Janus® Tacrolimus-Eluting Carbostent. Immediate and Medium-Term Clinical Results

This observational and clinical follow-up study involved the first 50 patients who were treated with the Janus® tacrolimus-eluting carbostent (Sorin Group) at our hospital. The patients' mean age was 66 (10) years, 38% were diabetic, and 56% were admitted with acute coronary syndrome. In total, 56 lesions were treated (52% were type B2/C), of which 12% involved in-stent restenosis, 5% were chronic occlusions, 23% were long lesions (>20 mm), 25% were in small vessels (≤2.5 mm), 7% were aorto-ostial lesions, 5% were in vein grafts, and 14% involved angiographically visible thrombus. Some 63 Janus® carbostents were implanted (ie, 1.26 [0.49] stents/patient). A successful outcome was achieved for all lesions. One patient (2%) required reintervention at the target lesion because of acute thrombosis. During a follow-up period of 10 (3) months, 8 (16%) major adverse cardiac events occurred: there was 1 (2%) death due to heart failure and 7 patients (14%) required revascularization, in 5 (10%) cases because of restenosis of the Janus® carbostent.

Estudio observacional con seguimiento clínico de los primeros 50 pacientes tratados en nuestro centro con el carbo-stent de tacrolimus Janus® (Sorin Group). La edad media de los pacientes fue 66 ± 10 años. El 38% era diabético y el 56% ingresó por un síndrome coronario agudo. Se trataron 56 lesiones (el 52% de tipo B2/C), incluidos un 12% de reestenosis intra-stent, un 5% de oclusiones crónicas, un 23% de lesiones difusas (> 20 mm), un 25% de lesiones en vaso pequeño (≤ 2,5 mm), un 7% de lesiones aortoostiales, un 5% de lesiones en puentes de safena y un 14% con trombo angiográfico. Se implantaron 63 carbo-stents Janus® (1,26 ± 0,49 stents/paciente). Se obtuvo éxito inmediato en todas las lesiones. Un paciente precisó reintervención de la lesión tratada por trombosis aguda (2%). Tras un seguimiento de 10 ± 3 meses se han producido 8 eventos adversos cardiacos mayores (16%): una muerte por insuficiencia cardiaca (2%) y 7 nuevos procedimientos de revascularización (14%), de los que 5 se debieron a reestenosis de carbo-stentsJanus® (10%).