Clinical feasibility of catheter-directed selective intracoronary computed tomography angiography using an extremely low dose of iodine in patients with coronary artery disease.

OBJECTIVE: This study aimed to evaluate the clinical feasibility of catheter-directed selective computed tomography angiography (S-CTA) in patients with coronary artery disease (CAD). METHODS: We prospectively enrolled 65 patients diagnosed with CAD who underwent conventional computed tomography angiography (C-CTA). C-CTA was performed with 60-90 mL of contrast medium (370 mg iodine/mL), whereas S-CTA was performed with 15 mL of contrast medium and 17.19 mg iodine/mL. Luminal enhancement range, homogeneity of luminal enhancement, image quality, plaque volume (PV), and percent aggregate plaque volume (%APV) were measured. Paired Student's t test, Wilcoxon rank-sum test, and Pearson's correlation coefficient were used to compare two methods. RESULTS: Luminal enhancement was significantly higher on S-CTA than on C-CTA (324.4 ± 8.0 Hounsfield unit (HU) vs. 312.0 ± 8.0 HU, p < 0.0001 in the per-vessel analysis). Transluminal attenuation gradient showed a significantly slower reduction pattern on S-CTA than on C-CTA (-0.65 HU/10 mm vs. -0.89 HU/10 mm, p < 0.0001 in the per-vessel analysis). Image noise was significantly lower on S-CTA than on C-CTA (39.6 ± 10.0 HU vs. 43.9 ± 9.4 HU, p < 0.0001). There was excellent correlation between S-CTA and C-CTA with respect to PV and %APV (r = 0.99, r = 0.98, respectively). CONCLUSIONS: S-CTA might be useful in facilitating atherosclerotic plaque analysis and providing guidance for complex lesions such as chronic total occlusion, particularly in cases in which on-site procedure planning is required. KEY POINTS: • Selective computed tomography angiography (S-CTA) can serve as an intraprocedural computed tomography angiography protocol. • S-CTA was performed with low dose of iodine compared with conventional computed tomography angiography. • S-CTA enables on-site atherosclerotic plaque analysis.

Randomized Prospective Comparison of Everolimus-Eluting vs. Sirolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention　- 3-Year Clinical Outcomes of the EXCELLENT Randomized Trial.

BACKGROUND: Everolimus-eluting stents (EES) have equivalent short-term angiographic and clinical outcomes to sirolimus-eluting stents (SES), but EES may be superior to SES with regard to long-term clinical safety. We report the 3-year clinical outcomes of EES and SES from the prospective EXCELLENT Randomized Trial (NCT00698607).Methods and Results:We randomly assigned 1,443 patients undergoing percutaneous coronary intervention 3:1 to receive EES and SES, respectively. We investigated endpoints including target lesion failure (TLF) and individual clinical outcomes including stent thrombosis (ST) at 3 years. For EES and SES, the TLF rate was 4.82% and 4.12% (risk ratio [RR], 1.16, 95% CI: 0.65-2.06, P=0.62), respectively. Results were similar in other efficacy endpoints including target lesion revascularization. For safety endpoints, rate of all-cause death was significantly lower for EES (1.67%) than SES (3.57%; RR, 0.46; 95% CI: 0.23-0.94, P=0.03), while the incidence of cardiac death or myocardial infarction was numerically lower in EES. On 1-year landmark analysis, rates of all-cause death and major adverse cardiovascular events were significantly lower for EES than SES. Definite or probable ST was numerically 3-fold higher for SES (1.37%) compared with EES (0.46%). CONCLUSIONS: EES and SES had similar efficacy with regard to 3-year outcomes in the EXCELLENT trial, while delayed safety events all trended to favor EES.

A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.

