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 aGFX 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.
RCT Entities:
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.
Authors: Luciano Maurício de Abreu Filho; Antonio Artur da Cruz Forte; Marcos Kiyoshi Sumita; Desidério Favarato; George Cesar Ximenes Meireles Journal: Clinics (Sao Paulo) Date: 2011 Impact factor: 2.365
Authors: John F LaDisa; Lars E Olson; Douglas A Hettrick; David C Warltier; Judy R Kersten; Paul S Pagel Journal: Biomed Eng Online Date: 2005-10-26 Impact factor: 2.819