomer patients with acute ST-segment elevation myocardial infarction (STEMI) (66.2 ± 12.1 years, 71.0% males) in Korea Acute Myocardial Infarction Registry (KAMIR) who underwent a successful PCI were enrolled. The study population underwent a successful PCI for a totally occluded IRA. They were divided into two groups according to whether they were prescribed RAS inhibitors at the time of discharge: group I (RAS inhibition, n = 556), and group II (no RAS inhibition, n = 113). Results During the one-year follow-up, major adverse cardiac events (MACE), which consist of cardiac death and myocardial infarction, occurred in 71 patients (10.6%). There were significantly reduced incidences of MACE in the group I (hazard ratio = 0.34, 95% confidence interval 0.199–0.588, p = 0.001). In subgroup analyses, RAS inhibition was beneficial in patients with male gender, history of hypertension or diabetes mellitus, and even in patients with left ventricular ejection fraction (LVEF) ≥40%. In the baseline and follow-up echocardiographic data, benefit in changes of LVEF and left ventricular end-systolic volume was noted in group I. Conclusions In latecomers with STEMI, RAS inhibition improved long-term clinical outcomes after a successful PCI, even in patients with low risk who had relatively preserved LVEF.

Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials.In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments.Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months.CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups.URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Background: To determine whether the effectiveness and safety of fixed-dose combinations (FDCs) of amlodipine orotate/valsartan (AML/VAL) 5/160 mg are noninferior to those of valsartan/hydrochlorothiazide (VAL/HCTZ) 160/12.5 mg in hypertensive patients with inadequate response to valsartan 160 mg monotherapy. Methods: This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascular centers in the Republic of Korea. Eligible patients had mean sitting diastolic blood pressure (msDBP) ≥90 mm Hg despite monotherapy with valsartan 160 mg for 4 weeks. Patients were randomly assigned to treatment with AML/VAL 5/160 mg FDC (AML/VAL) group or VAL/HCTZ 160/12.5 mg FDC (VAL/HCTZ) group once daily for 8 weeks. A total of 238 patients were enrolled (AML/VAL group, n = 121; VAL/HCTZ group, n = 117), of whom 228 completed the study. Results: At 8 weeks after randomization, msDBP was significantly decreased in both groups (−9.44 ± 0.69 mm Hg in the AML/VAL group and −7.47 ± 0.71 mm Hg in the VAL/HCTZ group, both P

The development of various techniques and equipments for percutaneous coronary artery intervention (PCI) has led to an increase in age of the PCI population, and an increase in complexity of cases such as chronic total occlusion and calcified lesion. However, on the other hand, these subsets can increase the rate of balloon failure (inability to cross or dilate a coronary stenosis with a balloon) [1]. Among the many devices for PCI, rotational atherectomy (RA) has shown high procedural success rates with non-crossable calcified stenosis [2]. It is well known that RA for this frustrating subset is limited by the required size of guiding catheters and the ability to cross the lesion with a dedicated RotaWire [3], and 1.25 mm burr passage failure after successful RotaWire delivery is uncommon situation. In this report, we present a case in which 1.25 mm rotational burr non-crossable heavily calcified lesion was successfully treated by the RA through 6 in 8Fr inner guiding system.

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.

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.

Sang-Hyun Ihm,1 Hui-Kyung Jeon,1 Tae-Joon Cha,2 Taek-Jong Hong,3 Sang-Hyun Kim,4 Nae-Hee Lee,5 Jung Han Yoon,6 Namsik Yoon,7 Kyung-Kuk Hwang,8 Sang-Ho Jo,9 Ho-JoongYoun1 1Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Seoul, 2Division ofCardiology, Department of Internal Medicine, Kosin University College of Medicine, 3Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, 4Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, 5Department of Cardiology, Soonchunhyang University Hospital, Bucheon, 6Division of Cardiology, Wonju College of Medicine, Yonsei University, Wonju, 7Department of Cardiology, Chonnam National University Hospital, Gwangju, 8Department of Internal Medicine, Chungbuk National University, College of Medicine, Cheongju, 9Division of Cardiology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, South Korea Purpose: To evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy.Patients and methods: Eligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ≥90 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.Results: After the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg (P

