Recently, MicroPort published the latest result of its clinical studies including FIREMAN, FOCUS, and FIM of the third generation drug-eluting stent Firehawk, in the China Interventional Therapeutics 2010 (CIT).
FIREMAN is a clinical study of using domestic drug-eluting stents Firebird to treat complex coronary artery disease. It was started in 2006, and had already completed a 3-year follow-up by September 2010, which covered MACE, TLR/TVR, in-stent thrombosis and stroke, and especially the analysis of related factors causing in-stent thrombosis, as well as analysis of different subgroups of patients divided by the age, sex, diabetes or hyperlipidemia history. The follow-up result showed that cumulative cardiac death rate was 1.7%, the incidence of MI, TVR and MACE was 1.4%, 5% and 7.1% respectively, and the thrombosis rate was 1.36%
FOCUS is currently the largest international preapproval multicenter clinical-registered study
which was started in 2009, with a total of 5084 patients selected. The follow-up result obtained 6 month after the launch of Firebird2 Rapamycin-Eluting Coronary CoCr Stent in China, showed that cumulative cardiac death rate was 0.63%, the incidence of MI, TVR and MACE was respectively 1.07%, 0.3% and 1.8%, and the thrombosis rate was 0.61%.