三联抗血小板降低ACS患者PCI后30天内并发症
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摘要
目的：回顾性分析急性冠脉综合征(ACS)患者植入药物洗脱支架(DES)后.30天内支架内血栓(ST)和主要不良心脏事件(MACE)的发生率,探究三联抗血小板(小剂量替罗非班加阿司匹林和氯吡格雷)较双联抗血小板(阿司匹林和氯吡咯雷)对预防ACS患者PCI术后30天内ST和MACE(心源性死亡、心肌梗死和紧急靶血管血.运重建)的有效性和安全性。而后,筛选年龄≥60岁的老年ACS患者,根据同样的分组及用药方法,探究三联抗血小板较双联抗血小板对预防老年ACS患者PCI术后30天内ST和MACE的有效性和安全性。
方法：采集2004年3月到2010年11月因ACS就诊于我院并植入DES的患者2904例,部分患者采用双联抗血小板治疗(双联组,n=1145),部分患者采用三联抗血小板治疗(三联组,n=1759),比较两组患者PCI术后30天内ST、MACE及临床不良反应的发生率。筛选年龄≥60岁的1629例老年ACS患者并分为三联组(n=1040例)和双联组(n=589例),比较两组老年ACS患者PCI术后30天内ST. MACE及临床不良反应的发生率。
结果：a.ACS患者：(1)虽然两组间患者的年龄,病变狭窄程度,吸烟、糖尿病、高脂血症和冠状动脉弥漫性病变的比率有差异,但通过cox分析发现以上因索对终点事件的发生无影响,两组患者其余基线资料基本一致。(2)三联组主要终点事件ST的发生率低于双联组(0.11%vs.1.05%,HR：0.108,95%CI：0.024-0.483,P＝0.0036),三联组较双联组相对风险降低89.52%。三联组次要终点事件MACE的发生率也低于双联组(0.17%vs.1.48%,HR：0.114,96%CI：0.034-0.390,P=0.0005),三联组较双联组相对风险降低88.51%,其中
三联组心源性死亡、紧急靶血管血运重建的发生率低于双联组,差异具有统计学意义,但两组间心肌梗死的发生率无统计学差异。(3)两组中均无严重出血事件,三联组轻度出血事件发生8例(0.45%),双联组发生4例(0.35%),差异无统计学意义(P＝0.6720)。三联组血小板减少症发生8例(0.45%),双联组发生1例(0.09%),差异也无统计学意义(P=-0.083)。h.老年ACS患者：(1)虽然两组间老年ACS患者的年龄、高脂血症和急性心肌梗死比率、右冠病变的比率、PIC前病与变狭窄程度、左室射血分数有差异,但通过CoX分析发现以上因素对终点事件的发生无影响,两组老年ACS患者其余基线资料的比较无统计学差异。(2)三联组老年ACS患者主要终点事件ST的发生率低于双联组(0.096%vs.1.19%, HR:13.422,95%CI:1.654-109.240, P=0.015),三联组较双联组相对风险降低91.93%。三联组次要终点事件MACE的发生率也低于双联组(0.192%vs.1.528%, HR:8.015,95%CI:1.732-37.094, P=0.0078),三联组较双联组相对风险降低87.43%,其中三联组紧急靶血管血运重建的发生率低于双联组,差异具有统计学意义,但两组间心源性死亡、心肌梗死的发生率无统计学差异。(3)两组间不良反应的比较：两组中均无严重出血事件,三联组轻度出血事件发生3例(0.29%),双联组发生1例(0.17%),差异无统计学意义(P＝1.00)。三联组血小板减少症发生3例(0.29%),双联组发生0例(0.00%),差异无统计学意义(P=0.482)。
结论：与双联组相比,三联组ACS患者PCI术后30天内发生ST和MACE的风险明显降低,而出血风险及血小板减少症的发生率并没有增加。同样,与双联组老年ACS患者相比,三联组老年ACS患者PCI术后30天内发生ST和MACE的风险也明显降低,而出血风险及血小板减少症的发生率并没有增加。
Objective:A retrospective study to investigate the safety and efficacy of triple anti-platelet therapy(low-dose tirofiban plus aspirin and clopidogrel)comparing to dual anti-platelet therapy (aspirin and clopidogrel) by analyzing the incidence of stent thrombosis (ST) and major adverse cardiac events (MACE) within30days after implantation of drug-eluting stent (DES) in patients with acute coronary syndrome (ACS).Then selecting the old acute coronary syndrome patients who is more than or equal to60yesrs old and dividing to the triple anti-platelet group and dual anti-platelet therapy group, we investigated the safety and efficacy of triple anti-platelet therapy comparing to dual anti-platelet therapy by analyzing the incidence of ST and MACE within30days after implantation of DES.