BACKGROUND Impaired exercise tolerance with dyspnea is common in hypertensive patients and this may be due to the exaggeration of nonuniform ventricular activation during exercise. So we want to evaluate the effect of left ventricular hypertrophy (LVH) on systolic intraventricular dyssynchrony during exercise. METHODS A total of 85 patients with hypertension who having exertional dyspnea and 30 control individuals were enrolled. Exercise stress echocardiography was performed using a symptom limited, multistage supine bicycle test. To evaluate the dyssynchrony of left ventricular (LV), we calculated the standard deviation (SD) of the averaged time-to-peak systolic velocity (TPs-SD, ms) of 12 middle and basal LV segments obtained from the three standard apical views at rest and peak exercise. RESULTS There was no significant difference in systolic blood pressure (BP) and heart rate between the two groups. TPs-SD was significantly higher in patients with LVH at rest (31.5 ± 12.1 vs. 22.0 ± 12.6 ms, p = 0.002) with exaggeration of the degree at peak exercise (39.0 ± 11.9 vs. 24.6 ± 13.3 ms, p < 0.001). Multiple regression analysis showed LV mass index was independently associated with LV dyssynchrony at peak exercise (β = 0.515, p = 0.001) when controlled for age, sex, and systolic BP at peak exercise. CONCLUSION Intraventricular systolic dyssynchrony during exercise is significantly associated with the degree of LVH in hypertensive patients.

Background— We developed a model that predicts difficulty of percutaneous coronary intervention for coronary chronic total occlusion (CTO) using coronary computed tomographic angiography. Methods and Results— A total of 684 CTO lesions with preprocedural computed tomographic angiography were enrolled from 4 centers. Data were randomly divided into derivation and validation datasets at 2:1 ratio. The end point was successful guidewire crossing ≤30 minutes, which was met in 50%. The KCCT (Korean Multicenter CTO CT Registry) score was developed based on independent predictors identified by multivariable analysis, which were proximal blunt entry, proximal side branch, bending, occlusion length ≥15 mm, severe calcification, whole luminal calcification, reattempt, and ≥12 months or unknown duration of occlusion. The KCCT score was compared with the other prediction scores, including angiography-based J-CTO, PROGRESS-CTO, CL-score, and CT-based CT-RECTOR. The probability of guidewire crossing ≤30 minutes declined consistently from 100% to 0% according to the KCCT score ( P P P P Conclusions— KCCT scoring could predict successful guidewire crossing ≤30 minutes and also procedural success. KCCT scoring may enable noninvasive grading difficulty of CTO percutaneous coronary intervention.

Purpose A fixed-dose combination of a stain and an antihypertensive drug may be useful for the treatment of patients with hypertension and hyperlipidemia. It may also improve patient drug compliance to help control risk factors of cardiovascular disease. This study was designed to evaluate the blood pressure–lowering and cholesterol-lowering effect of a fixed-dose combination of irbesartan-atorvastatin compared with monotherapy by either agent over an 8-week treatment period. Methods Patients with comorbid hypertension and hypercholesterolemia were screened for this randomized, double-blind, Phase III study. Eligible study patients were randomly assigned to test groups receiving a combination of irbesartan 300 mg and atorvastatin 40 mg or 80 mg (IRB300 + ATO40 and IRB300 + ATO80). Comparator groups comprised monotherapy groups with irbesartan 300 mg (IRB300) or atorvastatin 40 mg (ATO40) or atorvastatin 80 mg (ATO80), or placebo. Patients who were eligible at screening were subjected to a 4- to 6-week washout period before commencing 8 weeks of therapy per their assigned group. The primary efficacy end points were percent change in LDL-C and sitting diastolic blood pressure (DBP) levels from baseline to end of therapy. Tolerability profiles of combination therapy were compared with other groups. Findings A total of 733 patients with comorbid hypertension and hypercholesterolemia were screened for this study; 230 eligible patients were randomized to treatment. The mean age of patients was 58.9 (8.5) years, and their mean body mass index was 25.8 (3.2) kg/m2. More than two thirds (70.9%) of the study patients were male. Mean LDL-C and sitting DBP levels at baseline were 149.54 (29.19) mg/dL and 92.32 (6.03) mm Hg, respectively. Percent reductions in LDL-C after 8 weeks were 46.74% (2.06%) in the IRB300 + ATO40 group and 48.98% (2.12%) in the IRB300 + ATO80 group; these values were 47.13% (3.21%) and 48.30% (2.98%) in the ATO40 and ATO80 comparator groups. Similarly, a reduction in sitting DBP after 8 weeks was –8.50 (1.06) mm Hg in the IRB300 + ATO40 group and 10.66 (1.08) mm Hg in the IRB300 + ATO80 group compared with 8.40 (1.65) mm Hg in the IRB300 group. The incidence rate for treatment-emergent adverse events was 22.27% and was similar between the monotherapy and combination groups. Implications A once-daily combination product of irbesartan and atorvastatin provided an effective, safe, and more compliable treatment for patients with coexisting hypertension and hyperlipidemia. ClinicalTrials.gov identifier: NCT01442987.

