韩国汉城Ulsan大学药学院的Seung-Whan Lee博士曾经说：与标准疗法相比较，试验结果表明三联抗血小板疗法在2年内减少了靶病变血运重建（TLR）。同时保持了与包括死亡和MI在内的其他诊断终点相当的发生率。

加入西洛他唑的三重疗法也提高了2年无TLR存活率(95.5% vs. 90.0%; P=0.037)。李说：“3倍抗血小板疗法治疗两年内没有支架血栓发生”2年时，三重抗血小板疗法还提高使患者无MACE生存率 (94.5% vs. 89.5%; P=.071)。

这个采用2x2因子设计的多中心研究还进行了多变量分析，显示表明西洛他唑是减少TLR (OR=0.34, 95% CI, 0.14-0.84; P=.018) 和MACE(OR=0.43, 95% CI, 0.19-0.99; P=.048)。强有力的预测因素。

在三重抗血小板疗法实验组中患者中(n=200)，2名患者死于心脏病。标准疗法试验组 (n=200)的1名患者死于非心脏性疾病。在三重抗血小板疗法试验组有2例发生心梗；标准实验组有1例发生、2例支架血栓。

“在阿司匹林中加入西洛他唑和氯吡格雷，可能对防止糖尿病人血栓并发症有辅助作用。”李得出结论。

试验入选患有糖尿病、心绞痛、贫血和原发冠状动脉病变适于支架植入的患者。治疗禁忌症患者、LVEF <30%，肾功能不全，移植血管狭窄或左主干疾病患者被排除。

剂量细节

在试验中，对照组给予双重抗血小板疗法，阿司匹林100mg/日加氯吡格雷75mg/日，至少持续服药6个月。三重疗法为在支架植入后采用双重抗血小板治疗加200 mg西洛他唑，每2天200mg西洛他唑持续服药6个月。

（《医心评论》编辑 朱婧 翻译 刘瑞琦 校对）

（来源：www.tctmd.com）

DECLARE-DIABETES: Sustained Reduction in TLR at Two Years       
 
Key Points:

Cilostazol added to aspirin and clopidogrel after DES efficacious for patients with diabetes.

By TCT Daily Staff

Cilostazol added to standard dual antiplatelet therapy after DES implantation resulted in a sustained reduction in TLR at two-year follow-up in patients with diabetes, according to results of the DECLARE-DIABETES trial.

Seung-Whan Lee, MD, of the University of Ulsan College of Medicine, Seoul, South Korea, said the results of the trial showed that compared with standard therapy, triple antiplatelet therapy lowered TLR at two years while maintaining equivalent rates of other clinical endpoints including death and MI (see Figure).

Triple therapy with cilostazol also improved two-year TLR-free survival (95.5% vs. 90.0%; P=0.037).

"No stent thrombosis occurred over two years in the triple antiplatelet therapy group," Lee said.

Triple antiplatelet therapy also showed a trend for improved survival free of MACE at two years (94.5% vs. 89.5%; P=.071).

The researchers in this multicenter, 2x2 factorial designed study also conducted a multivariate analysis that demonstrated cilostazol was a strong predictor of reducing TLR (OR=0.34, 95% CI, 0.14-0.84; P=.018) and MACE (OR=0.43, 95% CI, 0.19-0.99; P=.048).

Two patients in the triple-antiplatelet-therapy group (n=200) died of cardiac causes and one patient in the standard therapy group (n=200) died of noncardiac causes. There were two MIs in the triple-therapy group and one in the standard group; two cases of stent thrombosis were reported in the standard-therapy group.

"The addition of cilostazol to aspirin plus clopidogrel might [have] an adjunctive role to prevent thrombotic complications in diabetic patients," Lee concluded.

Patients with diabetes, angina, and documented ischemia as well as de novo coronary lesions suitable for stent implantation were included in the trial. Patients with contraindications to therapy, LVEF <30%, renal dysfunction, graft vessel stenosis, or left main disease were excluded.

Dose details

In the trial, controls were given dual antiplatelet therapy consisting of aspirin 100 mg daily and clopidogrel 75 mg daily for at least six months. The triple therapy regimen consisted of dual antiplatelet therapy plus a loading dose of 200 mg of cilostazol immediately after stent implantation and a maintenance dose of cilostazol 100 mg twice daily for six months.

Disclosures:

Dr. Lee reports no relevant conflicts of interest.
 

（source：www.tctmd.com）