Everolimus-Eluting Stents or Bypass Surgery for Multivessel Disease in Diabetics: The BEST Extended Follow-Up Study.

BACKGROUND: Diabetes mellitus is associated with more complex coronary artery diseases. Coronary artery bypass grafting (CABG) is a preferred revascularization strategy over percutaneous coronary intervention (PCI) in diabetics with multivessel coronary artery disease (MVD). OBJECTIVES: This study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial. METHODS: Patients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years). RESULTS: In diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; Pinteraction= 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group. CONCLUSIONS: In diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828).

Association of Intima-Media Thickness Measured at the Common Carotid Artery With Incident Carotid Plaque: Individual Participant Data Meta-Analysis of 20 Prospective Studies.

Background The association between common carotid artery intima-media thickness (CCA-IMT) and incident carotid plaque has not been characterized fully. We therefore aimed to precisely quantify the relationship between CCA-IMT and carotid plaque development. Methods and Results We undertook an individual participant data meta-analysis of 20 prospective studies from the Proof-ATHERO (Prospective Studies of Atherosclerosis) consortium that recorded baseline CCA-IMT and incident carotid plaque involving 21 494 individuals without a history of cardiovascular disease and without preexisting carotid plaque at baseline. Mean baseline age was 56 years (SD, 9 years), 55% were women, and mean baseline CCA-IMT was 0.71 mm (SD, 0.17 mm). Over a median follow-up of 5.9 years (5th-95th percentile, 1.9-19.0 years), 8278 individuals developed first-ever carotid plaque. We combined study-specific odds ratios (ORs) for incident carotid plaque using random-effects meta-analysis. Baseline CCA-IMT was approximately log-linearly associated with the odds of developing carotid plaque. The age-, sex-, and trial arm-adjusted OR for carotid plaque per SD higher baseline CCA-IMT was 1.40 (95% CI, 1.31-1.50; I2=63.9%). The corresponding OR that was further adjusted for ethnicity, smoking, diabetes, body mass index, systolic blood pressure, low- and high-density lipoprotein cholesterol, and lipid-lowering and antihypertensive medication was 1.34 (95% CI, 1.24-1.45; I2=59.4%; 14 studies; 16 297 participants; 6381 incident plaques). We observed no significant effect modification across clinically relevant subgroups. Sensitivity analysis restricted to studies defining plaque as focal thickening yielded a comparable OR (1.38 [95% CI, 1.29-1.47]; I2=57.1%; 14 studies; 17 352 participants; 6991 incident plaques). Conclusions Our large-scale individual participant data meta-analysis demonstrated that CCA-IMT is associated with the long-term risk of developing first-ever carotid plaque, independent of traditional cardiovascular risk factors.

Genetic-Guided Oral P2Y12 Inhibitor Selection and Cumulative Ischemic Events After Percutaneous Coronary Intervention.

BACKGROUND: Genetic-guided P2Y12 inhibitor selection has been proposed to reduce ischemic events by identifying CYP2C19 loss-of-function (LOF) carriers at increased risk with clopidogrel treatment after percutaneous coronary intervention (PCI). A prespecified analysis of TAILOR-PCI (Tailored Antiplatelet Therapy Following PCI) evaluated the effect of genetic-guided P2Y12 inhibitor therapy on cumulative ischemic and bleeding events. OBJECTIVES: Here, the authors detail a prespecified analysis of cumulative endpoints. The primary endpoint was cumulative incidence rate of ischemic events at 12 months. Cumulative incidence of major and minor bleeding was a secondary endpoint. Cox proportional hazards models as adapted by Wei, Lin, and Weissfeld were used to estimate the effect of this strategy on all observed events. METHODS: The TAILOR-PCI trial was a prospective trial including 5,302 post-PCI patients with acute and stable coronary artery disease (CAD) who were randomized to genetic-guided P2Y12 inhibitor or conventional clopidogrel therapy. In the genetic-guided group, LOF carriers were prescribed ticagrelor, whereas noncarriers received clopidogrel. TAILOR-PCI's primary analysis was time to first event in LOF carriers. RESULTS: Among 5,276 patients (median age 62 years; 25% women; 82% acute CAD; 18% stable CAD), 1,849 were LOF carriers (903 genetic-guided; 946 conventional therapy). The cumulative primary endpoint was significantly reduced in the genetic-guided group compared with the conventional therapy (HR: 0.61; 95% CI: 0.41-0.89; P = 0.011) with no significant difference in cumulative incidence of major or minor bleeding (HR: 1.36; 95% CI: 0.67-2.76; P = 0.39). CONCLUSIONS: Among CYP2C19 LOF carriers undergoing PCI, a genetic-guided strategy resulted in a statistically significant reduction in cumulative ischemic events without a significant difference in bleeding. (Tailored Antiplatelet Therapy Following PCI [TAILOR-PCI]; NCT01742117).

