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.