The Carbostent is a new balloon-expandable, stainless steel, tubular stent
with innovative multicellular design and unique turbostratic carbon coating
(Carbofilm). This open nonrandomized 2-center study assesses the immediate
and long-term clinical and angiographic outcomes after Carbostent implanta
tion in patients with native coronary artery disease. The Carbostent was im
planted in 112 patients with 132 de novo lesions. Most patients (55%) had u
nstable angina, and 38% of lesions were type B2-C. The mean lesion length w
as 12.5 +/- 7.0 mm, and 29% of lesions were >15 mm in length, No stent depl
oyment failure occurred, as well as acute or subacute stent thrombosis, The
6-month event-free survival was 84 +/- 4%. One patient with a stented righ
t coronary artery and no restenosis at the angiographic follow-up died afte
r 6 months of fatal infarction due to abrupt closure of a nontarget vessel.
In-hospital non-Q-wave myocardial infarction occurred in 1 patient, and 11
patients had repeat target lesion revascularization (target lesion revascu
larization rate 10%). The 6-month angiographic follow-up was obtained in 10
8 patients (96%) (127 lesions). Angiographic restenosis rate was 11%. The l
oss index was 0.29 +/- 0.28. The results of this study indicate a potential
benefit of Carbostent for the prevention of stent thrombosis and restenosi
s in these relatively high-risk patients. A larger trial is being planned t
o confirm these promising results. (C)2000 by Excerpta Medica, Inc.