Abstract 5995: Efficacy Of The Everolimus-eluting Stent in Diabetic Patients: Comparison With The Paclitaxel-eluting Stent
Background: In the diabetic subgroup of the Spirit III trial (randomized, multicenter trial comparing Everolimus-eluting XIENCE™V stent (EES) to Paclitaxel-eluting Taxus™ stent (PES) in de novo native coronary artery lesions), PES showed a trend toward fewer major adverse cardiac event compared with EES during 1 year follow-up in patients with diabetes despite lower observed late loss with EES at 8 months.
Methods: The Stanford University IVUS Core Laboratory database was queried to evaluate the efficacy of EES in diabetics compared with PES. A total of 113 lesions treated with EES (n=58) and PES (n=55) undergoing 8 or 9 months follow up 3-D intravascular ultrasound (IVUS) were enrolled. Volume index (volume/length) was calculated for vessel (VVI), peri-plaque (PVI), neointima (NIV), and lumen (LVI). %NIV was calculated as neointimal volume / stent volume × 100. Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%). Late lumen area loss was calculated as minimum lumen area (MLA) at post-intervention (Post) minus MLA at follow-up (FUP). Late incomplete stent apposition (LISA) was defined as separation of at least 1 strut from the vessel wall with blood speckle behind the strut, where Post IVUS revealed well apposition.
Results: Average stent length was significantly longer in EES. EES showed less neointimal hyperplasia and smaller LVI loss than PES (Table⇓), whereas no statistical interactions were observed between EES and serial changes for VVI and PVI. PES showed a significant increase in PVI (Post: 7.6±3.1, FUP: 8.4±3.1; p=0.049) and a trend toward increase in VVI (Post: 14.8±5.5, FUP: 15.5±4.2; p=0.07) between Post and FUP. One case with LISA was observed in EES group.
Conclusions: EES demonstrated significant suppression of neointimal hyperplasia in diabetic patients without vessel expansion compared with PES up to 8 months follow up.