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坎格雷洛的临床应用:来自意大利南部的真实世界多中心经验。

Clinical use of cangrelor: a real-world multicenter experience from South Italy.

作者信息

Pepe Martino, Larosa Claudio, Cirillo Plinio, Carulli Eugenio, Forleo Cinzia, Nestola Palma L, Ercolano Vincenzo, D'Alessandro Pasquale, Giordano Arturo, Biondi-Zoccai Giuseppe, Moscarelli Marco, Palmiotto Angela I, Esposito Giovanni, Favale Stefano

机构信息

Section of Cardiovascular Diseases, Department of Cardiothoracic (DAI), University of Bari, Bari, Italy -

Division of Cardiology, Lorenzo Bonomo Hospital, Andria, Barletta-Andria-Trani, Italy.

出版信息

Panminerva Med. 2022 Mar;64(1):9-16. doi: 10.23736/S0031-0808.21.04437-2. Epub 2021 Jun 1.

Abstract

BACKGROUND

Dual antiplatelet therapy (DAPT) with acetylsalicylic acid and oral P2Y12 inhibitor (P2Y12-I) represents the standard of care for patients with acute coronary syndromes (ACS) or with chronic coronary syndromes (CCS) treated with percutaneous coronary intervention (PCI). Cangrelor, the first intravenous P2Y12-I, is deemed to overcome the drawbacks of the oral administration; nevertheless, real world data on this new drug are scanty. We sought to investigate routine clinical use of cangrelor in four interventional centers of Italy.

METHODS

We enrolled 241 consecutive patients (196 ACS, 45 CCS) treated with cangrelor during PCI. Drug administration modalities and in-hospital clinical outcomes were evaluated. A subanalysis in patients selected based on the CHAMPION Phoenix trial inclusion/exclusion criteria (CHAMPION-like subpopulation) was also performed.

RESULTS

Cangrelor was mainly utilized in ACS patients, who presented poorer clinical conditions and higher bleeding risk. Cangrelor was given only in P2Y12-I naïve patients; switch to clopidogrel was always done at the end of the infusion, while ticagrelor or prasugrel were prevalently given 30 minutes before. In-hospital mortality was 10.0% and GUSTO moderate/severe bleeding was 2.5%. Bleeding data showed nevertheless to be in line with the CHAMPION Phoenix results in the "CHAMPION-like" subpopulation.

CONCLUSIONS

Cangrelor was predominantly used in ACS with modalities substantially in accord with the label indications. Poor clinical outcomes are due to the prevalent utilization in highly challenging clinical settings, nevertheless the rate of bleeding and stent thrombosis are in line with the randomized trials if analyzed in a subpopulation of comparable risk profile.

摘要

背景

阿司匹林联合口服P2Y12抑制剂(P2Y12-I)的双联抗血小板治疗(DAPT)是急性冠脉综合征(ACS)患者或接受经皮冠状动脉介入治疗(PCI)的慢性冠脉综合征(CCS)患者的标准治疗方案。坎格雷洛是首个静脉用P2Y12-I,被认为可克服口服给药的缺点;然而,关于这种新药的真实世界数据较少。我们试图调查坎格雷洛在意大利四个介入中心的常规临床应用情况。

方法

我们纳入了241例在PCI期间接受坎格雷洛治疗的连续患者(196例ACS,45例CCS)。评估了药物给药方式和院内临床结局。还对根据CHAMPION Phoenix试验纳入/排除标准选择的患者进行了亚组分析(CHAMPION样亚组)。

结果

坎格雷洛主要用于临床状况较差且出血风险较高的ACS患者。坎格雷洛仅用于未用过P2Y12-I的患者;输注结束时总是换用氯吡格雷,而替格瑞洛或普拉格雷通常在输注前30分钟给药。院内死亡率为10.0%,GUSTO中度/重度出血率为2.5%。然而,出血数据在“CHAMPION样”亚组中与CHAMPION Phoenix试验结果一致。

结论

坎格雷洛主要用于ACS,给药方式基本符合药品说明书的适应证。临床结局较差是由于在极具挑战性的临床环境中普遍使用该药,不过,如果在具有可比风险特征的亚组中进行分析,出血和支架血栓形成的发生率与随机试验一致。

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