随机比较主血管支架置入术治疗冠状动脉分叉病变患者中最终吻球囊扩张与不进行最终吻球囊扩张的效果：北欧-波罗的海分叉研究 III。
Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III.
机构信息
Division of Cardiology, Department of Internal Medicine, University of Oulu, Finland.
出版信息
Circulation. 2011 Jan 4;123(1):79-86. doi: 10.1161/CIRCULATIONAHA.110.966879. Epub 2010 Dec 20.
BACKGROUND
It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD.
METHODS AND RESULTS
We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively.
CONCLUSIONS
MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.
背景
目前尚不清楚首选的 1 支架分叉支架治疗方法（主血管（MV）支架置入和选择性边支支架置入，使用药物洗脱支架）是否应通过球囊对吻扩张（FKBD）来完成。因此，我们比较了 MV 支架置入后行 FKBD 与不行 FKBD 的策略。
方法和结果
我们将 477 例分叉病变患者随机分为 FKBD 组（n=238）或不行 FKBD 组（n=239）。主要终点是 6 个月内的主要不良心脏事件：心源性死亡、与操作无关的罪犯病变心肌梗死、靶病变血运重建或支架血栓形成。FKBD 组和不行 FKBD 组的 6 个月主要不良心脏事件发生率分别为 2.1%和 2.5%（P=1.00）。FKBD 组的操作和透视时间较长，造影剂用量也较大。326 例患者进行了定量冠状动脉评估。8 个月时，整个分叉病变（MV 和边支）的二元（再）狭窄率分别为 FKBD 组 11.0%和不行 FKBD 组 17.3%（P=0.11），MV 为 FKBD 组 3.1%和不行 FKBD 组 2.5%（P=0.68），边支为 FKBD 组 7.9%和不行 FKBD 组 15.4%（P=0.039）。在真正的分叉病变患者中，FKBD 组和不行 FKBD 组的边支再狭窄率分别为 7.6%和 20.0%（P=0.024）。
结论
MV 支架置入后行 FKBD 与不行 FKBD 策略相关的临床结局相似。FKBD 降低了血管造影边支（再）狭窄率，尤其是在真正的分叉病变患者中。简单的不行 FKBD 操作减少了造影剂的使用，并缩短了操作和透视时间。需要长期的支架血栓形成数据。临床试验注册- URL：http://clinicaltrials.gov。独特标识符：NCT00914199。
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