Background— Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo stent-based coronary interventions. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and sirolimus-eluting stents (SES) for patients with de novo long coronary lesions. Methods and Results— This randomized, multicenter, prospective trial, called the Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV (LONG-DES IV) trial, compared long R-ZES and SES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The baseline characteristics were not different between R-ZES and SES groups, including lesion lengths (32.4±13.5 mm versus 31.0±13.5 mm, P =0.27). At 9-month angiographic follow-up, the R-ZES was noninferior to the SES with respect to in-segment late luminal loss, the primary study end point (0.14±0.38 mm versus 0.12±0.43 mm, P for noninferiority=0.03, P for superiority=0.68). In addition, in-stent late luminal loss (0.26±0.36 mm versus 0.24±0.42 mm, P =0.78) and the rates of in-segment (5.2% versus 7.2%, P =0.44) and in-stent (4.0% versus 6.0%, P =0.41) binary restenosis were not significantly different between the 2 groups. There were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target-lesion revascularization, and composite outcomes). Conclusions— For patients with de novo long coronary artery disease, R-ZES implantation showed noninferior angiographic outcomes as compared with SES implantation. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01186094.

Objectives: To compare the safety and efficacy of the new Coroflex TM Please stents with conventional Taxus TM Liberte stents in patients with coronary artery lesions. Background: The Coroflex TM Please stent is a new version of paclitaxel-eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first-generation stents. However, it has not been directly compared with the early generation paclitaxel-eluting stents in a multicenter, prospective, and randomized study. Methods: We randomly assigned 319 patients to receive Coroflex TM Please stents (159 patients; 198 lesions) or Taxus TM Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in-segment late luminal loss at 9 months. Results: Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex TM Please and Taxus TM Liberte stents showed similar in-segment late loss (0.40 6 0.53 mm vs. 0.39 6 0.52 mm, P 5 0.98) and rates of in-segment binary restenosis (22.2% vs. 18.8%, P 5 0.48) at 9 months. After clinical follow-up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P 5 0.22), stent thrombosis (2.5% vs. 1.9%, P 5 0.72), and target-lesion revascularization (7.5% vs. 7.5%, P 5 0.99). Conclusions: The Coroflex TM Please stent resulted in similar angiographic and clinical outcomes as the Taxus TM Liberte stent in patients with coronary artery lesions. V C 2012 Wiley Periodicals, Inc.

Objectives This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions. Background Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. Methods This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up. Results The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups. Conclusions For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different. (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III [LONG-DES-III]; NCT01078038 )

This study investigated the relationship between mast cell numbers and the grade of bladder transitional cell carcinoma (TCC). Bladder TCC biopsies were obtained via transurethral resection and 45 stage T1 specimens were included in the study. Specimens were sorted into two groups, low grade (grade I) and high grade (grades II and III). Samples were stained using haematoxylin and eosin, toluidine blue and immunohistochemical staining for tryptase. Mast cells were examined by light microscopy and cell density was recorded. Mast cell density was significantly higher in high-grade TCC than low-grade TCC. There was also a significant relationship between the number of mast cells identified using toluidine blue staining or immunohistochemical staining for tryptase. Detailed studies of mast cell function will enable the development of more effective antitumour therapies via mast cell manipulation.

Few studies have compared the ability of sodium bicarbonate plus N-acetylcysteine (NAC) and sodium chloride plus NAC to prevent contrast-induced nephropathy (CIN) in diabetic patients with impaired renal function undergoing coronary or endovascular angiography or intervention. Diabetic patients (n = 382) with renal disease (serum creatinine ≥1.1 mg/dl and estimated glomerular filtration rate60 ml/min/1.73 m(2)) were randomly assigned to receive prophylactic sodium chloride (saline group, n = 189) or sodium bicarbonate (bicarbonate group, n = 193) before elective coronary or endovascular angiography or intervention. All patients received oral NAC 1,200 mg 2 times/day for 2 days. The primary end point was CIN, defined as an increase in serum creatinine25% or an absolute increase in serum creatinine ≥0.5 mg/dl within 48 hours after contrast exposure. There were no significant between-group differences in baseline characteristics. The primary end point was met in 10 patients (5.3%) in the saline group and 17 (9.0%) in the bicarbonate group (p = 0.17), with 2 (1.1%) and 4 (2.1%), respectively, requiring hemodialysis (p = 0.69). Rates of death, myocardial infarction, and stroke did not differ significantly at 1 month and 6 months after contrast exposure. In conclusion, hydration with sodium bicarbonate is not superior to hydration with sodium chloride in preventing CIN in patients with diabetic nephropathy undergoing coronary or endovascular angiography or intervention.

