BiOSS 支架在冠状动脉分叉病变治疗中的 6 年结果。

6-year results of BiOSS stents in coronary bifurcation treatment.

机构信息

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Warsaw, Poland.

Department of Cardiology and Internal Medicine, Medical Faculty, University of Warmia and Mazury, Olsztyn, Poland.

出版信息

Eur J Clin Invest. 2021 Aug;51(8):e13555. doi: 10.1111/eci.13555. Epub 2021 Mar 29.

DOI:10.1111/eci.13555

PMID:33782985

Abstract

BACKGROUND

The wide variation in bifurcation anatomy has generated an ongoing search for stents explicitly designed for coronary bifurcations, and to date, results have been underachieved.

METHODS

The POLBOS I and POLBOS II were international, multicentre, randomized, open-label, controlled trials. Patients were randomly assigned to BiOSS Expert (in POLBOS I, biodegradable polymer eluting paclitaxel)/BiOSS LIM (in POLBOS II, biodegradable polymer eluting sirolimus) stent implantation or regular drug-eluting stent (rDES) deployment. A provisional T-stenting strategy was the default treatment option. The primary endpoint of this pooled data study was the cumulative rate of major adverse cardiovascular events (MACE) consisting of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Telephone follow-up was performed annually up to 72 months. (ClinicalTrials.gov Identifier: POLBOS I-NCT02192840, POLBOS II-NCT02198300).

RESULTS

The total study population consisted of 445 patients, 222 patients in the BiOSS group and 223 patients in the rDES group. The follow-up rate was 93.7% in the BiOSS group and 91.9% in the rDES group. At 72 months, there was no significant difference between BiOSS and rDES groups regarding MACE (25.7% vs 25.1%, HR 1.06, 95% CI 0.73-1.52), cardiac death (3.1% vs 4.0%, HR 0.94, 95% CI 0.43-2.34), MI (3.6% vs 4.9%, HR 0.76, 95% CI 0.32-2.89), TLR (18.9% vs 16.1%, HR 1.17, 95% CI 0.75-1.83) and stent thrombosis rates (0.9% vs 0.5%, HR 1.21, 95CI 0.75-2.09).

CONCLUSIONS

At the 6-year follow-up, clinically significant clinical events did not differ between BiOSS stents and rDES.

摘要

背景

分叉解剖结构的广泛变化导致了对专门为冠状动脉分叉设计的支架的持续探索，但迄今为止，结果仍不尽如人意。

方法

POLBOS I 和 POLBOS II 是国际、多中心、随机、开放标签、对照试验。患者被随机分配到 BiOSS Expert（在 POLBOS I 中，可生物降解聚合物洗脱紫杉醇）/BiOSS LIM（在 POLBOS II 中，可生物降解聚合物洗脱西罗莫司）支架植入或常规药物洗脱支架（rDES）部署。临时 T 支架策略是默认的治疗选择。这项汇总数据研究的主要终点是主要不良心血管事件（MACE）的累积发生率，包括心脏死亡、心肌梗死（MI）和靶病变血运重建（TLR）。电话随访每年进行一次，最长随访 72 个月。（临床试验.gov 标识符：POLBOS I-NCT02192840，POLBOS II-NCT02198300）。

结果

总研究人群包括 445 名患者，BiOSS 组 222 名，rDES 组 223 名。BiOSS 组的随访率为 93.7%，rDES 组为 91.9%。72 个月时，BiOSS 组和 rDES 组之间的 MACE（25.7%比 25.1%，HR 1.06，95%CI 0.73-1.52）、心脏死亡（3.1%比 4.0%，HR 0.94，95%CI 0.43-2.34）、MI（3.6%比 4.9%，HR 0.76，95%CI 0.32-2.89）、TLR（18.9%比 16.1%，HR 1.17，95%CI 0.75-1.83）和支架血栓形成率（0.9%比 0.5%，HR 1.21，95%CI 0.75-2.09）无显著差异。