Abstract
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.