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      Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry

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          Abstract

          Background

          Data regarding the clinical outcomes of covered stents (CSs) used to seal coronary artery perforations (CAPs) in the all-comer population are scarce. The aim of the CRACK Registry was to evaluate the procedural, 30-days and 1-year outcomes after CAP treated by CS implantation.

          Methods

          This multicenter all-comer registry included data of consecutive patients with CAP treated by CS implantation. The primary endpoint was the composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI).

          Results

          The registry included 119 patients (mean age: 68.9 ± 9.7 years, 55.5% men). Acute coronary syndrome, including: unstable angina 21 (17.6%), NSTEMI 26 (21.8%), and STEMI 26 (21.8%), was the presenting diagnosis in 61.3%, and chronic coronary syndromes in 38.7% of patients. The most common lesion type, according to ACC/AHA classification, was type C lesion in 47 (39.5%) of cases. A total of 52 patients (43.7%) had type 3 Ellis classification, 28 patients (23.5%) had type 2 followed by 39 patients (32.8%) with type 1 perforation. Complex PCI was performed in 73 (61.3%) of patients. Periprocedural death occurred in eight patients (6.7%), of which two patients had emergency cardiac surgery. Those patients were excluded from the one-year analysis. Successful sealing of the perforation was achieved in 99 (83.2%) patients. During the follow-up, 26 (26.2%) patients experienced MACE [7 (7.1%) cardiac deaths, 13 (13.1%) TLR, 11 (11.0%) MIs]. Stent thrombosis (ST) occurred in 6 (6.1%) patients [4(4.0%) acute ST, 1(1.0%) subacute ST and 1(1.0%) late ST].

          Conclusions

          The use of covered stents is an effective treatment of CAP. The procedural and 1-year outcomes of CAP treated by CS implantation showed that such patients should remain under follow-up due to relatively high risk of MACE.

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          Most cited references 35

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          2018 ESC/EACTS Guidelines on myocardial revascularization

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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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              Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty).

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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: ValidationRole: VisualizationRole: Writing – original draft
                Role: Formal analysisRole: MethodologyRole: Visualization
                Role: Data curationRole: Methodology
                Role: Data curation
                Role: Methodology
                Role: Methodology
                Role: Data curation
                Role: Data curation
                Role: Methodology
                Role: Data curation
                Role: Data curation
                Role: Methodology
                Role: InvestigationRole: Methodology
                Role: Data curation
                Role: Data curation
                Role: Investigation
                Role: Data curation
                Role: InvestigationRole: Methodology
                Role: Data curationRole: Formal analysis
                Role: Formal analysisRole: Methodology
                Role: Investigation
                Role: Methodology
                Role: Investigation
                Role: InvestigationRole: Methodology
                Role: Investigation
                Role: Investigation
                Role: Formal analysisRole: InvestigationRole: Methodology
                Role: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – original draft
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                12 May 2021
                2021
                : 16
                : 5
                Affiliations
                [1 ] Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
                [2 ] Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
                [3 ] Department of Anaesthesiology and Intensive Care, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Antoni Jurasz University Hospital No. 1, Bydgoszcz, Poland
                [4 ] Department of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland
                [5 ] Third Department of Cardiology, Medical University of Silesia, Zabrze, Poland
                [6 ] First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
                [7 ] Department of Heart Disease, Wroclaw Medical University, Poland
                [8 ] Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Gdansk, Poland
                [9 ] Regional Specialist Hospital, Research and Development Center, Wroclaw, Poland
                [10 ] Department of Cardiology, Miedziowe Centrum Zdrowia, Lubin, Poland
                [11 ] Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior, Centre of Postgraduate Medical Education, Warsaw, Poland
                [12 ] Thoracic Research Centre, Collegium Medicum, Nicolaus Copernicus University, Innovative Medical Forum, Bydgoszcz, Poland
                [13 ] Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland
                [14 ] Department of Cardiology, Pomeranian Medical University, Szczecin, Poland
                Baylor Scott and White, Texas A&M College of Medicine, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Article
                PONE-D-20-39990
                10.1371/journal.pone.0249698
                8115813
                33979357
                1f0beb4e-7f8c-4a5f-9ffa-dec18c51b24c
                © 2021 Wańha et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Figures: 2, Tables: 5, Pages: 15
                Product
                Funding
                The authors received no specific funding for this work.
                Categories
                Research Article
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Stent Implantation
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Cardiovascular Procedures
                Coronary Stenting
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Stent Implantation
                Coronary Stenting
                Medicine and Health Sciences
                Cardiology
                Myocardial Infarction
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Lesions
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Cardiovascular Procedures
                Cardiac Surgery
                Medicine and Health Sciences
                Medical Conditions
                Cardiovascular Diseases
                Coronary Heart Disease
                Medicine and Health Sciences
                Cardiology
                Cardiovascular Medicine
                Cardiovascular Diseases
                Coronary Heart Disease
                Medicine and Health Sciences
                Vascular Medicine
                Coronary Heart Disease
                Medicine and Health Sciences
                Hematology
                Blood Coagulation
                Coagulation Disorders
                Thrombosis
                Medicine and Health Sciences
                Medical Conditions
                Cardiovascular Diseases
                Coagulation Disorders
                Thrombosis
                Medicine and Health Sciences
                Cardiology
                Cardiovascular Medicine
                Cardiovascular Diseases
                Coagulation Disorders
                Thrombosis
                Medicine and Health Sciences
                Vascular Medicine
                Thrombosis
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Cardiovascular Procedures
                Angioplasty
                Coronary Angioplasty
                Custom metadata
                All relevant data are within the manuscript and its Supporting Information files.

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