Abstract 8974: Standard and off-Label Use of Drug-Eluting Stents and Patient-Reported Angina Three Years After Percutaneous Coronary Intervention - A Report From the NHLBI-sponsored Dynamic Registry
Background: While drug-eluting stent (DES) use expanded rapidly to include unapproved indications, the benefit of reduced restenosis as compared with bare metal stents (BMS) has been shown to be similar in both standard and off-label use. The relative impact on long-term angina relief in standard and off-label indications is unknown.
Methods: We compared three-year patient-reported angina status by stent type among 3905 patients enrolled in the National Heart, Lung and Blood Institute-sponsored Dynamic Registry (BMS only: wave 2, 1999; DES only: waves 4–5, 2004–6). Patients who received both stent types in waves 4 and 5 were excluded. Off-label use included restenotic, ostial, bifurcation, left main or graft lesions, total occlusions, vessel diameter <2.5mm or >3.75mm or lesion length >30mm.
Results: Off-label use occurred in 53% of the patients with BMS (N=1220) and 49% with DES (N=2685). In the overall cohort, fewer patients receiving DES vs. BMS reported angina after PCI (Figure A). In multivariable, hierarchical logistic regression analysis that accounted for within patient correlation, patients receiving DES had a 25% lower odds (95%CI: 0.64–0.88, p-value:0.001) of post-PCI angina when compared to those with BMS. Furthermore, this benefit with DES use was seen in both standard and off-label use (Odds ratio (95%CI): Standard use − 0.81 (0.64–1.02), p:0.08; Off-label use − 0.70 (0.55–0.88), p:0.002; Stent type*label indication interaction p-value = 0.68). The cumulative rates of repeat revascularization over three years in this cohort also favored DES (DES vs. BMS: 18% vs 20%, p:0.01, Figure B).
Conclusions: In this large registry of consecutively enrolled PCI patients, DES use as compared with bare metal stents is associated with better long-term angina status in both standard and off-label indications. These patient-centered benefits parallel the reduced need for repeat revascularization (clinical effectiveness) documented with these stents.
- © 2010 by American Heart Association, Inc.