三联抗血小板在老年复杂冠状动脉介入患者术后有效性和安全性对照研究

目的评价西洛他唑、氯吡格雷和阿司匹林三联抗血小板药物在老年复杂冠状动脉介入患者植入多枚药物洗脱支架（DES）术后的疗效和安全性。方法2006年3月至2009年9月人选128例冠状动脉B2／C型病变、采用多DES植入的老年（65-75岁）患者。所有入选患者术后随机分为两组：标准化治疗组（对照组，n=67）和三联抗血小板治疗组（试验组，n=61）。3个月后所有患者接受标准化治疗直至术后12个月。观察两组患者临床特征、冠状动脉病变特点以及支架植入特征，平均随访（20．4±5．1）个月主要心血管事件、支架内血栓和出血事件。结果试验组心肌梗死及再次血运重建发生率均显著低于对照组（6．56％vs11．94％，P=0．043；6．56％vs13．43％，P=0．042）。两组全因病死率差异无统计学意义（1．64％vs2．99％，P=0．615）。试验组主要终点事件绝对风险较对照组降低8．07％（P=0．043）。试验组近期、远期支架内血栓事件发生率显著低于对照组（0．00％vs2．99％，P=0．050；1．64％vs4．48％，P=0．048）：两组间出血发生率差异无统计学意义（P〉0．05）。结论三联抗血小板药物可降低复杂冠状动脉介入老年患者术后发生主要不良心血管事件、支架内血栓形成的风险，并且不增加出血事件的发生风险。

Efficacy and safety of triple antiplatelet therapy in senile patients undergoing drug-eluting stents for complex coronary lesions

Objective To evaluate the efficacy and safety of triple antiplatelet therapy （cilostazol combined with clopidogrel and aspirin） in senile patients undergoing multiple drug-eluting stents （DES） implantation of complex coronary lesions. Methods Totally 128 senile patients （65-75 years old） undergoing multiple DES implantation for complex coronary lesions were enrolled from March 2006 to September 2009. After percutaneous coronary intervention, the patients were randomly divided into control group （clopidogrel 75 mg/d and asprin 100mg/d, n=67） and triple antiplatelet therapy group （cilostazol 100mg twice a day for 3 months in addition to aspirin 100mg/d and clopidogrel 75rag/d, n=61）. From 3 months to 12 months after the operation, all patients received 75mg/d clopidogrel. The clinical data were analyzed, including the clinical characteristics, coronary lesion, paratmeter of multiple DES implantation and major cardiovascular event （MACE） of all the patients in a follow-up period of a mean （20.4 ±5.1） months. Results The ratios of fatal or non-fatal myocardial infarction （MI） and target vessel revascularization （TVR） were significantly lower in triple antiplatelet therapy group than in control group （6.56% vsl 1.94%, P=0.043; 6.56% vs 13.43%, P=0.042）. So the overall incidence of primary end point including death, MI and TVR was obviously lower in triple antiplatelet therapy group than in control group （9.84% vs 17.91%, absolute risk reduction 8.07%,P=0.043）. There was no significant difference in the incidence of all-cause death between the 2 groups（1.64% vs 2.99%, P=0.615）. The incidence of stent thrombosis during 30 days and follow-up period was obviously lower in triple antiplatelet therapy group than in control group （0.00% vs 2.99%, P=0.050; 1.64% vs 4.48%, P=0.048）. While for secondary end points such as major and minor bleeding events, no significant difference was found between the 2 groups（1.64% vs 0.00%, P=0.343; 3.28% vs 2.98%, P=-0.846）. Conclusion Triple antiplatelet therapy for 3 months after PCI procedure significantly reduces the risk of adverse events and stent thrombosis in senile patients undergoing multiple DESs for complex coronary lesions and appears to be safe.