Objectives The purpose of this study was to determine whether cilostazol reduces intimal hyperplasia in patients undergoing long zotarolimus-eluting stent implantation (stent length: ≥30 mm) for native long coronary lesions (length: ≥25 mm). Background Restenosis after drug-eluting stent implantation remains a significant clinical problem in long coronary lesions. Methods Patients (n = 499) were assigned randomly to triple (aspirin, clopidogrel, and cilostazol, triple group: n = 250) or dual antiplatelet therapy (aspirin and clopidogrel and placebo, dual group: n = 249) for 8 months after long zotarolimus-eluting stent implantation. The primary end point was in-stent late loss at the 8-month angiography according to the intention-to-treat principle. Results The 2 groups had similar baseline characteristics. The in-stent (0.56 ± 0.55 mm vs. 0.68 ± 0.59 mm, p = 0.045) and in-segment (0.32 ± 0.54 mm vs. 0.47 ± 0.54 mm, p = 0.006) late loss were significantly lower in the triple versus dual group, as were 8-month in-stent restenosis (10.8% vs. 19.1%, p = 0.016), in-segment restenosis (12.2% vs. 20.0%, p = 0.028), and 12-month ischemic-driven target lesion revascularization (5.2% vs. 10.0%, p = 0.042) rates. At 12 months, major adverse cardiac events including death, myocardial infarction, and ischemic-driven target lesion revascularization tended to be lower in the triple group than the dual group (7.2% vs. 12.0%, p = 0.07). Percent intimal hyperplasia volume by volumetric intravascular ultrasound analysis was reduced from 27.1 ± 13.2% for the dual group to 22.1 ± 9.9% for the triple group (p = 0.017). Conclusions Patients receiving triple antiplatelet therapy after long zotarolimus-eluting stent implantation had decreased extent of late luminal loss, percent intimal hyperplasia volume, and angiographic restenosis, resulting in a reduced risk of 12-month target lesion revascularization compared with patients receiving dual antiplatelet therapy. (Triple Versus Dual Antiplatelet Therapy after ABT578-Eluting Stent; NCT00589927)

Background Retrograde approach through collateral channels was recently proposed to increase the success rate of percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO), but this approach is still an incompletely described technique. Methods We analyzed 24 cases of retrograde PCI for CTO, which were done from July 2006 to April 2008. Results Septal collaterals were more frequently used than epicardial collaterals (75% vs. 25%), without showing statistical differences in wire passage rate according to the size or location of the collaterals. Once the retrograde wire successfully crossed collateral (18/24 cases), CTO lesion was successfully crossed in all cases by using 4 different kinds of techniques: retrograde wire crossing (44%), kissing wire (22%), controlled antegrade and retrograde subintimal tracking (22%), and reverse controlled antegrade and retrograde subintimal tracking (11%). Among them, successful recanalization was achieved in 17 cases, yielding 71% retrograde PCI success rate. In failed cases with retrograde approach, 4 cases were recanalized by switching to antegrade approach. Thus, total PCI success rate was 88% (21/24 cases). There were several cases of unexpected complications mainly related to collateral-donor artery without in-hospital major adverse cardiac events (MACE). During clinical follow-up (median 10.3 months), overall MACE rate was 18% in the successful retrograde PCI group. Conclusions The retrograde approach can improve the success rate with PCI for CTO. However, strict case selection with systemized approach is essential due to the technical complexities accompanied by the potential risk of unexpected complications.

Objectives The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice. Background Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined. Methods We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point. Results Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02). Conclusions In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067 )

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 drugeluting 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.)

Although cilostazol has decreased restenosis and target lesion revascularization (TLR) after drug-eluting stent implantation, it is not known if this effect is durable at 2 years. We analyzed 2 randomized studies (Drug-Eluting stenting followed by Cilostazol treatment reduces LAte REstenosis in patients with DIABETES mellitus and Drug-Eluting Stenting Followed by Cilostazol treatment reduces LAte REstenosis in patients with LONG native coronary lesions trials) in which 900 patients were randomly assigned to triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 450) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 450) for 6 months in patients with diabetes or long lesions receiving drug-eluting stents. We evaluated 2-year major adverse cardiac events (MACEs) including death, myocardial infarction (MI), and TLR. Nine-month TLRs and MACEs were significantly decreased in the triple versus standard group. At 2 years, the triple group sowed significantly decreased TLRs (4.2% vs 9.1%, hazard ratio 0.45, 95% confidence interval 0.26 to 0.78, p = 0.004) and MACEs (5.6% vs 10.4%, hazard ratio 0.52, 95% confidence interval 0.32 to 0.84, p = 0.008) compared to the standard group with no differences in death and MI. In subgroup analysis, triple antiplatelet therapy decrease of 2-year TLR was favorable in all subgroups, especially in patients with paclitaxel-eluting stents, diabetes mellitus, small vessels, long lesions, and left anterior descending coronary artery lesions. In conclusion, compared to the standard group, initial benefit in decreases of 9-month TLRs and MACEs in the triple group was sustained at 2 years with no differences in death or MI. Triple antiplatelet therapy decrease of 2-year TLR was favorable in all subgroups, especially in patients with high-risk profiles.

