目的对比研究两种国产雷帕霉素药物洗脱支架在心血管疾病临床应用中的近中期结果。方法58例符合药物洗脱支架(DES)置入术治疗入选条件的冠心病(或合并外周血管病变)患者被随机分为Firebird组30例与Partner组28例。两组的临床一般资料基本匹配,分别接受Firebird与Partner雷帕霉素DES置入术治疗,统计对比分析两组的术中应用及住院期与出院后随访期结果。结果Firebird与Partner组分别置入DES36枚与33枚,成功率相应为100%与97%(P>0.05)。Partner组有1枚DES未能通过C型成角病变,2例24atp加压后扩张时支架球囊未破裂;Firebird组2例18atp加压后扩张时支架球囊破裂,2例术后即刻DES内残余(<20%)狭窄(P>0.05)。两组随访时间不等,Firebird组明显长于Partner组[(9.4±5.5)个月和(3.9±2.1)个月,P<0.05]。随访期内,Firebird组2例再发非致命性ST段抬高的心肌梗死,1例术后再狭窄,均经再次PCI靶血管重建;Partner组猝死1例。Partner与Firebird组总的主要不良心脏事件(MACE)分别为3.6%与10.0%,但随访期内两组间的上述临床结果差异均无统计学意义(P>0.05)。结论两种国产DES对冠心病或伴下肢缺血性疾病均具有同样优良的近中期临床效果,安全可靠。 Objective To compare the near-term results of two domestic rapamycin-eluting stents in the clinical application of cardiovascular diseases. Methods Fifty-eight patients with coronary heart disease (or complicated with peripheral vascular disease) eligible for DES underwent placement in a randomized trial of 30 patients in the Firebird group and 28 in the Partner group. The general clinical data of the two groups were basically matched and received Firebird and Partner Rapamycin DES respectively. The data were compared between the two groups in terms of intraoperative application and the results of hospitalization and post-discharge follow-up. Results The Firebird and Partner groups included DES36 and 33 respectively, with success rates of 100% and 97%, respectively (P> 0.05). In the Partner group, 1 DES failed to pass through C-type angioplasty and 2 cases did not rupture after stent expansion under 24atp pressure. In 2 cases of Firebird group, stent stenting ballooned after 18atp pressurization and dilatation, Residual (<20%) stenosis (P> 0.05). Firebird was significantly longer than the Partner [(9.4 ± 5.5) months and (3.9 ± 2.1) months, P <0.05]. During the follow-up period, two patients in Firebird group had recurrent non-fatal ST-segment elevation myocardial infarction and one patient had restenosis. The total major adverse cardiac events (MACE) between the Partner and Firebird groups were 3.6% and 10.0%, respectively. However, there was no significant difference between the two groups in the follow-up period (P> 0.05). Conclusion Both domestic DES have the same excellent mid-to-near clinical effect on coronary heart disease or lower extremity ischemic disease, which is safe and reliable.