Rzeszutko Łukasz, Tokarek Tomasz, Siudak Zbigniew, Dziewierz Artur, Żmudka Krzysztof, 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(4):321-328. doi: 10.5114/aic.2016.63632. Epub 2016 Nov 17.
There are limited data on the comparison of bioresorbable vascular scaffold (BVS) and drug-eluting stent (DES)/bare-metal stent (BMS) implantation in an unselected population of patients with coronary artery disease.
To compare the periprocedural outcomes and patient profile of BVS and DES/BMS implantation in an all-comer population from the ORPKI Polish National Registry.
A total of 141,324 consecutive patients from 151 invasive cardiology centers in Poland were included in this prospective registry between January 2014 and June 2015. Periprocedural data on patients with at least one BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA), DES or BMS (all available types) implantation in de novo lesions during index percutaneous coronary intervention for stable angina (SA) or acute coronary syndrome were collected.
Bioresorbable vascular scaffold was the most often used in patients with SA, in single-vessel disease and in younger male patients. Bioresorbable vascular scaffold implantation was significantly more often associated with periprocedural administration of ticagrelor/prasugrel (6.8% vs. 3.6%; = 0.001) and use of intravascular ultrasound and optical coherence tomography in comparison with the DES/BMS group (2.8% vs. 0.6% and 1.8% vs. 0.1%, respectively; = 0.001 for both). The incidence of periprocedural death was significantly lower in the BVS group than the DES/BMS group (0.04% vs. 0.32%; = 0.02), but this difference was no longer significant after adjustment for covariates. On the other hand, coronary artery perforation occurred significantly more often during BVS delivery (0.31% vs. 0.12%; = 0.01), and BVS implantation was identified as an independent predictor of coronary artery perforation in multivariate logistic regression analysis (OR = 6.728, 95% CI: 2.394-18.906; = 0.001).
Patients treated with BVS implantation presented an acceptable safety and efficacy profile in comparison with the DES/BMS group. However, lower risk patients were the most frequent candidates for BVS implantation.
关于在未经过挑选的冠心病患者群体中比较生物可吸收血管支架(BVS)与药物洗脱支架(DES)/裸金属支架(BMS)植入情况的数据有限。
比较来自ORPKI波兰国家登记处的所有患者群体中BVS与DES/BMS植入的围手术期结局及患者特征。
2014年1月至2015年6月期间,来自波兰151个侵入性心脏病学中心的141324例连续患者被纳入该前瞻性登记研究。收集了在首次经皮冠状动脉介入治疗稳定型心绞痛(SA)或急性冠状动脉综合征期间,在原发病变中植入至少一个BVS(Absorb,雅培血管,美国加利福尼亚州圣克拉拉)、DES或BMS(所有可用类型)的患者的围手术期数据。
生物可吸收血管支架最常用于SA患者、单支血管病变患者及年轻男性患者。与DES/BMS组相比,生物可吸收血管支架植入术更常与围手术期使用替格瑞洛/普拉格雷相关(6.8%对3.6%;P = 0.001),以及更常使用血管内超声和光学相干断层扫描(分别为2.8%对0.6%和1.8%对0.1%;两者P均 = 0.001)。BVS组围手术期死亡发生率显著低于DES/BMS组(分别为0.04%对0.32%;P = 0.02),但在对协变量进行调整后,这种差异不再显著。另一方面,在BVS输送过程中冠状动脉穿孔的发生率显著更高(0.31%对0.12%;P = 0.01),并且在多因素逻辑回归分析中,BVS植入被确定为冠状动脉穿孔的独立预测因素(比值比 = 6.728,95%置信区间:2.394 - 18.906;P = 0.001)。
与DES/BMS组相比,接受BVS植入治疗的患者呈现出可接受的安全性和有效性特征。然而,低风险患者是BVS植入最常见的候选对象。