Mauro Gitto, Usman Baber, Samantha Sartori, Birgit Vogel, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, Dariusz Dudek, Angelo Oliva, Javier Escaned, Yihan Feng, C Michael Gibson, Ya-Ling Han, Francesca Maria Di Muro, Richard A Shlofmitz, Kurt Huber, Philippe Gabriel Steg, Samin Sharma, Gennaro Sardella, Adnan Kastrati, Upendra Kaul, Ran Kornowski, Vijay Kunadian, Giulio G Stefanini, Shamir R Mehta, George Dangas, Roxana Mehran
{"title":"替格瑞洛单药治疗与替格瑞洛加阿司匹林治疗慢性冠状动脉综合征和高缺血风险患者：暮光试验的事后分析","authors":"Mauro Gitto, Usman Baber, Samantha Sartori, Birgit Vogel, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, Dariusz Dudek, Angelo Oliva, Javier Escaned, Yihan Feng, C Michael Gibson, Ya-Ling Han, Francesca Maria Di Muro, Richard A Shlofmitz, Kurt Huber, Philippe Gabriel Steg, Samin Sharma, Gennaro Sardella, Adnan Kastrati, Upendra Kaul, Ran Kornowski, Vijay Kunadian, Giulio G Stefanini, Shamir R Mehta, George Dangas, Roxana Mehran","doi":"10.4244/EIJ-D-24-00973","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Short dual antiplatelet therapy (DAPT) followed by ticagrelor monotherapy may be a valuable therapeutic option for patients with chronic coronary syndrome (CCS) and high ischaemic risk (HIR) undergoing percutaneous coronary intervention (PCI).</p><p><strong>Aims: </strong>We aimed to compare ticagrelor monotherapy with ticagrelor-based DAPT in CCS patients with and without HIR undergoing PCI.</p><p><strong>Methods: </strong>The present analysis included the CCS cohort of the TWILIGHT trial, which randomised PCI patients to ticagrelor alone or in combination with aspirin for 12 months after 3 months of ticagrelor-based DAPT. Patients were stratified into HIR and non-HIR based on the 2019 European Society of Cardiology (ESC) CCS guidelines definition. Outcomes of interest were major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction or stroke, and Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding at 1 year.</p><p><strong>Results: </strong>Of the 2,503 CCS patients who underwent randomisation, the ESC definition classified 1,264 (50.5%) as HIR and 1,239 (49.5%) as non-HIR. HIR patients displayed a higher risk of MACCE (3.9% vs 2.3%; p=0.015) and similar rates of BARC Type 2-5 bleeding (5.1% vs 5.7%; p=0.455) as compared to non-HIR patients. Ticagrelor monotherapy and ticagrelor-based DAPT were associated with similar risks of MACCE (HIR: 4.0% vs 3.8%, hazard ratio [HR] 1.06, 95% confidence interval [CI]: 0.60-1.85; non-HIR: 2.1% vs 2.6%, HR 0.80, 95% CI: 0.38-1.66, p<sub>interaction</sub>=0.553) and bleeding (HIR: 4.7% vs 5.7%, HR 0.82, 95% CI: 0.50-1.33; non-HIR: 4.9% vs 6.7%, HR 0.71, 95% CI: 0.44-1.14; p<sub>interaction</sub>=0.684) in both the HIR and non-HIR groups.</p><p><strong>Conclusions: </strong>In a post hoc analysis of the TWILIGHT trial that included CCS patients undergoing PCI, ticagrelor monotherapy after 3 months of DAPT appeared to be safe and was not associated with increased risks of ischaemic or bleeding events, regardless of baseline HIR status, compared with standard ticagrelor-based DAPT. These findings suggest the potential to expand guideline recommendations for ticagrelor monotherapy in CCS.