Six-month data from the JUPITER II trial show a promising efficacy and safety profile for the JANUS tacrolimus-eluting carbostent, according to a presentation at the annual meeting of the European Society of Cardiology.

JUPITER II is an international clinical trial designed to evaluate the safety and efficacy of the JANUS tacrolimus-eluting carbostent in the treatment of coronary lesions in direct stenting procedures as compared with the corresponding bare stent, the TECNIC Carbostent.

A total of 332 patients were enrolled in 16 European centers and randomized to either JANUS (166 patients) or TECNIC (166 patients). Enrollment was completed on December 20, 2004: Direct stenting was done in 86.1 percent of procedures for the metal stent group and in 75.9 percent of procedures for the drug-eluting stent.
The complete six-month clinical data for 160 patients in the metal stent group and 157 patients in the drug-eluting stent group clearly highlight strong clinical efficacy and safety.

The major adverse cardiac event rate was 10.6 percent (target lesion revascularization, 17 of 160 patients) for the control group and 6.4 percent (revascularization, 9 of 157 and acute myocardial infarction, 1 of 157 patients) for the drug-eluting stent group.

The 6-month clinical efficacy of the drug-eluting stent is expressed by a reduction of 46 percent in target lesion revascularization rate compared with the corresponding bare stent (5.7 percent versus 10.6 percent).

Major adverse cardiac events in Jupiter II study were mainly related to target lesion revascularization, with the incidence of events such as death, acute myocardial infarction or need for bypass grafting negligible.

"These complete six-month clinical results of Jupiter II demonstrate the excellent clinical outcome and unprecedented safety profile for the JANUS polymer-free drug-eluting stent technology, as demonstrated by the low major adverse cardiac event rate with JANUS [the drug-eluting stent] and a reduction of target lesion revascularization of 46 percent versus the bare stent," commented Marie-Claude Morice, MD.

Compared with other drug-eluting stents, JANUS requires no polymer whatsoever to carry the drug, eliminating the shortcomings often associated with polymers, and utilizes a proprietary drug-release system with reservoirs on the stent's outer surface, ensuring targeted release only towards the vessel wall segment requiring treatment.