冠状动脉分叉病变应用常规药物洗脱支架和专用分叉药物洗脱 BiOSS 支架治疗后的血管造影再狭窄：基于随机 POLBOS I 和 POLBOS II 研究的分析。
Angiographic Restenosis in Coronary Bifurcations Treatment with Regular Drug Eluting Stents and Dedicated Bifurcation Drug-Eluting BiOSS Stents: Analysis Based on Randomized POLBOS I and POLBOS II Studies.
机构信息
Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
Department of Cardiology and Cardiosurgery, University of Varmia and Masuria, Olsztyn, Poland.
出版信息
Cardiovasc Ther. 2020 Jan 21;2020:6760205. doi: 10.1155/2020/6760205. eCollection 2020.
AIM
The marked variation in bifurcation anatomy has brought about an ongoing search for stents specifically constructed for coronary bifurcations. This study aimed to analyze the angiographic restenosis prevalence and patterns and predictors of different patterns in dedicated bifurcation BiOSS® vs. current generation drug-eluting stents implanted in coronary bifurcation lesions based on data from two clinical trials POLBOS I and II.
METHODS
Dedicated bifurcation BiOSS® stents were compared with drug-eluting stents (DES) in patients with stable coronary artery disease (CAD) or nonST elevation acute coronary syndrome (NSTE-ACS) (POLBOS I: paclitaxel eluting BiOSS® Expert vs. DES; POLBOS II: sirolimus eluting BiOSS® LIM vs. DES). Provisional T-stenting was the default treatment. Morphological pattern of in-stent restenosis according to the modified Mehran classification adopted for bifurcation lesions was assessed with bifurcation dedicated quantitative coronary angiographic software (CAAS 5.11, Pie Medical Imaging BV, the Netherlands).
RESULTS
In total, 445 patients (222 patients in BiOSS group and 223 patients in DES group) were included into the analysis. In BiOSS group 24 cases of angiographic restenosis (10.8%) were recorded, and in DES group-17 cases (7.6%) at 12 months follow-up (angiographic control rate at follow-up-90.3%). In the BiOSS group most frequent medina classification in restenotic cases was 0.0.1 (25%), whereas in DES-0.0.1 and 0.1.1 (23.5% each). In multivariate regression analysis proximal optimization technique was associated with the lowest chance for restenosis (OR 0.15, 95% CI 0.06-0.33), whereas diabetes on insulin was associated with the highest risk of restenosis (OR 4.21, 95% CI 1.48-11.44).
CONCLUSIONS
The angiographic restenosis pattern and rate was similar between BiOSS stents and DES in coronary bifurcation lesions.
目的
分叉解剖结构的明显差异导致人们不断寻找专门为冠状动脉分叉设计的支架。本研究旨在根据两项临床试验（POLBOS I 和 II）的数据，分析专用分叉 BiOSS®支架与目前一代药物洗脱支架（DES）在冠状动脉分叉病变中植入后，分叉病变的血管造影再狭窄发生率和模式，以及不同模式的预测因素。
方法
在稳定性冠心病（CAD）或非 ST 段抬高型急性冠脉综合征（NSTE-ACS）患者中，比较专用分叉 BiOSS®支架与 DES（POLBOS I：紫杉醇洗脱 BiOSS® Expert 与 DES；POLBOS II：西罗莫司洗脱 BiOSS® LIM 与 DES）。临时 T 支架术是默认的治疗方法。采用专为分叉病变设计的分叉专用定量冠状动脉造影软件（CAAS 5.11，荷兰 Pie Medical Imaging BV）评估根据改良 Mehran 分类的支架内再狭窄形态学模式。
结果
共纳入 445 例患者（BiOSS 组 222 例，DES 组 223 例）进行分析。BiOSS 组有 24 例（10.8%）发生血管造影再狭窄，DES 组有 17 例（7.6%）在 12 个月随访时发生（随访时的血管造影控制率为 90.3%）。BiOSS 组再狭窄病例中最常见的 Medina 分类为 0.0.1（25%），而 DES 组则为 0.0.1 和 0.1.1（各 23.5%）。多变量回归分析显示，近端优化技术与再狭窄的可能性最低相关（OR 0.15，95%CI 0.06-0.33），而胰岛素依赖型糖尿病与再狭窄的风险最高相关（OR 4.21，95%CI 1.48-11.44）。
结论
在冠状动脉分叉病变中，BiOSS 支架与 DES 的血管造影再狭窄模式和发生率相似。
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