Published Online
on September 2, 2003

A more recent version of this article appeared on September 16, 2003

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Submitted on March 20, 2003
Revised on July 10, 2003
Accepted on July 28, 2003

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)

Gary S. Mintz MD, Adrienne Tinana BS, Myeong-Ki Hong MD, Cheol Whan Lee MD, Jae-Joong Kim MD, Neal E. Fearnot PhD, Seong-Wook Park MD, Seung-Jung Park MD, and Neil J. Weissman MD^*

From the Department of Medicine (M.-K.H., C.W.L., J.-J.K., S.-W.P., S.-J.P.), University of Ulsan College of Medicine, Seoul, Korea; Cardiovascular Research Foundation (G.S.M.), New York, NY; Washington Hospital Center (A.T., N.J.W.), Washington, DC; and MED Institute, Inc (N.E.F.), West Lafayette, Ind.

^* To whom correspondence should be addressed. E-mail: Neil.J.Weissman{at}medstar.net.

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 µg/mm²; high dose, 3.10 µg/mm²). 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 mm³ in low-dose patients and 13.1±13.3 mm³ 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 mm³; P=0.0067) and in intermediate remodeling lesions (from 97±28 to 76±31 mm³; P=0.0004), but not in negative remodeling lesions (99±27 versus 92±32 mm³; P=0.15). The follow-up IH volume was lower in negative remodeling lesions (5±7 mm³) compared with positive remodeling (20±14 mm³; P=0.0051) and intermediate remodeling lesions (20±15 mm³; 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.

Key words: stents • remodeling • ultrasonics • hyperplasia • paclitaxel

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