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急性冠状动脉综合征血小板反应性低的患者中,半剂量与标准剂量替格瑞洛治疗期间出血事件的时间趋势:一项随机BLEEDING-ACS试验

Temporal Trends of Bleeding Episodes during Half- vs. Standard-Dose Ticagrelor in Acute Coronary Syndrome Patients with Low Platelet Reactivity: A Randomized BLEEDING-ACS Trial.

作者信息

Kim Laeun, Choe Jeong Cheon, Ahn Jin Hee, Lee Hye Won, Oh Jun-Hyok, Choi Jung Hyun, Lee Han Cheol, Cha Kwang Soo, Hong Taek Jong, Jeong Young-Hoon, Park Jin Sup

机构信息

Department of Cardiology and Medical Research Institute, Pusan National University Hospital, Busan 49241, Korea.

Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju 52727, Korea.

出版信息

J Clin Med. 2021 Mar 10;10(6):1159. doi: 10.3390/jcm10061159.

DOI:10.3390/jcm10061159
PMID:33802015
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8000097/
Abstract

To assess the temporal trends of bleeding episodes during half- vs. standard-dose ticagrelor in acute coronary syndrome (ACS) patients with low platelet reactivity (LPR) during standard-dose ticagrelor (90 mg bid). ACS Patients with LPR (<85 P2Y reaction units) ( = 122) were randomly assigned to receive either half-dose (45 mg bid) or standard-dose ticagrelor (90 mg bid). The primary endpoint was incidence of Bleeding Academic Research Consortium (BARC) bleeding at 1 week, 1, 3 and 6 months. Dyspnea and ischemic events were also evaluated. Bleeding episodes were most commonly observed at 1 month and then decreased over time. Half-dose ticagrelor did not reduce any BARC bleeding (odds ratio [OR] 0.900, 95% confidence interval [CI] 0.563-1.440, = 0.661). However, serious bleeding (BARC type ≥2) occurred less often in half-dose ticagrelor (OR 0.284, 95% CI 0.088-0.921, = 0.036). The rate of moderate-to-severe dyspnea was highest at 1 month, then decreased over time. Half-dose ticagrelor did not decrease moderate-to-severe dyspnea (Borg scale ≥ 3) (OR 1.066, 95% CI 0.322-3.530, = 0.916). The risk of ischemic events was also similar between the groups. In conclusions, compared with standard-dose ticagrelor, half-dose ticagrelor reduced serious bleeding events during early period of dual-antiplatelet therapy in ACS patients with LPR; however, the risk of any bleeding events and dyspnea did not differ according to ticagrelor dose. Clinical registration: KCT0004640.

摘要

为评估在标准剂量替格瑞洛(90毫克,每日两次)治疗期间血小板反应性低(LPR)的急性冠状动脉综合征(ACS)患者中,半剂量与标准剂量替格瑞洛治疗时出血事件的时间趋势。将LPR(<85个P2Y反应单位)的ACS患者(n = 122)随机分配接受半剂量(45毫克,每日两次)或标准剂量替格瑞洛(90毫克,每日两次)治疗。主要终点是1周、1、3和6个月时出血学术研究联盟(BARC)出血的发生率。还评估了呼吸困难和缺血事件。出血事件最常见于1个月时,然后随时间减少。半剂量替格瑞洛未减少任何BARC出血(比值比[OR] 0.900,95%置信区间[CI] 0.563 - 1.440,P = 0.661)。然而,半剂量替格瑞洛治疗时严重出血(BARC≥2型)的发生频率较低(OR 0.284,95% CI 0.088 - 0.921,P = 0.036)。中重度呼吸困难的发生率在1个月时最高,然后随时间下降。半剂量替格瑞洛未降低中重度呼吸困难(Borg量表≥3)(OR 1.066,95% CI 0.322 - 3.530,P = 0.916)。两组之间缺血事件的风险也相似。总之,与标准剂量替格瑞洛相比,半剂量替格瑞洛在LPR的ACS患者双联抗血小板治疗早期减少了严重出血事件;然而,任何出血事件和呼吸困难的风险并未因替格瑞洛剂量而有所不同。临床注册号:KCT0004640。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f41/8000097/3ba8e05ce519/jcm-10-01159-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f41/8000097/a143baa8cc05/jcm-10-01159-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f41/8000097/e34caa91ebb9/jcm-10-01159-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f41/8000097/3ba8e05ce519/jcm-10-01159-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f41/8000097/a143baa8cc05/jcm-10-01159-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f41/8000097/e34caa91ebb9/jcm-10-01159-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f41/8000097/3ba8e05ce519/jcm-10-01159-g003.jpg

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