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      The Impact of Diabetes Mellitus on Clinical Outcomes after Percutaneous Coronary Intervention with Drug-Eluting Stents for Left Main Distal Bifurcation Lesions in Patients with Chronic Kidney Disease

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          Abstract

          Background: The impact of diabetes mellitus (DM) on clinical outcomes after percutaneous coronary intervention (PCI) for unprotected left main (ULM) distal bifurcation lesions in patients with chronic kidney disease (CKD) is poorly understood in the era of drug-eluting stents (DESs). Objective: We assessed the impact of DM on clinical outcomes after PCI for ULM distal bifurcation lesions in CKD patients compared to patients without DM. Methods: We identified 1,832 consecutive patients who underwent PCI for ULM lesions at New Tokyo Hospital, Matsudo, Japan, San Raffaele Scientific Institute, Milan, Italy, and EMO-GVM, Centro Cuore Columbus, Milan, Italy between January 2005 and August 2015. Of the 1,832 patients, 1,391 were treated with DESs. We excluded 750 patients without CKD and 89 hemodialysis patients. Finally, 552 patients with CKD were included: 219 with DM (DM group) and 333 without DM (no DM group). The primary endpoint was target lesion failure (TLF) at 5 years. TLF was defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction. Results: Patients in the DM group were more likely to have hypertension, dyslipidemia, peripheral artery disease, and lower ejection fraction and were more frequently using insulin for DM. The TLF rate during the follow-up period was significantly higher in the DM than in the no DM group (adjusted hazard ratio [HR] 1.50; 95% confidence interval [CI] 1.06–2.13; p = 0.023). Cardiac mortality was comparable between both groups (adjusted HR 1.11; 95% CI 0.63–1.95; p = 0.71). The TLR rate was significantly higher in the DM group than in the no DM group (adjusted HR 1.69; 95% CI 1.12–2.54; p = 0.012). Conclusion: DM is strongly associated with adverse event after PCI for ULM distal bifurcation lesions in CKD patients compared to those without DM.

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          Most cited references39

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          Fourth Universal Definition of Myocardial Infarction (2018).

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            Clinical end points in coronary stent trials: a case for standardized definitions.

            Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
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              Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.

              Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization. We conducted a randomized, double-blind trial comparing a sirolimus-eluting stent with a standard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery. The coronary disease in these patients was complex because of the frequent presence of diabetes (in 26 percent of patients), the high percentage of patients with longer lesions (mean, 14.4 mm), and small vessels (mean, 2.80 mm). The primary end point was failure of the target vessel (a composite of death from cardiac causes, myocardial infarction, and repeated percutaneous or surgical revascularization of the target vessel) within 270 days. The rate of failure of the target vessel was reduced from 21.0 percent with a standard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion (16.6 percent in the standard-stent group vs. 4.1 percent in the sirolimus-stent group, P<0.001). The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined. In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed. Copyright 2003 Massachusetts Medical Society
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                Author and article information

                Journal
                CRM
                Cardiorenal Med
                10.1159/issn.1664-5502
                Cardiorenal Medicine
                S. Karger AG
                1664-3828
                1664-5502
                2020
                December 2020
                07 September 2020
                : 10
                : 6
                : 382-391
                Affiliations
                [_a] aInterventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
                [_b] bInterventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan
                [_c] cDepartment of Cardiology, Ogaki Municipal Hospital, Gifu, Japan
                [_d] dMaria Cecilia Hospital, GVM, Care and Research, Cotignola (RA) and EMO-GVM, Centro Cuore Columbus, Milan, Italy
                Author notes
                *Yusuke Watanabe, Interventional Cardiology Unit, New Tokyo Hospital, 1271 Wanagaya, Matsudo, Chiba 270-2232 (Japan), yusukeltcr@yahoo.co.jp, Antonio Colombo, Maria Cecilia Hospital, GVM, Care and Research, Cotignola (RA) and EMO-GVM, Centro Cuore Columbus, Via Michelangelo Buonarroti, 48, IT–20145 Milan (Italy), acolombo50@me.com
                Article
                508465 Cardiorenal Med 2020;10:382–391
                10.1159/000508465
                32894836
                d85f108b-c9ae-4a3b-b7db-5735952220f9
                © 2020 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 28 January 2020
                : 07 April 2020
                Page count
                Figures: 2, Tables: 4, Pages: 10
                Categories
                Research Article

                Cardiovascular Medicine,Nephrology
                Percutaneous coronary intervention,Chronic kidney disease,Drug-eluting stents,Left main distal bifurcation lesions,Diabetes mellitus

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