Grundeken Maik J, Kraak Robin P, Baan Jan, Arkenbout E Karin, Piek Jan J, Vis M Marije, Henriques Jose P S, Koch Karel T, Tijssen Jan G P, de Winter Robbert J, Wykrzykowska Joanna J
Catheter Cardiovasc Interv. 2014 Nov 1;84(5):759-65. doi: 10.1002/ccd.25350.
To improve clinical outcomes after percutaneous coronary interventions of coronary bifurcation lesions, the Tryton Side Branch Stent™ (Tryton Medical, Durham) was developed. Registry studies evaluating the Tryton stent has shown promisingclinical results and the stent is currently compared with the provisional single stent strategy in a randomized trial. However, clinical results beyond one year are lacking, and therefore, we investigated the one- and two-year outcomes after Tryton stent placement in a single-center registry study.
All patients in our center in whom Tryton placement was attempted between October 2010 and December 2011 were included. Clinical outcomes were defined as cardiac death, any myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), stent thrombosis (ST), and target vessel failure (TVF; composite of cardiac death, MI, and TVR). Event rates were estimated using the Kaplan-Meier method. We included 91 patients. Almost half (42%) of the patients included had acute coronary syndrome (ACS) as indication for PCI (12% unstable angina, 14% NSTEMI, and 16% STEMI). Median follow-up duration was 713 days (IQR 617-840). TVF rates were 14.5% (one year) and 20.3% (two year). Two-year cardiac death, MI, TVR, TLR and ST rates were 4.4%, 10.2%, 12.7%, 9.2%, and 2.2%, respectively.
In this single-center registry, use of the Tryton stent was associated with acceptable clinical outcomes at two-year follow-up.
为改善冠状动脉分叉病变经皮冠状动脉介入治疗后的临床疗效,研发了Tryton边支支架™(Tryton Medical公司,达勒姆)。评估Tryton支架的注册研究已显示出有前景的临床结果,且该支架目前正在一项随机试验中与临时单支架策略进行比较。然而,缺乏一年以上的临床结果,因此,我们在一项单中心注册研究中调查了Tryton支架置入术后1年和2年的结局。
纳入2010年10月至2011年12月期间在本中心尝试置入Tryton支架的所有患者。临床结局定义为心源性死亡、任何心肌梗死(MI)、靶血管血运重建(TVR)、靶病变血运重建(TLR)、支架血栓形成(ST)和靶血管失败(TVF;心源性死亡、MI和TVR的复合终点)。使用Kaplan-Meier方法估计事件发生率。我们纳入了91例患者。纳入患者中近一半(42%)以急性冠状动脉综合征(ACS)作为PCI的适应证(12%为不稳定型心绞痛,14%为非ST段抬高型心肌梗死,16%为ST段抬高型心肌梗死)。中位随访时间为713天(四分位间距617 - 840天)。TVF发生率为14.5%(1年)和20.3%(2年)。2年的心源性死亡、MI、TVR、TLR和ST发生率分别为4.4%、10.2%、12.7%、9.2%和2.2%。
在这项单中心注册研究中,Tryton支架的使用在2年随访时具有可接受的临床结局。