Han Ya-Ling, Wang Bin, Li Yi, Xu Kai, Wang Shou-Li, Jing Quan-Min, Wang Zu-Lu, Wang Dong-Mei, Ma Ying-Yan, Wang Geng
Department of Cardiology, Shenyang Northern Hospital, Shenyang, Liaoning 110016, China.
Chin Med J (Engl). 2009 Apr 5;122(7):793-7.
Recurrent ischemic events occurred even during routine use of 75 mg clopidogrel in addition to aspirin, that indicated a potentially insufficient maintenance dosage of clopidogrel. The aim of the present study was to evaluate the short-term efficacy and safety of a 150 mg maintenance dose of clopidogrel following a 600 mg loading dose in patients with an acute coronary syndrome (ACS) undergoing drug eluting stent (DES) implantation.
Between November 2005 and November 2006, a total of 813 consecutive ACS patients undergoing DES implantation were enrolled. A 600 mg loading dose was administered before percutaneous coronary intervention (PCI) and patients were randomized to receive clopidogrel 75 mg or 150 mg for 30 days in addition to 300 mg aspirin daily. Primary end points were the composite of cardiac death, non-fatal myocardial infarction (MI) and urgent target vessel revascularization (UTVR). Secondary end points included stent thrombosis (ST), major and minor bleeding events at 30 days.
At a follow-up period of 30 days, 4 (1.0%) patients in the 150 mg group and 9 (2.2%) patients in the 75 mg group (P > 0.05) reached the primary end points. There was no significant difference in the incidences of MI (0.5% vs 1.2%, P > 0.05), UTVR (0.7% vs 2.0%, P > 0.05), and cardiac death (0.2% vs 0.2%, P > 0.05) between the two groups. The incidence of ST (0 vs 1.5%, P < 0.05) was significantly lower in the 150 mg group than that in the 75 mg group. There were no significant differences between both groups regarding the risk of major (0.2% vs 0, P > 0.05) or minor (0.5% vs 0.2%, P > 0.05) bleedings.
A high clopidogrel maintenance dose of 150 mg daily following a 600 mg loading dose for the first month after PCI procedure reduces the risk of ST and appears to be safe in patients with ACS undergoing DES implantation.
即便在常规使用氯吡格雷75毫克联合阿司匹林的情况下,仍会发生复发性缺血事件,这表明氯吡格雷的维持剂量可能不足。本研究的目的是评估急性冠状动脉综合征(ACS)患者在接受药物洗脱支架(DES)植入术后,给予600毫克负荷剂量后,氯吡格雷150毫克维持剂量的短期疗效和安全性。
在2005年11月至2006年11月期间,共纳入813例连续接受DES植入的ACS患者。在经皮冠状动脉介入治疗(PCI)前给予600毫克负荷剂量,患者被随机分为接受氯吡格雷75毫克或150毫克治疗30天,同时每日服用300毫克阿司匹林。主要终点是心源性死亡、非致命性心肌梗死(MI)和紧急靶血管血运重建(UTVR)的复合终点。次要终点包括30天时的支架血栓形成(ST)、主要和次要出血事件。
在30天的随访期内,150毫克组有4例(1.0%)患者达到主要终点,75毫克组有9例(2.2%)患者达到主要终点(P>0.05)。两组之间MI(0.5%对1.2%,P>0.05)、UTVR(0.7%对2.0%,P>0.05)和心源性死亡(0.2%对0.2%,P>0.05)的发生率无显著差异。150毫克组的ST发生率(0对1.5%,P<0.05)显著低于75毫克组。两组在主要出血风险(0.2%对0,P>0.05)或次要出血风险(0.5%对0.2%,P>0.05)方面无显著差异。
PCI术后第一个月,在给予600毫克负荷剂量后,每日150毫克的高氯吡格雷维持剂量可降低ST风险,且对于接受DES植入的ACS患者似乎是安全的。