Drug-eluting stents (DESs) are increasingly used for treatment of acute ST-segment elevation myocardial infarction (STEMI), but there are few comparisons of outcomes of various types of DES. We compared the efficacy and safety of zotarolimus-eluting stents (ZESs), sirolimus-eluting stents (SESs), and paclitaxel-eluting stents (PESs) in primary intervention for STEMI. This multicenter, prospectively randomized ZEST-AMI trial included 328 patients at 12 medical centers who were randomly assigned to ZES (n = 108), SES (n = 110), or PES (n = 110) deployment. The primary end point was major adverse cardiac events (death, MI, and ischemia-driven target vessel revascularization) at 12 months. Secondary end points included the individual components of the primary end point, late loss, angiographic restenosis, and stent thrombosis. Baseline clinical and angiographic characteristics were well matched. In-segment late loss (0.28 +/- 0.42 vs 0.46 +/- 0.48 vs 0.47 +/- 0.50 mm, respectively, p = 0.029) and restenosis rate (2.7% vs 15.9% vs 12.3%, respectively, p = 0.027) at 8 months were lowest in the SES group compared to the ZES and PES groups. At 12 months, cumulative incidence rates of primary end points in the ZES, SES, and PES groups were 11.3%, 8.2%, and 8.2%, respectively (p = 0.834). There were 2 acute (in the SES group) and 5 subacute (2 in the SES group and 3 in the PES group) stent thromboses. Incidence of death, recurrent MI, or ischemia-driven target vessel revascularization did not differ among the 3 groups. In conclusion, despite the difference in restenosis rate, the efficacy and safety of the 3 different DESs showed similar, acceptable results in the treatment of STEMI.

Objectives We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Background Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. Methods This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. Results The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 ± 0.53 mm vs. 0.38 ± 0.54 mm, p = 0.025) and in-segment (0.42 ± 0.50 mm vs. 0.53 ± 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0% vs. 15.6%, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Conclusions Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.

Background The aim of this study was to assess the impact of more aggressive pharmacological treatment on short-term clinical outcomes in patients with acute non ST-segment elevation myocardial infarction (NSTEMI) who do not undergo percutaneous coronary intervention (PCI). Methods and Results The 924 NSTEMI patients treated with early conservative strategy (69.2±12.5 years, 637 males) in 50 hospitals that were high-volume centers with facilities for primary PCI were recruited to the Korean Acute Myocardial Infarction Registry (KAMIR) from November 2005 to August 2007. For all patients, the pharmacotherapy index based on the use of drugs during hospital stay was assessed (range of points 0-10). Primary endpoint was the combined in-hospital mortality and morbidity and major adverse cardiac events during 1 month of clinical follow-up. Of the patients, data from 847 who were followed-up for 1 month after discharge were analyzed. The rate of the primary endpoint decreased with an increase of the pharmacotherapy index and this result was similar in the low- and high-risk groups. In the multivariate analysis, low pharmacotherapy index (≤4 points) was an independent predictor of the primary endpoint. Conclusions More intensive pharmacological treatment may improve short-term clinical outcomes in acute NSETMI patients who do not undergo PCI. (Circ J 2008; 72: 1403 - 1409)

To evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation for long coronary lesions, we performed a randomized multicenter prospective study comparing triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 250) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 250) for 6 months in patients with long lesions (or =25 mm) requiring a long DES (or =32 mm). The primary end point was in-stent late loss at 6-month angiography. The 2 groups had similar baseline clinical and angiographic characteristics. In-stent late loss (0.22 +/- 0.48 mm vs 0.32 +/- 0.51 mm, p = 0.031) and in-segment late loss (0.34 +/- 0.49 mm vs 0.51 +/- 0.49 mm, p = 0.001) at 6-month follow-up angiography were significantly lower in the triple group versus the standard group. There was a trend toward lower rates of in-segment restenosis in the triple group versus the standard group (6.7% vs 11.2%, p = 0.104). Target lesion revascularization (TLR; 2.8% vs 6.8%, p = 0.036) and major adverse cardiac events (2.8% vs 7.6%, p = 0.016), including death, myocardial infarction, and TLR at 9 months were significantly lower in the triple group than in the standard group. At 9 months, the 2 groups had similar rates of stent thrombosis (0.4% vs 0.4%, p = 0.999), death (0% vs 0.8%, p = 0.499), and myocardial infarction (0.4% vs 0.4%, p = 0.999). In conclusion, cilostazol significantly reduced late loss at 6 months after DES implantation and the occurrence of TLR and major adverse cardiac events in patients with long coronary lesions.