Recent studies suggest that the intracoronary administration of bone marrow (BM)-derived mesenchymal stem cells (MSCs) may improve left ventricular function in patients with acute myocardial infarction (AMI). However, there is still argumentative for the safety and efficacy of MSCs in the AMI setting. We thus performed a randomized pilot study to investigate the safety and efficacy of MSCs in patients with AMI. Eighty patients with AMI after successful reperfusion therapy were randomly assigned and received an intracoronary administration of autologous BM-derived MSCs into the infarct related artery at 1 month. During follow-up period, 58 patients completed the trial. The primary endpoint was changes in left ventricular ejection fraction (LVEF) by single-photon emission computed tomography (SPECT) at 6 month. We also evaluated treatment-related adverse events. The absolute improvement in the LVEF by SPECT at 6 month was greater in the BM-derived MSCs group than in the control group (5.9% ± 8.5% vs 1.6% ± 7.0%; P=0.037). There was no treatment-related toxicity during intracoronary administration of MSCs. No significant adverse cardiovascular events occurred during follow-up. In conclusion, the intracoronary infusion of human BM-derived MSCs at 1 month is tolerable and safe with modest improvement in LVEF at 6-month follow-up by SPECT. (ClinicalTrials.gov registration number: NCT01392105).

Effect of statin treatment in patients with acute myocardial infarction and left ventricular systolic dysfunction according to the level of high-sensitivity C-reactive protein.

The effects of statins on the prognosis of patients with left ventricular (LV) systolic dysfunction remain controversial. The aim of this study was to assess the effect of statin treatment on clinical outcomes in acute myocardial infarction (AMI) patients with LV systolic dysfunction. A total of 5,119 AMI patients with LV ejection fraction less than 50% on the initial echocardiogram were analyzed in the Korean Acute Myocardial Infarction Registry. The study population was divided into 4 groups according to the level of high sensitivity C-reactive protein (hs-CRP) and statin treatment: low hs-CRP (hs-CRP ≤ 2.0 mg/L) and high hs-CRP (hs-CRP > 2 mg/L) with or without statin therapy. We evaluated the incidence of major adverse cardiac events (MACEs) including cardiac death, reinfarction, target lesion revascularization, and coronary artery bypass grafting during a 12-month period in each group. Statin therapy did not significantly prevent the MACEs in the low hs-CRP groups (with statin: 10.1% versus without statin: 12.0%, P = 0.249). In the high hs-CRP groups, however, the incidence of MACEs was significantly decreased with statin treatment (with statin: 11.3%, without statin: 20.8%, P < 0.001). These findings were consistently observed in all subgroups of the high-hs CRP group, including the subgroup with an LV ejection fraction less than 40%. In a multivariable logistic regression analysis of the high hs-CRP group, lack of statin therapy was a significant predictor of MACE incidence (odds ratio: 1.573, 95% confidence interval: 1.079-2.293, P = 0.018). The statin treatment was associated with better outcome in AMI and LV dysfunction patients with hs-CRP ≥ 2 mg/dL.

Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice.

BACKGROUND/AIMS: The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention. METHODS: The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%. CONCLUSION: In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.

Standard versus high loading doses of clopidogrel in Asian ST-segment elevation myocardial infarction patients undergoing percutaneous coronary intervention: insights from the Korea Acute Myocardial Infarction Registry.

BACKGROUND: The optimal loading dose of clopidogrel in Asian patients with ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. We compared bleeding, vascular complications, and midterm outcomes of a 300-mg versus a 600-mg loading dose of clopidogrel in a large series of Korean patients with STEMI undergoing primary percutaneous coronary intervention (PCI). METHODS: A total of 2,664 STEMI patients (age 61.96 ± 11.91 years, men 70.4%) who underwent primary PCI were enrolled in this study. The patients were divided into a standard loading dose group (300 mg; n = 1,447 patients) and a high loading dose group (600 mg; n = 1,217 patients). Bleeding and vascular complications, and in-hospital and clinical outcomes up to 12 months were compared between the 2 groups. RESULTS: In-hospital bleeding and vascular complications were similar between the 2 groups. There were no differences in bleeding and vascular complications and in 1- and 12-month clinical outcomes, including mortality, myocardial infarction, repeated PCI, and major adverse cardiac events, between the 2 groups. These findings were consistent even after the propensity score-matched analysis. CONCLUSIONS: The standard loading dose of clopidogrel may be as safe and similarly effective as the high loading dose in Asian STEMI patients undergoing primary PCI.

