{"title":"替格瑞洛与氯吡格雷对经皮冠状动脉介入治疗的COVID-19急性冠脉综合征患者短期预后的影响随机临床试验。","authors":"Reza Arefizadeh, Seyed Hossein Moosavi, Sayied Towfiqie, Seyed Abolfazl Mohsenizadeh, Mehdi Pishgahi","doi":"10.22037/aaem.v11i1.1870","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Acute COVID-19 infection is associated with increased adverse clinical outcomes in patients with acute coronary syndromes (ACS). Given that some studies suggested improved pulmonary function with Ticagrelor, this clinical trial aimed to compare the effects of Ticagrelor versus Clopidogrel on the short-term outcomes of these patients.</p><p><strong>Methods: </strong>In this multicenter clinical trial, 180 COVID-19 patients with ACS who underwent urgent percutaneous coronary intervention (PCI) were randomized to receive Ticagrelor (180mg loading dose followed by 90mg twice daily, n=90) or Clopidogrel (600mg loading dose with 75mg daily, n=90), and then followed for one month after their procedure. The primary composite endpoint was a combination of all-cause mortality, myocardial infarction, and early stent thrombosis within the first month after stent implantation.</p><p><strong>Results: </strong>After thirty days of follow-up, the primary composite endpoint was non-significantly lower in the Ticagrelor compared to the Clopidogrel group (18.5% vs 23.5% respectively, p = 0.254). Based on the time-to-event analysis, the mean survival rate was 26.8 ±7.7 and 24.7 ±9.9 days, respectively, for the Ticagrelor and the Clopidogrel arms (Log-rank p = 0.275). Secondary endpoints were similar in the two trial arms, except for the mean oxygen saturation, which was higher in the Ticagrelor group (95.28 ±2.68 % vs. 94.15 ± 3.55 %, respectively; p = 0.021).</p><p><strong>Conclusion: </strong>Among COVID-19 patients with concomitant ACS, who were treated with urgent PCI, the composite outcome of death, myocardial infarction, and early stent thrombosis was not different between Ticagrelor and Clopidogrel groups. However, administration of Ticagrelor was associated with a slight but statistically significant increase in oxygen saturation compared to Clopidogrel, but this difference wasn't clinically important.</p>","PeriodicalId":8146,"journal":{"name":"Archives of Academic Emergency Medicine","volume":"11 1","pages":"e14"},"PeriodicalIF":2.9000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3f/b2/aaem-11-e14.PMC9807941.pdf","citationCount":"2","resultStr":"{\"title\":\"Effect of Ticagrelor Compared to Clopidogrel on Short-term Outcomes of COVID-19 Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention; a Randomized Clinical Trial.\",\"authors\":\"Reza Arefizadeh, Seyed Hossein Moosavi, Sayied Towfiqie, Seyed Abolfazl Mohsenizadeh, Mehdi Pishgahi\",\"doi\":\"10.22037/aaem.v11i1.1870\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Acute COVID-19 infection is associated with increased adverse clinical outcomes in patients with acute coronary syndromes (ACS). Given that some studies suggested improved pulmonary function with Ticagrelor, this clinical trial aimed to compare the effects of Ticagrelor versus Clopidogrel on the short-term outcomes of these patients.</p><p><strong>Methods: </strong>In this multicenter clinical trial, 180 COVID-19 patients with ACS who underwent urgent percutaneous coronary intervention (PCI) were randomized to receive Ticagrelor (180mg loading dose followed by 90mg twice daily, n=90) or Clopidogrel (600mg loading dose with 75mg daily, n=90), and then followed for one month after their procedure. The primary composite endpoint was a combination of all-cause mortality, myocardial infarction, and early stent thrombosis within the first month after stent implantation.</p><p><strong>Results: </strong>After thirty days of follow-up, the primary composite endpoint was non-significantly lower in the Ticagrelor compared to the Clopidogrel group (18.5% vs 23.5% respectively, p = 0.254). Based on the time-to-event analysis, the mean survival rate was 26.8 ±7.7 and 24.7 ±9.9 days, respectively, for the Ticagrelor and the Clopidogrel arms (Log-rank p = 0.275). Secondary endpoints were similar in the two trial arms, except for the mean oxygen saturation, which was higher in the Ticagrelor group (95.28 ±2.68 % vs. 94.15 ± 3.55 %, respectively; p = 0.021).