Clinical Implication of 'Obesity Paradox' in Elderly Patients With Acute Myocardial Infarction.

BACKGROUND: The clinical impact of body mass index (BMI), especially in the elderly with acute myocardial infarction (AMI), has not been sufficiently evaluated. The purpose of this study was to elucidate the clinical impact of BMI in very old patients (≥80 years) with AMI. METHODS: The study analysed 2,489 AMI patients aged ≥80 years from the Korea Acute Myocardial Infarction Registry and the Korea Working Group on Myocardial Infarction (KAMIR/KorMI) registries between November 2005 and March 2012. The study population was categorised into four groups based on their BMI: underweight (n=301), normal weight (n=1,150), overweight (n=890), and obese (n=148). The primary endpoint was major adverse cardiovascular event (MACE), a composite of cardiac death, myocardial infarction, target lesion revascularisation, and target vessel revascularisation. RESULTS: Baseline characteristics among the four groups were similar, except for hypertension (45.1 vs 58.4 vs 66.2 vs 69.9%, respectively; p<0.001) and diabetes (16.6 vs 23.6 vs 30.7 vs 35.1%, respectively; p<0.001). Coronary care unit length of stay was significantly different among the four groups during hospitalisation (5.3±5.9 vs 4.8±6.8 vs 4.2±4.0 vs 3.5±2.1 days; p=0.007). MACE (16.9 vs 14.9 vs 13.7 vs 8.8%; p=0.115) and cardiac death (10.3 vs 8.4 vs 7.9 vs 4.1%; p=0.043) less frequently occurred in the obese group than in other groups during the 1-year follow-up. A multivariate regression model showed obese status (BMI ≥27.5 kg/m2) as an independent predictor of reduced MACE (hazard ratio [HR], 0.20; 95% confidence interval [CI], 0.06-0.69; p=0.010) along with reduced left ventricular ejection fraction (≤40%) as a predictor of increased MACE (HR,1.87; 95% CI, 1.31-2.68; p=0.001). CONCLUSION: Body mass index in elderly patients with acute myocardial infarction was significantly associated with coronary care unit stay and clinical cardiovascular outcomes.

Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial.

BACKGROUND: Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. METHODS: In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. RESULTS: At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P=0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P=0.04) and fatal bleeding (1% [4/400] vs 0%, P=0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P=0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. CONCLUSIONS: In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02094963.

Addition of routine blood biomarkers to TIMI risk score improves predictive performance of 1-year mortality in patients with ST-segment elevation myocardial infarction.

BACKGROUND: Several biomarkers have been proposed as independent predictors of poor outcomes in ST-segment elevation myocardial infarction (STEMI). We investigated whether adding information obtained from routine blood tests including hypoxic liver injury (HLI), dysglycemia, anemia, and high neutrophil to lymphocyte ratio (NLR) could improve the prognostic performance of the TIMI risk score for the prediction of 1-year mortality. METHODS: A total of 1057 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) between 2007 and 2014 were retrospectively enrolled from 4-regional hospitals. HLI and dysglycemia were defined as serum transaminase > twice the normal upper limit and glucose < 90 or > 250 mg/dL, respectively. The effect of adding biomarkers to the TIMI risk score on its discriminative ability was assessed using c-statistic, net reclassification improvement (NRI), and integrated discrimination improvement (IDI). RESULTS: The 1-year mortality rate was 7.1%. The best cutoff value of NLR for the prediction of 1-year mortality was 4.3 (sensitivity, 67%; specificity, 65%). HLI (HR 2.019; 95% CI 1.104-3.695), dysglycemia (HR 2.535; 95% CI 1.324-3.923), anemia (HR 2.071; 95% CI 1.093-3.923), and high NLR (HR 3.651; 95% CI 1.927-6.918) were independent predictors of 1-year mortality. When these 4 parameters were added to the TIMI risk score, the c-statistic significantly improved from 0.841 to 0.876 (p < 0.001), and the NRI and IDI were estimated at 0.203 (95% CI 0.130-0.275; p < 0.001) and 0.089 (95% CI 0.060-0.119; p < 0.001), respectively. CONCLUSIONS: The addition of HLI, dysglycemia, anemia, and high NLR to the TIMI risk score may be useful for very early risk stratification in patients with STEMI receiving primary PCI.

Diagnostic performance of dual-energy computed tomography for detection of acute spinal fractures.