Characteristics and predictors of drug-eluting stent thrombosis: results from the multicenter 'Korea Stent Thrombosis (KoST)' registry.

BACKGROUND: Previous studies have reported possible predictors of drug-eluting stent thrombosis (ST), but data for Asians are relatively limited. This study was performed to elucidate clinical predictors of ST in Koreans. METHODS AND RESULTS: From May 2003 to May 2007, consecutive patients presenting with ST were enrolled from 10 cardiovascular centers in Korea. They were compared with 2,192 controls (3,223 lesions) who had received percutaneous coronary intervention with at least 6 months of follow-up without ST. On multivariate analysis, acute myocardial infarction (AMI) as initial diagnosis, drug-eluting stents (DES) in-stent restenosis (ISR), low ejection fraction (EF), small stent diameter, left anterior descending artery intervention, and young age were independent predictors of total ST. When divided into early (ST within 30 days of index procedure) and delayed ST (ST after 30 days of index procedure), low EF, small stent diameter, DES ISR and AMI as initial diagnosis were universal risks for both early and delayed ST. The time from antiplatelet agent discontinuation to ST occurrence was significantly shorter in late compared with very late ST. CONCLUSIONS: Predictors of ST may be slightly different for early vs. delayed ST. However, low EF, small stent diameter, DES ISR lesion, and AMI as initial diagnosis were universal risk factors for both early and delayed ST cases. The relationship between antiplatelet agent discontinuation and ST occurrence seems stronger in late compared with very late ST.

High plasma interleukin-6 is associated with drug-eluting stent thrombosis: possible role of inflammatory cytokines in the development of stent thrombosis from the Korea Stent Thrombosis Registry.

BACKGROUND: Inflammation might contribute to the development of stent thrombosis (ST). The association between inflammatory cytokine concentrations and drug-eluting ST were evaluated. METHODS AND RESULTS: Among the 123 ST patients enrolled in the multicenter Korea Stent Thrombosis registry, plasma samples were available in 41 patients. The patients' clinical characteristics and plasma concentrations of monocyte chemoattractant protein-1, tumor necrosis factor-alpha, and interleukin (IL)-6 were compared with 81 matched controls. Although the concentrations of 3 cytokines were higher in the ST group, they did not have significant differences. When divided into quartiles, the proportion of patients with the highest quartile of IL-6 was higher in the ST group than in the control group (44% vs. 16%, P = 0.001), and the highest IL-6 quartile was an independent predictor of ST for both early (adjusted hazard ratio [HR] 6.96; 95% confidence interval [CI] 1.75-27.66) and late ST (adjusted HR 4.71; 95%CI 1.06-20.92). In addition, the highest IL-6 quartile was an independent predictor of ST in those on clopidogrel (adjusted HR 7.70; 95%CI 1.97-30.13) but not in those who were off clopidogrel. CONCLUSIONS: Highest IL-6 quartile was associated with ST, especially in clopidogrel users regardless of the time of ST, suggesting the involvement of inflammatory cytokines in ST.

Comparison of paclitaxel-, sirolimus-, and zotarolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction and metabolic syndrome.

BACKGROUND: The purpose of the present study was to compare the efficacy and safety of paclitaxel-eluting stent (PES), sirolimus-eluting stent (SES), and zotarolimus-eluting stent (ZES) in primary percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI) with metabolic syndrome (MS). METHODS AND RESULTS: Using data from Korea Acute Myocardial Infarction Registry (KAMIR; November 2005-December 2007), a total of 1,768 MS patients with STEMI who underwent primary PCI were enrolled: The PES group was 634, SES group, 906, and ZES group, 228. The primary endpoint was major adverse cardiac event (all-cause death, re-myocardial infarction, target lesion revascularization) during 12 months follow-up. At 12 months, the cumulative incidence of primary endpoint in the PES, SES, and ZES groups was 10.9%, 9.1%, and 11.0%, respectively (P=0.086). Incidence of death, recurrent myocardial infarction, or target lesion revascularization did not differ among the 3 groups. There were 7 episodes of acute (0.3% in PES group, 0.4% in SES group, and 0.4% in ZES group, respectively, P=0.773) and 18 episodes of cumulative stent thrombosis including late stent thrombosis (0.9% in PES group, 1.0% in SES group, and 1.3% in ZES group, respectively, P=0.448). CONCLUSIONS: Implantation of SES, PES, and ZES in MS patients with STEMI undergoing primary PCI provided comparable clinical outcomes in patients enrolled in KAMIR.