A 64-year-old woman was admitted due to exertional dyspnoea (New York Heart Association functional class III) and pitting oedema. She had a past medical history of hypertension 4 years ago and hypercholesterolaemia 3 years ago. Her electrocardiogram showed normal sinus rhythm with enlargement of left atrium (LA). The echocardiogram showed …

Background— Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. This study compared sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) for long coronary lesions. Methods and Results— The present randomized, multicenter, prospective study compared the use of long (≥32 mm) SES with PES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was the rate of binary in-segment restenosis according to follow-up angiography at 6 months. The SES and PES groups had similar baseline characteristics. Lesion length was 33.9±11.6 mm in the SES group and 34.5±12.6 mm in the PES group ( P =0.527). The in-segment binary restenosis rate was significantly lower in the SES group than in the PES group (3.3% versus 14.6%; relative risk 0.23; P P P =0.031). Consequently, SES patients had a lower rate of target-lesion revascularization at 9 months (2.4% versus 7.2%, P =0.012). The incidence of death (0.8% in SES versus 0% in PES, P =0.499) or myocardial infarction (8.8% in SES versus 10.8% in PES, P =0.452) at 9 months of follow-up was not statistically different between the 2 groups. Conclusions— For patients with long native coronary artery disease, SES implantation was associated with a reduced incidence of angiographic restenosis and a reduced need for target-lesion revascularization compared with PES implantation.

We thank Dr Sardar and colleagues for their interest in our recent article1 and appreciate the opportunity to reply. We agree that medication adherence is associated with clinical outcomes and remains an important issue in clinical drug trials. Unfortunately, there are no definite methods for assessing adherence to medications. In our study, pill count was used to determine medication adherence, and pharmacy data were electronically checked by medical insurance system. Medical adherence in this type of study is considered generally poor. Even in the Platelet Inhibition and Patient Outcome (PLATO) trial, medical adherence was ≈80%.2 In this context, we believe that medical adherence in our study seems to be acceptable. Time from index procedure to randomization was rather variable, but most patients were enrolled between 12 …

Abciximab has a key role in the treatment of patients with acute coronary syndromes undergoing percutaneous coronary intervention; however, an increased risk of bleeding complications is well recognized. We report a case of serious pulmonary hemorrhage after use of abciximab therapy. A definitive indication and treatment guideline should be available to minimize serious bleeding complications. Additionally, respiratory symptoms should be monitored closely for early detection of serious pulmonary hemorrhage in patients receiving abciximab therapy during percutaneous coronary intervention.

Objective To investigate the factors influencing testicular volume in young men in the community. Subjects and methods Between May and November 2001, 2700 men aged 20 years and dwelling in the community were randomly selected at a 10% sampling fraction after a sampling process by census district; 2080 men agreed to participate in the study. All volunteers underwent a standard evaluation, including a detailed medical history and physical examination. After excluding those with testicular diseases the study comprised 1792 men. Results There were significant but weak correlations between testicular volumes and height, body weight and body mass index. In a multivariate model, high environmental temperature was associated with a decreased likelihood (odds ratio, OR, 0.42; 95% confidence interval, CI, 0.29–0.60; P

The standard 60-mg dose of fimasartan, a newly developed selective angiotensin II receptor blocker, is effective and safe for use in patients with mild to moderate hypertension. This study aimed to compare the efficacy and safety of low-dose (30 mg) fimasartan and placebo or valsartan (80 mg) for 8 weeks in patients with mild to moderate hypertension.In this randomized trial, 293 patients (219 men; mean age, 54.24 [9.77] years) with mild to moderate hypertension were enrolled. After randomization to receive 30-mg fimasartan (n = 115), placebo (n = 117), or 80-mg valsartan (n = 61), the treatment dose was kept constant without dose escalation for 8 weeks. The primary end point was improvement in sitting diastolic blood pressure (SiDBP) from baseline to 8 weeks that was compared between treatments with low-dose fimasartan and placebo. The secondary end point was the overall efficacy and safety of low-dose fimasartan compared with that of placebo or valsartan.At week 8, SiDBP changed by -9.93 (8.86) mm Hg in the fimasartan group and by -2.08 (9.47) mm Hg in the placebo group, which indicated significant antihypertensive efficacy (P0.0001). Efficacy was shown at week 4 as measured by SiDBP (-9.96 [7.73] vs -2.27 [7.85] mm Hg; P0.0001) or sitting systolic blood pressure (SiSBP) (-16.18 [14.44] vs -1.95 [13.48] mmHg; P0.0001) and at week 8 as determined by SiSBP (-15.35 [16.63] vs -2.30 [14.91] mm Hg; P0.0001). The fimasartan group exhibited more potent antihypertensive efficacy than the valsartan group both at week 4 (SiDBP, -9.96 [7.73] vs -6.53 [9.58] mm Hg [P = 0.0123]; SiSBP, -16.18 [14.4] vs -7.65 [12.89] mm Hg [P = 0.0002]) and at week 8 (SiDBP, -9.93 [8.86] vs -5.47 [8.96] mm Hg [P = 0.0021]; SiSBP, -15.35 [16.63] vs -7.49 [13.68] mm Hg [P = 0.0021]). Most treatment-emergent adverse events (TEAEs) were mild (89 of 95), and there were no serious TEAEs. The incidence of TEAEs was 19.1% in the fimasartan group, 22.6% in the placebo group, and 13.6% in the valsartan group, with no significant differences.Low-dose fimasartan (30 mg) was well tolerated during the study period with no significant TEAEs. Low-dose fimasartan had an effective blood pressure-lowering effect that was greater than that of 80-mg valsartan in patients with mild to moderate hypertension. ClinicalTrials.gov identifier: NCT01672476.