OBJECTIVE: To assess the diagnostic performance of dual-energy computed tomography (DECT) with the color-coded virtual non-calcium (VNC) technique for detecting acute fractures in patients after acute spine trauma, especially in an emergency clinical setting. MATERIALS AND METHODS: Our retrospective study included 31 patients presented to emergency department with suspected spine trauma. All patients underwent both DECT (80 kVp and 140 kVp) and MRI. Post-processing was performed using color-coded VNC technique. Two independent radiologists visually assessed color-coded VNC images in a random order, and one of the two readers re-assessed the images in 4 weeks after the initial assessment. They were allowed to read only color-coded VNC images and asked to determine the presence of acute fracture. To determine the standard reference point, the other two experienced radiologists made consensus readings on both grayscale CT and MRI. Sensitivity, specificity, PPV, NPV, and accuracy analyses were determined. Both intra- and inter-observer agreements were also calculated. RESULTS: A total of 217 vertebral bodies (65 thoracic and 152 lumbar vertebrae) were included in our study. Sensitivity was 83.3% and 76.7% for first and second readers, respectively. Specificity of 99.5% and 98.9%, PPV of 96.1% and 96.3%, NPV of 97.3% and 96.3%, and accuracy of 97.2% and 95.8%, respectively, were noted. Both intra-observer and inter-observer agreements indicated excellent agreement (κ = 0.86 and κ = 0.84, respectively). CONCLUSION: In spite of the relatively low sensitivity, DECT-based detection of acute spinal fractures showed good specificity, positive predictive value, negative predictive value, accuracy, and inter-/intra-observer agreements.

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.

Comparison of Outcomes after Device Closure with Transseptal Puncture and Standard Technique in Patients with Patent Foramen Ovale and Ischemic Events.

OBJECTIVES: The purpose of this study was to compare the effectiveness of device closure with the transseptal puncture and standard technique in patients with patent foramen ovale (PFO) and ischemic events. METHODS: Eighty-two consecutive patients (men: 60 patients, mean age: 45.2 years) who underwent PFO closure with the Amplatzer PFO Occluder were enrolled. PFO closure with the transseptal puncture was performed in 22 patients (transseptal puncture technique, group I). In the remaining patients (n = 60), PFO closure was performed with the standard technique (group II). The co-primary end points were the incidence of significant residual shunt on follow-up transesophageal echocardiography (TEE) and a composite of death, stroke, transient ischemic attack (TIA), and peripheral embolism. RESULTS: Baseline characteristics were similar between the two groups. On TEE, despite similar grade of interatrial right-to-left shunt, shunt at rest/septal hypermobility was less common in group I than in group II (40.9% vs. 72.9%, P < 0.010). The device was successfully implanted in all patients. On follow-up TEE, significant residual shunt was more common in group I than in group II (28.6% vs. 4.3%, P = 0.021). In addition, composite of death, stroke, TIA, or peripheral embolism was more common in group I than in group II (13.6% vs. 0%, P = 0.017) during the follow-up period (mean 25.4 months). CONCLUSION: Compared to the standard technique, PFO closure with the transseptal puncture technique showed higher incidence of residual shunt and ischemic events. Therefore, this technique might be considered in only highly selected patients as the last option.

Increasing injection frequency enhances the survival of injected bone marrow derived mesenchymal stem cells in a critical limb ischemia animal model.

Critical limb ischemia (CLI) is one of the most severe forms of peripheral artery diseases, but current treatment strategies do not guarantee complete recovery of vascular blood flow or reduce the risk of mortality. Recently, human bone marrow derived mesenchymal stem cells (MSCs) have been reported to have a paracrine influence on angiogenesis in several ischemic diseases. However, little evidence is available regarding optimal cell doses and injection frequencies. Thus, the authors undertook this study to investigate the effects of cell dose and injection frequency on cell survival and paracrine effects. MSCs were injected at 106 or 105 per injection (high and low doses) either once (single injection) or once in two consecutive weeks (double injection) into ischemic legs. Mice were sacrificed 4 weeks after first injection. Angiogenic effects were confirmed in vitro and in vivo, and M2 macrophage infiltration into ischemic tissues and rates of limb salvage were documented. MSCs were found to induce angiogenesis through a paracrine effect in vitro, and were found to survive in ischemic muscle for up to 4 weeks dependent on cell dose and injection frequency. In addition, double high dose and low dose of MSC injections increased vessel formation, and decreased fibrosis volumes and apoptotic cell numbers, whereas a single high dose did not. Our results showed MSCs protect against ischemic injury in a paracrine manner, and suggest that increasing injection frequency is more important than MSC dosage for the treatment CLI.

Frequent premature ventricular complex is associated with left atrial enlargement in patients with normal left ventricular ejection fraction.

