Key result
The Janus tacrolimus-eluting stent significantly reduced major adverse cardiac events compared to the Tecnic Carbostent bare metal stent (6% vs 15%, P=0.038) at an average 246-day follow-up.
Why the study?
Does the Janus tacrolimus-eluting stent reduce MACE compared to a bare metal stent in patients with coronary artery disease undergoing PCI?
RCT (n=200)
randomly assigned
No
Does the Janus tacrolimus-eluting stent reduce MACE compared to a bare metal stent in patients with coronary artery disease undergoing PCI?
Absolute Event Rate: 6% vs 15%
p-value: p=0.038
The Janus tacrolimus-eluting stent significantly reduced MACE compared to a bare metal stent at 8 months follow-up, with 4-month clopidogrel therapy appearing safe.
Supports Janus tacrolimus-eluting stent use over bare metal stents in PCI; extends randomized evidence for this platform in coronary disease.
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.
No takes yet. Share an insight, caveat, or question.
Han et al. (2007) conducted an RCT in coronary artery disease (n=200). Janus tacrolimus-eluting stent vs. Tecnic Carbostent (bare metal stent) was evaluated on major adverse cardiac events (MACE) (p=0.038). The Janus tacrolimus-eluting stent significantly reduced major adverse cardiac events compared to the Tecnic Carbostent bare metal stent (6% vs 15%, P=0.038) at an average 246-day follow-up.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: