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

Autor: Kyo-e Tanaka, Shunichi Kojima, Michiko Endo, Michiko Yano, Yuji Matsumoto, Masao Saotome, Toshihiko Sugi, Yuji Yoshitomi, Morio Kuramochi
Rok vydání: 2001
Předmět:
Zdroj: American Heart Journal. 142:445-451
ISSN: 0002-8703
Popis: 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).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).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).With deployment of the GFX stent, a thicker neointima develops within the stent. Stent configuration may affect clinical outcomes.
Databáze: OpenAIRE