De Luca Leonardo, Calabrò Paolo, Capranzano Piera, Di Mario Carlo, Chirillo Fabio, Rolfo Cristina, Menozzi Alberto, Menichelli Maurizio, Bolognese Leonardo, Musumeci Giuseppe
Division of Cardiology, Department of Cardiosciences, Azienda Ospedaliera San Camillo-Forlanini, Circonvallazione Gianicolense, 87, 00152 Roma, Italy.
UOC Cardiologia Clinica con UTIC. A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy.
Eur Heart J Open. 2023 Aug 28;3(4):oead076. doi: 10.1093/ehjopen/oead076. eCollection 2023 Jul.
Cangrelor is the only intravenous P2Y inhibitor available. Safety, efficacy, and transitioning from cangrelor to oral P2Y inhibitors were recorded in patients with acute coronary syndrome (ACS). The ARCANGELO study aims to assess the safety of cangrelor on bleeding and the effects of the transition to oral P2Y inhibitors in a real-world setting according to the European Medical Agency's requirement.
Adult patients with ACS undergoing percutaneous coronary intervention (PCI) receiving cangrelor were included in the study. Patients were followed for 30 days. Incidence of bleeding events, major adverse cardiac events, and transition strategy to oral P2Y were recorded. Among 1004 ACS patients undergoing PCI, 995 (99.1%) were eligible for the analysis; 597 (60.0%) of them had ST-segment elevation myocardial infarction. A total of 925 (93.1%) patients underwent PCI by radial catheter access, and 972 (97.2%) received drug-eluting stents. All eligible patients received bolus and cangrelor infusion between 2 and 4 h in 95% of the cases. A total of 730 patients (73.4%) received ticagrelor, 127 (12.8%) prasugrel, and 138 (13.9%) clopidogrel as transition therapy. Bleeding, according to Bleeding Academic Research Consortium (BARC) criteria, within 30 days post-PCI occurred in 5.2% of patients (95% confidence interval: 3.9-6.8%); 0.5% experienced a moderate (BARC 3), and all others mild (BARC 1-2) bleeding events. Major adverse cardiac events occurred in 14 (1.4%) patients, principally all-cause mortality ( = 6 patients) and myocardial infarction ( = 7 patients).
The use of cangrelor in ACS patients undergoing PCI and the transition strategy to P2Y inhibitors are confirmed as safe and effective in daily practice.
坎格雷洛是唯一可用的静脉注射P2Y抑制剂。记录了急性冠状动脉综合征（ACS）患者使用坎格雷洛的安全性、有效性以及从坎格雷洛转换为口服P2Y抑制剂的情况。ARCANGELO研究旨在根据欧洲药品管理局的要求，在实际临床环境中评估坎格雷洛对出血的安全性以及转换为口服P2Y抑制剂的效果。
纳入接受坎格雷洛治疗的接受经皮冠状动脉介入治疗（PCI）的成年ACS患者。对患者进行30天随访。记录出血事件、主要不良心脏事件的发生率以及转换为口服P2Y的策略。在1004例接受PCI的ACS患者中，995例（99.1%）符合分析条件；其中597例（60.0%）为ST段抬高型心肌梗死患者。共有925例（93.1%）患者通过桡动脉导管途径进行PCI，972例（97.2%）患者接受药物洗脱支架。在95%的病例中，所有符合条件的患者在2至4小时内接受了负荷剂量和坎格雷洛输注。共有730例患者（73.4%）接受替格瑞洛作为转换治疗，127例（12.8%）接受普拉格雷，138例（13.9%）接受氯吡格雷。根据出血学术研究联盟（BARC）标准，PCI术后30天内5.2%的患者发生出血（95%置信区间：3.9 - 6.8%）；0.5%的患者经历中度（BARC 3级）出血，其他所有患者为轻度（BARC 1 - 2级）出血事件。14例（1.4%）患者发生主要不良心脏事件，主要为全因死亡（6例）和心肌梗死（7例）。
在日常临床实践中，坎格雷洛在接受PCI的ACS患者中的应用以及转换为P2Y抑制剂的策略被证实是安全有效的。
