Rzeszutko Łukasz, Siudak Zbigniew, Tokarek Tomasz, Plens Krzysztof, Włodarczak Adrian, Lekston Andrzej, Ochała Andrzej, Gil Robert J, Balak Wojciech, Dudek Dariusz
2 Department of Cardiology, Institute of Cardiology, Jagiellonian University, Medical College, Krakow, Poland.
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Postepy Kardiol Interwencyjnej. 2016;12(2):108-15. doi: 10.5114/aic.2016.59360. Epub 2016 May 11.
There are limited data describing bioresorbable vascular scaffold (BVS) implantation in complex lesions. Only short-term clinical outcomes are available for patients with acute coronary syndrome (ACS).
To evaluate 12-month clinical outcome, safety and effectiveness of BVS implantation in complex lesions and in stable angina (SA) or ACS.
Five hundred ninety-one patients with SA/ACS were enrolled between October 2012 and November 2013 in 30 invasive cardiology centres in Poland. At least one BVS implantation during percutaneous coronary intervention (PCI) was the only inclusion criteria. The clinical endpoint was the occurrence of a major adverse cardiovascular event (MACE) (all-cause death, myocardial infarction (MI), clinically driven target lesion revascularisation (TLR) with urgent PCI or target vessel revascularisation (TVR) with urgent coronary artery bypass grafting (CABG)) and device-oriented composite endpoint (DOCE) (cardiac death, urgent target vessel revascularisation with PCI/CABG, target vessel MI) during 12-month follow-up.
After 12 months TLR with urgent PCI was significantly more often reported in patients with diagnosed UA (4.59%; p < 0.02) in comparison with other PCI indications. No significant differences were found in terms of composite MACE endpoint, cumulative MACE (p = 0.09), stent thrombosis (p = 0.2) or restenosis (p = 0.2). There were no significant differences in cumulative MACE and composite MACE endpoint between patients with no/mild versus moderate/severe tortuosity and no/mild versus moderate/severe calcification of the target vessel. No significant difference was found between groups of patients with or without bifurcation of the target vessel. Device-oriented composite endpoint was significantly more often reported in the ACS group (3.2% vs. 0.47%; p < 0.03), most frequently in patients with diagnosed UA (5.5%).
Bioresorbable vascular scaffold can be successfully and safely used for ACS treatment and in lesions of higher complexity.
关于生物可吸收血管支架（BVS）植入复杂病变的相关数据有限。目前仅有急性冠状动脉综合征（ACS）患者的短期临床结果。
评估BVS植入复杂病变以及稳定型心绞痛（SA）或ACS患者的12个月临床结果、安全性和有效性。
2012年10月至2013年11月期间，波兰30个介入心脏病中心纳入了591例SA/ACS患者。经皮冠状动脉介入治疗（PCI）期间至少植入一枚BVS是唯一的纳入标准。临床终点为12个月随访期间主要不良心血管事件（MACE）（全因死亡、心肌梗死（MI）、因临床需要进行的靶病变血运重建（TLR）且行紧急PCI或靶血管血运重建（TVR）且行紧急冠状动脉旁路移植术（CABG））以及器械相关复合终点（DOCE）（心源性死亡、因PCI/CABG进行的紧急靶血管血运重建、靶血管MI）的发生情况。
12个月后，与其他PCI指征相比，确诊为不稳定型心绞痛（UA）的患者因紧急PCI进行TLR的报告频率显著更高（4.59%；p<0.02）。在复合MACE终点、累积MACE（p = 0.09）、支架血栓形成（p =0.2）或再狭窄（p = 0.2）方面未发现显著差异。在靶血管无/轻度与中度/重度迂曲以及无/轻度与中度/重度钙化的患者之间，累积MACE和复合MACE终点无显著差异。在靶血管有或无分叉的患者组之间未发现显著差异。器械相关复合终点在ACS组中的报告频率显著更高（3.2%对0.47%；p<0.03），在确诊为UA的患者中最为常见（5.5%）。
生物可吸收血管支架可成功且安全地用于ACS治疗以及更高复杂性的病变。
