van Houwelingen K Gert, van der Heijden Liefke C, Lam Ming Kai, Kok Marlies M, Löwik Marije M, Louwerenburg J W, Linssen Gerard C M, IJzerman Maarten J, Doggen Carine J M, von Birgelen Clemens
Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Haaksbergerstraat 55, 7513 ER, Enschede, The Netherlands.
Department of Cardiology, Ziekenhuisgroep Twente, Almelo and Hengelo, The Netherlands.
Heart Vessels. 2016 Nov;31(11):1731-1739. doi: 10.1007/s00380-015-0786-6. Epub 2016 Jan 8.
The objective of this study is to assess 3-year clinical outcome of patients with true bifurcation lesions (TBLs) versus non-true bifurcation lesions (non-TBLs) following treatment with second-generation drug-eluting stents (DES). TBLs are characterized by the obstruction of both main vessel and side-branch. Limited data are available on long-term clinical outcome following TBL treatment with newer-generation DES. We performed an explorative sub-study of the randomized TWENTE trial among 287 patients who had bifurcated target lesions with side-branches ≥2.0 mm. Patients were categorized into TBL (Medina classes: 1.1.1; 1.0.1; 0.1.1) versus non-TBL to compare long-term clinical outcome. A total of 116 (40.4 %) patients had TBL, while 171 (59.6 %) had non-TBL only. Target-lesion revascularization rates were similar (3.5 vs. 3.5 %; p = 1.0), and definite-or-probable stent thrombosis rates were low (both <1.0 %). The target-vessel myocardial infarction (MI) rate was 11.3 versus 5.3 % (p = 0.06), mostly driven by (periprocedural) MI ≤48 h from PCI. All-cause mortality and cardiac death rates were 8.7 versus 3.5 % (p = 0.06) and 3.5 versus 1.2 % (p = 0.22), respectively. The 3-year major adverse cardiac event rate for patients with TBL versus non-TBL was 20.0 versus 11.7 % (p = 0.05). At 1-, 2-, and 3-year follow-up, 6.5, 13.0, and 11.0 % of patients reported chest pain at less than or equal moderate physical effort, respectively, without any between-group difference. Patients treated with second-generation DES for TBL had somewhat higher adverse event rates than patients with non-TBL, but dissimilarities did not reach statistical significance. Up to 3-year follow-up, the vast majority of patients of both groups remained free from chest pain.
本研究的目的是评估接受第二代药物洗脱支架（DES）治疗的真性分叉病变（TBL）患者与非真性分叉病变（non-TBL）患者的3年临床结局。TBL的特征是主血管和分支血管均发生阻塞。关于新一代DES治疗TBL后的长期临床结局，现有数据有限。我们在一项针对287例分支靶病变且分支血管≥2.0 mm的患者进行的随机TWENTE试验中开展了一项探索性子研究。将患者分为TBL组（Medina分型：1.1.1；1.0.1；0.1.1）和非TBL组，以比较长期临床结局。共有116例（40.4%）患者为TBL，171例（59.6%）患者仅为非TBL。靶病变血运重建率相似（3.5%对3.5%；p = 1.0），明确或可能的支架血栓形成率较低（均<1.0%）。靶血管心肌梗死（MI）率为11.3%对5.3%（p = 0.06），主要由PCI术后≤48小时内的（围手术期）MI所致。全因死亡率和心源性死亡率分别为8.7%对3.5%（p = 0.06）和3.5%对1.2%（p = 0.22）。TBL患者与非TBL患者的3年主要不良心脏事件发生率分别为20.0%和11.7%（p = 0.05）。在1年、2年和3年随访时，分别有6.5%、13.0%和11.0%的患者报告在轻度或中度体力活动时出现胸痛，组间无差异。接受第二代DES治疗的TBL患者不良事件发生率略高于非TBL患者，但差异未达到统计学意义。至3年随访时，两组绝大多数患者仍无胸痛。