Korea Heart Disease Fact Sheet 2020: Analysis of Nationwide Data.

BACKGROUND AND OBJECTIVES: Cardiovascular disease (CVD) is the leading cause of death and disability worldwide. To provide an overview of the temporal trends in the burden of CVD, the Korean Society of Cardiology has published the Korea Heart Disease Fact Sheet in 2020. METHODS: We analyzed anonymized data of the Causes of Death Statistics, National Health Insurance Claims Database, and Korea National Health and Nutrition Examination Survey to assess mortality, hospitalizations, and risk factors for CVD. RESULTS: The CVD mortality decreased until 2010, then steadily increased up to 123 per 100,000 persons in 2018. Since 2002, the number and rate of CVD hospitalization have continued to grow. In 2018, approximately 12.1 million Korean adults had hypertension, 4.3 million had diabetes, 8.7 million had hypercholesterolemia, 14.9 million had obesity, and 8.8 million were currently smoking. The number of risk factors increased markedly with older age; 58.4% of adults age ≥70 years had ≥2 risk factors. CONCLUSIONS: CVD mortality and hospitalization have gradually increased in the last decade, and a substantially high proportion of adults were carrying more than 1 cardiovascular risk factor in 2018. With the rapid population aging, a continued increase in CVD appears inevitable in Korea. Concerted and sustained approaches are essential to achieve early prevention and reduce the burden of CVD.

Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial.

BACKGROUND: The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. METHODS AND DESIGN: The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year. RESULTS: Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. CONCLUSION: This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.

Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial.

Importance: After percutaneous coronary intervention (PCI), patients with CYP2C19*2 or *3 loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown. Objective: To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes in CYP2C19 LOF carriers after PCI. Design, Setting, and Participants: Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019. Interventions: Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping. CYP2C19 LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months. Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients with CYP2C19 LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50. Results: Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 with CYP2C19 LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903 CYP2C19 LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02]; P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07]; P = .16). Conclusions and Relevance: Among CYP2C19 LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT01742117.

The Effect of Cilostazol on the Angiographic Outcome of Drug-Eluting Coronary Stents Angiographic Analysis of the CILON-T (Influence of CILostazol-Based Triple Antiplatelet Therapy ON Ischemi Complication after Drug-Eluting StenT Implantation) Trial.

It is not clear if anti-restonotic effect of cilostazol is consistent for different types of drug-eluting stents (DES).The purpose of this study was to compare the anti-proliferative effect of cilostazol between DAT and TAT with consideration of confounding influences of DES type.Nine hundred and fifteen patients were randomized to either dual antiplatelet therapy (DAT; aspirin and clopidogrel) or triple antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol) in the previous CILON-T trial. After excluding 70 patients who received both or neither stents, we analyzed 845 patients who received exclusively PES or ZES, and compared in-stent late loss at 6 months between both antiplatelet regimens (DAT versus TAT).Baseline angiographic and clinical characteristics were similar between the DAT (656 lesions in 425 patients) and the TAT group (600 lesions in 420 patients). The 6-month follow-up angiography was completed in 745 patients (88.2%). Quantitative coronary angiography showed that TAT significantly reduced in-stent late loss (DAT 0.62 ± 0.62 mm versus TAT 0.54 ± 0.49 mm, P = 0.015). Stent type, diabetes or lesion length did not interact with difference of late loss. However, reduction of late loss by cilostazol did not lead to a significant reduction in the rate of target lesion revascularization (TLR) (DAT 7.8% versus TAT 6.9%, P = 0.69) due to a nonlinear relationship found between late loss and TLR.The TAT group showed less in-stent late loss as compared to the DAT group. This was consistently observed regardless of DES type, lesion length, or diabetic status. However, reduction of late loss by cilostazol did not lead to a significant reduction in TLR.