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 10","pages":"550-559"},"PeriodicalIF":7.6000,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12063552/pdf/","citationCount":"0","resultStr":"{\"title\":\"Ticagrelor monotherapy versus ticagrelor plus aspirin in patients with chronic coronary syndrome and high ischaemic risk: a post hoc analysis of the TWILIGHT trial.\",\"authors\":\"Mauro Gitto, Usman Baber, Samantha Sartori, Birgit Vogel, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, Dariusz Dudek, Angelo Oliva, Javier Escaned, Yihan Feng, C Michael Gibson, Ya-Ling Han, Francesca Maria Di Muro, Richard A Shlofmitz, Kurt Huber, Philippe Gabriel Steg, Samin Sharma, Gennaro Sardella, Adnan Kastrati, Upendra Kaul, Ran Kornowski, Vijay Kunadian, Giulio G Stefanini, Shamir R Mehta, George Dangas, Roxana Mehran\",\"doi\":\"10.4244/EIJ-D-24-00973\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Short dual antiplatelet therapy (DAPT) followed by ticagrelor monotherapy may be a valuable therapeutic option for patients with chronic coronary syndrome (CCS) and high ischaemic risk (HIR) undergoing percutaneous coronary intervention (PCI).</p><p><strong>Aims: </strong>We aimed to compare ticagrelor monotherapy with ticagrelor-based DAPT in CCS patients with and without HIR undergoing PCI.</p><p><strong>Methods: </strong>The present analysis included the CCS cohort of the TWILIGHT trial, which randomised PCI patients to ticagrelor alone or in combination with aspirin for 12 months after 3 months of ticagrelor-based DAPT. Patients were stratified into HIR and non-HIR based on the 2019 European Society of Cardiology (ESC) CCS guidelines definition. Outcomes of interest were major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction or stroke, and Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding at 1 year.</p><p><strong>Results: </strong>Of the 2,503 CCS patients who underwent randomisation, the ESC definition classified 1,264 (50.5%) as HIR and 1,239 (49.5%) as non-HIR. HIR patients displayed a higher risk of MACCE (3.9% vs 2.3%; p=0.015) and similar rates of BARC Type 2-5 bleeding (5.1% vs 5.7%; p=0.455) as compared to non-HIR patients. Ticagrelor monotherapy and ticagrelor-based DAPT were associated with similar risks of MACCE (HIR: 4.0% vs 3.8%, hazard ratio [HR] 1.06, 95% confidence interval [CI]: 0.60-1.85; non-HIR: 2.1% vs 2.6%, HR 0.80, 95% CI: 0.38-1.66, p<sub>interaction</sub>=0.553) and bleeding (HIR: 4.7% vs 5.7%, HR 0.82, 95% CI: 0.50-1.33; non-HIR: 4.9% vs 6.7%, HR 0.71, 95% CI: 0.44-1.14; p<sub>interaction</sub>=0.684) in both the HIR and non-HIR groups.</p><p><strong>Conclusions: </strong>In a post hoc analysis of the TWILIGHT trial that included CCS patients undergoing PCI, ticagrelor monotherapy after 3 months of DAPT appeared to be safe and was not associated with increased risks of ischaemic or bleeding events, regardless of baseline HIR status, compared with standard ticagrelor-based DAPT. These findings suggest the potential to expand guideline recommendations for ticagrelor monotherapy in CCS.</p>\",\"PeriodicalId\":54378,\"journal\":{\"name\":\"Eurointervention\",\"volume\":\"21 10\",\"pages\":\"550-559\"},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2025-05-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12063552/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eurointervention\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4244/EIJ-D-24-00973\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eurointervention","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4244/EIJ-D-24-00973","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：短期双重抗血小板治疗（DAPT）后替格瑞洛单药治疗可能是慢性冠状动脉综合征（CCS）和高缺血风险（HIR）患者接受经皮冠状动脉介入治疗（PCI）的一种有价值的治疗选择。