Direct stenting of de novo coronary stenoses with tacrolimus-eluting versus carbon-coated carbostents. The randomized JUPITER II trial.
OBJECTIVE
Drug-eluting stents are being increasingly used for the treatment of de novo coronary lesions. This trial compared the performance of tacrolimus-eluting stents (TES) with that of equivalent carbon-coated stents (CCS).


RESULTS
The JUPITER II trial enrolled 332 patients (mean age = 64 years, 75% men) with de novo coronary stenoses. Patients were randomly assigned to TES versus CCS and underwent repeat coronary angiography at 6 months. The primary study endpoint was in-stent and in-segment late lumen loss (LLL). The main secondary endpoints included binary restenosis, and rates of major adverse clinical events (MACE), including death, myocardial infarction, target lesion revascularisation and stent thrombosis at 1, 6, and 12 months of follow-up. The procedure was successful in 99.4% of patients in both groups. There was no procedural death, 1 cardiac death at 2 months, and 1 acute and 2 subacute CCS thromboses. Angiographic follow-ups were available in 94.4% and 95.1% of patients assigned to TES and CCS, respectively. The mean in-segment and in-stent LLL was 0.42+/-0.46 mm and 0.65+/-0.47 mm, respectively, in the TES, versus 0.48+/-0.52 mm and 0.66+/-0.53 mm, respectively, in the CCS group (ns). The 12-month cumulative MACE rate was 19.5% in the CCS versus 16.1% in the TES group (ns).


CONCLUSIONS
Both stents showed high safety, with no stent thrombosis in the TES group. No difference was observed in 6-month angiographic results and 12-month MACE rates between TES and CCS.
Morice
Marie-Claude
MC
Institut Jacques Cartier, Massy, France.
Bestehorn
Hans-Peter
HP
Carrié
Didier
D
Macaya
Carlos
C
Aengevaeren
Wim
W
Wijns
William
W
Dubois
Christophe
C
de Winter
Robert
R
Verheye
Stefan
S
Hoffmann
Stefan
S
Pachinger
Otmar
O
Di Mario
Carlo
C