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JUPITER II - JUPITER II
Description:
The goal of the trial was to evaluate the safety and efficacy of direct stenting with the Janus tacrolimus drug-eluting Carbostent among patients with ischemic cardiovascular disease and native coronary artery lesions.
Study Design
Patients Enrolled: 332
Mean Follow Up: Six months reported to date; 24 months total
Mean Patient Age: Mean age 64 years
Female: 25
Patient Populations:
Presence of ≤2 de novo coronary lesions in maximum of two native coronary arteries, target vessel of 2.7-4.0 mm, and anatomy suitable for direct stenting
Primary Endpoints:
In-stent and peri-stent late lumen loss at six months
Secondary Endpoints:
Angiographic binary in-stent restenosis at six months
MACE at 1, 6, 12, and 24 months
Clinically driven target lesion revascularization at 6, 12, and 24 months
Drug/Procedures Used:
Patients were randomized at multiple European centers in a double-blind manner to the tacrolimus-eluting Carbostent (n=166) or Carbostent without drug (n=166). The Janus Carbostent contains reservoirs on the outer surface, allowing for targeted release of the tacrolimus towards the vessel wall segment that needs to be treated, without release into the blood stream. Percutaneous coronary intervention (PCI) was to be performed via direct stenting. Patients underwent repeat angiography at six-month follow-up.
Concomitant Medications:
All patients were to receive clopidogrel (300 mg loading dose and 75 mg per day for at least two months) and aspirin (>100 mg loading dose and ≥75 mg indefinitely).
Principal Findings:
There were 189 lesions in the 166 patients randomized to the bare stent group and 191 lesions in the 166 patients randomized to the tacrolimus-eluting stent group. Approximately two-thirds of patients had stable angina, and 19% were diabetics. Single-vessel disease was present in 61% of patients. The number of stents used was 1.18 in the bare metal group and 1.23 in the tacrolimus-eluting stent group. Direct stenting was attempted in 86% of the bare metal group and 76% of the tacrolimus-eluting stent group (p=0.028). Procedural success was 99.4% in each group.
Preprocedure minimum lumen diameter was 1.03 mm in the bare metal group and 1.02 in the tacrolimus-eluting stent group, while lesion length was 11.8 mm and 12.3 mm, respectively. The primary endpoint of in-segment late lumen loss at six months did not differ by treatment group (0.44 mm in the bare metal group vs. 0.40 mm in the tacrolimus-eluting stent group, p=NS), nor did in-stent late loss (0.63 mm each). Diameter stenosis was slightly but nonsignificantly lower in the tacrolimus-eluting stent group (33.0% vs. 36.4%, p=0.053), but there was no difference in binary restenosis (9.4% vs. 15.8%, p=NS).
Major adverse cardiac events (MACE) at six months occurred in 10.6% of the bare metal group and 7.6% of the tacrolimus-eluting stent group (p=0.36), the majority of which were target vessel revascularization (10.6% vs. 6.4%, p=0.17). There was one death and one myocardial infarction in the tacrolimus-eluting stent group. There was one case of acute thrombosis in the bare metal stent group, and no late thrombosis in either group through six months.
Interpretation:
Among patients with ischemic cardiovascular disease and native coronary artery lesions, treatment with the tacrolimus-eluting Carbostent was not associated with a difference in the primary endpoint of late lumen loss compared with the bare Carbostent.
The Carbostent contains reservoirs on the outer surface, allowing for targeted release of the tacrolimus towards the vessel wall segment that needs to be treated, without release into the lumen. Additionally, the drug is delivered without the use of a polymer. It is not known if the lack of efficacy difference between the bare metal and the tacrolimus eluting groups is due to the potency of the drug or the release kinetics of the drug.
References:
Morice MC, Bestehorn HP, Carrié D, et al. Direct stenting of de novo coronary stenoses with tacrolimus-eluting versus carbon-coated carbostents. The randomized JUPITER II trial. EuroIntervention. 2006 May;2(1):45-52.
Presented by Dr. Marie-Claude Morice at TCT 2005, Washington, DC.
Presented by Dr. Marie-Claude Morice at the European Society of Cardiology Hot Line Session, September 2005.
Presented by Dr. Marie-Claude Morice at the EuroPCR meeting, Paris France, May 2005.
Keywords: Myocardial Infarction, Follow-Up Studies, Angina, Stable, Coronary Restenosis, Constriction, Pathologic, Tacrolimus, Percutaneous Coronary Intervention, Stents, Metals, Thrombosis, Polymers, Coronary Vessels, Diabetes Mellitus
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