摘要
目的：多中心、前瞻性评估国产Firebird雷帕霉素洗脱支架在冠心病患者中应用的安全性及1年临床随访结果。方法：2004年6月至9月,入选上海地区6家医院接受国产雷帕霉素药物洗脱支架治疗的冠心病患者360例。记录各例基础临床、介入治疗情况及1年临床随访结果．并与RESEARCH研究结果进行比较。结果：与RESEARCH研究资料比较,本研究组中患者高胆固醇血症(24．2%对56%)、既往接受CABG(0．3%对9%)或PCI(7．2%对19%)、多支冠脉病变(27．2%对54%)、复杂病变(B2型病变：30%对49%．C型病变：36．4%对43%)及支架术后行后扩张者(13．1%对55%)较少,P均＜0．001。本研究介入治疗成功率高于RE- SEARCH研究(99．2%对97%,P=0．03)。术后1年临床随访率93．9%,严重心脏不良事件(MACE,包括死亡、非致命性心梗及靶血管再次血运重建)发生率为8．3%,与RESEARCH研究中药物支架组相似(9．7%．P=0．58),显著低于普通支架组(14．8%,P=0．001)。Firebird支架术后1年血栓事件发生率为0．9%。结论：国产Firebird雷帕霉素洗脱支架治疗冠心病安全、有效,术后1年MACE发生率与RE- SEARCH研究Cypher支架组相似。
Objective： To investigate one year clinical outcomes of unselected patients with coronary artery disease（CAD） treated by Chinese Sirolimus Eluting stem （Firebird）. Methods： From June to September 2004, a total of 360 consecutive patients with CAD who received Firebird stent implantation were included from 6 cardiac centers. Major adverse cardiac events （MACE） including cardiac death, non fatal myocardial infarction or target vessel revascularization in one year after initial procedure were compared with the results from RESEARCH. Results： Compared with RESEARCH, less patients in the current study had hypercholesterolemia, prior CABG or PCI, multi vessel disease or complex lesion characteristics. Post-dilation was performed in fewer patients in the current study than the RESEARCH study. At one year clinical follow-up, MACE occurred in 8.3% of the patients who received Firebird stent, which is similar to the Cypher group in RESEARCH study（9.7%, P= 0. 58） but significantly lower than the bare metal stent group（14. 8%, P= 0. 001）. Angiographieally identified stent thrombosis occurred in 0. 9% of the patients implanted Firebird stent during one year follow-up. Conclusions： Implantation of the Firebird stent in unselected patients with CAD is safe and one-year clinical follow-up showed non-inferiority compared to the Cypher group in RESEARCH study.
出处
《国际心血管病杂志》
2006年第5期338-341,共4页
International Journal of Cardiovascular Disease
关键词
冠心病
支架
再狭窄
Coronary artery disease
Stent
Restenosis
