Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Daily glucose fluctuation may have an effect on coronary plaque vulnerability in patients with CAD pre-treated with lipid-lowering therapy. Further investigations should address the rationale for the early detection and control of glucose fluctuation in the era of universal statin use for CAD patients.
Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp benefit of routine FKI after single stenting of bifurcation lesions. 6 In addition, inadequate side-branch dilatation may result in stent deformation or incomplete stent apposition. 7 In contrast, quantitative coronary angiography (QCA) conducted in the Nordic-Baltic Bifurcation Study III showed better expansion of the side-branch orifice in the FKI group. 6 Because delayed arterial healing characterized by exposed stent struts is considered a possible risk factor for stent thrombosis, 8 struts floating at the side-branch orifice (jailing strut) could affect thrombus formation after DES implantation. Despite these controversies, the relationship between stenting strategies and local findings, such as stent apposition, thrombus formation, and neointimal coverage, which may be associated with long-term clinical outcome, has not been well evaluated to date.Several studies have shown that the high resolution of optical coherence tomography (OCT) enables visualization of coronary arteries at the micron level for evaluation of strut coverercutaneous coronary intervention (PCI) using drugeluting stents (DES) reduces restenosis and major adverse cardiac events (MACE) compared to PCI with bare metal stents. 1 Even in the DES era, however, the procedures for bifurcation remain complex and challenging. 2,3 The single-stent strategy is currently considered preferable because the 2-stent strategy has higher rates of periprocedural myocardial infarction and long-term MACE, 4,5 which is probably associated with the increased use of contrast and prolonged procedure time. Therefore, a 1-stent strategy with a provisional approach to the side branch with final kissing inflation (FKI) might be the most acceptable strategy in clinical practice.Recently, the Nordic-Baltic Bifurcation Study III, a randomized comparison of clinical outcomes in patients with coronary bifurcation lesions treated with FKI vs. without FKI after main vessel (MV) stenting, found a similar 6-month clinical outcome between the 2 groups, raising questions regarding the Background: Treatment of coronary bifurcation lesions using a single stenting strategy is preferable over that using a 2-stent technique. The benefit of final kissing inflation (FKI), however, has not been established.
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