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替格瑞洛与阿司匹林对冠状动脉旁路移植术(CABG)后移植血管通畅的影响:TARGET(替格瑞洛抗血小板治疗以减少移植血管事件和血栓形成)随机对照试验(NCT02053909)的原理与设计。

Impact of ticagrelor versus aspirin on graft patency after CABG: Rationale and design of the TARGET (ticagrelor antiplatelet therapy to reduce graft events and thrombosis) randomized controlled trial (NCT02053909).

作者信息

Kulik Alexander, Abreu Amy M, Boronat Viviana, Kouchoukos Nicholas T, Ruel Marc

机构信息

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, United States.

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, United States.

出版信息

Contemp Clin Trials. 2018 May;68:45-51. doi: 10.1016/j.cct.2018.03.008. Epub 2018 Mar 15.

Abstract

RATIONALE

Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). Up to 20% of vein grafts will occlude within the first year after CABG despite standard aspirin antiplatelet therapy. However, more potent postoperative platelet inhibition with ticagrelor may improve graft patency. The goal of this study will be to evaluate the efficacy of ticagrelor, as compared to aspirin, for the prevention of saphenous vein graft occlusion following CABG.

STUDY DESIGN

The Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET) study is a multi-center double-blind randomized controlled trial enrolling patients who have undergone multi-vessel CABG with at least one saphenous vein graft. Patients are being randomized to receive either aspirin 81 mg twice per day or ticagrelor 90 mg twice per day for 2 years starting within 7 days after surgery. The projected enrollment is 150 patients in each arm (300 total patients). Patients will undergo computed tomography (CT) coronary angiography at 1 and 2 years after surgery to assess the incidence of vein graft occlusion and stenosis.

CONCLUSION

To our knowledge, this trial is the first prospective study to evaluate the impact of early postoperative ticagrelor on 1- and 2-year graft patency after CABG. Furthermore, it is also the first trial to use a novel antiplatelet agent as a standalone, without aspirin, after CABG. Should ticagrelor reduce the incidence of postoperative graft occlusion, the results of this study will redefine modern antiplatelet management following coronary bypass surgery (ClinicalTrials.govNCT02053909).

摘要

理论依据

大隐静脉移植血管病变仍然是冠状动脉旁路移植术(CABG)的一个主要限制因素。尽管采用标准的阿司匹林抗血小板治疗,但高达20%的静脉移植物会在CABG术后第一年内发生闭塞。然而,替格瑞洛更强效的术后血小板抑制作用可能会改善移植物通畅率。本研究的目的是评估替格瑞洛与阿司匹林相比,在预防CABG术后大隐静脉移植物闭塞方面的疗效。

研究设计

替格瑞洛抗血小板治疗以减少移植物事件和血栓形成(TARGET)研究是一项多中心双盲随机对照试验,纳入接受了多支血管CABG且至少有一支大隐静脉移植物的患者。患者被随机分为两组,从术后7天内开始,一组每天两次服用81毫克阿司匹林,另一组每天两次服用90毫克替格瑞洛,持续2年。预计每组招募150名患者(共300名患者)。患者将在术后1年和2年接受计算机断层扫描(CT)冠状动脉造影,以评估静脉移植物闭塞和狭窄的发生率。

结论

据我们所知,本试验是第一项评估术后早期使用替格瑞洛对CABG术后1年和2年移植物通畅率影响的前瞻性研究。此外,它也是第一项在CABG术后使用新型抗血小板药物作为单一用药(不联用阿司匹林)的试验。如果替格瑞洛能降低术后移植物闭塞的发生率,本研究结果将重新定义冠状动脉搭桥术后的现代抗血小板治疗管理(ClinicalTrials.govNCT02053909)。

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