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Twelve-month clinical outcomes in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: insights from the ISAR-REACT 5 trial
European Heart Journal - Acute Cardiovascular Care ( IF 3.9 ) Pub Date : 2021-08-17 , DOI: 10.1093/ehjacc/zuab077
J J Coughlan 1, 2 , Alp Aytekin 1 , Gjin Ndrepepa 1 , Stefanie Schüpke 1, 3 , Isabell Bernlochner 3, 4 , Katharina Mayer 1 , Franz Josef Neumann 5 , Maurizio Menichelli 6 , Gert Richardt 7 , Jochen Wöhrle 8 , Erion Xhepa 1 , Sebastian Kufner 1 , Hendrik B Sager 1, 3 , Michael Joner 1, 3 , Tareq Ibrahim 4 , Massimiliano Fusaro 1 , Karl Ludwig Laugwitz 3, 4 , Heribert Schunkert 1, 3 , Adnan Kastrati 1, 3 , Salvatore Cassese 1
Affiliation  

Aims Complex percutaneous coronary intervention (PCI) is associated with a higher risk of ischaemic events. However, no study has analysed the effect of PCI complexity on outcomes in a contemporary cohort of acute coronary syndrome (ACS) patients treated with a dual anti-platelet therapy regimen based on potent P2Y12-inhibitors. Therefore, we performed the current analysis. Methods and results This analysis included all ACS patients treated with PCI in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5 trial. Complex PCI was defined as at least one of: multi-vessel PCI, ≥3 stents implanted, ≥3 lesions treated, and total stented length >60 mm. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 12 months; the safety endpoint was Bleeding Academic Research Consortium types 3–5 bleeding at 12 months. Overall, 3377 patients were included in this analysis (complex PCI, n = 1429; non-complex PCI, n = 1948). The primary endpoint occurred more frequently in the complex PCI group than the non-complex PCI group [10.1% vs. 7.2%, hazard ratio (HR): 1.44, 95% confidence interval (CI) (1.14–1.82), P = 0.002], driven primarily by a higher risk of MI [HR: 1.62, (1.17–2.26), P = 0.004]. The safety endpoint was not statistically different between patients undergoing complex vs. non-complex PCI, although it was numerically higher in the complex PCI group [6.7% vs. 5.3%, HR: 1.28, (0.97–1.70), P = 0.08]. Conclusions Acute coronary syndrome patients undergoing complex PCI have an increased incidence of ischaemic events compared with ACS patients undergoing non-complex PCI. Clinical Trial Registration NCT01944800, Prospective, Randomized Trial of Ticagrelor Vs. Prasugrel in Patients With Acute Coronary Syndrome—Full-Text View—ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01944800

中文翻译:

接受复杂经皮冠状动脉介入治疗的急性冠状动脉综合征患者的 12 个月临床结果:来自 ISAR-REACT 5 试验的见解

目的 复杂的经皮冠状动脉介入治疗 (PCI) 与较高的缺血事件风险相关。然而,没有研究分析 PCI 复杂性对当代急性冠状动脉综合征 (ACS) 患者队列的结果的影响,这些患者接受了基于强效 P2Y12 抑制剂的双重抗血小板治疗方案。因此,我们进行了当前的分析。方法和结果 该分析包括冠状动脉内支架置入和抗血栓治疗方案中所有接受 PCI 治疗的 ACS 患者:冠状动脉治疗的快速早期行动 (ISAR-REACT) 5 试验。复杂 PCI 定义为以下至少一项:多血管 PCI、植入 ≥3 个支架、治疗的病灶≥3 个、支架总长度 > 60 mm。主要终点是 12 个月时全因死亡、心肌梗死 (MI) 或卒中的复合终点;安全终点是 12 个月时出血学术研究联盟 3-5 型出血。总体而言,该分析包括 3377 名患者(复杂 PCI,n = 1429;非复杂 PCI,n = 1948)。复杂 PCI 组的主要终点发生率高于非复杂 PCI 组 [10.1% vs. 7.2%,风险比 (HR):1.44,95% 置信区间 (CI) (1.14–1.82),P = 0.002 ],主要是由于 MI 风险较高 [HR:1.62, (1.17–2.26), P = 0.004]。接受复杂 PCI 与非复杂 PCI 的患者的安全性终点没有统计学差异,尽管复杂 PCI 组的安全性终点在数值上更高 [6.7% vs. 5.3%,HR:1.28,(0.97–1.70),P = 0.08] . 结论 与接受非复杂 PCI 的 ACS 患者相比,接受复杂 PCI 的急性冠脉综合征患者缺血事件发生率增加。临床试验注册 NCT01944800,替格瑞洛 Vs 的前瞻性随机试验。普拉格雷用于急性冠脉综合征患者的治疗—全文视图—ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01944800
更新日期:2021-08-17
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