Development of a biodegradable sirolimus-eluting stent coated by ultrasonic atomizing spray.

In this study, poly(D,L lactic-co-glycolic acid) (PLGA) was used as a drug carrier to generate two types of stents loaded with different concentrations of sirolimus. These stents were prepared by ultrasonic atomizing spray coating. Ultrasonic atomizing spray nozzle uses a low-pressure air/gas to produce a soft, highly focused beam of small spray drops. An isolated hypotube delivers liquid to the nozzle's atomizing surface while air/gas, delivered through the nozzle orifice at a fixed low pressure, shapes the atomized drops into a very precise, targeted spray. The stent was moved both in the traverse direction and rotated during the spraying process. The morphology of the sirolimus-eluting stents was examined by scanning electron microscopy (SEM) which indicated that the coating was very smooth and uniform. The coating was found to have the ability to withstand the compressive and tensile strains imparted without cracking during the stent inflation process. Release profile of sirolimus was measured by high performance liquid chromatography (HPLC). The release behavior of sirolimus from the stent surface had a two phase release profile with a burst release period of about 2 days, followed by a sustained and slow release phase. The mass loss behavior of PLGA appeared linear throughout most of the degradation period. At 28 days, neointimal formation was found to be significantly decreased for both sirolimus-eluting stents as compared to bare-metal stents (BMS). Assessment of vascular healing revealed an absence of increased inflammation in both sirolimus-eluting stents. Inflammation is commonly observed in drug-eluting stents (DES) with nonbiodegradable polymeric coatings. Taking these results into account, these novel sirolimus-eluting stents may be good candidates to resolve in-stent restenosis.

Triple versus dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

BACKGROUND: Whether triple antiplatelet therapy is superior or similar to dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention in the era of drug-eluting stents remains unclear. METHODS AND RESULTS: A total of 4203 ST-segment elevation myocardial infarction patients who underwent primary percutaneous coronary intervention with drug-eluting stents were analyzed retrospectively in the Korean Acute Myocardial Infarction Registry (KAMIR). They received either dual (aspirin plus clopidogrel; dual group; n=2569) or triple (aspirin plus clopidogrel plus cilostazol; triple group; n=1634) antiplatelet therapy. The triple group received additional cilostazol at least for 1 month. Various major adverse cardiac events at 8 months were compared between these 2 groups. Compared with the dual group, the triple group had a similar incidence of major bleeding events but a significantly lower incidence of in-hospital mortality. Clinical outcomes at 8 months showed that the triple group had significantly lower incidences of cardiac death (adjusted odds ratio, 0.52; 95% confidence interval, 0.32 to 0.84; P=0.007), total death (adjusted odds ratio, 0.60; 95% confidence interval, 0.41 to 0.89; P=0.010), and total major adverse cardiac events (adjusted odds ratio, 0.74; 95% confidence interval, 0.58 to 0.95; P=0.019) than the dual group. Subgroup analysis showed that older (>65 years old), female, and diabetic patients got more benefits from triple antiplatelet therapy than their counterparts who received dual antiplatelet therapy. CONCLUSIONS: Triple antiplatelet therapy seems to be superior to dual antiplatelet therapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with drug-eluting stents. These results may provide the rationale for the use of triple antiplatelet therapy in these patients.

Low-molecular-weight heparin versus unfractionated heparin in acute ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with drug-eluting stents.

