国产药物洗脱支架治疗急性冠状动脉综合征轻中度钙化病变的安全性和有效性  

The Safety and Efficacy of China-made Drug Eluting Stent Implantation for the Application in Mild-to-modest Calcified Lesions of Acute Coronary Syndrome

作　　者：洪李锋[1,2] 罗松辉[1,2] 项金洲[1,2] 黄超[1,2] 胡家顺[1,2] 胡良焱[1,2] 范莹[1,2] 盛蕾[1,2] 任萌[1,2] 李建军[3] 

机构地区：[1]武汉市第五医院心内科 [2]江汉大学心血管研究所,湖北省武汉市430050 [3]国家心血管病中心中国医学科学院阜外心血管病医院,北京市100037

出　　处：《中国动脉硬化杂志》2014年第5期480-484,共5页Chinese Journal of Arteriosclerosis

基　　金：中国高校博士点基金(20111106110013);首都临床特色应用研究(Z121107001012015)

摘　　要：目的探讨国产药物洗脱支架（CM-DES）对急性冠状动脉综合征患者冠状动脉钙化病变的安全性和有效性。方法连续入选自2006年6月至2012年6月在我院诊断为急性冠状动脉综合症并行冠状动脉介入治疗的患者320例,缺血相关病变434处,按缺血相关动脉钙化与否分为钙化病变组（n=167）和非钙化病变组（n=267）。通过定量冠状动脉造影术比较两组患者介入手术即刻及术后6~12个月的疗效及并发症。结果两组患者基线情况包括临床特征、冠状动脉病变特征等无明显差别。两组患者支架内再狭窄（3.9%比4.3%,P=0.079）、节段内再狭窄（8.9%比10.7%,P=0.449）、靶病变血运重建率（5.1%比6.7%,P=0.401）、晚期管腔丢失（0.18±0.42 mm比0.19±0.43 mm,P〉0.05）及总体血栓形成发生率（1.7%比1.4%,P〉0.05）均无显著差别。结论冠状动脉钙化增加介入治疗难度,但并不增加不良事件发生率,提示CM-DES用于急性冠状动脉综合征患者钙化病变安全有效。Aim To retrospectively assess the effectiveness and safety of China-made drug eluting stent（ CMDES） implantation for the treatment of mild-to-modest calcified lesions in patients with acute coronary syndrome（ ACS）.Methods Three hundred and twenty consecutive patients of ACS with 434 ischemia related lesions were implanted with CM-DES and received 6 ~ 12 months angiographic follow-up. The patients were divided into two groups according to whether the calcification exists or not： non-calcification groups（ n = 267） and calcification group（ n = 167）. Lesions treated with CM-DES were subjected to quantitative coronary angiography（ QCA） at immediately and 6 ~ 12 months following stenting. Results Baseline clinical,demographic or angiographic characteristics were well comparable between the two groups. At follow-up,no differences were found between the two groups regarding in-stent restenosis（ ISR） and in-segment restenosis rate（ ISRR）（ ISR： 3. 9% vs. 4. 3%; P = 0. 079; ISRR： 8. 9% vs. 10. 7%,P = 0. 449）. The similar result was also observed concerning the target lesion revascularization（ 5. 1% vs. 6. 7%; P = 0. 401）. Besides,no difference about in-stent late loss（ ISLL） and overall thrombosis rate（ TR） was detected in both groups（ ISLL： 0. 18 ±0. 42 mm vs. 0. 19 ± 0. 43 mm; TR： 1. 7% vs. 1. 4%,P 0. 05 respectively）. Conclusion Our results indicated that implantation of CM-DES for patient of ACS with mild-to-modest calcified lesions was effective and conferred to similar outcomes compared with non-calcified coronary arteries without additional increase in major adverse cardiac events.

关 键 词：药物洗脱支架 急性冠状动脉综合征 再狭窄 晚期管腔丢失 血栓形成 

分 类 号：R5[医药卫生—内科学]