JUPITER II: Double blind randomised comparison of JANUS Tacrolimus-eluting stent with the Tecnic Carbostent

JUPITER II is an international multi-centre, double blind, randomized clinical trial designed to evaluate the safety and efficacy of JANUS Tacrolimus-eluting Carbostent in the treatment of coronary lesions in “direct stenting” procedures as compared to TECNIC Carbostent. A total of 332 patients were enrolled in 16 European centers and randomized to either JANUS (166 patients) or TECNIC (166 patients). Enrolment was completed on 21 December 2004 and direct stenting was performed in 86.1% of procedures for Tecnic group and in 75.9% of procedures for Janus group. The complete six-month clinical data (160 patients in Tecnic group and 157 patients in Janus group) clearly highlight strong clinical efficacy and safety.

The study reported stent related MACE of 10.6% (17 TLR out of 160 patients) for the control Tecnic group and a more favourable rate of 6.4% (9 TLR and 1 MI out of 157 patients) for Janus group (ns). The 6 month clinical efficacy of Janus stent is expressed by a 46% reduction in TLR in respect to Tecnic stent (TLR of 5.7% with Janus versus 10.6% with Tecnic). The occurrence of MACE in Jupiter II study is mainly related to TLR, the incidence of events such as death, AMI or CABG is negligible.

The Janus stent also exhibits a high level of safety, as demonstrated by 0% stent thrombosis rate (sub-acute and late) in both groups, confirming all previous clinical results with Tecnic and other Carbofilm coated stents.

Analysis of the angiographic follow-up data is almost completed and I will be delighted to present them at TCT in Washington,” commented Dr. Marie-Claude Morice. “The complete six-month clinical results of Jupiter II demonstrate the excellent clinical outcome and safety profile for the JANUS polymer-free drug-eluting stent technology, as demonstrated by the low MACE rate with Janus and a 46% reduction of TLR of versus Tecnic”.