</p><p><strong>Conclusion: </strong>Among COVID-19 patients with concomitant ACS, who were treated with urgent PCI, the composite outcome of death, myocardial infarction, and early stent thrombosis was not different between Ticagrelor and Clopidogrel groups. However, administration of Ticagrelor was associated with a slight but statistically significant increase in oxygen saturation compared to Clopidogrel, but this difference wasn't clinically important.</p>\",\"PeriodicalId\":8146,\"journal\":{\"name\":\"Archives of Academic Emergency Medicine\",\"volume\":\"11 1\",\"pages\":\"e14\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3f/b2/aaem-11-e14.PMC9807941.pdf\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Academic Emergency Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.22037/aaem.v11i1.1870\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"EMERGENCY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Academic Emergency Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.22037/aaem.v11i1.1870","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"EMERGENCY MEDICINE","Score":null,"Total":0}
引用次数: 2
摘要
急性COVID-19感染与急性冠状动脉综合征(ACS)患者不良临床结局增加相关。鉴于一些研究表明替格瑞洛可改善肺功能,本临床试验旨在比较替格瑞洛与氯吡格雷对这些患者短期预后的影响。方法:在本多中心临床试验中,180例接受紧急经皮冠状动脉介入治疗(PCI)的COVID-19合并ACS患者随机分为替格瑞洛(负载剂量180mg, 90mg,每日2次,n=90)或氯吡格雷(负载剂量600mg,每日75mg, n=90),术后随访1个月。主要的综合终点是全因死亡率、心肌梗死和支架植入术后第一个月内的早期支架血栓形成。结果:随访30天后,替格瑞洛组的主要综合终点与氯吡格雷组相比无显著性降低(分别为18.5% vs 23.5%, p = 0.254)。根据事件发生时间分析,替格瑞洛组和氯吡格雷组的平均生存率分别为26.8±7.7天和24.7±9.9天(Log-rank p = 0.275)。两个试验组的次要终点相似,除了替格瑞洛组的平均血氧饱和度更高(分别为95.28±2.68%和94.15±3.55%);P = 0.021)。结论:在紧急PCI治疗的COVID-19合并ACS患者中,替格瑞洛组与氯吡格雷组的死亡、心肌梗死、早期支架血栓形成等综合结局无显著差异。然而,与氯吡格雷相比,替格瑞洛的使用与氧饱和度的轻微但有统计学意义的增加有关,但这种差异在临床上并不重要。
Effect of Ticagrelor Compared to Clopidogrel on Short-term Outcomes of COVID-19 Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention; a Randomized Clinical Trial.
Introduction: Acute COVID-19 infection is associated with increased adverse clinical outcomes in patients with acute coronary syndromes (ACS). Given that some studies suggested improved pulmonary function with Ticagrelor, this clinical trial aimed to compare the effects of Ticagrelor versus Clopidogrel on the short-term outcomes of these patients.
Methods: In this multicenter clinical trial, 180 COVID-19 patients with ACS who underwent urgent percutaneous coronary intervention (PCI) were randomized to receive Ticagrelor (180mg loading dose followed by 90mg twice daily, n=90) or Clopidogrel (600mg loading dose with 75mg daily, n=90), and then followed for one month after their procedure. The primary composite endpoint was a combination of all-cause mortality, myocardial infarction, and early stent thrombosis within the first month after stent implantation.
Results: After thirty days of follow-up, the primary composite endpoint was non-significantly lower in the Ticagrelor compared to the Clopidogrel group (18.5% vs 23.5% respectively, p = 0.254). Based on the time-to-event analysis, the mean survival rate was 26.8 ±7.7 and 24.7 ±9.9 days, respectively, for the Ticagrelor and the Clopidogrel arms (Log-rank p = 0.275). Secondary endpoints were similar in the two trial arms, except for the mean oxygen saturation, which was higher in the Ticagrelor group (95.28 ±2.68 % vs. 94.15 ± 3.55 %, respectively; p = 0.021).
Conclusion: Among COVID-19 patients with concomitant ACS, who were treated with urgent PCI, the composite outcome of death, myocardial infarction, and early stent thrombosis was not different between Ticagrelor and Clopidogrel groups. However, administration of Ticagrelor was associated with a slight but statistically significant increase in oxygen saturation compared to Clopidogrel, but this difference wasn't clinically important.