Hossein Behzad, Sina Mashayekhi, Hila Asham, Parvin Sarbakhsh, Taher Entezari-Maleki
{"title":"评估empagliflozin在预防经皮冠状动脉介入治疗患者心肌损伤方面的作用:双盲随机临床试验。","authors":"Hossein Behzad, Sina Mashayekhi, Hila Asham, Parvin Sarbakhsh, Taher Entezari-Maleki","doi":"10.34172/jcvtr.33103","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Percutaneous Coronary Intervention (PCI) is a fundamental procedure for coronary artery disease management, yet the risk of adverse events such periprocedural myocardial injury (PMI) persists. This double-blind, randomized clinical trial aims to assess the efficacy of empagliflozin in preventing myocardial injury during PCI procedure.</p><p><strong>Methods: </strong>A total of 90 patients were randomly assigned to two groups A and B; Group A as the intervention group received empagliflozin 25 mg 24 hours before and empagliflozin 10 mg 1-2 hours before coronary intervention and group Bas the control group received placebo at similar intervals. The primary outcome involved comparing baseline, 8-hour, and 24-hour cTnI and baseline and 24-hour hs-CRP levels after PCI in both groups to measure the incidence of periprocedural myocardial injury (PMI) and anti-inflammatory effects of empagliflozin.</p><p><strong>Results: </strong>Baseline cTnI levels with <i>P</i>=0.955, 8 hours after PCI with <i>P</i>=0.469, and 24 hours after the intervention with <i>P</i>=0.980 were not statistically different in the two groups. Baseline levels of hs-CRP in both intervention and control groups were not statistically significantly different (<i>P</i>=0.982). Also, there was no statistically significant difference in hs-CRP levels 24 hours after PCI in two groups (<i>P</i>=0.198). Finally, the results showed that MACEs did not occur in any of the groups.</p><p><strong>Conclusion: </strong>The results of this trial could not express the advantages of acute pretreatment with empagliflozin in preventing PCI-related myocardial injury.</p>","PeriodicalId":15207,"journal":{"name":"Journal of Cardiovascular and Thoracic Research","volume":"16 2","pages":"113-119"},"PeriodicalIF":1.2000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380744/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluating the effects of empagliflozin in preventing myocardial injury in patients undergoing percutaneous coronary intervention: A double-blind, randomized clinical trial.\",\"authors\":\"Hossein Behzad, Sina Mashayekhi, Hila Asham, Parvin Sarbakhsh, Taher Entezari-Maleki\",\"doi\":\"10.34172/jcvtr.33103\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Percutaneous Coronary Intervention (PCI) is a fundamental procedure for coronary artery disease management, yet the risk of adverse events such periprocedural myocardial injury (PMI) persists. This double-blind, randomized clinical trial aims to assess the efficacy of empagliflozin in preventing myocardial injury during PCI procedure.</p><p><strong>Methods: </strong>A total of 90 patients were randomly assigned to two groups A and B; Group A as the intervention group received empagliflozin 25 mg 24 hours before and empagliflozin 10 mg 1-2 hours before coronary intervention and group Bas the control group received placebo at similar intervals. The primary outcome involved comparing baseline, 8-hour, and 24-hour cTnI and baseline and 24-hour hs-CRP levels after PCI in both groups to measure the incidence of periprocedural myocardial injury (PMI) and anti-inflammatory effects of empagliflozin.</p><p><strong>Results: </strong>Baseline cTnI levels with <i>P</i>=0.955, 8 hours after PCI with <i>P</i>=0.469, and 24 hours after the intervention with <i>P</i>=0.980 were not statistically different in the two groups. Baseline levels of hs-CRP in both intervention and control groups were not statistically significantly different (<i>P</i>=0.982). Also, there was no statistically significant difference in hs-CRP levels 24 hours after PCI in two groups (<i>P</i>=0.198). Finally, the results showed that MACEs did not occur in any of the groups.</p><p><strong>Conclusion: </strong>The results of this trial could not express the advantages of acute pretreatment with empagliflozin in preventing PCI-related myocardial injury.</p>\",\"PeriodicalId\":15207,\"journal\":{\"name\":\"Journal of Cardiovascular and Thoracic Research\",\"volume\":\"16 2\",\"pages\":\"113-119\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380744/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cardiovascular and Thoracic Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.34172/jcvtr.33103\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/6/25 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cardiovascular and Thoracic Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.34172/jcvtr.33103","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/25 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Evaluating the effects of empagliflozin in preventing myocardial injury in patients undergoing percutaneous coronary intervention: A double-blind, randomized clinical trial.
Introduction: Percutaneous Coronary Intervention (PCI) is a fundamental procedure for coronary artery disease management, yet the risk of adverse events such periprocedural myocardial injury (PMI) persists. This double-blind, randomized clinical trial aims to assess the efficacy of empagliflozin in preventing myocardial injury during PCI procedure.
Methods: A total of 90 patients were randomly assigned to two groups A and B; Group A as the intervention group received empagliflozin 25 mg 24 hours before and empagliflozin 10 mg 1-2 hours before coronary intervention and group Bas the control group received placebo at similar intervals. The primary outcome involved comparing baseline, 8-hour, and 24-hour cTnI and baseline and 24-hour hs-CRP levels after PCI in both groups to measure the incidence of periprocedural myocardial injury (PMI) and anti-inflammatory effects of empagliflozin.
Results: Baseline cTnI levels with P=0.955, 8 hours after PCI with P=0.469, and 24 hours after the intervention with P=0.980 were not statistically different in the two groups. Baseline levels of hs-CRP in both intervention and control groups were not statistically significantly different (P=0.982). Also, there was no statistically significant difference in hs-CRP levels 24 hours after PCI in two groups (P=0.198). Finally, the results showed that MACEs did not occur in any of the groups.
Conclusion: The results of this trial could not express the advantages of acute pretreatment with empagliflozin in preventing PCI-related myocardial injury.