ACTION Study Group, Sorbonne Université, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France; Département de Cardiologie, CHU de Caen, Caen, France.
Département de Cardiologie, CHU de Caen, Caen, France.
Can J Cardiol. 2024 Jan;40(1):31-39. doi: 10.1016/j.cjca.2023.08.028. Epub 2023 Sep 3.
There are dated and conflicting data about the optimal timing of initiation of P2Y inhibitors in elective percutaneous coronary intervention (PCI). Peri-PCI myocardial necrosis is associated with poor outcomes. We aimed to assess the impact of the P2Y inhibitor loading time on periprocedural myocardial necrosis in the population of the randomized Assessment of Loading With the P2Y Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting (ALPHEUS) trial, which compared ticagrelor with clopidogrel in high-risk patients who received elective PCI.
The ALPHEUS trial divided 1809 patients into quartiles of loading time. The ALPHEUS primary outcome was used (type 4 [a or b] myocardial infarction or major myocardial injury) as well as the main secondary outcome (type 4 [a or b] myocardial infarction or any type of myocardial injury).
Patients in the first quartile group (Q1) presented higher rates of the primary outcome (P = 0.01). When compared with Q1, incidences of the primary outcome decreased in patients with longer loading times (adjusted odds ratio [adjOR], 0.70 [0.52.-0.95]; P = 0.02 for Q2; adjOR 0.65 [0.48-0.88]; P < 0.01 for Q3; adjOR 0.66 [0.49-0.89]; P < 0.01 for Q4). Concordant results were found for the main secondary outcome. There was no interaction with the study drug allocated by randomization (clopidogrel or ticagrelor). Bleeding complications (any bleeding ranging between 4.9% and 7.3% and only 1 major bleeding at 48 hours) and clinical ischemic events were rare and did not differ among groups.
In elective PCI, administration of the oral P2Y inhibitor at the time of PCI could be associated with more frequent periprocedural myocardial necrosis than an earlier administration. The long-term clinical consequences remain unknown.
关于择期经皮冠状动脉介入治疗(PCI)中开始使用 P2Y 抑制剂的最佳时机,存在过时且相互矛盾的数据。PCI 围术期心肌坏死与不良结局相关。我们旨在评估在随机评估替格瑞洛或氯吡格雷负荷剂量对接受择期冠状动脉支架置入术的高危患者缺血事件的影响(ALPHEUS)试验人群中,P2Y 抑制剂负荷时间对围手术期心肌坏死的影响,该试验比较了替格瑞洛与氯吡格雷在接受择期 PCI 的高危患者中的疗效。
ALPHEUS 试验将 1809 例患者分为负荷时间四分位组。采用 ALPHEUS 主要终点(4 型[ a 或 b ]心肌梗死或主要心肌损伤)和主要次要终点(4 型[ a 或 b ]心肌梗死或任何类型的心肌损伤)进行分析。
第 1 四分位组(Q1)患者的主要终点发生率较高(P=0.01)。与 Q1 相比,负荷时间较长的患者主要终点发生率降低(校正优势比[adjOR],0.70[0.52.-0.95];P=0.02 对于 Q2;adjOR 0.65[0.48-0.88];P<0.01 对于 Q3;adjOR 0.66[0.49-0.89];P<0.01 对于 Q4)。主要次要终点也有一致的结果。与随机分配的研究药物(氯吡格雷或替格瑞洛)之间没有相互作用。出血并发症(任何出血 4.9%-7.3%,48 小时仅 1 例大出血)和临床缺血事件罕见,且各组之间无差异。
在择期 PCI 中,PCI 时给予口服 P2Y 抑制剂可能与更频繁的围手术期心肌坏死相关,而不是更早的给药。长期临床后果尚不清楚。