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      Comprehensive safety profile evaluation of bivalirudin in Chinese ST-segment elevation myocardial infarction patients receiving percutaneous coronary intervention: a prospective, multicenter, intensive monitoring study

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          Abstract

          Background

          This prospective, multi-center, intensive monitoring study aimed to systematically assess the occurrence of adverse events (AEs) and adverse drug reactions (ADRs), especially thrombocytopenia and bleeding, as well as their risk factors in Chinese ST-segment elevation myocardial infraction (STEMI) patients receiving bivalirudin as anticoagulant for percutaneous coronary intervention (PCI).

          Methods

          In total, 1244 STEMI patients undergoing PCI and receiving bivalirudin as anticoagulant were enrolled in the present study. Safety data were collected from hospital admission to 72 h after bivalirudin administration; in addition, patients were further followed up at the 30th day with safety data collected at that time.

          Results

          AEs, severe AEs, ADRs and severe ADRs were reported in 224 (18.0%), 15 (1.2%), 49 (3.9%) and 5 (0.4%) patients, respectively. Importantly, 4 (0.3%) patients were submitted to hospitalization and 6 (0.5%) patients died due to AEs, while 1 (0.1%) patient was submitted to hospitalization but no (0.0%) patient died due to ADRs. Meanwhile, thrombocytopenia and bleeding occurred in 24 (1.9%) and 21 (1.7%) patients, respectively. Further multivariate logistic analysis identified several important independent factors related to AEs, ADRs, thrombocytopenia or bleeding, which included history of cardiac surgery and renal function impairment, high CRUSADE risk stratification, elective operation and combination with glycoprotein IIb/IIIa inhibitors. Moreover, 4 multivariate models were constructed based on the above-mentioned factors, which all showed acceptable predictive value for AEs, ADRs, thrombocytopenia and bleeding, respectively.

          Conclusion

          Bivalirudin is a well-tolerant anticoagulant in Chinese STEMI patients undergoing PCI procedure.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12872-022-02716-4.

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          Most cited references29

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          Mortality in relation to smoking: 50 years' observations on male British doctors.

          To compare the hazards of cigarette smoking in men who formed their habits at different periods, and the extent of the reduction in risk when cigarette smoking is stopped at different ages. Prospective study that has continued from 1951 to 2001. United Kingdom. 34 439 male British doctors. Information about their smoking habits was obtained in 1951, and periodically thereafter; cause specific mortality was monitored for 50 years. Overall mortality by smoking habit, considering separately men born in different periods. The excess mortality associated with smoking chiefly involved vascular, neoplastic, and respiratory diseases that can be caused by smoking. Men born in 1900-1930 who smoked only cigarettes and continued smoking died on average about 10 years younger than lifelong non-smokers. Cessation at age 60, 50, 40, or 30 years gained, respectively, about 3, 6, 9, or 10 years of life expectancy. The excess mortality associated with cigarette smoking was less for men born in the 19th century and was greatest for men born in the 1920s. The cigarette smoker versus non-smoker probabilities of dying in middle age (35-69) were 42% nu 24% (a twofold death rate ratio) for those born in 1900-1909, but were 43% nu 15% (a threefold death rate ratio) for those born in the 1920s. At older ages, the cigarette smoker versus non-smoker probabilities of surviving from age 70 to 90 were 10% nu 12% at the death rates of the 1950s (that is, among men born around the 1870s) but were 7% nu 33% (again a threefold death rate ratio) at the death rates of the 1990s (that is, among men born around the 1910s). A substantial progressive decrease in the mortality rates among non-smokers over the past half century (due to prevention and improved treatment of disease) has been wholly outweighed, among cigarette smokers, by a progressive increase in the smoker nu non-smoker death rate ratio due to earlier and more intensive use of cigarettes. Among the men born around 1920, prolonged cigarette smoking from early adult life tripled age specific mortality rates, but cessation at age 50 halved the hazard, and cessation at age 30 avoided almost all of it.
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            The NLRP3 inflammasome in acute myocardial infarction

            The heart is extremely sensitive to ischaemic injury. During an acute myocardial infarction (AMI) event, the injury is initially caused by reduced blood supply to the tissues, which is then further exacerbated by an intense and highly specific inflammatory response that occurs during reperfusion. Numerous studies have highlighted the central role of the NACHT, LRR, and PYD domains-containing protein 3 (NLRP3) inflammasome in this process. The inflammasome, an integral part of the innate immune system, is a macromolecular protein complex that finely regulates the activation of caspase 1 and the production and secretion of powerful pro-inflammatory cytokines such as IL-1β and IL-18. In this Review, we summarize evidence supporting the therapeutic value of NLRP3 inflammasome-targeted strategies in experimental models, and the data supporting the role of the NLRP3 inflammasome in AMI and its consequences on adverse cardiac remodelling, cytokine-mediated systolic dysfunction, and heart failure.
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              Population trends in the incidence and outcomes of acute myocardial infarction.

