ClinicalTrials.gov, number NCT01844284.

Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227).

Background: Despite recommendations in the guidelines and consensus documents, there has been no randomized controlled trial evaluating oral anticoagulation (OAC) alone without antiplatelet therapy (APT) in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after coronary stenting. Methods: This study was a prospective, multicenter, open-label, noninferiority trial comparing OAC alone to combined OAC and single APT among patients with atrial fibrillation beyond 1 year after stenting in a 1:1 randomization fashion. The primary end point was a composite of all-cause death, myocardial infarction, stroke, or systemic embolism. The major secondary end point was a composite of the primary end point or major bleeding according to the International Society on Thrombosis and Haemostasis classification. Although the trial was designed to enroll 2000 patients during 12 months, enrollment was prematurely terminated after enrolling 696 patients in 38 months. Results: Mean age was 75.0±7.6 years, and 85.2% of patients were men. OAC was warfarin in 75.2% and direct oral anticoagulants in 24.8% of patients. The mean CHADS 2 score was 2.5±1.2. During a median follow-up interval of 2.5 years, the primary end point occurred in 54 patients (15.7%) in the OAC-alone group and in 47 patients (13.6%) in the combined OAC and APT group (hazard ratio, 1.16; 95% CI, 0.79–1.72; P =0.20 for noninferiority, P =0.45 for superiority). The major secondary end point occurred in 67 patients (19.5%) in the OAC-alone group and in 67 patients (19.4%) in the combined OAC and APT group (hazard ratio, 0.99; 95% CI, 0.71–1.39; P =0.016 for noninferiority, P =0.96 for superiority). Myocardial infarction occurred in 8 (2.3%) and 4 (1.2%) patients, whereas stroke or systemic embolism occurred in 13 (3.8%) and 19 (5.5%) patients, respectively. Major bleeding occurred in 27 (7.8%) and 36 (10.4%) patients, respectively. Conclusions: This randomized trial did not establish noninferiority of OAC alone to combined OAC and APT in patients with atrial fibrillation and stable coronary artery disease beyond 1 year after stenting. Because patient enrollment was prematurely terminated, the study was underpowered and inconclusive. Future larger studies are required to establish the optimal antithrombotic regimen in this population. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01962545.

Circ J 2009; 73: 718 -725 here have been many reports that intensive lowering of low-density lipoprotein-cholesterol (LDL-C) with 3-hydroxy-3-methylglutaryl-coenzyme A (HMGCoA) reductase inhibitors (statins) is effective in preventing cardiovascular events. [1][2][3] Although the mechanism by which statins confer cardiovascular benefit is not precisely understood, regression of coronary plaque volume and reduction of plaque vulnerability are presumed to play important roles. Angioscopic observations have shown that the presence of yellow plaque is associated with unstable symptoms, which suggests that as plaques become more yellow in appearance, they also become more prone to rupture. [4][5][6] Editorial p 628Angioscopy is used to assess plaque vulnerability on the basis of its color and the presence of thrombi. 7,8 Angioscopy gives a full-color, 3-dimensional perspective of the intracoronary surface morphology, and reasonably accurate information regarding a specific lesion, if performed by trained technicians. Intravascular ultrasound (IVUS) is an alternative imaging modality that provides real-time tomographic images of blood vessels on a monitor. It generates information on vessel wall structure, atheroma volume, and the echogenicity of plaque, which is amenable to qualitative and quantitative analysis and can be used to evaluate plaque regression. 9 The effects of statins on coronary plaque have been evaluated by angioscopy, as well as IVUS, in patients with hypercholesterolemia. Using angioscopy, Takano et al demonstrated that the grade of yellow color decreased during statin therapy, 10 and Nissen et al 11 and Okazaki et al 12 used IVUS to investigate the effects of statins on atheroma volume. However, because no study has serially monitored the coronary plaques of patients receiving statin therapy using both angioscopy and IVUS, the relationship between changes in plaque color and changes in atheroma volume has not been elucidated. Therefore, we used both imaging modalities concurrently to investigate the qualitative and quantitative changes over time in coronary plaques in patients receiving atorvastatin therapy to reduce LDL-C levels to ≤100 mg/dl. Methods Study PopulationPatients with coronary artery disease (CAD) complicated by hypercholesterolemia, with a fasting LDL-C level (Received August 10, 2008; accepted December 2, 2008; released online February 18, 2009

The present study provides the most recent data about the characteristics and the mortality of AF patients in Tokyo, thus serving as the basic information for finding problems to solve regarding Japanese AF patients.

, the Shinken Database Study GroupThe incidence of diabetes is increasing, and the disease has become an important predictor of prognosis in patients with coronary artery disease (CAD), although adverse events often occur without warning. Thus, risk stratification of diabetic CAD patients is important for secondary prevention. This study tests the hypothesis that brachial-ankle pulse wave velocity (baPWV), a marker for arterial stiffness obtained by simple and noninvasive automated devices, can be a risk stratification index to predict prognosis in diabetic patients with CAD. The prognosis of CAD patients with diabetes in the Shinken Database cohort study was investigated by dividing patients into two groups based on baPWV measurements. The composite endpoint was death, nonfatal myocardial infarction, repeat revascularization or readmission for heart failure. Data were available on 564 CAD patients, with a median follow-up of 25.4 months. Of these patients, 191 had type 2 diabetes. The higher baPWV among diabetic patients was defined as a median baPWV of 1730 cm s -1 or more. The 3-year Kaplan-Meier estimates of event-free survival were 72.8% in diabetic patients with lower baPWV and 51.3% in those with higher baPWV, respectively (P¼0.031). Multivariate analysis revealed that a higher baPWV was independently associated with poorer short-term prognosis (hazard ratio, 1.97; 95% confidence interval, 1.01-3.84) in diabetic CAD patients. In conclusion, baPWV, a marker for arterial stiffness, can be a risk stratification index for short-term prognosis in clinical practice, suggesting the need for further aggressive treatment and strict follow-up in CAD patients with diabetes and higher baPWV.

No abstract

Delirium, an acute alteration in attention and cognition, is the most common neurological complication after cardiac surgery in older patients, and it has been shown to be associated with multiple negative outcomes, such as mortality, morbidity, increased length of hospital stay, functional and cognitive decline, increased medical costs, and reduced health-related quality of life [1][2][3][4][5][6][7]. The incidence of delirium greatly increases with age [8-10], and it is expected to continue to increase as the population ages, especially in an aging society such as that in Japan.The rate of physical frailty and cognitive impairment also increases with age, and they are well-known risk factors for the incidence of delirium after surgery [11][12][13][14][15][16]. As delirium is thought to result from acute stress on the "vulnerable" body and brain, attention should be paid to both physical and cognitive functions for better perioperative care in older patients. Further, in a previous study, mild cognitive impairment (MCI), the transitional state between cognitive change associated with normal aging and dementia, has also been detected as a risk factor for delirium [17]. Therefore, close attention should be paid to patients who show even mild decline in cognitive function.Several cross-sectional studies have reported an association between physical frailty and cognitive function [18,19]. In addition,