Gil Robert J, Kern Adam, Bojko Krystian, Gziut-Rudkowska Aneta, Vassilev Dobrin, Bil Jacek
Department of Cardiology, State Medical Institute of the Ministry of Interior and Administration, 02-507 Warsaw, Poland.
Department of Cardiology and Internal Medicine, School of Medicine, Collegium Medicum, University of Warmia and Mazury, 10-719 Olsztyn, Poland.
Biomedicines. 2024 Apr 23;12(5):938. doi: 10.3390/biomedicines12050938.
This multicenter, randomized study aimed to compare the sirolimus-eluting BiOSS LIM C dedicated coronary bifurcation stent with second-generation -limus drug-eluting stents (rDESs) in the treatment of non-left main (non-LM) coronary bifurcation. The deployment of a single stent in the main vessel-main branch across a side branch was the default strategy in all patients. The primary endpoint was the rate of major cardiovascular events (cardiac death, myocardial infarction, and target lesion revascularization) at 48 months. We enrolled 230 patients, allocating 116 patients to the BiOSS LIM C group and 114 patients to the rDES group. Most procedures were elective (BiOSS vs. rDES: 48.3% vs. 59.6%, = 0.09) and performed in bifurcations within the left anterior descending/diagonal branch (BiOSS vs. rDES: 51.7% vs. 61.4%, = 0.15). At 48 months, there were no statistically significant differences between the BiOSS and rDES groups in terms of major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) as follows: MACEs-18.1% vs. 14.9%, HR 1.36, 95% CI 0.62-2.22, and = 0.33; cardiac death-4.3% vs. 3.5%, HR 1.23, 95% CI 0.33-4.56, and = 0.75; MI-2.6% vs. 3.5%, HR 0.73, 95% CI 0.17-3.23, and = 0.68; and TLR-11.2% vs. 7.9%, HR 1.66, 95% CI 0.75-3.71, and = 0.21. The implantation success rate of the BiOSS LIM C stent was very high, and the cumulative MACE rates were promising. The POLBOS 3 trial sets an important benchmark for treating non-LM coronary bifurcations (ClinicalTrials.gov NCT03548272).
这项多中心随机研究旨在比较西罗莫司洗脱的BiOSS LIM C专用冠状动脉分叉支架与第二代雷帕霉素药物洗脱支架（rDES）在治疗非左主干（非LM）冠状动脉分叉中的效果。在所有患者中，默认策略是在主支血管-主分支中横跨一个侧支植入单个支架。主要终点是48个月时的主要心血管事件（心源性死亡、心肌梗死和靶病变血运重建）发生率。我们纳入了230例患者，将116例患者分配至BiOSS LIM C组，114例患者分配至rDES组。大多数手术为择期手术（BiOSS组与rDES组：48.3%对59.6%，P = 0.09），且在左前降支/对角支内的分叉处进行（BiOSS组与rDES组：51.7%对61.4%，P = 0.15）。在48个月时，BiOSS组和rDES组在主要不良心血管事件（MACE）、心源性死亡、心肌梗死（MI）或靶病变血运重建（TLR）方面无统计学显著差异，具体如下：MACE发生率分别为18.1%对14.9%，风险比（HR）为1.36，95%置信区间（CI）为0.62 - 2.22，P = 0.33；心源性死亡发生率分别为4.3%对3.5%，HR为1.23，95% CI为0.33 - 4.56，P = 0.75；MI发生率分别为2.6%对3.5%，HR为0.73，95% CI为0.17 - 3.23，P = 0.68；TLR发生率分别为11.2%对7.9%，HR为1.66，95% CI为0.75 - 3.71，P = 0.21。BiOSS LIM C支架的植入成功率非常高，累积MACE发生率也很可观。POLBOS 3试验为治疗非LM冠状动脉分叉设定了一个重要基准（ClinicalTrials.gov NCT03548272）。
