Midterm outcomes of prospective,randomized,single-center study of the Janus tacrolimus-eluting stent for treatment of native coronary artery lesions

<正> Background Long-term efficacy and safety of tacrolimus-eluting stent(Janus)for treatment of coronary artery diseasein percutaneous coronary interventions(PCI)"real world"is uncertain.The aim of this study was to evaluate the efficacyand safety of Janus stent for treating coronary heart disease in PCI daily practice,the safety of 4-month clopidogreltherapy after Janus stent implantation and the feasibility for treating patients with acute myocardial infarction(AMI)forfirst time.Methods From February 20,2006 to August 26,2006,a total of 200 patients were enrolled and randomly assigned toreceive either Janus stent(n=100)or bare metal stent(Tecnic Carbostent,n=100).All patients were administered withclopidogrel for 4 months and aspirin for life long after stenting.Results Baseline clinical and angiographic characteristics were comparable between the two groups.AMI was presentin 37% of patients with Janus and 36% with Tecnic Carbostent.At an average of 246-day follow-up,major adversecardiac events(MACE)was 6% with the Janus stent and 15% with the Tecnic Carbostent(P=0.038).Primary eventsincluded 1 cardiac death,1 myocardial infarction(MI)due to subacute stent thrombosis and 13 target lesionrevascularizations(TLR)due to restenosis in patients with Tecnic Carbostent and 6 TLR due to restenosis in patients withJanus stent.Although all patients had discontinued clopidogrel for an average of 126 days,there was no additionalthrombotic event in the two groups.Conclusions Janus stent is efficient in reducing MACE compared with Tecnic Carbostent at an average of 8-monthfollow-up.Discontinuation of clopidogrel at 4 months after PCI is safe for patients with Janus stent,including AMI patients.Long-term efficacy of Janus stent in reducing restenosis requires further study.