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

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 mm2, 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. (Am Heart J 2001;142:445-51.)