BACKGROUND: Premature ventricular complex (PVC) has been regarded as benign; however, when frequent, the arrhythmia can induce left ventricular (LV) systolic dysfunction. Meanwhile, the influence of PVCs on cardiac structural remodeling and functional change before occurrence of overt systolic heart failure has not been fully described. In this study, we attempted to identify early cardiac structural/functional manifestations of frequent PVCs in patients with normal LV systolic function. METHODS: A total of 146 patients (age: 55 ± 15 years, 48 males) with frequent PVCs observed on 24-hour Holter monitoring (>10/h) and normal LV ejection fraction (LV EF ≥ 55% on echocardiography) were enrolled. Clinical characteristics and echocardiographic parameters of the patients were compared with those of an age-/sex-matched control group (n = 292, age: 55 ± 15 years, 96 males). RESULTS: Patients with frequent PVCs had significantly larger left atrial volume index (LAVI [28 ± 9 mL/m(2) vs. 24 ± 7 mL/m(2) ]), along with larger LV end-diastolic dimension (49.4 ± 4.4 mm vs. 48.5 ± 3.9 mm), lower LV EF (63 ± 7% vs. 66 ± 6%), and lower peak systolic mitral annular velocity (7 ± 2 cm/s vs. 8 ± 2 cm/s; P < 0.05 for all), whereas other clinical characteristics were similar. In particular, in patients with frequent PVCs, LAVI showed linear correlation with PVC burden (R = 0.30, P < 0.001), and, in a multiple regression model, PVC burden independently estimated LAVI, even after controlling for age, sex, comorbidities, and systolic function (ß = 0.309, P < 0.001). CONCLUSION: Frequent PVC is associated with LA enlargement in patients with normal LV EF. Atrial anatomical remodeling may precede LV geometry change and systolic dysfunction in patients with frequent PVCs.

Efficacy and safety of aspirin, clopidogrel, and warfarin after coronary artery stenting in Korean patients with atrial fibrillation.

There are limited data on the optimal antithrombotic therapy for patients with atrial fibrillation (AF) who undergoing coronary stenting. We reviewed 203 patients (62.6 % men, mean age 68.3 ± 10.1 years) between 2003 and 2012, and recorded clinical and demographic characteristics of the patients. Clinical follow-up included major adverse cardiac and cerebrovascular events (MACCE) (cardiac death, myocardial infarction, target lesion revascularization, and stroke), stent thrombosis, and bleeding. The most commonly associated comorbidities were hypertension (70.4 %), diabetes mellitus (35.5 %), and congestive heart failure (26.6 %). Sixty-three percent of patients had stroke risk higher than CHADS2 score 2. At discharge, dual-antiplatelet therapy (aspirin, clopidogrel) was used in 166 patients (81.8 %; Group I), whereas 37 patients (18.2 %) were discharged with triple therapy (aspirin, clopidogrel, warfarin; Group II). The mean follow-up period was 42.0 ± 29.0 months. The mean international normalized ratio (INR) in group II was 1.83 ± 0.41. The total MACCE was 16.3 %, with stroke in 3.4 %. Compared with the group II, the incidence of MACCE (2.7 % vs 19.3 %, P = 0.012) and cardiac death (0 % vs 11.4 %, P = 0.028) were higher in the group I. Major and any bleeding, however, did not differ between the two groups. In multivariate analysis, no warfarin therapy (odds ratio 7.8, 95 % confidence interval 1.02-59.35; P = 0.048) was an independent predictor of MACCE. By Kaplan-Meier survival analysis, warfarin therapy was associated with a lower risk of MACCE (P = 0.024). In patients with AF undergoing coronary artery stenting, MACCE were reduced by warfarin therapy without increased bleeding, which might be related to tighter control with a lower INR value.

Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study.

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. METHODS AND RESULTS: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.

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

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

Real-World Treatment Selection Factors and 7-Year Clinical Outcomes between Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Left Main Disease.

BACKGROUND: The decision-making factors and long-term clinical outcomes between PCI and CABG in left main (LM) disease are still not well defined in the real world. METHODS: We evaluated consecutive patients (n = 230) with LM disease either treated by PCI (n = 118) or CABG (n = 112). The primary endpoint was major adverse cardiovascular events (MACE), defined as a composite of cardiac death, spontaneous myocardial infarction (MI), stroke, and target vessel revascularization (TVR) for 7 years. RESULTS: In the multivariate-adjusted analysis, the presence of intermediate EuroSCORE II and high SYNTAX scores predisposed to CABG. Isolated LM disease was associated with receiving PCI. The PCI group had a similar rate of MACE (HRadj 0.97, 95% CI [0.48-1.94], p = 0.92) and a lower tendency of hard MACE (HRadj 0.49, 95% CI [0.22-1.07], p = 0.07) compared to the CABG group, mainly due to the balance between a higher rate of TVR (HRadj 9.71, p = 0.02) and a lower rate of stroke (HRadj 0.22, p = 0.09) with the PCI group than in the CABG group. CONCLUSIONS: The decision making of treatment strategy was made based on clinical and angiographic factors. The selected patients who received PCI showed similar MACE and trend of a lower rate of composite hard endpoints despite multivariate adjustment.

