Background The research and development of drug-eluting stents are mainly concentrates in countries of Europe and America presently, but it is encouraging that the home-made drug-eluting stents are invented and recommended constantly in recent years. For example, Firebird sirolimus drug-eluting stent has been got a widespread application in china today, and its safety and effectiveness are generally acknowledged. Firebird2 sirolimus drug-eluting Co-based alloy supporting system is the second generation DES which is researched and developmented independently by ShangHai MicroPort medical instrument Corporation. It had got the registered certificate in January 15, 2008. It is a new generation drug-eluting stent that bases on the cobalt-based alloy platform, completely new stent structures, a better biological compatibility, and two-layer SBS polymer coating sirolimus drug-eluting stent, which have higher safty and effectiveness. This study was made in the base of Clinical application registration, making a comparison with that of the imported ENDEAVOR-Sprint drug-eluting stent, and makes a further observation on its safety and effectiveness.
Objectives To make a comparison on the safty and effectiveness of home-made Firebird2 sirolimus drug-eluting Co-based alloy stent with that of the imported ENDEAVOR-Sprint drug-eluting stent.
Methods 100 Coronary artery disease cases that Accept interventional therapy were divided into Firebird group (50 cases) and Endeavor group (50 cases) Randomly, the curative effect was compared between two groups.
Results The average ages, sex ratio, hypertension, diabetes mellitus, and myocardial infarction history in two groups have no statistical differentiation. One-vessel, two-vessel and three vessel lesion, bifurcation lesions, chronic total occlusion, and left main lesions in two groups have no statistical differentiation (p>0.05). The average Vascular diameter and target Lesion length in two groups have no statistical differentiation (p>0.05). The operation success rate were 100% in both groups. No thrombosis event happened in Firebird group, one subacute thrombosis event happened in Endeavor group, which a revascularisation was needed. 28 cases in Firebird group were accepted reexaminnation of the coronary angiography (CAG) and one got restenosis, and 2 got restenosis in 19 cases which accepted reexaminnation of CAG in Endeavor group, there was no statistical differentiation between two groups (p>0.05).
Conclusions We can obtain a favourable safty and satisfying near and medium-term curative effects from the implantation of home-made Firebird2 sirolimus drug-eluting Co-based alloy stents in CHD cases, and it has no statistical differentiation when compared with that of the imported ENDEAVOR-Sprint drug-eluting stent.
- Coronary artery disease
- drug eluting stent
- comparative study