Manual thrombus aspiration during primary percutaneous coronary intervention: Impact of total ischemic time.

BACKGROUND: The benefit of manual thrombus aspiration (TA) during primary percutaneous coronary intervention (PCI) remains uncertain, and the effect of TA in relation to total ischemic time has not been evaluated. METHODS: We analyzed 5641 patients with ST-elevation myocardial infarction (STEMI) (<12h) from the Korea Acute Myocardial Infarction Registry undergoing primary PCI. Patients were divided into 2 groups: TA (n=1245) and PCI only (n=4396). Propensity-matched 12-month clinical outcome was compared between the groups according to different total ischemic times (≤2h, 2-4h, 4-6h, >6h). RESULTS: Twelve-month rates of death and major adverse cardiac events (MACE: composite of death, recurrent myocardial infarction, target-vessel revascularization, and coronary artery bypass grafting) were not different between TA and PCI only. After propensity matching (n=1162 for each group), there were no differences in the 12-month outcome between TA and PCI only, which was consistent across subgroups. In the propensity-matched cohort, the effect of TA on 12-month outcome showed a U-shaped relationship with longer total ischemic time: TA in patients with total ischemic time between 4 and 6h was associated with lower rates of death [hazard ratio (HR): 0.53, 95% confidence interval (CI): 0.24-1.19, p for interaction=0.01] and MACE (HR: 0.28, 95% CI: 0.12-0.66, p for interaction=0.01). CONCLUSIONS: Manual TA during primary PCI was not associated with improved clinical outcome at 12 months. The impact of TA may become clinically relevant with longer total ischemic time, forming a U-shaped relationship.

Pharmacoinvasive Strategy Versus Primary Percutaneous Coronary Intervention in Patients With ST-Segment-Elevation Myocardial Infarction: A Propensity Score-Matched Analysis.

BACKGROUND: The Strategic Reperfusion Early After Myocardial Infarction trial and the French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015 suggested that pharmacoinvasive strategy compares favorably with primary percutaneous coronary intervention (PPCI). We sought to assess the clinical impact of pharmacoinvasive strategy compared with PPCI in real-world patients with ST-segment-elevation myocardial infarction. METHODS AND RESULTS: We used the Korea Acute Myocardial Infarction Registry to identify ST-segment-elevation myocardial infarction patients receiving either pharmacoinvasive strategy defined as fibrinolysis followed by percutaneous coronary intervention (rescue/urgent or routine elective; n=708) or PPCI (n=8878). Patients receiving facilitated percutaneous coronary intervention within 3 hours from fibrinolysis were excluded. Propensity-matched 12-month clinical outcome was compared. In the propensity-matched cohort (n=706 in each group), the pharmacoinvasive group had shorter time to reperfusion therapy (165 versus 241 minutes; P<0.001) and higher rate of pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction grade 3 (50.4% versus 13.7%; P<0.001). Incidences of major bleeding and stroke during hospitalization were not different. Twelve-month rates of death and major adverse cardiac events (composite of death, recurrent myocardial infarction, target-vessel revascularization, and coronary artery bypass graft surgery) were similar between pharmacoinvasive strategy and PPCI: 4.4% versus 4.1% and 7.5% versus 7.8%, respectively. Equipoise between pharmacoinvasive strategy and PPCI for 12-month major adverse cardiac events occurred when percutaneous coronary intervention-related delay was ≈100 minutes. CONCLUSIONS: ST-segment-elevation myocardial infarction patients receiving pharmacoinvasive treatment, compared with PPCI, had shorter time to reperfusion, higher culprit-vessel patency, and similar 12-month clinical outcome.

