急诊经皮冠状动脉介入治疗术后抗栓治疗个体化方案研究

Study of individualized antithrombus therapy after emergency percutaneous coronary intervention

目的探讨急性冠状动脉综合征患者经皮冠状动脉介入（PCI）后根据全血凝血检测值调整抗血小板治疗方案的安全性和有效性。方法收集行急性冠状动脉综合征急诊PCI患者中凝血速率〉23cP／min的48例患者进行试验，并将其完全随机分为对照组和优化组，各24例。对照组所有病例均采用标准阿司匹林、氯吡格雷二联抗血小板治疗，优化组在标准二联基础上加服西洛他唑1个月。观察2组主要终点事件和次要终点事件的发生率及不良反应发生率并加以比较。结果优化组治疗后凝血速率为（13．6±2．3）cP／min，明显低于治疗前[（25．3±1．6）cP／min，P〈0．01]。随访1年后优化组主要终点事件发生率为4．2％（1／24），次要终点事件发生率为8．3％（2／24）；对照组主要终点事件发生率为16．7％（4／24），次要终点事件发生率为37．5％（9／24）。2组主要终点事件发生率比较差异无统计学意义（P〉0．05），次要终点事件发生率差异有统计学意义（P〈0．05）。优化组与对照组次要出血事件分别为1例（4．2％）和0例，轻微出血事件分别为3例（12．5％）和2例（8．3％），差异均无统计学意义（均P〉0．05）。结论根据凝血速率检测结果调整抗血小板治疗可能有利于改善高凝状态急性冠状动脉综合征PCI患者的预后，但其有效性及安全性还需要大样本临床研究证实。

Objective To explore the safety and efficacy of an optimized antiplatelet therapy according to laboratory test after coronary stenting. Methods From June 2010 to February 2011, a total of 48 patients who underwent coronary stenting were enrolled. Patients with clot rate （CR） 〉 23 clot signaL/rain were randomly assigned to receive optimal therapy （optimal group, n = 24） or standard antiplatelet therapy （control group, n = 24）. Hypercoagulable states was defined as clotrate larger than 23 clot signal/rain, The antiplatelet regimen for control group was dual antiplatelet therapy with aspirin and cloidogrel. In optimal group, patients received cilostazol for 1 month in addition to dual antiplatelet therapy. The primary endpoint of present study was the composite analysis of death, myocardial infarction （MI） or stroke. Secondary endpoint was the composite analysis of death, MI, stroke, revascularization or peripheral artery occlusion. Results After cilostazol in addition to dual antiplatelet therapy, CR in optimal group was less than that before treatment [ （25.3 ± 1.6） vs （ 13.6± 2. 3） clot signal/min, P 〈 0.01 ]. At one-year follow-up, the patients in optimal group were associated with a 12. 5% reduction in the risk of cardiovascular events compared with those in control group [ 4. 2% （ 1/24 ） vs 16.7% （4/24）, P 〉 0. 05 ]. The incidence of a composite of cardiac death, myocardial infarction, stroke, revascularization or occlusion of lower extremity artery was decreased in optimal group compared with those in control group [ 8.3 % （2/24）vs 37.5 % （9/ 24）, P 〈 0.05 ]. No significant difference was shown in incidence of stent thrombosis and hemorrhagic events between the two groups. Conclusions Adjusting antiplatelet regimen according to CR assay results might be effective in improving long-term outcomes for patients undergoing coronary stenting especially for those diagnosed as CR 〉23 clot signaL/min. However, the effectiveness and safety need further be confirmed by large-scale clinical trials.