Angiographic and clinical outcomes remain relatively unfavorable for diabetic patients even after the use of drug-eluting stent. This prospective, multicenter, randomized study compared the relative efficacy and safety of resolute zotarolimus-eluting stent (R-ZES) and sirolimus-eluting stent (SES) implantation in diabetic patients with coronary artery disease. The primary end point was noninferiority of angiographic in-segment late loss at 9 months. Clinical events were also monitored for at least 12 months. Patient recruitment was prematurely stopped after enrollment of 256 patients (127 in R-ZES group and 129 in SES) because of discontinuing production of SES. The R-ZES was noninferior to the SES for 9-month in-segment late loss (0.34 ± 0.30 vs 0.39 ± 0.43 mm; difference -0.048; 95% confidence interval -0.157 to 0.061; upper 1-sided 95% confidence interval 0.044; p0.001 for noninferiority). In addition, in-stent late loss (0.22 ± 0.29 vs 0.21 ± 0.40 mm, p = 0.849) and the rates of in-segment (1.2% vs 6.7%, p = 0.119) and in-stent (1.2% vs 3.3%, p = 0.621) binary restenoses were similar between the 2 groups. At 12 months, there were no statistical differences between the 2 groups in the incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, ischemia-driven target vessel revascularization, and composite outcomes). In conclusion, despite having reduced power because of early study termination, our study suggests that the R-ZES has noninferior angiographic outcomes at 9 months to the SES in diabetic patients with coronary artery disease.

Background— It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. Methods and Results— We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84–1.12, P =0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82–1.12, P =0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67–1.30, P =0.68), MI (HR, 0.97; 95% CI, 0.79–1.18, P =0.74), and TVR (HR, 1.10; 95% CI, 0.82–1.49, P =0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47–2.84, P =0.75). Conclusions— In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01070420.

Background— Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus. Methods and Results— This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23±0.27 versus 0.37±0.52 mm; difference, −0.13 mm; 95% confidence interval, −0.25 to −0.02; upper 1-sided 95% confidence interval, −0.04; P P =0.029) and in-segment restenosis (0.9% versus 6.5%; P =0.035). However, in-stent late loss (0.11±0.26 versus 0.20±0.49 mm; P =0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P =0.317), death (1.3% versus 3.3%; P =0.448), and myocardial infarction (0% versus 1.3%; P =0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P =0.218), were also not statistically different between the 2 groups. Conclusions— Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00997763.

Objectives The purpose of this study is to compare the efficacy of the treatment strategies for in-stent restenosis (ISR) of drug-eluting stents (DES) according to the morphologic pattern of restenosis. Background Optimal treatment strategies for ISR within DES have not been adequately addressed yet. Methods Patients with ISR of DES were randomized according to the lesion length to compare outcomes of sirolimus-eluting stent (SES) versus cutting balloon angioplasty for focal type (≤10 mm) and SES versus everolimus-eluting stent (EES) for diffuse type (>10 mm). The primary endpoint was in-segment late loss at 9 months. Overall 162 patients, 96 with focal ISR and 66 with diffuse ISR, were enrolled. Results In focal lesions, in-segment late loss was significantly higher in the cutting balloon group (n = 48) than in the SES group (n = 48; 0.25 mm, interquartile range [IQR]: −0.01 to 0.68 mm vs. 0.06 mm, IQR: −0.08 to 0.17 mm; p = 0.04). Consequently, in-segment restenosis rate tended to be higher in the cutting balloon group than in the SES group (20.7% vs. 3.1%, p = 0.06) with comparable incidences of the composite of death, myocardial infarction, or target vessel revascularization at 12 months of clinical follow up (6.3% vs. 6.3%, p > 0.99). In 66 cases of diffuse ISR, in-segment late loss (0.11 mm, IQR: −0.02 to 0.30 mm; vs. 0.00 mm, IQR: −0.08 to 0.25 mm; p = 0.64), in-segment restenosis rate (5.0% vs. 14.3%, p = 0.32), and the composite incidence of death, myocardial infarction, or target lesion revascularization (9.6% vs. 8.8%, p > 0.99) did not differ between SES group (n = 32) and EES group (n = 34). Conclusions For lesions of focal DES restenosis, repeat implantation of SES is more effective in reducing late luminal loss and subsequent restenosis rate than cutting balloon angioplasty. For diffuse DES restenosis, implantation of SES or EES is comparably effective in terms of angiographic and clinical outcomes.