Method:we enrolled2904ACS patients who underwent coronary stenting with DES from March2004to November2010.Some patients were treated with dual anti-platelet therapy (DAT, n=1145) while others with triple anti-platelet therapy (TAT, n1759). We compared the incidence of ST,MACE and side effects between the two groups within30days after PCI. Then, selecting1629senile patients(more than or equal to60years old) and dividing to the triple anti-platelet group(n=1040)and dual anti-platelet therapy group(n=589), we investigated the safety and efficacy of triple anti-platelet therapy comparing to dual anti-platelet therapy by analyzing the incidence of ST and MACE within30days after implantation of DES.
Result:a. the ACS patients:(1) Although there are significant differences between the two groups in age,the degree of coronary stenosis, the ratio of smoking, diabetes, hyperlipidemia and coronary diffuse lesion, they have no influence to the end points by cox anlalysis. The rest of the baseline between the two groups is similar.(2)The incidence of primary end point (ST) is lower in TAT group than DAT group (0.11%vs.1.05%, HR:0.108,95%CI:0.024-0.483,P=0.0036), reducing the relative risk by89.52%.In addition,the incidence of secondary end point (MACE) is also lower in TAT group than DAT group(0.17%vs.1.48%, HR:0.114,95%CI:0.034-0.390, P0.0005) which reduced the relative risk by88.51%.Among the total,the incidence of cardiac death and urgent target vessel revascularization in TAT group is lower than DAT group and the difference is significant. However, there is no difference between the two groups in the incidence of myocardial infarction.(3)Both of the two groups have no severe hemorrhage,the incidence of mild hemorrhage is similar in the two groups(0.45%vs.0.35%, p=0.6720).Besides,the incidence of thrombocytopenia between the two groups is also similar.(0.45%vs.0.09%, p=0.083). b. the senile ACS patients:(1) Although there are significant differences between the two groups in age, hyperlipidemia, the ratio of acute myocardial infarction and right coronary artery lesion, left ventricular ejection fraction, they have no influence to the end points by cox anlalysis. The rest of the baseline between the two groups is similar.(2)The incidence of primary end point (ST) is lower in senile TAT group than senile DAT group(0.096%vs.1.19%, HR:13.422,95%CI:1.654-109.240,P=0.015), reducing the relative risk by91.93%.In addition,the incidence of secondary end point (MACE) is also lower in senile TAT group than senile DAT group(0.192%vs.1.528%, HR:8.015,95%CI:1.732-37.094,P=0.0078) which reduced the relative risk by87.43%.Among the total,the incidence of urgent target vessel revascularization in senile TAT group is lower than senile DAT group and the difference is significant. However, there is no difference between the two groups in the incidence of myocardial infarction and cardiac death.(3)Both of the two groups have no severe hemorrhage,the incidence of mild hemorrhage is similar in the two groups(0.29%vs.0.17%, p=1.00).Besides,the incidence of thrombocytopenia between the two groups is also similar.(0.29%vs.0.00%, p-0.482).
