Background: Steroids have known powerful anti-inflammatory effects. This study was designed to assess the possible antiproliferative action of the Dexamet(R)dexamethasone-loaded stent.
Methods: This was a prospective, controlled registry performed in 20 Italian centers that enrolled 332 patients with acute coronary syndromes (ACS) treated according to an early-invasive approach with the implantation of 420 dexamethasone-eluting stents in 387 coronary lesions. Six of the enrolling centers participated in the angiographic substudy: elective 6-month follow-up angiography was performed in 140/151 patients (92.7%). Quantitative coronary analysis (QCA) was performed at a centralized core laboratory on 156 lesions treated with the Dexamet stent.
Results: One hundred forty patients (156 lesions) underwent elective QCA. Patients presented with either unstable angina (80%) or Non-ST-elevation myocardial infarction (20%); 70 patients (50%) had ST-T segment changes, 81 (58%) had troponin elevation and 31 (22.1%) were diabetic. One hundred twenty-five patients had a single lesion, 117 of which were treated with a single stent, while 8 received multiple stents. Mean lesion and stent lengths were 11.94 +/- 6.30 and 17.30 +/- 6.08 mm, respectively. In-segment binary restenosis (percent [%] diameter stenosis >/= 50%) was 34.3% per patient (48/140), or 33.3% per lesion (52/156); the mean late lumen loss was 0.95 +/- 0.64 mm in-stent and 1.02 +/- 0.59 mm in-segment. At multivariate analysis, baseline minimum luminal diameter (MLD) (MLD - odds ratio [OR] = 0.18; 95% confidence interval [CI] = 0.04-0.72; p = 0.01) and lesion length (OR = 1.12; 95% CI = 1.04-1.2; p < 0.01) were independent predictors of 6-months binary restenosis
Conclusions: This is the first large, multicenter analysis of the angiographic outcome obtained with Dexamet. Our results do not support any effective antiproliferative action of this device implanted in patients with ACS.