Objectives: The aims of this study were to investigate the long-term clinical outcomes of patients with successful versus unsuccessful revascularization with drug-eluting stents (DES) for chronic total occlusion (CTO). Background: The benefits of successful revascularization of CTO remain unclear. Methods: Consecutive patients (n = 333) with “true” CTO, defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 on angiography and duration ≥3 months, were divided into two groups, those with successful (CTO success group, n = 251) and unsuccessful (CTO failure group, n = 82) revascularization with DES for CTO lesions. The primary endpoint was defined as major adverse cardiac events (MACE) the composite of death, Q-wave myocardial infarction (MI), or target vessel revascularization (TVR). Results: The CTO success group was significantly younger, with a higher involvement of LAD, and lower incidences of renal failure, previous myocardial infarction, and previous coronary intervention than the CTO failure group. After a median follow up of 1,317 days (interquartile range, 1,059–1,590 days), there were no significant between-group differences in rate of MACE, both after crude analysis (9.4% vs. 11.8%, log-rank P = 0.16) and after adjustment (HR 1.17; 95% CI 0.47–2.88, P = 0.53). On multivariate analysis, major predictors of MACE were left ventricle ejection fraction (LVEF)

Intravascular ultrasonography (IVUS) imaging is a user-friendly technique widely used during coronary interventions. An 80-year-old man was admitted with chest pain, and successful percutaneous coronary intervention was performed with stent implantation. One week later, the patient complained of further chest pain. Urgent coronary angiography showed total occlusion of the middle left anterior descending artery and the aspiration of thrombi was high. IVUS imaging showed inadequate stent strut apposition and distal dissection. We attempted another stent implantation but the IVUS catheter was stuck on the 0.014 inch wire. Therefore, we tried to pass the wire across the lateral side. After the wire was successfully passaged, the sprinter balloon was passed through the crushed stent to expand it. After 4 days later, the patient was discharged with no symptoms or electrocardiographic change.

A retrograde approach through the collateral channels is considered to improve the success rate of percutaneous coronary intervention for coronary chronic total occlusion (CTO). Various kinds of strategies and techniques are required to improve the success rate of this novel approach. We describe a case in which a CTO was successfully recanalized by the retrograde approach, using a new anchoring balloon technique (double anchoring balloon technique) which enabled the successful balloon passage through the hard CTO lesion.

Recently, a retrograde approach through collateral channels was introduced to improve the success rate of percutaneous coronary intervention (PCI) for a coronary chronic total occlusion (CTO). Among the various wire-crossing techniques via the retrograde approach, the reverse controlled antegrade and retrograde subintimal tracking (reverse CART) technique is the most rarely used due to technical difficulties and the probability of causing an iatrogenic dissection. We describe a case in which the conventional antegrade approach failed and the reverse CART technique was performed successfully in the setting of severe dissection, suggesting the usefulness of this novel technique. However, we encountered unexpected collateral-donor vessel complications that could have resulted in life-threatening ischemia, suggesting that a systemized approach by a highly-experienced operator is essential in ensuring the success of this complex procedure.

Objective: The aim of this study was to compare effectiveness of the Sirolimus- (SES) and Paclitaxel-eluting stent (PES) in primary angioplasty for acute ST-elevation myocardial infarction (STEMI). Background: It has been reported that SES and PES have been more effective than bare-metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there may be differences between these two drug-eluting stents in terms of efficacy in the setting of acute STEMI. Methods: Acute STEMI patients (n = 308) undergoing primary angioplasty were randomly assigned to SES (n = 154) or PES (n = 154) deployment. The routine angiographic follow-up was performed at 6 months and clinical follow-up data was obtained at 12 months. The primary end point was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis, and target lesion revascularization (TLR) at 12 months. Results: The baseline clinical, angiographic, and procedural characteristics were similar between the 2 groups. Two patients (all from the PES group) experienced stent thrombosis (1 acute and 1 subacute). The SES group revealed lower in-segment restenosis (5.9% vs. 14.8%, P = 0.03) and in-segment late loss (0.09 ± 0.45 vs. 0.33 ± 0.68 mm, P = 0.002) than PES group on follow-up angiography. Twelve-month TLR rates (2.6% vs. 6.5%, P = 0.17) were similar between two groups. MACE rates were lower in the SES group than in the PES group, but it did not reach statistical significance (5.8% vs. 11.7%, P = 0.07). Conclusion: In the setting of primary angioplasty for STEMI, there were no statistically significant differences between the SES and the PES in terms of 12-month MACE. However, binary angiographic in-segment restenosis and in-segment late loss were significantly lower in the SES group. © 2008 Wiley-Liss, Inc.