国产雷帕霉素洗脱支架在急性冠脉综合征的临床研究

Clinical Application of Domestic Rapamycin-Eluting Stent in the Emergency Intervention of Acute Coronary Syndrome(ACS)

目的对比研究国产雷帕霉素洗脱支架(Firebird)和进口雷帕霉素洗脱支架(Cypher)在急性冠脉综合征(ACS)患者临床应用疗效。方法本研究选取了我科自2007年8月—2008年7月住院治疗的ACS患者173例,均于发病后12h内行介入治疗(PCI),随机分为Firebird支架和Cypher支架两组,其中Firebird支架组93例,Cypher支架组80例。173例患者共植入Firebird支架132枚,Cypher支架124枚。结果两组患者一般资料比较差异无统计学意义(P均>0.05)。两组患者靶血管特征差异无统计学意义(P均>0.05)。两组患者平均靶血管直径和平均靶病变长度对比,Firebird支架组比Cypher支架组为:(3.11±0.54)mm比(3.0±0.58)mm,(25.42±10.61)mm比(24.72±12.21)mm,P值均>0.05,统计学无差异性。临床随访6个月,两组均有1例急性支架内血栓形成,各有1例死亡,无亚急性、慢性血栓形成、再发心肌梗死。再发心绞痛、再次血运重建和主要心血管事件(MACE)间差异无统计学意义(P值均>0.05)。结论国产和进口雷帕霉素洗脱支架治疗急性冠脉综合征近期疗效相似。

Objective To compare the clinical effect of domestic （Firebird）and foreign （Cypher）rapamycin-eluting stent on ACS patient.Methods From Aug.2007 to Jul.2008,a total of 173 patients with ACS were randomly enrolled into two groups：Firebird drug-eluting stent group （93 patients）and Cypher drug-eluting stent group （80 patients）.All patients received emergency percutaneous coronary intervention （PCI）within 12 hours from the beginning of the heart attack.132 Firebird and 124 Cypher stents were implanted into 173 patients.Results There was no significant difference （P〉0.05）between two groups whether on normal information or target vessel character.The mean diameter of target vessel and lesion length were （3.11±0.54）mm Vs （3.0±0.58）mm and （25.42±10.61）mm Vs （24.72±12.21）mm,respectively for Firebird stent group Vs Cypher stent group,there was also no significant difference （P〉0.05）between the two.At six months follow-up,one in-stent acute thrombus and one death but no subacute,chronic thrombus or recurrent myocardial infarction happened in both groups.Significant difference was not appear （P〉0.05）too,when recurrence of angina pectoris,re-revascularization and major adverse cardiac event （MACE）were compared between the two groups.Conclusion Domestic （Firebird）and foreign （Cypher）rapamycin-eluting stent owned the same short-term clinical effect on the treatment of ACS.