Gil Robert J, Bil Jacek, Costa Ricardo A, Gil Katarzyna E, Vassiliev Dobrin
Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland.
Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland.
Int J Cardiovasc Imaging. 2016 Sep;32(9):1339-1347. doi: 10.1007/s10554-016-0926-9. Epub 2016 Jun 17.
The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.
本研究的目的是分析在12个月随访时，血管内超声（IVUS）评估的两种专用分叉支架BiOSS® Expert和BiOSS® LIM内膜增生模式的差异。本手稿报告了对最初纳入评估BiOSS Expert®（紫杉醇）和BiOSS LIM®（西罗莫司）支架的人体首例注册研究患者进行分析所获得的IVUS结果。在支架置入前、置入后及随访时进行定量血管造影分析。在12个月时进行IVUS检查。共分析了34例病例（BiOSS Expert®组11例患者，BiOSS LIM®组23例患者）。两组的手术特征相似，但主血管预扩张率和最终球囊对吻/近端优化技术（FKB/POT）除外，BiOSS® LIM组的主血管预扩张率和FKB/POT更高，分别为54.5%对73.9%（P＜0.05）和0%对39.1%（P＜0.05）。比较两种支架的晚期管腔丢失（LLL）时，BiOSS® Expert组主血管和主分支的LLL值显著更大，但侧支血管并非如此。血管内超声检查显示，与BiOSS Expert®组相比，BiOSS LIM®组整个支架的内膜增生负担更低（24.7±7.5%对19.4±8.6%，P＜0.05），主血管（22.8±5.6%对16.9±6.1%，P＜0.05）和主分支（36.1±6.5%对27.6±8.7%，P＜0.05）也是如此，但分叉处水平并非如此（15.1±3.8%对13.6±5.4%，P=无显著性差异）。此外，我们发现最终球囊对吻/近端优化技术（FKB/POT）与主血管中显著更小的LLL值相关（0.24±0.09mm对0.32±0.14mm，P＜0.05），在IVUS分析中，这导致主血管（13.7±3.9%对18.9±4.45%，P＜0.05）以及分叉部位（12.6±4.1%对14.1±2.4%，P＜0.05）的内膜增生负担更小。所获得的结果表明，在定量血管造影（LLL）以及IVUS（内膜增生负担）评估中，两种支架的主分支内膜增生最为明显，且BiOSS LIM®支架的内膜增生增加幅度小于BiOSS Expert®支架。此外，支架中部似乎与过度的内膜增生无关，采用更积极的FKB/POT植入方案似乎可减少这一过程。
