VerifyNow指导小剂量替格瑞洛在急性心肌梗死PCI术后安全性研究

Safety of VerifyNow in the guidance of low dose ticagrelor after PCI in patients with acute myocardial infarction

目的观察VerifyNow-P2Y12检测指导替格瑞洛45 mg bid口服,对急性ST段抬高型心肌梗死(STEMI)急诊经皮冠脉介入治疗(PCI)术后抗血小板聚集的安全性。方法选择2017年5月至2018年5月STEMI且行急诊PCI术的患者100例,均于PCI术后规律替格瑞洛90 mg bid口服达30 d。然后从中随机选取50例为替格瑞洛标准剂量组(标准剂量组),继续原剂量服用至术后12个月。另50例患者(减量组)检测VerifyNow-P2Y12基线值,并将替格瑞洛减量为45 mg bid口服;1周后再次复测VerifyNow-P2Y12,若P2Y12反应单位(PRU)在40~150,则继续45 mg bid口服,应用至PCI术后12个月;若PRU<40,则停用替格瑞洛,换用硫酸氢氯吡格雷(波立维),并剔出研究。对两组患者进行对比,于PCI术后12个月时观察两组主要有效性终点:出血事件、心血管死亡、心肌梗死和卒中的复合事件。结果减量组成功纳入研究共44例,标准剂量组为50例。PCI术后12个月时两组均未发生心源性死亡、急性再发心肌梗死及脑卒中。两组共发生出血事件16例。按TIMI标准定义的出血事件,减量组3例(6.8%),标准剂量组13例(26.0%),差异有统计学意义(χ^2=6.10,P=0.01);减量组无主要出血事件发生,轻微出血3例;标准剂量组主要出血事件2例,轻微出血8例。采用GUSTO出血分级标准,减量组无出血严重或危及生命的出血,标准剂量组1例,为消化道出血。结论STEMI急诊PCI术后应用替格瑞洛45 mg bid口服的抗血小板聚集治疗方案是安全的,同时出血事件发生率较替格瑞洛标准剂量组低。

Objective To investigate the safety of an antiplatelet aggregation VerifyNow-P2Y12 in the guidance of low dose ticagrelor in patients with acute ST segment elevation myocardial infarction(STEMI)after emergency percutaneous coronary intervention(PCI).Methods A total of 100 patients with STEMI who received emergency PCI from May 2017 to May 2018 were selected.All the patients were treated with ticagrelor 90 mg twice a day for 30 days after PCI.Then,50 patients were selected randomly as the standard dose group,and continued to take the original dose until 12 months after operation.The other 50 patients(reduction group),the baseline value of VerifyNow-P2Y12 was measured,and ticagrelor was reduced to 45 mg twice a day for oral administration;after one week,VerifyNow-P2Y12 was retested,if P2Y12 reaction unit(PRU)was 40-150,ticagrelor was taken twice a day for oral administration for 12 months after PCI;if PRU was less than 40,ticagrelor was stopped and replaced by clopidogrel,and the study was excluded.A comparative study was carried out between the two groups.At 12 months after PCI,the main efficacy endpoints of the two groups were observed(including bleeding events,cardiovascular death,recurrent acute myocardial infarction and stroke complex events).Results Fortyfour patients in the reduction group and 50 patients in the standard dose group were included in the study.At 12 months after PCI,no cardiac death,recurrent acute myocardial infarction or stroke occurred in both groups;but 16 bleeding events occurred.According to the TIMI standard definition of bleeding events,there were 3 cases(6.8%)in the reduction group and 13 cases(26.0%)in the standard dose group(χ^2=6.10,P=0.01).In the reduction group,there were no case in major bleeding event and 3 cases in minor bleeding.In the standard dose group,the main bleeding events were gastrointestinal bleeding in 2 cases,and minor bleeding in 8 cases.According to GUSTO bleeding grading standard,there was no serious or life-threatening bleeding in the reduction group,and 1 case(gastrointestinal bleeding)in the standard dose group.Conclusion After STEMI emergency PCI,the antiplatelet aggregation therapy with ticagrelor 45 mg twice a day is safe,and the incidence of bleeding events is lower than that of the conventional dose therapy.