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Am Heart J. 2001 Sep;142(3):445-51.

Does stent design affect probability of restenosis? A randomized trial comparing Multilink stents with GFX stents.

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1
Division of Cardiology, Tohsei National Hospital, Shizuoka, Japan. ytommy@sage.ocn.ne.jp

Abstract

BACKGROUND:

Experimental studies have revealed that stent configuration influences intimal hyperplasia. The purpose of this study was to evaluate clinical outcomes for 2 stent designs in a randomized trial with quantitative coronary angiography (QCA) and intravascular ultrasonography (IVUS).

METHODS:

We randomly assigned 100 patients with 107 lesions and symptomatic coronary artery disease to deployment of a Multilink stent (Advanced Cardiovascular Systems, Guidant, Santa Clara, Calif) or a GFX stent (Applied Vascular Engineering, Santa Rosa, Calif) with IVUS guidance. QCA and IVUS studies were performed before and after intervention and at follow-up (4.2 +/- 1.0 months).

RESULTS:

There were no significant differences in baseline characteristics and QCA and IVUS parameters before and after intervention between the 2 groups. However, minimal lumen diameter at follow-up was significantly larger in the Multilink group (2.46 +/- 0.59 vs 2.08 +/- 0.79 mm, P <.05). Maximal in-stent intimal hyperplasia was significantly larger in the GFX group (2.9 +/- 1.7 vs 1.8 +/- 1.2 mm(2), P <.01). The restenosis rate differed between the 2 groups (Multilink 4% vs GFX 26%, P =.003). In multiple stepwise logistic regression analysis, the only predictor that significantly correlated with restenosis was stent type (P <.01). The odds ratio for the GFX stent-treated vessels was 18.65 (95% confidence interval 2.10-165.45).

CONCLUSIONS:

With deployment of the GFX stent, a thicker neointima develops within the stent. Stent configuration may affect clinical outcomes.

PMID:
11526357
DOI:
10.1067/mhj.2001.117321
[Indexed for MEDLINE]
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