Background: Glucagon-like peptide 1 agonists differ in chemical structure, duration of action and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. Methods: We randomly assigned patients with type 2 diabetes and cardiovascular disease to the addition of once-weekly subcutaneous injection of albiglutide (30 mg to 50 mg) or matching placebo to standard care. We hypothesized that albiglutide would be noninferior to placebo for the primary outcome of first occurrence of cardiovascular death, myocardial infarction, or stroke. If noninferiority was confirmed by an upper limit of the 95% confidence interval for the hazard ratio of less than 1.30, closed-testing for superiority was prespecified. Findings: Overall, 9463 participants were followed for a median of 1.6 years. The primary composite outcome occurred in 338 of 4731 patients (7.1%; 4.6 events per 100 person-years) in the albiglutide group and in 428 of 4732 patients (9.0%; 5.9 events per 100 person-years) in the placebo group (hazard ratio, 0.78; 95% confidence interval [CI ], 0.68 to 0.90), indicating that albiglutide, was superior to placebo (P<0.0001 for noninferiority, P=0.0006 for superiority). The incidence of acute pancreatitis (albiglutide 10 patients and placebo 7 patients), pancreatic cancer (6 and 5), medullary thyroid carcinoma (0 and 0), and other serious adverse events did not differ significantly between the two groups. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. (Funded by GlaxoSmithKline; Harmony Outcomes ClinicalTrials.gov number, NCT02465515.) noninferiority; P = 0.06 for superiority). There seems to be variation in the results of existing trials with GLP-1 receptor agonists, which if correct, might reflect drug structure or duration of action, patients studied, duration of follow-up or other factors.
Background and ObjectivesAlthough several multicenter registries have evaluated percutaneous coronary intervention (PCI) procedures in Korea, those databases have been limited by non-standardized data collection and lack of uniform reporting methods. We aimed to collect and report data from a standardized database to analyze PCI procedures throughout the country.Materials and Methods Both clinical and procedural data, as well as clinical outcomes data during hospital stay, were collected based on case report forms that used a standard set of 54 data elements. This report is based on 2014 Korean PCI registry cohort data.ResultsA total of 92 hospitals offered data on 44967 PCI procedures. The median age was 66.0 interquartile range 57.0-74.0 years, and 70.3% were men. Thirty-eight percent of patients presented with acute myocardial infarction and one-third of all PCI procedures were performed in an urgent or emergency setting. Non-invasive stress tests were performed in 13.9% of cases, while coronary computed tomography angiography was used in 13.7% of cases prior to PCI. Radial artery access was used in 56.1% of all PCI procedures. Devices that used PCI included drug-eluting stent, plain old balloon angioplasty, drug-eluting balloon, and bare-metal stent (around 91%, 19%, 6%, and 1% of all procedures, respectively). The incidences of in-hospital death, non-fatal myocardial infarction, and stroke were 2.3%, 1.6%, and 0.2%, respectively.ConclusionThese data may provide an overview of the current PCI practices and in-hospital outcomes in Korea and could be used as a foundation for developing treatment guidelines and nationwide clinical research.
Cardiovascular autonomic dysfunction was significantly associated with the development of ischaemic stroke in patients with Type 2 diabetes.
OBJECTIVE -We investigated whether cardiovascular autonomic dysfunction was associated with glycemic control status over time in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS-From 1999 to 2000, cardiovascular autonomic nerve function testing (AFT) was performed on patients with type 2 diabetes (n ϭ 1,021) and was followed-up in 2006 and February 2008. Tests for cardiovascular autonomic functions measured heart rate variability parameters (expiration-to-inspiration [E/I] ratio, responses to the Valsalva maneuver, and standing). AFT scores were determined from the results of the each test as follows: 0 for normal and 1 for abnormal. We began with those who had a score of 0 and assessed the changes in total score along with biannual A1C levels.RESULTS -At follow-up, the development of cardiovascular autonomic dysfunction was 34.5% (E/I ratio 21.9%, Valsalva maneuver 77.8%, and posture 58.9%; n ϭ 783). The development of cardiovascular autonomic dysfunction was higher in older patients (P Ͻ 0.001); in those with longer duration of diabetes (P Ͻ 0.001); of hypertension (P ϭ 0.005), and of diabetic retinopathy (P Ͻ 0.001); and in those who had higher levels of microalbuminuria (P ϭ 0.002). Logistic regression analysis revealed that the development of cardiovascular autonomic dysfunction was strongly associated with the mean A1C level during the follow-up period (mean A1C Ͼ9.0% vs. Յ7.0%, odds ratio 2.984, 95% CI 1.177-7.561; P ϭ 0.021).CONCLUSIONS -The development of cardiovascular autonomic dysfunction was independently associated with microvascular complications and glycemic control status during this 7.5-year follow-up in patients with type 2 diabetes.
