Real world safety and efficacy of the Janus tacrolimus-eluting stent: Long-term clinical outcome and angiographic findings from the tacrolimus-eluting stent (TEST) registry

Objectives: We sought to evaluate the safety and performance of the Janus Tacrolimus-Eluting stent (TES) in an unselected population of patients, without application of restrictive clinical or angiographic criteria. Background: Continued attention to the safety, efficacy, and deliverability of first-generation drug eluting stents has led to the development of new antiproliferative agents with alternative stent platforms and different drug carrier vehicles. Methods: The TEST (Tacrolimus Eluting STent) registry is a prospective, nonrandomized single-center registry in which 140 consecutive patients who underwent single- or multi-vessel percutaneous coronary intervention between February 2005 and August 2005 were enrolled. Results: The composite rate of major adverse cardiac events (MACE) at 22 months clinical follow-up was 40.9%. The rate of mortality, myocardial infarction, and target lesion revascularization (TLR) were 5.5%, 11%, and 31.5%, respectively. Angiographic follow-up at 8 months was achieved in 74% of patients; binary restenosis occurred in 39.4% of lesions. Most restenosis lesions (94.6%) had a diffuse pattern, while focal restenosis was observed in 5.4% of cases. Definite or probable stent thrombosis was observed in 2.4% of patients. Conclusions: The present prospective, nonrandomized, TEST registry indicated high-MACE and restenosis rates, and thereby rather discouraging long-term outcomes with use of the Janus TES in an unselected "real world" population of patients who underwent single- or multi-vessel percutaneous coronary intervention. © 2009 Wiley-Liss, Inc.