Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Department of Cardiology, Amsterdam UMC, Vrije University (VU), Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
EuroIntervention. 2023 May 15;19(1):63-72. doi: 10.4244/EIJ-D-22-00886.
Early P2Y inhibitor monotherapy has emerged as a promising alternative to 12 months of dual antiplatelet therapy following percutaneous coronary intervention (PCI).
In this single-arm pilot study, we evaluated the feasibility and safety of ticagrelor or prasugrel monotherapy directly following PCI in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
Patients received a loading dose of ticagrelor or prasugrel before undergoing platelet function testing and subsequent PCI using new-generation drug-eluting stents. The stent result was adjudicated with optical coherence tomography in the first 35 patients. Ticagrelor or prasugrel monotherapy was continued for 12 months. The primary ischaemic endpoint was the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis or stroke within 6 months. The primary bleeding endpoint was Bleeding Academic Research Consortium type 2, 3 or 5 bleeding within 6 months.
From March 2021 to March 2022, 125 patients were enrolled, of whom 75 ultimately met all in- and exclusion criteria (mean age 64.5 years, 29.3% women). Overall, 70 out of 75 (93.3%) patients were treated with ticagrelor or prasugrel monotherapy directly following PCI. The primary ischaemic endpoint occurred in 3 (4.0%) patients within 6 months. No cases of stent thrombosis or spontaneous myocardial infarction occurred. The primary bleeding endpoint occurred in 7 (9.3%) patients within 6 months.
This study provides first-in-human evidence that P2Y inhibitor monotherapy directly following PCI for NSTE-ACS is feasible, without any overt safety concerns, and highlights the need for randomised controlled trials comparing direct P2Y inhibitor monotherapy with the current standard of care.
经皮冠状动脉介入治疗(PCI)后,早期 P2Y 抑制剂单药治疗已成为替代双抗血小板治疗 12 个月的有前途的选择。
在这项单臂试验研究中,我们评估了替格瑞洛或普拉格雷单药治疗在非 ST 段抬高型急性冠状动脉综合征(NSTE-ACS)患者 PCI 后的可行性和安全性。
患者在接受血小板功能检测和随后使用新一代药物洗脱支架进行 PCI 之前接受替格瑞洛或普拉格雷负荷剂量。在最初的 35 例患者中,使用光学相干断层扫描(OCT)对支架结果进行了裁决。替格瑞洛或普拉格雷单药治疗持续 12 个月。主要缺血终点是 6 个月内全因死亡率、心肌梗死、明确或可能的支架血栓形成或中风的复合终点。主要出血终点是 6 个月内 Bleeding Academic Research Consortium 2、3 或 5 型出血。
2021 年 3 月至 2022 年 3 月,共纳入 125 例患者,其中最终符合所有纳入和排除标准的患者有 75 例(平均年龄 64.5 岁,29.3%为女性)。总体而言,75 例患者中有 70 例(93.3%)直接接受了 PCI 后替格瑞洛或普拉格雷单药治疗。6 个月内,主要缺血终点在 3 例患者(4.0%)中发生。无支架血栓形成或自发性心肌梗死发生。6 个月内主要出血终点在 7 例患者(9.3%)中发生。
本研究首次为人类提供了直接在 NSTE-ACS 患者 PCI 后进行 P2Y 抑制剂单药治疗可行的证据,没有明显的安全性问题,并强调需要进行随机对照试验,比较直接 P2Y 抑制剂单药治疗与当前的标准治疗。