Cho Jae Young, Joo Donghyeon, Yun Kyeong Ho, Kim Byeong-Keuk, Hong Myeong-Ki, Jang Yangsoo, Oh Seok Kyu
Departments of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, Republic of Korea.
Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Front Cardiovasc Med. 2023 Aug 8;10:1237826. doi: 10.3389/fcvm.2023.1237826. eCollection 2023.
The aim of this study was to evaluate the efficacy and safety of ticagrelor monotherapy in patients with small vessel disease compared with ticagrelor-based DAPT within the Ticagrelor Monotherapy after 3 Months in the Patients Treated with New Generation Sirolimus Eluting Stent for Acute Coronary Syndrome (TICO) trial population.
Reference vessel diameter ≤2.5 mm was considered as small vessel disease. We conducted a comparison of the incidence of target lesion failure (TLF) and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. TLF was defined as a composite of cardiac death, target lesion myocardial infarction, stent thrombosis, and target lesion revascularization.
652 patients among 3,056 TICO population (21.3%) had small vessel disease. Patients with small vessel disease showed a higher rate of TLF compared to those without small vessel disease (2.9% vs. 1.0%, log-rank < 0.001). The presence of small vessel disease emerged as an independent predictor for 1-year TLF (HR 2.84, 95% CI 1.54-5.25), while it did not show a significant association with bleeding complications. The 12-month TLF rate was 1.6% for ticagrelor monotherapy after 3-month DAPT, and 4.2% for ticagrelor-based 12-month DAPT ( = 0.059) in patients with small vessel disease (HR 0.38, 95% CI 0.14-1.04, for interaction = 0.261). The incidence of BARC type 3 or 5 bleeding rate 2.5% for ticagrelor monotherapy after 3-month DAPT, and 5.6% for ticagrelor-based 12-month DAPT ( = 0.052) in patients with small vessel disease (HR 0.44, 95% CI 0.19-1.01, for interaction = 0.322). In the 3-month landmark analysis, ticagrelor monotherapy significantly reduced BARC type 3 or 5 bleeding in patients with small vessel disease (HR 0.09, 95% CI 0.01-0.69, log-rank = 0.005) while demonstrating a similar incidence of TLF compared to ticagrelor based 12-month DAPT during the 3-12 months period.
There are no significant interactions between the antiplatelet strategy regarding the 12-month incidence of ischemic and bleeding complications. Ticagrelor monotherapy demonstrated a reduction in bleeding complications after a 3-month period of DAPT without increasing the rate of TLF, when compared to ticagrelor-based 12-month DAPT, specifically in patients with small vessel disease. : www.ClinicalTrials.gov, identifier, NCT02494895.
本研究旨在评估新一代西罗莫司洗脱支架治疗急性冠状动脉综合征患者3个月后替格瑞洛单药治疗与基于替格瑞洛的双联抗血小板治疗（DAPT）相比，在小血管疾病患者中的疗效和安全性。
参考血管直径≤2.5毫米被视为小血管疾病。我们比较了靶病变失败（TLF）的发生率和出血学术研究联盟（BARC）3型或5型出血的发生率。TLF被定义为心脏死亡、靶病变心肌梗死、支架血栓形成和靶病变血运重建的复合事件。
3056名TICO研究人群中有652名患者（21.3%）患有小血管疾病。与无小血管疾病的患者相比，患有小血管疾病的患者TLF发生率更高（2.9%对1.0%，对数秩检验＜0.001）。小血管疾病的存在成为1年TLF的独立预测因素（风险比2.84，95%置信区间1.54 - 5.25），而它与出血并发症无显著关联。在患有小血管疾病的患者中，3个月DAPT后替格瑞洛单药治疗的12个月TLF率为1.6%，基于替格瑞洛的12个月DAPT为4.2%（P = 0.059）（风险比0.38，95%置信区间0.14 - 1.04，交互作用P = 0.261）。在患有小血管疾病的患者中，3个月DAPT后替格瑞洛单药治疗的BARC 3型或5型出血发生率为2.5%，基于替格瑞洛的12个月DAPT为5.6%（P = 0.052）（风险比0.44，95%置信区间0.19 - 1.01，交互作用P = 0.322）。在3个月的标志性分析中，替格瑞洛单药治疗显著降低了小血管疾病患者的BARC 3型或5型出血（风险比0.09，95%置信区间0.01 - 0.69，对数秩检验P = 0.005），同时在3 - 12个月期间与基于替格瑞洛的12个月DAPT相比，TLF发生率相似。
关于缺血和出血并发症的12个月发生率，抗血小板策略之间没有显著的相互作用。与基于替格瑞洛的12个月DAPT相比，替格瑞洛单药治疗在3个月DAPT后显示出血并发症减少，且未增加TLF发生率，特别是在小血管疾病患者中。：www.ClinicalTrials.gov，标识符，NCT02494895
