Angiographic results of a Tacrolimus-eluting stent in acute coronary syndrome lesions.

BACKGROUND: The Janus stent releases Tacrolimus from reservoirs located at the abluminal stent surface without any polymer. In stable coronary lesions the stent did not show relevant antiproliferative effects. Since Tacrolimus provides antiproliferative and antiinflammatory properties, we sought to investigate the efficacy of the Tacrolimus eluting Janus stent in acute coronary syndrome lesions with a more pronounced inflammatory cell reaction compared to stable coronary artery lesions.
METHODS: Patients with acute coronary syndrome (STEMI or NSTEMI) undergoing cardiac catheterization and stent implantation were enrolled in this prospective registry. Primary outcome measure was in-stent late lumen loss at 6 months. There were two pre-specified subgroups based on presence or absence of high-pressure post-dilation (HPPD) with a balloon >or= 0.25 mm larger than the delivery balloon.
RESULTS: Sixty patients were enrolled. In 34 patients HPPD was performed. Reference diameter was 2.85+/-0.57 mm. Stented length was 30.8+/-23.8 mm in HPPD and 19.7+/-7.3 mm in non-HPPD group. For the total population in-stent late loss was 0.92+/-0.80 mm and binary restenosis rate 32.6%. Late loss (1.09+/-0.74 mm Vs. 0.64+/-0.83 mm) and binary restenosis rate (37.0% Vs. 25.0%) were higher in the HPPD subgroup compared to lesions in non-HPPD. The angiographic evidence of thrombus was associated with a higher late loss. Restenotic pattern was occlusive in 40%, diffuse in 33% and focal in 27%.
CONCLUSION: The use of the Tacrolimus eluting Janus stent in acute coronary syndrome lesions was associated with a high late lumen loss, a high angiographic restenosis rate and a mainly occlusive or diffuse pattern of restenosis.