Clinical impact of immediate invasive strategy in patients with non-ST-segment elevation myocardial infarction.

BACKGROUND: Immediate invasive approach for non-ST-segment elevation myocardial infarction (NSTEMI) may permit treatment of the underlying plaque rupture as early as possible with subsequent reduction of death and myocardial infarction (MI). We sought to assess clinical impact of immediate percutaneous coronary intervention (PCI) for NSTEMI. METHODS: A total of 6134 NSTEMI patients undergoing PCI from the Korea Acute Myocardial Infarction Registry were divided into group 1 (immediate PCI within 4h, n=1132) and group 2 (non-immediate PCI after 4h, n=5002). Propensity-matched 12-month clinical outcome was compared. RESULTS: In all patients and propensity-matched cohort (n=1131 in each group), group 1 had higher peak troponin level, higher rate of pre-PCI Thrombolysis In Myocardial Infarction (TIMI) grade 0 or 1, higher use of glycoprotein IIb/IIIa inhibitor, and lower use of unfractionated heparin and nitrates. In all patients, 12-month rates of MI and death/MI were higher in group 1. No differences were observed in 12-month death and major adverse cardiac events (MACE: composite of death, MI, target-vessel revascularization, and coronary artery bypass graft surgery). In propensity-matched cohort, no significant differences were observed in 12-month rates of death, MI, death/MI or MACE. However, group 1 had less major bleeding (0.8% vs. 3.0%, p=0.024) and shorter hospital stay. CONCLUSIONS: Immediate PCI for patients with NSTEMI was associated with lower pre-PCI culprit vessel patency and not with improved 12-month clinical outcome.

Late-acquired incomplete stent apposition after everolimus-eluting stent versus sirolimus-eluting stent implantation in patients with non-ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction.

AIMS: Our aim was to evaluate the incidence and clinical outcomes of late-acquired incomplete stent apposition (LAISA) after implantation of first- and second-generation drug-eluting stents in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: Late-Acquired incomplete stent aPPOsition after everolimus-eluting stent versus sirolimus-eluting Stent ImplanTatION in pAtients with non ST-segment elevation Myocardial Infarction and ST-segment elevation myocardial infarction (APPOSITION-AMI) was a prospective, randomised study comparing LAISA after everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) implantation in AMI patients. Intravascular ultrasound examination was serially performed post-procedurally and at eight-month follow-up in 195 AMI patients (205 native coronary lesions: 100 EES; 105 SES). LAISA was observed in 6.0% and 16.2% of EES- vs. SES-treated lesions (p=0.021), respectively. In 64.7% of SES-treated lesions, LAISA was caused by positive remodelling, whereas thrombus dissolution or plaque reduction was observed in 66.7% of EES-treated lesions. Among patients with LAISA, MACE developed in one (4.5%) in the SES group with no ST in either group up to one year. CONCLUSIONS: The incidence of LAISA was lower in AMI patients treated with EES as compared to SES, mainly secondary to positive remodelling in SES- but not EES-treated lesions. Patients with LAISA in both groups showed a very low MACE incidence at one-year follow-up.

Efficacy and tolerability of amlodipine camsylate/losartan 5/100-mg versus losartan/hydrochlorothiazide 100/12.5-mg fixed-dose combination in hypertensive patients nonresponsive to losartan 100-mg monotherapy.

