Abstract 12891: Stenting for the Lesion with Multiple Off-Label Parameters Increased Mace, but Did Not for Single Characteristics Following Des Implantation: 5-Year Follow-Up of 2050 Patients
Background: The aim of this study was to evaluate the impact of multiple off-label variables to major adverse cardiac events after drug-eluting stent (DES) implantation.
Method and Results: We used the J-PMS (multicenter registry for post marketing surveillance of sirolimus-eluting stent) database that achieved 5-year follow-up in 94.4% of patients. 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 acute myocardial infarction (5.0%). Off-label was identified in 2020 lesions (85.6% of registered lesions) from 1665 patients. The lesion subset was classified into 3 categories based on the number of off-label variable; single, double and >3, and these were compared with on-label indication as control. The incidence of death, target lesion revascularization (TLR), any revascularization of target vessel (TVR), TVF and MACE were analyzed. Any event associated with target vessel was defined as TVF, and major adverse cardiac event (MACE) included as death, MI and TLR. The results are shown in Figure. Multivariate analysis predicted >3 variables of off-label accumulation as the only risk factor of major adverse cardiac event (OR: 1.9, 95%CI: 1.28-2.76: P=0.001).
Conclusion: Single off-label lesion subset was similar to on-label indication, but lesions with multiple off-label characteristics increased MACE following DES implantation.
- © 2012 by American Heart Association, Inc.