Stents versus coronary-artery bypass grafting for left main coronary artery disease.

BACKGROUND: Several studies have compared the treatment effects of coronary stenting and coronary-artery bypass grafting (CABG). However, there are limited data regarding the long-term outcomes of these two interventions for patients with unprotected left main coronary artery disease. METHODS: We evaluated 1102 patients with unprotected left main coronary artery disease who underwent stent implantation and 1138 patients who underwent CABG in Korea between January 2000 and June 2006. We compared adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) with the use of propensity-score matching in the overall cohort and in separate subgroups according to type of stent. RESULTS: In the overall matched cohort, there was no significant difference between the stenting and CABG groups in the risk of death (hazard ratio for the stenting group, 1.18; 95% confidence interval [CI], 0.77 to 1.80) or the risk of the composite outcome (hazard ratio for the stenting group, 1.10; 95% CI, 0.75 to 1.62). The rates of target-vessel revascularization were significantly higher in the group that received stents than in the group that underwent CABG (hazard ratio, 4.76; 95% CI, 2.80 to 8.11). Comparisons of the group that received bare-metal stents with the group that underwent CABG and of the group that received drug-eluting stents with the group that underwent CABG produced similar results, although there was a trend toward higher rates of death and the composite end point in the group that received drug-eluting stents. CONCLUSIONS: In a cohort of patients with unprotected left main coronary artery disease, we found no significant difference in rates of death or of the composite end point of death, Q-wave myocardial infarction, or stroke between patients receiving stents and those undergoing CABG. However, stenting, even with drug-eluting stents, was associated with higher rates of target-vessel revascularization than was CABG.

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

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

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.

Diagnostic and prognostic role of nitroglycerin-induced dilation in patients with suspected vasospastic angina, combined with ergonovine provocation test.

The diagnostic and prognostic role of nitroglycerin-induced dilation (NID) combined with ergonovine provocation test in patients with suspected VSA patients is not clear. A total of 438 consecutive patients who underwent the ergonovine provocation test for the diagnosis of vasospastic angina (VSA) were enrolled. Patients with VSA (n = 52) had a significantly greater coronary response to ergonovine (- 84.3 ± 10.5% vs. - 38.4 ± 17.9%, p < 0.001) and NID (26.3 ± 31.0% vs. 12.5 ± 19.0%, p < 0.001) than non-VSA patients. However, positive NID (more than 13.8% dilation, n = 170) showed a poor accuracy (AUC 0.64 [95% CI: 0.56-0.73], p = 0.001, sensitivity 60.4%, specificity 61.3%) for the diagnosis of VSA by ergonovine provocation test. Major adverse cardiovascular events (MACE) occurred more frequently in the VSA group than in the non-VSA group (9.6% vs. 2.2%, p = 0.006). In addition, the positive NID group showed a lower rate of MACE than the negative NID group (1.2% vs. 4.3%, p = 0.021). Interestingly, the group of VSA with negative NID had poor prognosis than any other combinations (Log-rank, p < 0.0001). Although NID had a limited role in the detection of VSA defined by ergonovine provocation test, NID combined with the ergonovine provocation test has an additive prognostic role in the clinical outcomes in patients with suspected VSA.

A First-in-Man Clinical Evaluation of Sirolimus and Ascorbic Acid-Eluting Stent Systems: a Multicenter, Subject-Blinded, Randomized Study.