PURPOSE: The aim of this study was to determine whether the efficacy and tolerability of amlodipine camsylate/losartan 5/100 mg/d (AML/LOS) are noninferior to those of losartan/hydrochlorothiazide 100/12.5 mg/d (LOS/HCTZ) fixed-dose combination in hypertensive patients unresponsive to losartan 100-mg/d monotherapy. METHODS: Male and female patients aged ≥ 18 years with hypertension despite 4-week, stable treatment with losartan 100-mg/d monotherapy were eligible for inclusion in this multicenter, randomized, double-blind study. Patients were randomly assigned to receive AML/LOS or LOS/HCTZ once daily for 8 weeks. The primary end point was the change from baseline to week 8 in sitting diastolic blood pressure (ΔsiDBP), and the secondary end points were the changes from baseline to 4 weeks in siDBP and sitting systolic BP (ΔsiSBP) and changes from baseline to 4 and 8 weeks in BP response rate. Tolerability was evaluated by physical examination, including vital sign measurement; laboratory analysis; and ECG. FINDINGS: Of 275 patients screened at 9 cardiovascular centers, 199 were enrolled (AML/LOS, n = 101; LOS/HCTZ, n = 98), and 183 completed the study. The demographic characteristics were similar between the 2 groups (mean age, 51.56 [9.97] years; men, 70.53%). At 8 weeks, the mean ΔsiDBP values were -11.54 (7.89) and -9.05 (6.57) mm Hg in the AML/LOS and LOS/HCTZ groups, respectively (both, P < 0.0001 vs baseline). The mean difference between the 2 groups was -2.57 mm Hg, a nonsignificant difference, meaning that AML/LOS was noninferior to LOS/HCTZ with regard to the primary end point. At 8 weeks, the mean uric acid level was changed significantly from baseline in the LOS/HCTZ group (+0.41 [0.80] mg/dL; P < 0.0001) but not in the AML/LOS group (-0.12 [0.82] mg/dL), representing a significant intergroup difference (P < 0.0001). Nineteen patients each in the AML/LOS (18.81%) and LOS/HCTZ (20.00%) groups experienced ≥ 1 adverse event, with 4 (3.96%) and 3 (3.16%) patients, respectively, experiencing 1 or more events considered by the investigators to have been treatment related. IMPLICATIONS: The efficacy and tolerability of AML/LOS 5/100 mg/d was found to have been noninferior to those of LOS/HCTZ 100/12.5 mg/d in these hypertensive patients nonresponsive to losartan 100-mg/d monotherapy.

Cilostazol eliminates adverse smoking outcome in patients with drug-eluting stent implantation.

BACKGROUND: The present study investigated whether cilostazol can eliminate adverse smoking outcome after percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 914 patients with successful drug-eluting stent (DES) implantation were randomly assigned to dual antiplatelet therapy (DAT; aspirin and clopidogrel, n=457) or to triple antiplatelet therapy (TAT; DAT with cilostazol, n=457). The effect of smoking on 2-year major adverse cardio/cerebrovascular events (MACCE) in both the TAT and DAT groups was evaluated. Total MACCE were not significantly different between the 2 anti-platelet regimens (9.8% in TAT vs. 11.4% in DAT groups, P=0.45), but the adverse effects of smoking on clinical outcome were different between DAT vs. TAT. Current smokers had a higher prevalence of MACCE than non-smokers in the DAT group (16.7% vs. 9.5%, P=0.04). In the TAT group, however, the adverse effect of smoking was abolished (9.2% vs. 10.1%, P=0.85). Regarding the effects of smoking on the antiplatelet effects of DAT or TAT, post-treatment platelet reactivity (in P2Y12 reaction units; PRU) in current smokers was not significantly lower than that in non-smokers in the DAT group, whereas, in the TAT group, it was significantly lower than that of non-smokers (189±88 vs. 216±89 PRU, P=0.01). CONCLUSIONS: Adverse clinical effects of smoking may be eliminated by the addition of cilostazol to DAT after DES implantation. This may be due to the stimulation of cilostazol's antiplatelet effects by smoking.

Comparative assessment of angiotensin II type 1 receptor blockers in the treatment of acute myocardial infarction: surmountable vs. insurmountable antagonist.