BACKGROUND: Whether low-molecular-weight heparin (LMWH) is superior to unfractionated heparin (UFH) in acute ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) remains unclear. METHODS: A total of 3,372 STEMI patients who underwent primary PCI with DESs received either LMWH (n = 1,531 patients, subcutaneous enoxaparin 1 mg/kg, bid for 3-5 days plus reduced dose of UFH [50 U/kg] during PCI) or UFH alone (n = 1,841 patients, intravenous bolus injection of 5,000 U, followed by 24,000 U/d infusion for at least 48 hours). The bleeding events and clinical outcomes during in-hospital and at 8 months were compared. RESULTS: The incidences of major and minor bleeding events were similar between the 2 groups. Multivariable Cox regression analysis showed that LMWH group had lower incidences of cardiac death (adjusted odds ratio [OR] 0.55, 95% CI 0.39-0.77, P < .001), total death (adjusted OR 0.50, 95% CI 0.37-0.68, P < .001), and total major adverse cardiac events (adjusted OR 0.77, 95% CI 0.62-0.95, P = .017) at 8 months as compared with UFH group. Similar results were obtained across different subgroups including different DESs, age, and sex. CONCLUSIONS: The LMWH enoxaparin combined with reduced dose of UFH (50 U/kg) administration as an adjunctive antithrombotic therapy in STEMI patients undergoing primary PCI with DESs seems to be safe and efficacious. However, randomized clinical trials are needed to confirm this conclusion.

A multicenter, eight-week treatment, single-step titration, open-label study assessing the percentage of Korean dyslipidemic patients achieving LDL cholesterol target with atorvastatin starting doses of 10 mg, 20 mg and 40 mg.

BACKGROUND: This study was designed to evaluate the safety and efficacy of algorithm-based atorvastatin therapy initiated at different starting doses of 10, 20, and 40 mg in Korean dyslipidemic patients. METHODS: Five hundred seventy-four patients were screened, and 425 were enrolled (low risk, n = 29; intermediate risk, n = 45; high risk, n = 351). The starting dose depended on a patient's cardiovascular risk and LDL-cholesterol (LDL-C) levels. RESULTS: Of the patients, 253 (59.5%), 63 (14.8%) and 109 (25.6%) patients were assigned at baseline to 10 mg, 20 mg and 40 mg atorvastatin, respectively. 390 patients (91.8%) completed the study, and 35 discontinued prematurely. No patient in the low or intermediate risk groups was titrated to 80 mg at Week 4, whereas, 26 in the high risk group were. 81.9% of patients achieved their LDL-C target at Week 4, which was sustained through to Week 8 (86.0%). 89.1% of patients who were not titrated achieved their LDL-C target at Week 8, and 82.1% of patients who were titrated 1 step up achieved their LDL-C target at Week 8. Overall, about 40% reduction in LDL-C, non-HDL-C levels, and LDL-C/HDL-C ratio was observed during the follow-up. Triglyceride was reduced by approximately 10% by Week 8. HDL cholesterol was slightly increased over 8 weeks (2.6%). Atorvastatin was well tolerated at all dose levels. CONCLUSIONS: Patient-tailored statin therapy according to an individual's risk category and LDL-C levels was safe and effective with a quick achievement of LDL-C target in Korean dyslipidemic patients.

Clinical benefit of low molecular weight heparin for ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with glycoprotein IIb/IIIa inhibitor.

The efficacy of low molecular weight heparin (LMWH) with low dose unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) with or without glycoprotein (Gp) IIb/IIIa inhibitor compared to UFH with or without Gp IIb/IIIa inhibitor has not been elucidated. Between October 2005 and July 2007, 2,535 patients with ST elevation acute myocardial infarction (STEMI) undergoing PCI in the Korean Acute Myocardial Infarction Registry (KAMIR) were assigned to either of two groups: a group with Gp IIb/IIIa inhibitor (n=476) or a group without Gp IIb/IIIa inhibitor (n=2,059). These groups were further subdivided according to the use of LMWH with low dose UFH (n=219) or UFH alone (n=257). The primary end points were cardiac death or myocardial infarction during the 30 days after the registration. The primary end point occurred in 4.1% (9/219) of patients managed with LMWH during PCI and Gp IIb/IIIa inhibitor and 10.8% (28/257) of patients managed with UFH and Gp IIb/IIIa inhibitor (odds ratio [OR], 0.290; 95% confidence interval [CI], 0.132-0.634; P=0.006). Thrombolysis In Myocardial Infarction (TIMI) with major bleeding was observed in LMHW and UFH with Gp IIb/IIIa inhibitor (1/219 [0.5%] vs 1/257 [0.4%], P=1.00). For patients with STEMI managed with a primary PCI and Gp IIb/IIIa inhibitor, LMWH is more beneficial than UFH.

