Impact of preinterventional arterial remodeling on neointimal hyperplasia after implantation of (non-polymer-encapsulated) paclitaxel-coated stents - A serial volumetric intravascular ultrasound analysis from the ASian Paclitaxel-Eluting Stent Clinical Trial (ASPECT)

Background-This study used serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of preinterventional arterial remodeling on in-stent intimal hyperplasia (IH) after implantation of non-polymer-encapsulated paclitaxel-coated stents. Methods and Results-Patients were randomized to placebo or one of two doses of paclitaxel ( low dose, 1.28 mug/mm(2); high dose, 3.10 mug/mm(2)). Complete preinterventional, post-stent implantation, and follow-up IVUS were available in 18 low-dose and 21 high-dose patients. IH volumes were similar in low-dose and high-dose patients: 17.6+/-15.1 mm(3) in low-dose patients and 13.1+/-13.3 mm(3) in high-dose patients (P=0.3). Therefore, IVUS findings in low- and high-dose patients were combined. Preinterventional remodeling was assessed by comparing lesion site to proximal and distal reference arterial area: positive remodeling (lesion>proximal reference, n=13), intermediate remodeling ( distal reference<lesion<proximal reference, n=13), and negative remodeling (lesion<distal reference, n=13). During follow-up, there was a decrease in lumen volume in positive remodeling lesions (from 106±30 to 90±27 mm(3); P=0.0067) and in intermediate remodeling lesions (from 97±28 to 76±31 mm(3); P=0.0004), but not in negative remodeling lesions (99±27 versus 92±32 mm(3); P=.15). The follow-up IH volume was lower in negative remodeling lesions (5±7 mm(3)) compared with positive remodeling (20±14 mm(3); P=.0051) and intermediate remodeling lesions (20±15 mm(3); P=0.0043); however, IH volume was virtually identical in positive and intermediate remodeling lesions. Multivariate linear regression analysis determined that remodeling and inflation pressure were independent predictors of IH volume; variables tested in the model included diabetes, acute coronary syndromes, dose, remodeling, and preinterventional plaque burden. Conclusions-Preinterventional arterial remodeling, especially negative remodeling, influences neointimal hyperplasia suppression after implantation of non-polymer-encapsulated paclitaxel-coated stents.