Abstract 4156: Comparison of Sirolimus-Eluting NEVO™ Stents With Paclitaxel-eluting CoStar™ Stents and Paclitaxel-eluting Taxus Liberte™ Stents: Insights From Intravascular Ultrasound Analysis of the Res-elution I and Costar II Trials
Background: The NEVO™ Stent (NEVO) is a novel cobalt-chromium stent with laser-cut reservoirs containing bioresorbable polylactic-co-glycolic acid polymer that elutes sirolimus. The Costar™ Stent (Costar) uses a similar focal formulation strategy with reservoirs to elute paclitaxel. The NEVO formulation strategy offers both a significant decrease in total polymer mass and decrease of tissue/polymer contact area as compared with clinically approved surface coated drug-eluting stents.
Methods: The NEVO Res-elution I trial is a multicenter, randomized, controlled study comparing NEVO to the paclitaxel-eluting Taxus Liberte ™ stent (PES). The COSTAR II study is a multicenter, prospective, randomized study comparing CoStar with the Taxus Express ™ stent. Data were obtained from NEVO Res-elution I and the randomized Costar arm in the COSTAR II. Volumetric IVUS data were available at 6 –9 months in 125 lesions (35 NEVO: 38 PES: 52 Costar). Volume index (volume/length) was calculated for vessel, lumen, plaque, stent (SVI), and neointima (NIV). Percent neointimal volume (%NIV) was calculated as (NIV/SVI) X100. 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-stenting - MLA at follow up.
Results: NEVO showed significantly less neointimal proliferation, resulting in less late lumen area loss and smaller max %CSN than PES and Costar (Table⇓). Serial IVUS analysis revealed significantly greater positive vessel remodeling in PES than in NEVO and Costar (Table⇓).
Conclusion: Detailed IVUS analysis showed significantly greater neointimal suppression with NEVO than PES and Costar up to 6 –9 months and less positive remodeling with reservoir technology versus surface coated stents. The combination of different formulation strategy with different types of drug appeared to impact arterial response after drug-eluting stenting.