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      Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group

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          Abstract

          Coronary artery disease (CAD) is currently the leading cause of death globally, and the prevalence of this disease is growing more rapidly in the Asia-Pacific region than in Western countries. Although the use of metal coronary stents has rapidly increased thanks to the advancement of safety and efficacy of newer generation drug eluting stent (DES), patients are still negatively affected by some the inherent limitations of this type of treatment, such as stent thrombosis or restenosis, including neoatherosclerosis, and the obligatory use of dual antiplatelet therapy (DAPT) with unknown optimal duration.

          Drug-coated balloon (DCB) treatment is based on a leave-nothing-behind concept and therefore it is not limited by stent thrombosis and long-term DAPT; it directly delivers an anti-proliferative drug which is coated on a balloon after improving coronary blood flow. At present, DCB treatment is recommended as the first-line treatment option in metal stent-related restenosis linked to DES and bare metal stent. For de novo coronary lesions, the application of DCB treatment is extended further, for conditions such as small vessel disease, bifurcation lesions, and chronic total occlusion lesions, and others. Recently, several reports have suggested that fractional flow reserve guided DCB application was safe for larger coronary artery lesions and showed good long-term outcomes. Therefore, the aim of these recommendations of the consensus group was to provide adequate guidelines for patients with CAD based on objective evidence, and to extend the application of DCB to a wider variety of coronary diseases and guide their most effective and correct use in actual clinical practice.

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          Most cited references80

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          2018 ESC/EACTS Guidelines on myocardial revascularization

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            Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study.

            The long-term safety of drug-eluting stents (DES) for acute myocardial infarction (AMI) remains uncertain. Using autopsy data, we evaluated the pathological responses of the stented segment in patients treated with DES for AMI and compared with patients with stable angina. From the CVPath Registry of 138 DES autopsies, we identified 25 patients who presented with AMI and had an underlying necrotic core with a ruptured fibrous cap. Twenty-six patients who had stable angina with thick-cap fibroatheroma treated by DES were selected as controls. Histomorphometric analysis was performed in patients with >30-day stent duration. We compared the response to stenting at the culprit site in these 2 groups and to nonculprit sites within each stent. Late stent thrombosis was significantly less frequent in stable (11%) than in AMI (41%; P=0.04) patients. Although neointimal thickness in the AMI culprit site was significantly less (median, 0.04 mm; interquartile range [IQR], 0.02 to 0.09 mm), the prevalence of uncovered struts (49%; IQR, 16% to 96%), fibrin deposition (63+/-28%), and inflammation (35%; IQR, 27% to 49%) were significantly greater compared with the culprit site in stable patients (neointimal thickness: 0.11 mm [IQR, 0.07 to 0.21 mm], P=0.008; uncovered struts: 9% [IQR, 0% to 39%], P=0.01; fibrin: 36+/-27%, P=0.008; inflammation, 17% [IQR, 7% to 25%], P=0.003) and the nonculprit site within each stent. Vessel healing at the culprit site in AMI patients treated with DES is substantially delayed compared with the culprit site in patients receiving DES for stable angina, emphasizing the importance of underlying plaque morphology in the arterial response to DES. Our data suggest an increased risk of thrombotic complications in patients treated with DES for AMI.
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              Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.

              Treatment of coronary in-stent restenosis is hampered by a high incidence of recurrent in-stent restenosis. We assessed the efficacy and safety of a paclitaxel-coated balloon in this setting. We enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 microg per square millimeter of balloon surface area) with those of an uncoated balloon catheter in coronary angioplasty. The primary end point was late luminal loss as seen on angiography. Secondary end points included the rates of restenosis (a binary variable) and major adverse cardiac events. Multivessel disease was present in 80% of patients in both groups. Quantitative coronary angiography revealed no significant differences in baseline measures. At 6 months, angiography showed that the mean (+/-SD) in-segment late luminal loss was 0.74+/-0.86 mm in the uncoated-balloon group versus 0.03+/-0.48 mm in the coated-balloon group (P=0.002). A total of 10 of 23 patients (43%) in the uncoated-balloon group had restenosis, as compared with 1 of 22 patients (5%) in the coated-balloon group (P=0.002). At 12 months, the rate of major adverse cardiac events was 31% in the uncoated-balloon group and 4% in the coated-balloon group (P=0.01). This difference was primarily due to the need for target-lesion revascularization in six patients in the uncoated-balloon group (P=0.02). Treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly reduced the incidence of restenosis. These data suggest that the inhibition of restenosis by local drug delivery may not require stent implantation and sustained drug release at the site of injury. (ClinicalTrials.gov number, NCT00106587 [ClinicalTrials.gov].).
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                Author and article information

                Journal
                Cardiol J
                Cardiol J
                Cardiology Journal
                Via Medica
                1897-5593
                1898-018X
                February 2021
                25 February 2021
                : 28
                : 1
                : 136-149
                Affiliations
                [1 ]Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea
                [2 ]Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea
                [3 ]Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia
                [4 ]Cardiology Department, National Heart Institute Malaysia, Kuala Lumpur, Malaysia
                [5 ]Division of Cardiology, Department of Internal Medicine, Beijing University ShouGang Hospital, Beijing, China
                [6 ]Department of Cardiology, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan
                [7 ]Department of Cardiology, Far Eastern Memorial Hospital, New Taipei, Taiwan
                [8 ]Cardiology Department, Sarawak Heart Center, Kota Samarahan, Malaysia
                [9 ]Division of Cardiology, Department of Internal Medicine, The First Affiliated Hospital of Zheng Zhou University, ZhengZhou, China
                [10 ]Division of Cardiology, Department of Internal Medicine, Beijing FuWai Hospital, Beijing, China
                [11 ]Division of Cardiology, Department of Medicine, University Malaya Medical Center, Kuala Lumpur, Malaysia
                [12 ]Cardiac Vascular Sentral Kuala Lumpur, Kuala Lumpur, Malaysia
                Author notes
                Address for correspondence: Eun-Seok Shin, MD, PhD, Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, 13, Wolpyeong-ro 171beon-gil, Nam-gu, Ulsan, 44686, South Korea, tel: 82-52-250-5020, fax: 82-52-259-5117, e-mail: sesim1989@ 123456gmail.com
                Article
                cardj-28-1-136
                10.5603/CJ.a2019.0093
                8105061
                31565793
                d4ee2c4e-6dd9-4be0-8eb2-79b2011957a2
                Copyright © 2021 Via Medica

                This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license, allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially.

                History
                : 03 August 2019
                : 17 September 2019
                Categories
                Review Article

                drug-coated balloon,asia-pacific,coronary artery disease,de novo lesion,in-stent restenosis

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