Impact of the metabolic syndrome on the clinical outcome of patients with acute ST-elevation myocardial infarction.

We sought to determine the prevalence of metabolic syndrome (MS) in patients with acute myocardial infarction and its effect on clinical outcomes. Employing data from the Korea Acute Myocardial Infarction Registry, a total of 1,990 patients suffered from acute ST-elevation myocardial infarction (STEMI) between November 2005 and December 2006 were categorized according to the National Cholesterol Education Program-Adult Treatment Panel III criteria of MS. Primary study outcomes included major adverse cardiac events (MACE) during one-year follow-up. Patients were grouped based on existence of MS: group I: MS (n=1,182, 777 men, 62.8±12.3 yr); group II: Non-MS (n=808, 675 men, 64.2±13.1 yr). Group I showed lower left ventricular ejection fraction (LVEF) (P=0.005). There were no differences between two groups in the coronary angiographic findings except for multivessel involvement (P=0.01). The incidence of in-hospital death was higher in group I than in group II (P=0.047), but the rates of composite MACE during one-year clinical follow-up showed no significant differences. Multivariate analysis showed that low LVEF, old age, MS, low high density lipoprotein cholesterol and multivessel involvement were associated with high in-hospital death rate. In conclusion, MS is an important predictor for in-hospital death in patients with STEMI.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice.

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent. METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up. RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects. CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.

Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: study design and rationale of a Korean multicenter prospective randomized trial.

BACKGROUND: The everolimus-eluting stent (EES) is a newly developed drug-eluting stent using the MULTILINK VISION stent platform combined with the drug everolimus contained in a polymer coating. Recently reported randomized trials have shown the noninferiority and subsequent superiority of the EES compared with the paclitaxel-eluting stent regarding in-stent late loss (LL) at 180 days. However, there have been no studies comparing head to head the EES with the sirolimus-eluting stent (SES), which has shown the least amount of LL among the previously released drug-eluting stent (DES). In addition, adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite the recommendation of the American Heart Association/American College of Cardiology to maintain 12 months of dual antiplatelet therapy, there have been no prospective randomized trials comparing the efficacy and safety of different durations. STUDY DESIGN: In the Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial, approximately 1,400 patients are being prospectively and randomly assigned in a 2 x 2 factorial design according to the type of stent (EES vs SES) and the duration of dual antiplatelet therapy (6 vs 12 months). The primary end point is in-segment LL at 9 months for comparison of type of stent, and the coprimary end point is target vessel failure at 12 months for comparison of dual antiplatelet therapy duration. SUMMARY: The EXCELLENT trial is the largest study yet performed to directly compare the efficacy and safety of the EES versus the SES. In addition, this study will also address the issue of a 6- versus 12-month duration of dual antiplatelet therapy for post-percutaneous coronary intervention management.

Clinical effects of hypertension on the mortality of patients with acute myocardial infarction.

The incidence of ischemic heart disease has been increased rapidly in Korea. However, the clinical effects of antecedent hypertension on acute myocardial infarction have not been identified. We assessed the relationship between antecedent hypertension and clinical outcomes in 7,784 patients with acute myocardial infarction in the Korea Acute Myocardial Infarction Registry during one-year follow-up. Diabetes mellitus, hyperlipidemia, cerebrovascular disease, heart failure, and peripheral artery disease were more prevalent in hypertensives (n=3,775) than nonhypertensives (n=4,009). During hospitalization, hypertensive patients suffered from acute renal failure, shock, and cerebrovascular event more frequently than in nonhypertensives. During follow-up of one-year, the incidence of major adverse cardiac events was higher in hypertensives. In multi-variate adjustment, old age, Killip class > or =III, left ventricular ejection fraction <45%, systolic blood pressure <90 mmHg on admission, post procedural TIMI flow grade < or =2, female sex, and history of hypertension were independent predictors for in-hospital mortality. However antecedent hypertension was not significantly associated with one-year mortality. Hypertension at the time of acute myocardial infarction is associated with an increased rate of in-hospital mortality.

