国产雷帕霉素药物洗脱支架治疗冠心病患者的一年随访结果

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目的:本文观察火鸟支架(Firebird Stent,国产雷帕霉素药物洗脱支架)对冠心病患者治疗的一年临床随访结果,并与心扉支架(Cypher select stent)对比。方法:症状发作的冠心病患者,结合冠状动脉造影结果需行冠脉介入治疗,并分别置入火鸟支架或Cypher支架的原发冠状动脉病变,进行连续入选。冠状动脉介入治疗按常规进行,支架置入后均双联抗血小板治疗至少一年。对完全血管重建患者进行住院期间、6个月及一年临床随访。随访指标包括:死亡、心肌梗死、心绞痛复发,主要心脏不良事件(包括心源性死亡、心肌梗死、心绞痛发作、心力衰竭、再次血运重建、恶性心律失常等),以及支架血栓。与心扉支架对比,观察国产雷帕霉素洗脱支架的疗效和安全性。结果:2006年4月至2007年7月期间入选155例患者。其中完全血管重建107例,火鸟完全重建组48例,Cypher完全重建组59例。两组患者基线临床特征、所有冠状动脉造影及介入治疗过程特征均无显著性差异。住院期间、6个月、12个月临床随访结果显示,死亡率、心肌梗死、心绞痛复发,主要心脏不良事件,以及支架血栓发生率均无统计学显著差异。结论:根据住院期间、6个月及12个月临床随访结果显示,国产雷帕霉素药物洗脱支架治疗冠心病可取得与进口雷帕霉素药物洗脱支架同样的疗效和安全性,但需扩大样本数长期随访进一步研究。 OBJECTIVE: To observe the one-year clinical follow-up of Firebird Stent (domestic rapamycin-eluting stent) for treatment of patients with coronary heart disease and to compare with the Cypher select stent. Methods: Patients with coronary artery disease who developed symptoms and who underwent coronary angiography with coronary angiography were enrolled in consecutive coronary angioplasty on the flamingo or Cypher stents. Coronary interventional therapy was routinely performed with dual antiplatelet therapy for at least one year after stent placement. Patients undergoing complete revascularization were followed up for 6 months and one year of clinical follow-up. Follow-up measures included death, myocardial infarction, recurrence of angina, major adverse cardiac events (including cardiogenic death, myocardial infarction, angina pectoris, heart failure, revascularization, malignant arrhythmia, etc.) and stent thrombosis. Contrast with the heart stent, observe the efficacy and safety of domestic rapamycin-eluting stent. Results: From April 2006 to July 2007, 155 patients were enrolled. Among them, 107 cases were completely revascularized, 48 cases were completely reconstructed by Flamingo, and 59 cases were completely reconstructed by Cypher. There was no significant difference in baseline clinical characteristics, coronary angiography and the characteristics of interventional therapy between the two groups. Clinical follow-up at 6 months and 12 months during hospitalization showed no statistically significant differences in mortality, myocardial infarction, recurrence of angina, major adverse cardiac events, and stent thrombosis. Conclusion: According to the clinical follow-up results of 6 months and 12 months during hospitalization, domestic rapamycin-eluting stents have the same efficacy and safety as imported rapamycin-eluting stents in the treatment of coronary heart disease Need to expand the number of samples for long-term follow-up for further study.
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