目的：我们的目的是比较替格瑞洛单药治疗与替格瑞洛为基础的DAPT对接受PCI的伴有和不伴有HIR的CCS患者的疗效。方法：目前的分析包括暮光试验的CCS队列，该试验将PCI患者随机分组，在以替卡格雷为基础的DAPT治疗3个月后，接受单独替卡格雷或联合阿司匹林治疗12个月。根据2019年欧洲心脏病学会（ESC） CCS指南定义，将患者分为HIR和非HIR。研究的结果是主要的心脑血管不良事件（MACCE）、死亡、心肌梗死或中风的复合情况，以及出血学术研究联盟（BARC） 1年内2-5型出血。结果：在接受随机分组的2503例CCS患者中，ESC定义将1264例（50.5%）归为HIR， 1239例（49.5%）归为非HIR。HIR患者显示出更高的MACCE风险(3.9% vs 2.3%；p=0.015)和相似的BARC 2-5型出血率(5.1% vs 5.7%；p=0.455)，与非hir患者相比。替格瑞洛单药治疗和以替格瑞洛为基础的DAPT与MACCE的风险相似(HIR: 4.0% vs 3.8%，风险比[HR] 1.06, 95%可信区间[CI]: 0.60-1.85；非HIR: 2.1% vs 2.6%, HR 0.80, 95% CI: 0.38-1.66，相互作用=0.553)和出血(HIR: 4.7% vs 5.7%, HR 0.82, 95% CI: 0.50-1.33；非hir: 4.9% vs 6.7%, HR 0.71, 95% CI: 0.44-1.14；HIR组和非HIR组的p - interaction=0.684)。结论：在暮色试验（包括接受PCI的CCS患者）的事后分析中，与以替格瑞洛为基础的标准DAPT相比，接受DAPT 3个月后的替格瑞洛单药治疗似乎是安全的，并且与缺血性或出血事件的风险增加无关，无论基线HIR状态如何。这些发现提示有可能扩大替格瑞洛单药治疗CCS的指南推荐。
Ticagrelor monotherapy versus ticagrelor plus aspirin in patients with chronic coronary syndrome and high ischaemic risk: a post hoc analysis of the TWILIGHT trial.
Background: Short dual antiplatelet therapy (DAPT) followed by ticagrelor monotherapy may be a valuable therapeutic option for patients with chronic coronary syndrome (CCS) and high ischaemic risk (HIR) undergoing percutaneous coronary intervention (PCI).
Aims: We aimed to compare ticagrelor monotherapy with ticagrelor-based DAPT in CCS patients with and without HIR undergoing PCI.
Methods: The present analysis included the CCS cohort of the TWILIGHT trial, which randomised PCI patients to ticagrelor alone or in combination with aspirin for 12 months after 3 months of ticagrelor-based DAPT. Patients were stratified into HIR and non-HIR based on the 2019 European Society of Cardiology (ESC) CCS guidelines definition. Outcomes of interest were major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction or stroke, and Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding at 1 year.
Results: Of the 2,503 CCS patients who underwent randomisation, the ESC definition classified 1,264 (50.5%) as HIR and 1,239 (49.5%) as non-HIR. HIR patients displayed a higher risk of MACCE (3.9% vs 2.3%; p=0.015) and similar rates of BARC Type 2-5 bleeding (5.1% vs 5.7%; p=0.455) as compared to non-HIR patients. Ticagrelor monotherapy and ticagrelor-based DAPT were associated with similar risks of MACCE (HIR: 4.0% vs 3.8%, hazard ratio [HR] 1.06, 95% confidence interval [CI]: 0.60-1.85; non-HIR: 2.1% vs 2.6%, HR 0.80, 95% CI: 0.38-1.66, pinteraction=0.553) and bleeding (HIR: 4.7% vs 5.7%, HR 0.82, 95% CI: 0.50-1.33; non-HIR: 4.9% vs 6.7%, HR 0.71, 95% CI: 0.44-1.14; pinteraction=0.684) in both the HIR and non-HIR groups.
Conclusions: In a post hoc analysis of the TWILIGHT trial that included CCS patients undergoing PCI, ticagrelor monotherapy after 3 months of DAPT appeared to be safe and was not associated with increased risks of ischaemic or bleeding events, regardless of baseline HIR status, compared with standard ticagrelor-based DAPT. These findings suggest the potential to expand guideline recommendations for ticagrelor monotherapy in CCS.
期刊介绍：
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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