DECLARE-DIABETES

试验设计: 糖尿病患者行药物洗脱支架（DES）置入后被随机分为：西洛他唑、阿司匹林和氯吡格雷（三联药物治疗）或阿司匹林加氯吡格雷组（二联药物治疗）。研究其中期临床和血管造影结果。

结果
    ● 6个月时支架内晚期丢失：0.25 ± 0.53 mm（三联治疗组） vs. 0.38 ± 0.54 mm （双联药物治疗组）；P=0.025 

    ● 血管造影显示再狭窄：8.0% vs. 15.6%；P=0.03

    ● 靶病变重建率（TLR）在：三联药物治疗组（2.5%）低于二联药物治疗组 （7.0%），P=0.03

    结论
    ● 与二联药物治疗相比，三联药物治疗在减少再狭窄和TLR上较好，但在6~9个月时的心肌梗死、死亡率和支架血栓等方面无优势

    ● 三联药物治疗组中途停药发生率高 

    Lee SW， et al. J Am Coll Cardiol. 2008;51:1181-1187.

     原始摘要：

OBJECTIVES: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM).

BACKGROUND: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation， it is not known whether this effect occurs after DES implantation in diabetic patients.

METHODS: This randomized， multicenter， prospective study compared triple antiplatelet therapy (aspirin， clopidogrel， and cilostazol， triple group， n = 200) and dual antiplatelet therapy (aspirin and clopidogrel， standard group， n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months.

RESULTS: The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 +/- 0.53 mm vs. 0.38 +/- 0.54 mm， p = 0.025) and in-segment (0.42 +/- 0.50 mm vs. 0.53 +/- 0.49 mm， p = 0.031) late loss were significantly lower in the triple versus standard group， as were 6-month in-segment restenosis (8.0% vs. 15.6%， p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%， p = 0.034). At 9 months， major adverse cardiac events， including death， myocardial infarction， and TLR， tended to be lower in the triple than in the standard group (3.0% vs. 7.0%， p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR.

CONCLUSIONS: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss， resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.