BACKGROUND: The mechanisms of antagonism vary between the angiotensin II type 1 receptor blockers (ARBs): insurmountable antagonism and surmountable antagonism. Recent retrospective observational studies suggest that ARBs may not have equivalent benefits in various clinical situations. The aim of this study was to compare the effect of two categories of ARBs on the long-term clinical outcomes of patients with acute myocardial infarction (AMI). METHODS: We analyzed the large-scale, prospective, observational Korea Acute Myocardial Infarction Registry study, which enrolled 2740 AMI patients. They divided by the prescription of surmountable ARBs or insurmountable ARBs at discharge. Primary outcome was major adverse cardiac events (MACEs), defined as a composite of cardiac death, nonfatal MI, and re-percutaneous coronary intervention, coronary artery bypass graft surgery. RESULTS: In the overall population, the MACEs rate in 1 year was significantly higher in the surmountable ARB group (14.3% vs. 11.2%, p=0.025), which was mainly due to increased cardiac death (3.3% vs. 1.9%, p=0.031). Matching by propensity-score showed consistent results (MACEs rate: 14.9% vs. 11.4%, p=0.037). In subgroup analysis, the insurmountable ARB treatment significantly reduced the incidence of MACEs in patients with left ventricular ejection fraction greater than 40%, with a low killip class, with ST segment elevation MI, and with normal renal function. CONCLUSIONS: In our study, insurmountable ARBs were more effective on long-term clinical outcomes than surmountable ARBs in patients with AMI.

A prospective, randomized comparison of promus everolimus-eluting and TAXUS Liberte paclitaxel-eluting stent systems in patients with coronary artery disease eligible for percutaneous coronary intervention: the PROMISE study.

We aimed comparing two-year clinical outcomes of the Everolimus-Eluting Promus and Paclitaxel-Eluting TAXUS Liberte stents used in routine clinical practice. Patients with objective evidence of ischemia and coronary artery disease eligible for PCI were prospectively randomized to everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) groups. The primary end-point was ischemia-driven target vessel revascularization (TVR) at 2 yr after intervention, and the secondary end-point was a major adverse cardiac event (MACE), such as death, myocardial infarction (MI), target lesion revascularization (TLR), TVR or stent thrombosis. A total of 850 patients with 1,039 lesions was randomized to the EES (n=425) and PES (n=425) groups. Ischemic-driven TVR at 2 yr was 3.8% in the PES and 1.2% in the EES group (P for non-inferiority=0.021). MACE rates were significantly different; 5.6% in PES and 2.5% in EES (P = 0.027). Rates of MI (0.8% in PES vs 0.2% in EES, P = 0.308), all deaths (1.5% in PES vs 1.2% in EES, P = 0.739) and stent thrombosis (0.3% in PES vs 0.7% in EES, P = 0.325) were similar. The clinical outcomes of EES are superior to PES, mainly due to a reduction in the rate of ischemia-driven TVR.

Comparison of clinical outcomes between octogenarians and non-octogenarians with acute myocardial infarction in the drug-eluting stent era: analysis of the Korean Acute Myocardial Infarction Registry.

BACKGROUND AND PURPOSE: Octogenarians (age ≥ 80 years) with coronary artery disease constitute a high-risk group. However, octogenarian patients with acute myocardial infarction (AMI) in the drug-eluting stents (DES) era have not been widely reported. We aimed to identify clinical outcomes in octogenarian compared with non-octogenarian AMI patients. METHODS AND SUBJECTS: We retrospectively analyzed 9877 patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and who were enrolled in the Korean Acute Myocardial Infarction Registry (KAMIR). They were divided into 2 groups, octogenarians (n=1494) and non-octogenarians (n=8383), in order to compare the incidence of 1-year all-cause death and 1-year major adverse cardiac events (MACE), where MACE included all-cause death, recurrent myocardial infarction, target vessel revascularization (TVR), target lesion revascularization (TLR), and coronary artery bypass grafting (CABG). RESULTS: The clinical status was significantly inferior in octogenarians compared to non-octogenarians: Killip class ≥ II (34.8% vs. 22.5%, p<0.001), multivessel disease (65.8% vs. 53.7%, p<0.001). Rates of 1-year all-cause death were significantly higher in octogenarians than in non-octogenarians (22.3% vs. 6.5%, p<0.001). However, the rates of 1-year recurrent myocardial infarction (1.3% vs. 0.9%, p=0.68), TLR (2.4% vs. 3.1%, p=0.69), TVR (3.6% vs. 4.3%, p=0.96), and CABG (0.9% vs. 0.9%, p=0.76) did not differ significantly between the 2 groups. CONCLUSIONS: Octogenarian AMI patients have higher rates of mortality and MACE even in the DES era. According to KAMIR subgroup analysis, the TLR/TVR rates in octogenarians were comparable to those in non-octogenarian AMI patients.

