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 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.
Yoshitomi
Y
Y
Division of Cardiology, Tohsei National Hospital, Shizuoka, Japan. ytommy@sage.ocn.ne.jp
Kojima
S
S
Yano
M
M
Sugi
T
T
Matsumoto
Y
Y
Saotome
M
M
Tanaka
K
K
Endo
M
M
Kuramochi
M
M
D000368:Aged; D013504:Cardiovascular Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D003327:Coronary Disease / Q000473:pathology / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D016037:Single-Blind Method; D015607:Stents; D016896:Treatment Outcome