Abstract 15618: What Off-label Parameter Was the Risk Factor to Target Vessel Failure after Drug-eluting Stent Implantation?
It has been known that drug-eluting stent implantation for off-label lesion subsets led to adverse cardiac events. However, what parameter correlates to worse outcomes has not been clarified. The aim of this study was to investigate the impact of drug-eluting stent implantation for off-label lesion to target vessel failure (TVF). We used the J-PMS database, a multicenter registry of sirolimus-eluting stent (SES) data for post-marketing surveillance in Japan. Five-year follow-up was achieved in 94.4% of entry patients. Off-label indication was identified in 2020 lesions from 1665 patients (85.6%) in this cohort. Off-label lesion subsets were the followings; ostial location (19.8%), left main artery (4.5%), vein graft (0.7%), in-stent restenosis (16.9%), total occlusion (12.6%), bifurcation (38.2%), small caliber reference<2.5mm (54.9%), long lesion length>30mm (13.2%) and culprit lesion of acute myocardial infarction (5.0%). TVF included cardiac death, all MI associated with target vessel, and the ratio of target vessel revascularization (TVR). MACE consisted of death, MI and TLR. Off-label lesion had revealed higher frequency of revascularization-related events, such as MACE, TLR and non-TL TVR at 5-year follow-up compared with on-label lesion subsets (24.0% vs 18.0%,P=0.03; 10.3% vs 5.1%, P=0.007; 10.1% vs 4.8%, P=0.005 ). All cause death and MI were also frequent in off-label indication, but there was no statistical significance (13.6% vs 11.8%, 3.5% vs 2.2%). The impact of each off-label parameter on TVF is shown in the figure. In conclusion, ostial lesion, small vessel with reference diameter<2.5mm, and saphenous vein graft were independent risk factors to target vessel-related clinical events following sirolimus-eluting stent implantation.
- © 2011 by American Heart Association, Inc.