Midterm outcomes of prospective, randomized, single-center study of the Janus tacrolimus-eluting stent for treatment of native coronary artery lesions.
BACKGROUND
Long-term efficacy and safety of tacrolimus-eluting stent (Janus) for treatment of coronary artery disease in percutaneous coronary interventions (PCI) "real world" is uncertain. The aim of this study was to evaluate the efficacy and safety of Janus stent for treating coronary heart disease in PCI daily practice, the safety of 4-month clopidogrel therapy after Janus stent implantation and the feasibility for treating patients with acute myocardial infarction (AMI) for first time.


METHODS
From February 20, 2006 to August 26, 2006, a total of 200 patients were enrolled and randomly assigned to receive either Janus stent (n = 100) or bare metal stent (Tecnic Carbostent, n = 100). All patients were administered with clopidogrel for 4 months and aspirin for life long after stenting.


RESULTS
Baseline clinical and angiographic characteristics were comparable between the two groups. AMI was present in 37% of patients with Janus and 36% with Tecnic Carbostent. At an average of 246-day follow-up, major adverse cardiac events (MACE) was 6% with the Janus stent and 15% with the Tecnic Carbostent (P = 0.038). Primary events included 1 cardiac death, 1 myocardial infarction (MI) due to subacute stent thrombosis and 13 target lesion revascularizations (TLR) due to restenosis in patients with Tecnic Carbostent and 6 TLR due to restenosis in patients with Janus stent. Although all patients had discontinued clopidogrel for an average of 126 days, there was no additional thrombotic event in the two groups.


CONCLUSIONS
Janus stent is efficient in reducing MACE compared with Tecnic Carbostent at an average of 8-month follow-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.
Han
Ya-ling
YL
Department of Cardiology, Shenyang General Hospital of PLA, Shenyang 110016, China. hanyal@mail.sy.ln.cn
Wang
Shou-li
SL
Jing
Quan-min
QM
Yu
Hai-bo
HB
Wang
Bin
B
Ma
Ying-yan
YY
Luan
Bo
B
Wang
Geng
G
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage*
D016559:Tacrolimus