Gil Robert J, Bil Jacek, Kern Adam, Iñigo Garcia Luis A, Formuszewicz Radosław, Dobrzycki Sławomir, Vassilev Dobrin, Segiet Agnieszka
Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
Cardiol J. 2018;25(3):308-316. doi: 10.5603/CJ.a2017.0098. Epub 2017 Aug 25.
Coronary bifurcation treatment poses a therapeutic challenge. The aim of this study was to analyze pooled data of two randomized clinical trials, POLBOS I and POLBOS II, to compare 1-year follow-up results and identify possible prognostic factors.
In POLBOS trials dedicated bifurcation BiOSS® stents were compared with regular drug eluting stents (rDES) in patients with stable coronary artery disease or non ST-segment elevation acute coronary syndrome (POLBOS I: paclitaxel eluting BiOSS® Expert vs. rDES; POLBOS II: sirolimus eluting BiOSS® LIM vs. rDES). Provisional T-stenting was the default strategy. Angiographic control was performed at 12 months. The primary endpoint was major adverse cardiovascular events (MACE) rate defined as the rate of cardiac death, myocardial infarction (MI) or target lesion revascularization (TLR).
445 patients, with 222 patients in the BiOSS group and 223 patients in the rDES group, were analyzed. In 26.7% cases procedures were performed within distal left main, and true bifurca-tions which accounted for 81.6% of treated lesions. At 12 months the whole population exhibited no statistical differences in terms of MACE, TLR, MI or cardiac death between rDES and BiOSS groups. In multivariate analysis odds for MACE decreased with female sex (OR 0.433, 95% CI 0.178-0.942, p = 0.047) and with proximal optimization technique use (OR 0.208, 95% CI 0.097-0.419, p < 0.001), whereas the odds for MACE increased with main vessel predilatation (OR 2.191, 95% CI 1.042-5.066, p = 0.049) and diabetes mellitus treated with insulin (OR 2.779, 95% CI 1.1-6.593, p = 0.024).
Pooled data showed no significant difference between MACE and TLR rates for BiOSS® group vs. rDES group.
冠状动脉分叉病变的治疗具有挑战性。本研究旨在分析两项随机临床试验POLBOS I和POLBOS II的汇总数据，以比较1年随访结果并确定可能的预后因素。
在POLBOS试验中，将专用分叉BiOSS®支架与稳定型冠状动脉疾病或非ST段抬高急性冠状动脉综合征患者的常规药物洗脱支架（rDES）进行比较（POLBOS I：紫杉醇洗脱BiOSS® Expert与rDES；POLBOS II：西罗莫司洗脱BiOSS® LIM与rDES）。临时T型支架置入是默认策略。在12个月时进行血管造影对照。主要终点是主要不良心血管事件（MACE）发生率，定义为心源性死亡、心肌梗死（MI）或靶病变血运重建（TLR）的发生率。
分析了445例患者，其中BiOSS组222例，rDES组223例。在26.7%的病例中，手术在左主干远端进行，真正的分叉病变占治疗病变的81.6%。在12个月时，rDES组和BiOSS组在MACE、TLR、MI或心源性死亡方面无统计学差异。多因素分析显示，女性发生MACE的几率降低（OR 0.433，95%CI 0.178 - 0.942，p = 0.047），使用近端优化技术发生MACE的几率降低（OR 0.208，95%CI 0.097 - 0.419，p < 0.001），而主血管预扩张（OR 2.191，95%CI 1.042 - 5.066，p = 0.049）和胰岛素治疗的糖尿病（OR 2.779，95%CI 1.1 - 6.593，p = 0.024）会使发生MACE的几率增加。
汇总数据显示，BiOSS®组与rDES组在MACE和TLR发生率方面无显著差异。
