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双抗血小板治疗与三联抗血小板治疗减少糖尿病患者新生内膜组织增殖的随机血管造影和血管内超声比较

Randomized Angiographic and Intravascular Ultrasound Comparison of Dual-Antiplatelet Therapy vs Triple-Antiplatelet Therapy to Reduce Neointimal Tissue Proliferation in Diabetic Patients.

作者信息

Zuliani Mauro Maria Fernanda, Mangione J Armando, Costa J Ribamar, Costa Ricardo, Piva E Mattos Luiz Alberto, Staico Rodolfo, Feres Fausto, Siqueira Dimytri, Sousa Amanda, Abizaid Alexandre

机构信息

Department of Interventional Cardiology, Hospital Beneficência Portuguesa, R. Maestro Cardim, 769 - Bela Vista, São Paulo, SP - Brazil 01323-001.

出版信息

J Invasive Cardiol. 2017 Mar;29(3):76-81.

PMID:28255102

Abstract

BACKGROUND

Previous studies have suggested a benefit of cilostazol in addition to standard dual-antiplatelet therapy (DAPT), reducing in-stent late luminal loss and restenosis after percutaneous coronary intervention (PCI) with bare-metal and drug-eluting stent (DES) implantation. However, there is a paucity of intravascular ultrasound (IVUS) assessment of neointimal tissue hyperplasia (NIH) after triple-antiplatelet therapy (TAPT), especially in diabetic patients treated with DES.

METHODS

This prospective, placebo-controlled trial was conducted in diabetic patients randomized (1:1) to receive either standard DAPT (aspirin and clopidogrel) vs TAPT with cilostazol for a minimum of 12 months after PCI with Endeavor zotarolimus-eluting stent (E-ZES). The primary endpoint was the 9-month comparison of percentage of NIH in both groups. Additionally, we compared in-stent late lumen loss, binary restenosis, major adverse cardiac event (MACE; cardiac death, non-fatal myocardial infarction, and restenosis) rates, and the incidence of vascular/bleeding complications.

RESULTS

In total, 133 diabetic patients were enrolled (cilostazol cohort = 65 patients) with 56.4% male and mean age of 60.8 years. Overall, the two cohorts were comparable in terms of baseline clinical and angiographic characteristics, except for the reference vessel diameter, which was smaller among patients randomized to cilostazol (2.48 ± 0.46 mm vs 2.69 ± 0.48 mm; P=.01). At 9 months, there was a non-significant trend toward less percentage of NIH obstruction in the TAPT cohort (33.2 ± 8.29% vs 35.1 ± 8.45%; P=.07). However, this finding did not impact angiographic late-lumen loss (0.60 ± 0.46 mm cilostazol group vs 0.64 ± 0.48 mm control group; P=.30) and binary restenosis (9.8% vs 6.8%; P=.99). MACE rate also did not significantly differ between the cohorts (13.8% cilostazol group vs 8.8% control group; P=.81). Of note, the addition of a third antiplatelet agent did not increase vascular and bleeding complications.

CONCLUSION

In diabetic patients treated with E-ZES, TAPT with cilostazol did not add any significant benefit in terms of NIH suppression or MACE reduction.

摘要

背景

既往研究表明，除标准双联抗血小板治疗（DAPT）外，西洛他唑有益，可减少裸金属支架和药物洗脱支架（DES）植入的经皮冠状动脉介入治疗（PCI）后的支架内晚期管腔丢失和再狭窄。然而，关于三联抗血小板治疗（TAPT）后新生内膜组织增生（NIH）的血管内超声（IVUS）评估较少，尤其是在接受DES治疗的糖尿病患者中。

方法

本前瞻性、安慰剂对照试验纳入糖尿病患者，随机（1:1）接受标准DAPT（阿司匹林和氯吡格雷）或接受西洛他唑的TAPT，在使用安进佐他莫司洗脱支架（E-ZES）进行PCI后至少12个月。主要终点是两组9个月时NIH百分比的比较。此外，我们比较了支架内晚期管腔丢失、二元再狭窄、主要不良心脏事件（MACE；心源性死亡、非致死性心肌梗死和再狭窄）发生率以及血管/出血并发症的发生率。

结果

总共纳入133例糖尿病患者（西洛他唑组 = 65例患者），男性占56.4%，平均年龄60.8岁。总体而言，两组在基线临床和血管造影特征方面具有可比性，但随机接受西洛他唑治疗的患者参考血管直径较小（2.48±0.46 mm对2.69±0.48 mm；P = 0.01）。9个月时，TAPT组NIH阻塞百分比有减少的趋势，但无统计学意义（33.2±8.29%对35.1±8.45%；P = 0.07）。然而，这一发现并未影响血管造影晚期管腔丢失（西洛他唑组0.60±0.46 mm对对照组0.64±0.48 mm；P = 0.30）和二元再狭窄（9.8%对6.8%；P = 0.99）。两组间MACE发生率也无显著差异（西洛他唑组13.8%对对照组8.8%；P = 0.81）。值得注意的是，添加第三种抗血小板药物并未增加血管和出血并发症。