Safety of cangrelor and transition to oral P2Y12 inhibitors in patients undergoing percutaneous coronary intervention: the ARCANGELO study.

European Heart Journal Open Pub Date : 2023-08-28 eCollection Date: 2023-07-01 DOI:10.1093/ehjopen/oead076
Leonardo De Luca, Paolo Calabrò, Piera Capranzano, Carlo Di Mario, Fabio Chirillo, Cristina Rolfo, Alberto Menozzi, Maurizio Menichelli, Leonardo Bolognese, Giuseppe Musumeci
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Abstract

Aims: Cangrelor is the only intravenous P2Y12 inhibitor available. Safety, efficacy, and transitioning from cangrelor to oral P2Y12 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 P2Y12 inhibitors in a real-world setting according to the European Medical Agency's requirement.

Methods and results: 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 P2Y12 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 (n = 6 patients) and myocardial infarction (n = 7 patients).

Conclusion: The use of cangrelor in ACS patients undergoing PCI and the transition strategy to P2Y12 inhibitors are confirmed as safe and effective in daily practice.

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经皮冠状动脉介入治疗患者服用坎格雷罗的安全性和向口服 P2Y12 抑制剂过渡:ARCANGELO 研究。
目的:坎格列罗是目前唯一的静脉注射 P2Y12 抑制剂。研究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、疗效以及从坎格雷洛向口服 P2Y12 抑制剂过渡的情况。ARCANGELO 研究旨在根据欧洲医疗机构的要求,在真实世界环境中评估坎格雷洛对出血的安全性以及过渡到口服 P2Y12 抑制剂的效果:研究纳入了接受经皮冠状动脉介入治疗(PCI)的成人 ACS 患者。对患者进行了 30 天的随访。记录出血事件、主要心脏不良事件的发生率以及向口服 P2Y12 过渡的策略。在 1004 名接受 PCI 治疗的 ACS 患者中,995 人(99.1%)符合分析条件,其中 597 人(60.0%)患有 ST 段抬高型心肌梗死。共有 925 名(93.1%)患者通过桡动脉导管入路接受了 PCI 治疗,其中 972 名(97.2%)患者接受了药物洗脱支架治疗。在 95% 的病例中,所有符合条件的患者都接受了 2 至 4 小时的栓剂和坎格雷洛输注。共有 730 名患者(73.4%)、127 名患者(12.8%)和 138 名患者(13.9%)接受了替卡格雷、普拉格雷和氯吡格雷作为过渡疗法。根据出血学术研究联盟(BARC)的标准,PCI 术后 30 天内有 5.2% 的患者发生出血(95% 置信区间:3.9-6.8%);0.5% 的患者发生中度(BARC 3)出血事件,其他患者均为轻度(BARC 1-2)出血事件。14例(1.4%)患者发生了重大心脏不良事件,主要是全因死亡(6例)和心肌梗死(7例):结论:在接受 PCI 治疗的 ACS 患者中使用坎格雷洛以及向 P2Y12 抑制剂过渡的策略在日常实践中被证实是安全有效的。
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