Conclusion:The patients with ACS in the TAT group have significant lower incidence of ST and MACE than the DAT group within30days after PCI. While the risk of bleeding and the incidence of thrombocytopenia are not increased. Similar, The senile patients with ACS in the TAT group have significant lower incidence of ST and MACE than the senile DAT group within30days after PCI. While the risk of bleeding and the incidence of thrombocytopenia are not increased.
方法：采集2004年3月到2010年11月因ACS就诊于我院并植入DES的患者2904例,部分患者采用双联抗血小板治疗(双联组,n=1145),部分患者采用三联抗血小板治疗(三联组,n=1759),比较两组患者PCI术后30天内ST、MACE及临床不良反应的发生率。筛选年龄≥60岁的1629例老年ACS患者并分为三联组(n=1040例)和双联组(n=589例),比较两组老年ACS患者PCI术后30天内ST. MACE及临床不良反应的发生率。
结果：a.ACS患者：(1)虽然两组间患者的年龄,病变狭窄程度,吸烟、糖尿病、高脂血症和冠状动脉弥漫性病变的比率有差异,但通过cox分析发现以上因索对终点事件的发生无影响,两组患者其余基线资料基本一致。(2)三联组主要终点事件ST的发生率低于双联组(0.11%vs.1.05%,HR：0.108,95%CI：0.024-0.483,P＝0.0036),三联组较双联组相对风险降低89.52%。三联组次要终点事件MACE的发生率也低于双联组(0.17%vs.1.48%,HR：0.114,96%CI：0.034-0.390,P=0.0005),三联组较双联组相对风险降低88.51%,其中
三联组心源性死亡、紧急靶血管血运重建的发生率低于双联组,差异具有统计学意义,但两组间心肌梗死的发生率无统计学差异。(3)两组中均无严重出血事件,三联组轻度出血事件发生8例(0.45%),双联组发生4例(0.35%),差异无统计学意义(P＝0.6720)。三联组血小板减少症发生8例(0.45%),双联组发生1例(0.09%),差异也无统计学意义(P=-0.083)。h.老年ACS患者：(1)虽然两组间老年ACS患者的年龄、高脂血症和急性心肌梗死比率、右冠病变的比率、PIC前病与变狭窄程度、左室射血分数有差异,但通过CoX分析发现以上因素对终点事件的发生无影响,两组老年ACS患者其余基线资料的比较无统计学差异。(2)三联组老年ACS患者主要终点事件ST的发生率低于双联组(0.096%vs.1.19%, HR:13.422,95%CI:1.654-109.240, P=0.015),三联组较双联组相对风险降低91.93%。三联组次要终点事件MACE的发生率也低于双联组(0.192%vs.1.528%, HR:8.015,95%CI:1.732-37.094, P=0.0078),三联组较双联组相对风险降低87.43%,其中三联组紧急靶血管血运重建的发生率低于双联组,差异具有统计学意义,但两组间心源性死亡、心肌梗死的发生率无统计学差异。(3)两组间不良反应的比较：两组中均无严重出血事件,三联组轻度出血事件发生3例(0.29%),双联组发生1例(0.17%),差异无统计学意义(P＝1.00)。三联组血小板减少症发生3例(0.29%),双联组发生0例(0.00%),差异无统计学意义(P=0.482)。
结论：与双联组相比,三联组ACS患者PCI术后30天内发生ST和MACE的风险明显降低,而出血风险及血小板减少症的发生率并没有增加。同样,与双联组老年ACS患者相比,三联组老年ACS患者PCI术后30天内发生ST和MACE的风险也明显降低,而出血风险及血小板减少症的发生率并没有增加。
Objective:A retrospective study to investigate the safety and efficacy of triple anti-platelet therapy(low-dose tirofiban plus aspirin and clopidogrel)comparing to dual anti-platelet therapy (aspirin and clopidogrel) by analyzing the incidence of stent thrombosis (ST) and major adverse cardiac events (MACE) within30days after implantation of drug-eluting stent (DES) in patients with acute coronary syndrome (ACS).Then selecting the old acute coronary syndrome patients who is more than or equal to60yesrs old and dividing to the triple anti-platelet group and dual anti-platelet therapy group, we investigated the safety and efficacy of triple anti-platelet therapy comparing to dual anti-platelet therapy by analyzing the incidence of ST and MACE within30days after implantation of DES.