Autologous bone marrow cell transplantation combined with off-pump coronary artery bypass grafting in patients with ischemic cardiomyopathy.

BACKGROUND: Clinical studies have demonstrated that intracoronary or intramyocardial transplantation of bone marrow mononuclear cells (BMMNCs) into ischemic myocardium improves cardiac function. The objective of the present study was to evaluate the safety and feasibility of intramyocardial BMMNC transplantation into nongraftable areas in combination with off-pump coronary artery bypass grafting in patients with ischemic cardiomyopathy. METHODS: Five male patients with myocardial infarction lasting for more than 1 month and with nongraftable myocardium received autologous mononuclear cell transplantation during off-pump coronary artery bypass grafting. Autologous bone marrow was aspirated from the iliac crest. BMMNCs (mean 1.6, standard error [SE] 0.3 x 10(9)) including CD34-positive cells (mean 6.8, SE 1.1 x 10(6)) and AC133-positive cells (mean 3.1, SE 1.7 x 10(6)) were injected into the nongraftable ischemic myocardium. Heart function was evaluated with the use of echocardiography, and myocardial perfusion was examined with single photon emission computed tomography technetium-99mTc sestamibi scans. RESULTS: Two months after cell transplantation, the mean ejection fraction had increased by 7.4%, SE 1.9% (p = 0.016) compared with that before cell transplantation and off-pump coronary artery bypass grafting. The increase in ejection fraction was not correlated with the number of transplanted total mononuclear cells, CD34-positive cells and AC133-positive cells. Myocardial perfusion at the cell-transplanted area increased after cell transplantation and off-pump coronary artery bypass grafting. No arrhythmia was observed. CONCLUSION: The present clinical study suggests that intramyocardial transplantation of autologous BMMNCs into the ischemic area during off-pump coronary artery bypass grafting is both feasible and safe and has beneficial effects on cardiac function.

Benefit of Prolonged Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stent for Coronary Bifurcation Lesions: Results From the Coronary Bifurcation Stenting Registry II.

BACKGROUND: Whether prolonged dual antiplatelet therapy (DAPT) improves clinical outcomes after percutaneous coronary intervention for coronary bifurcation lesion is uncertain. METHODS AND RESULTS: We evaluated 2082 patients who were treated with drug-eluting stent for bifurcation lesions and were event free (no death, myocardial infarction [MI], cerebrovascular accident, stent thrombosis, or any revascularization) at 12 months after the index procedure. Patients were divided into 2 groups: DAPT ≥12-month group (n=1776) and DAPT <12-month group (n=306). Primary outcome was all-cause death or MI. At 4 years after the index procedure, death or MI occurred less frequently in the DAPT ≥12-month group than the DAPT <12-month group (2.8% versus 12.3%; adjusted hazard ratio, 0.21; 95% confidence interval, 0.13-0.35; P<0.001). After propensity score matching, incidence of death or MI was still lower in the DAPT ≥12-month group than the DAPT <12-month group (2.6% versus 12.3%; adjusted hazard ratio, 0.22; 95% confidence interval, 0.12-0.38; P<0.001). In subgroup analysis, the treatment effect of prolonged DAPT was consistent across subgroups regardless of lesion location, stenting technique, or type of used drug-eluting stent. CONCLUSIONS: The risk of all-cause death or MI was significantly lower in the ≥12-month DAPT group than the <12-month DAPT group after percutaneous coronary intervention for bifurcation lesion using drug-eluting stent. Our results suggest that prolonged DAPT may improve long-term clinical outcomes after percutaneous coronary intervention for bifurcation lesions. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01642992.