BACKGROUND AND OBJECTIVES: This clinical trial was conducted to evaluate the safety and efficacy of D+Storm™ drug-eluting stent (DES) and BioMatrix Flex™ DES. METHODS: This study was a multicenter, subject-single-blind, randomized, and confirmed comparative clinical trial. According to the inclusion criteria, those diagnosed with stable angina, unstable angina, silent ischemia, or non-ST-segment myocardial infarction were selected among patients with coronary artery stenosis as subjects. Among the subjects with 50% stenosis on coronary angiography, the experiment was performed on those who had a lesion with reference vessel 2.5-4.0 mm in diameter and ≤40 mm in length. The primary endpoint was an in-segment late loss and the secondary endpoints were in-stent late lumen loss, stent malapposition, the incidence of mortality, myocardial infarction, reoperation, and stent thrombosis at 36 weeks. RESULTS: 57 patients in the D+Storm™ DES group and 55 patients in the BioMatrix Flex™ DES group were enrolled in the study. Fifty-seven patients in the D+Storm™ DES group and Fifty-five patients in the BioMatrix Flex™ DES group were enrolled in the study. An average of in-segment late lumen loss was 0.08±0.13 mm in the D+Storm™ DES group and 0.14±0.32 mm in the BioMatrix Flex™ DES group with no significant difference between the 2 groups (p=0.879). In addition, there was no significant difference in adverse events between D+Storm™ DES and BioMatrix Flex™ DES. CONCLUSIONS: This study demonstrated the clinical effectiveness and safety of D+Storm™ DES implantation in patients with coronary artery disease over a 36-week follow-up period.

Current status of cardiac rehabilitation among representative hospitals treating acute myocardial infarction in South Korea.

Cardiac rehabilitation services are mostly underutilized despite the documentation of substantial morbidity and mortality benefits of cardiac rehabilitation post-acute myocardial infarction. To assess the implementation rate and barriers to cardiac rehabilitation in hospitals dealing with acute myocardial infarction in South Korea, between May and July 2016, questionnaires were emailed to cardiology directors of 93 hospitals in South Korea; all hospitals were certified institutes for coronary interventions. The questionnaires included 16 questions on the hospital type, cardiology practice, and implementation of cardiac rehabilitation. The obtained data were categorized into two groups based on the type of the hospital (secondary or tertiary) and statistically analysed. Of the 72 hospitals that responded (response rate of 77%), 39 (54%) were tertiary medical centers and 33 (46%) were secondary medical centers. All hospitals treated acute myocardial infarction patients and performed emergency percutaneous coronary intervention; 79% (57/72) of the hospitals performed coronary artery bypass grafting. However, the rate of implementation of cardiac rehabilitation was low overall (28%, 20/72 hospitals) and even lower in secondary medical centers (12%, 4/33 hospitals) than in tertiary centers (41%, 16/39 hospitals, p = 0.002). The major barriers to cardiac rehabilitation included the lack of staff (59%) and lack of space (33%). In contrast to the wide availability of acute-phase invasive treatment for AMI, the overall implementation of cardiac rehabilitation is extremely poor in South Korea. Considering the established benefits of cardiac rehabilitation in patients with acute myocardial infarction, more administrative support, such as increasing the fee for cardiac rehabilitation services by an appropriate level of health insurance coverage should be warranted.

Long-term safety and effectiveness of unprotected left main coronary stenting with drug-eluting stents compared with bare-metal stents.

BACKGROUND: Limited information is available on long-term outcomes for patients with unprotected left main coronary artery disease who received drug-eluting stents (DES). METHODS AND RESULTS: In the multicenter registry evaluating outcomes among patients with unprotected left main coronary artery stenosis undergoing stenting with either bare metal stents (BMS) or DES, 1217 consecutive patients were divided into 2 groups: 353 who received only BMS and 864 who received at least 1 DES. The 3-year outcomes were compared by use of the adjustment of inverse-probability-of-treatment-weighted method. Patients receiving DES were older and had a higher prevalence of diabetes mellitus, hypertension, hyperlipidemia, and multivessel disease. In the overall population, with the use of DES, the 3-year adjusted risk of death (8.0% versus 9.5%; hazard ratio, 0.71; 95% confidence interval, 0.36 to 1.40; P=0.976) or death or myocardial infarction (14.3% versus 14.9%; hazard ratio, 0.83; 95% confidence interval, 0.49 to 1.40; P=0.479) was similar compared with BMS. However, the risk of target lesion revascularization was significantly lower with the use of DES than BMS (5.4% versus 12.1%; hazard ratio, 0.40; 95% confidence interval, 0.22 to 0.73; P=0.003). When patients were classified according to lesion location, DES was still associated with lower risk of target lesion revascularization in patients with bifurcation (6.9% versus 16.3%; hazard ratio, 0.38; 95% confidence interval, 0.18 to 0.78; P=0.009) or nonbifurcation (3.4% versus 10.3%; hazard ratio, 0.39; 95% confidence interval, 0.17 to 0.88; P=0.024) lesions with a comparable risk of death or myocardial infarction. CONCLUSIONS: Compared with BMS, DES was associated with a reduction in the need for repeat revascularization without increasing the risk of death or myocardial infarction for patients with unprotected left main coronary artery stenosis.