Randomized trial comparing the efficacy between different types of paclitaxel-eluting stents: the comparison of efficacy between COroflex PLEASe ANd Taxus stent (ECO-PLEASANT) randomized controlled trial.

AIMS: Paclitaxel-eluting stents (PESs) have been shown to inhibit neointimal hyperplasia after percutaneous coronary intervention. Coroflex Please (B Braun, Melsungen, Germany) is a newly developed PES. We compared the clinical and angiographic efficacy of Coroflex Please with Taxus Liberte (Boston Scientific, Natick, MA) in a real-world practice. METHODS AND RESULTS: We performed a prospective, open-label, randomized, controlled study that enrolled 945 patients undergoing percutaneous coronary interventions in 18 centers in Korea. The primary end point was clinically driven target vessel revascularization at 9 months. The baseline characteristics were mostly similar and comparable between 2 groups. At 9 months, the incidence of clinically driven target vessel revascularization was 14.6% for Coroflex and 6.4% for Taxus, which was significantly different (hazard ratio 2.43, 95% CI 1.50-3.94, noninferiority P value = 1.000). This is well corroborated by the difference of in-stent late loss between 2 stents (0.71 ± 0.64 mm vs 0.52 ± 0.50 mm, P < .001) by 9-month follow-up angiography (n = 415 vs 215). Among secondary clinical end points, stent thrombosis (definite and probable) for 1 year was 2.2% in Coroflex and 1.3% in Taxus (P = .317). Also, myocardial infarction for 9 months was higher in Coroflex group than that in Taxus (4.9% vs 1.6%, P = .012), which was partly contributed by the higher incidence of periprocedural myocardial infarction in Coroflex arm (2.2% vs 0.3%, P = .028). CONCLUSIONS: Coroflex Please was inferior to Taxus Liberte with regard to clinical and angiographic efficacy.

Hypercholesterolemia and in-vivo coronary plaque composition in patients with coronary artery disease: a virtual histology - intravascular ultrasound study.

BACKGROUND AND OBJECTIVES: Hypercholesterolemia is a key factor in the development of atherosclerosis. We sought to evaluate the relation between hypercholesterolemia and plaque composition in patients with coronary artery disease. SUBJECTS AND METHODS: Study subjects consisted of 323 patients (mean 61.5 years, 226 males) who underwent coronary angiography and virtual histology-intravascular ultrasound examination. Patients were divided into two groups according to total cholesterol level: hypercholesterolemic group (≥200 mg/dL, n=114) and normocholesterolemic group (<200 mg/dL, n=209). RESULTS: Hypercholesterolemic patients were younger (59.7±13.3 years vs. 62.6±11.5 years, p=0.036), than normocholesterolemic patients, whereas there were no significant differences in other demographics. Hypercholesterolemic patients had higher corrected necrotic core volume (1.23±0.85 mm(3)/mm vs. 1.02±0.80 mm(3)/mm, p=0.029) as well as percent necrotic core volume (20.5±8.5% vs. 18.0±9.2%, p=0.016) than normocholesterolemic patients. At the minimal lumen area site, percent necrotic core area (21.4±10.5% vs. 18.4±11.3%, p=0.019) and necrotic core area (1.63±1.09 mm(2) vs. 1.40±1.20 mm(2), p=0.088) were also higher than normocholesterolemic patients. Multivariate linear regression analysis showed that total cholesterol level was an independent factor of percent necrotic core volume in the culprit lesion after being adjusted with age, high density lipoprotein-cholesterol , hypertension, diabetes mellitus, smoking and acute coronary syndrome (beta 0.027, 95% confidence interval 0.02-0.053, p=0.037). CONCLUSION: Hypercholesterolemia was associated with increased necrotic core volume in coronary artery plaque. This study suggests that hypercholesterolemia plays a role in making plaque more complex, which is characterized by a large necrotic core, in coronary artery disease.