Background and objectivesIn this second report from Korean percutaneous coronary intervention (K-PCI) registry, we sought to describe the updated information of PCI practices and Korean practice pattern of PCI (KP3).MethodsIn addition to K-PCI registry of 2014, new cohort of 2016 from 92 participating centers was appended. Demographic and procedural information, as well as in-hospital outcomes, of PCI was collected using a web-based reporting system. KP3 class C was defined as any strategy with less evidence from randomized trials and more aggressive for PCI than medical therapy or bypass-surgery.ResultsIn 2016, total 48,823 PCI procedures were performed at 92 participating centers. Mean age of the patients was 65.7±11.6 years, and 71.7% were males. Overall patient characteristics and PCI practices in 2016 were similar to those in 2014. The biggest change was the decrease in the in-hospital occurrence of myocardial infarction (MI;1.6%→0.7%, p<0.001). Many associations between PCI volumes and demographic/procedural characteristics observed in 2014 have disappeared. The median of door-to-balloon time was 62 minutes, and 83.3% of ST-elevation MI patients received primary PCI within 90 minutes, while the median of total ischemic time was 168 minutes and patients who had total ischemic time within 120 and 180 minutes were 29.1% and 54.1%, respectively. The proportion of KP3 class C cases in non-acute coronary syndrome patients decreased from 13.5% in 2014 to 12.1% in 2016 (p<0.001).ConclusionsIn this second report from K-PCI registry, we described the current practices of PCI and changes from 2014 to 2016 in Korea.
We quantified radial artery atherosclerosis by intravascular ultrasound (IVUS) and determined the relationship between established cardiovascular risk factors and the extent of atherosclerotic plaque. Intravascular ultrasound examination of the radial artery was performed in patients undergoing transradial angiography or intervention. Total 50-mm segments starting at the radioulnar bifurcation were analyzed at 2-mm intervals to compute atheroma volume. In 115 consecutive patients, atheroma volume averaged 67.4 mm(3) and percentage atheroma volume was 25.2%. Radial arteries showed age-related acceleration of atherosclerosis. Total atheroma volume was strongly associated with square of age and male gender. Hypertension and diabetes were strong independent predictors of larger radial artery atheroma burden. Radial artery atherosclerosis, which can be quantitatively analyzed by IVUS, could be used as a surrogate marker for atherosclerosis.
Background: Many studies have reported both systemic inflammatory response and malnutrition provide valuable predictions of prognosis in patients with acute coronary syndrome (ACS). This study aims to assess the association between the Glasgow prognostic score (GPS) by combining C-reactive protein and serum albumin concentration, and clinical outcomes in patients with ACS. Methods: This retrospective study included patients admitted for ACS between June 2010 and May 2013 in St. Vincent's Hospital, The Catholic University of Korea. In this study, high GPS was defined as a GPS ! 1. Primary outcomes were 12-month all-cause and cardiovascular mortality, stroke, stent thrombosis and target vessel revascularization. We used an inverse probability of treatment weighting (IPTW) analysis to adjust for potential confounding covariates and presented event rates with Kaplan-Meier curves. Results: Total 593 patients were included and follow-up for a median 3.7 years. The patients were classified into two groups: GPS = 0 (n = 424, 71.5%) and GPS ! 1 (n = 169, 28.5%). The incidences of primary outcomes were 4% and 8.9% for the GPS = 0 and GPS ! 1, respectively. The primary outcomes and all-cause mortality difference between the two groups were significantly within 1 month in the Kaplan-Meier curve analysis (log rank p < 0.001, log rank p < 0.001, respectively). IPTW analysis showed high GPS was independently associated with higher incidence of primary outcomes (HR: 2.206; 95% CI: 1.085-4.486; p = 0.029), higher all-cause mortality (HR: 5.963; 95% CI: 2.068-17.190; p < 0.001) and higher cardiovascular mortality (HR: 6.122; 95% CI: 1.882-19.914; p = 0.003). Conclusions: High GPS is independently associated with both total and cardiovascular mortality in patients with ACS. Hence, GPS could be helpful in predicting mortality in ACS patients.
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