用于有大分支的冠状动脉分叉病变的专用支架的疗效：随机TRYTON分叉病变研究的亚组分析
Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.
作者信息
Généreux Philippe, Kini Annapoorna, Lesiak Maciej, Kumsars Indulis, Fontos Géza, Slagboom Ton, Ungi Imre, Metzger D Christopher, Wykrzykowska Joanna J, Stella Pieter R, Bartorelli Antonio L, Fearon William F, Lefèvre Thierry, Feldman Robert L, Tarantini Giuseppe, Bettinger Nicolas, Minalu Ayele Girma, LaSalle Laura, Francese Dominic P, Onuma Yoshinobu, Grundeken Maik J, Garcia-Garcia Hector M, Laak Linda L, Cutlip Donald E, Kaplan Aaron V, Serruys Patrick W, Leon Martin B
机构信息
Columbia University Medical Center/NewYork Presbyterian Hospital, New York, New York.
Cardiovascular Research Foundation, New York, New York.
出版信息
Catheter Cardiovasc Interv. 2016 Jun;87(7):1231-41. doi: 10.1002/ccd.26240. Epub 2015 Sep 23.
OBJECTIVES
To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs.
BACKGROUND
The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs).
METHODS
The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA.
RESULTS
Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004).
CONCLUSIONS
Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc.
目的
比较Tryton专用侧支（SB）支架与临时支架置入术在治疗累及大侧支的复杂分叉病变中的益处。
背景
TRYTON试验旨在评估专用SB支架治疗累及大（视觉估计≥2.5 mm）侧支的真性分叉病变的效用。纳入该试验的患者侧支直径小于预期（核心实验室定量冠状动脉造影分析显示59%的侧支≤2.25 mm）。由于围手术期心肌梗死（MI）发生率增加，TRYTON试验未达到其主要终点。
方法
TRYTON试验将704例患者随机分为Tryton SB支架联合主血管药物洗脱支架（DES）组和临时SB治疗联合主血管DES组。在由核心实验室定量冠状动脉造影分析确定的基线时侧支直径≥2.25 mm的患者中，评估并比较两种治疗策略在9个月时的主要终点即靶血管失败率和次要有效终点即侧支血管造影直径狭窄百分比。
结果
在TRYTON试验纳入的704例患者中，289例患者（143例临时支架组和146例Tryton支架组；占整个队列的41%）侧支直径≥2.25 mm。Tryton组的靶血管失败主要终点在数值上低于临时支架组（11.3%对15.6%，P = 0.38），且在非劣效界值范围内。临床驱动的靶血管血运重建率（3.5%对4.3%，P = 0.77）或心源性死亡率（两组均为0%）未见差异。Tryton组侧支血管节段内直径狭窄百分比显著低于临时支架组（30.4%对40.6%，P = 0.004）。
结论
对TRYTON试验中侧支直径≥2.25 mm的队列分析支持，与临时支架置入策略相比，Tryton SB支架在治疗累及大侧支的分叉病变中具有安全性和有效性。© 2015威利期刊出版公司
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