Method:we enrolled2904ACS patients who underwent coronary stenting with DES from March2004to November2010.Some patients were treated with dual anti-platelet therapy (DAT, n=1145) while others with triple anti-platelet therapy (TAT, n1759). We compared the incidence of ST,MACE and side effects between the two groups within30days after PCI. Then, selecting1629senile patients(more than or equal to60years old) and dividing to the triple anti-platelet group(n=1040)and dual anti-platelet therapy group(n=589), we investigated the safety and efficacy of triple anti-platelet therapy comparing to dual anti-platelet therapy by analyzing the incidence of ST and MACE within30days after implantation of DES.
Result:a. the ACS patients:(1) Although there are significant differences between the two groups in age,the degree of coronary stenosis, the ratio of smoking, diabetes, hyperlipidemia and coronary diffuse lesion, they have no influence to the end points by cox anlalysis. The rest of the baseline between the two groups is similar.(2)The incidence of primary end point (ST) is lower in TAT group than DAT group (0.11%vs.1.05%, HR:0.108,95%CI:0.024-0.483,P=0.0036), reducing the relative risk by89.52%.In addition,the incidence of secondary end point (MACE) is also lower in TAT group than DAT group(0.17%vs.1.48%, HR:0.114,95%CI:0.034-0.390, P0.0005) which reduced the relative risk by88.51%.Among the total,the incidence of cardiac death and urgent target vessel revascularization in TAT group is lower than DAT group and the difference is significant. However, there is no difference between the two groups in the incidence of myocardial infarction.(3)Both of the two groups have no severe hemorrhage,the incidence of mild hemorrhage is similar in the two groups(0.45%vs.0.35%, p=0.6720).Besides,the incidence of thrombocytopenia between the two groups is also similar.(0.45%vs.0.09%, p=0.083). b. the senile ACS patients:(1) Although there are significant differences between the two groups in age, hyperlipidemia, the ratio of acute myocardial infarction and right coronary artery lesion, left ventricular ejection fraction, they have no influence to the end points by cox anlalysis. The rest of the baseline between the two groups is similar.(2)The incidence of primary end point (ST) is lower in senile TAT group than senile DAT group(0.096%vs.1.19%, HR:13.422,95%CI:1.654-109.240,P=0.015), reducing the relative risk by91.93%.In addition,the incidence of secondary end point (MACE) is also lower in senile TAT group than senile DAT group(0.192%vs.1.528%, HR:8.015,95%CI:1.732-37.094,P=0.0078) which reduced the relative risk by87.43%.Among the total,the incidence of urgent target vessel revascularization in senile TAT group is lower than senile DAT group and the difference is significant. However, there is no difference between the two groups in the incidence of myocardial infarction and cardiac death.(3)Both of the two groups have no severe hemorrhage,the incidence of mild hemorrhage is similar in the two groups(0.29%vs.0.17%, p=1.00).Besides,the incidence of thrombocytopenia between the two groups is also similar.(0.29%vs.0.00%, p-0.482).
Conclusion:The patients with ACS in the TAT group have significant lower incidence of ST and MACE than the DAT group within30days after PCI. While the risk of bleeding and the incidence of thrombocytopenia are not increased. Similar, The senile patients with ACS in the TAT group have significant lower incidence of ST and MACE than the senile DAT group within30days after PCI. While the risk of bleeding and the incidence of thrombocytopenia are not increased.
引文
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