              Few studies have characterized recent population trends in the incidence and outcomes of myocardial infarction. We identified patients 30 years of age or older in a large, diverse, community-based population who were hospitalized for incident myocardial infarction between 1999 and 2008. Age- and sex-adjusted incidence rates were calculated for myocardial infarction overall and separately for ST-segment elevation and non-ST-segment elevation myocardial infarction. Patient characteristics, outpatient medications, and cardiac biomarker levels during hospitalization were identified from health plan databases, and 30-day mortality was ascertained from administrative databases, state death data, and Social Security Administration files. We identified 46,086 hospitalizations for myocardial infarctions during 18,691,131 person-years of follow-up from 1999 to 2008. The age- and sex-adjusted incidence of myocardial infarction increased from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, and it decreased each year thereafter, to 208 cases per 100,000 person-years in 2008, representing a 24% relative decrease over the study period. The age- and sex-adjusted incidence of ST-segment elevation myocardial infarction decreased throughout the study period (from 133 cases per 100,000 person-years in 1999 to 50 cases per 100,000 person-years in 2008, P<0.001 for linear trend). Thirty-day mortality was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76; 95% confidence interval, 0.65 to 0.89). Within a large community-based population, the incidence of myocardial infarction decreased significantly after 2000, and the incidence of ST-segment elevation myocardial infarction decreased markedly after 1999. Reductions in short-term case fatality rates for myocardial infarction appear to be driven, in part, by a decrease in the incidence of ST-segment elevation myocardial infarction and a lower rate of death after non-ST-segment elevation myocardial infarction. Copyright 2010 Massachusetts Medical Society.
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                Author and article information

                Contributors
                huaicheng5223@163.com
                zhong01646011@163.com
                qiurao959605@163.com
                jiaying812288@163.com
                luanyi4609160@163.com
                anshichikexin@163.com
                DJPDBY@163.com
                sgh7058@126.com
                Journal
                BMC Cardiovasc Disord
                BMC Cardiovasc Disord
                BMC Cardiovascular Disorders
                BioMed Central (London )
                1471-2261
                25 June 2022
                25 June 2022
                2022
                : 22
                : 290
                Affiliations
                [1 ]Department of Cardiology, Jiaozuo People’s Hospital, Jiaozuo, China
                [2 ]GRID grid.459429.7, Department of Cardiology, , Chenzhou First People’s Hospital, ; Chenzhou, China
                [3 ]GRID grid.411634.5, ISNI 0000 0004 0632 4559, Department of Cardiology, , Peking University People’s Hospital, ; Beijing, China
                [4 ]GRID grid.24696.3f, ISNI 0000 0004 0369 153X, Department of Cardiology, Beijing Institute of Heart Lung and Blood Vessel Disease, Beijing Anzhen Hospital, , Capital Medical University, ; Beijing, China
                [5 ]GRID grid.417020.0, ISNI 0000 0004 6068 0239, Department of Cardiology, , Tianjin Chest Hospital, ; Tianjin, China
                [6 ]GRID grid.461857.9, Department of Cardiology, , The First People’s Hospital of Jinzhou District, ; Dalian, China
                [7 ]GRID grid.452642.3, Department of Cardiology, , Nanchong Central Hospital, ; No. 97, Renmin South Road, Shunqing District, Nanchong, 637000 China
                [8 ]GRID grid.27255.37, ISNI 0000 0004 1761 1174, Department of Cardiology, Jinan Clinical Medical College, Jinan Central Hospital, , Shan-Dong University, ; No. 105 Jiefang Road, Jinan, 250000 Jinan China
                Article
                2716
                10.1186/s12872-022-02716-4
                9233771
                35752771
                3ea019f7-ed5f-46fd-b425-636eaa1b53bb
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 26 September 2021
                : 12 January 2022
                Categories
                Research
                Custom metadata
                © The Author(s) 2022

                Cardiovascular Medicine
                bivalirudin,percutaneous coronary intervention,st-segment elevation myocardial infarction,adverse events and drug reactions,thrombocytopenia and bleeding

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