Risk Factors for Failure of Early Catheter Removal After Greenlight HPS Laser Photoselective Vaporization Prostatectomy in Men With Benign Prostatic Hyperplasia.

PURPOSE: To assess the risk factors for developing urinary retention after removal of the urethral catheter on postoperative day 1 in benign prostatic hyperplasia patients who underwent Greenlight HPS laser photoselective vaporization prostatectomy (PVP). MATERIALS AND METHODS: The study included 427 men who underwent Greenlight HPS laser PVP between 2009 and 2012, excluding patients in whom a catheter was maintained for more than 1 day because of urethral procedures. In all patients, a voiding trial was performed on postoperative day 1; if patients were unable to urinate, the urethral catheter was replaced before hospital discharge. The patients were divided into two groups: early catheter removal (postoperative day 1) and late catheter removal (urethral catheter reinsertion). Preoperative and perioperative parameters were compared between the groups. RESULTS: Catheters were successfully removed in 378 (88.6%) patients on postoperative day 1. In 49 patients, the catheters were reinserted and removed a mean of 6.45±0.39 days after surgery. In a multivariate analysis, a history of diabetes was the most significant predictor (p=0.028) of failure of early catheter removal, followed by operative time (p=0.039). There were no significant differences in age, prostate volume, International Prostate Symptom Score, or urodynamic parameters between the two groups. CONCLUSIONS: It is feasible, safe, and cost-effective to remove the urethral catheter on postoperative day 1 after Greenlight HPS laser PVP, but the procedure should be done carefully in patients who have history of diabetes or an extended operative time.

Desmopressin add-on therapy for refractory nocturia in men receiving α-blockers for lower urinary tract symptoms.

PURPOSE: Alpha-blockers improve lower urinary tract symptoms associated with benign prostatic obstruction. Nocturia, a storage symptom, is a common complaint in men. However, it does not fully respond to α-blocker therapy, likely due to its multifactorial pathophysiology. We evaluated the efficacy and safety of desmopressin as add-on therapy for refractory nocturia in men previously treated with an α-blocker for lower urinary tract symptoms. MATERIALS AND METHODS: Eligible patients were men 50 years old or older with lower urinary tract symptoms and persistent nocturia despite α-blocker treatment for a minimum of 4 weeks. The optimum dose of oral desmopressin was determined during a 4-week dose titration period and this dose was maintained for 24 weeks. Flow volume charts, International Prostate Symptom Score total and subscores, uroflowmetry and post-void residual urine volume were assessed. RESULTS: A total of 216 patients were enrolled in the study. Of these patients there were 158 (76%) with nocturnal polyuria, 15 (7.2%) with decreased nocturnal bladder capacity and 35 (16.8%) with nocturia due to both causes. The number of nocturnal voids significantly decreased from a baseline mean of 7.0 to 5.7 episodes for 3 days at the 24-week visit. The average International Prostate Symptom Score total and subscore significantly decreased by 4 weeks and were maintained at 24 weeks. In patients younger than 65 years, International Prostate Symptom Score voiding subscores were significantly improved at 24 weeks compared to those age 65 years or older. CONCLUSIONS: Desmopressin add-on therapy for refractory nocturia in men previously treated with an α-blocker for lower urinary tract symptoms improved voiding symptoms as well as nocturia, storage symptoms.