Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.
The aim of this study was to investigate the incidence and clinical sequelae of small side branch occlusion (SBO) after Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold (BVS) implantation.
The thicker strut of metallic stents potentially contributes to a higher incidence of SBO.
We performed a post-hoc angiographic assessment of 1,209 side branches in 435 patients enrolled in the ABSORB-EXTEND single-arm trial (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions), in comparison with 682 side branches in 237 patients treated with the everolimus-eluting metallic stent (EES) in the SPIRIT (A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) first and II trials. Any visible side branches originating within the device implantation site or the 5-mm proximal and distal margins were included in the angiographic assessment. The SBO was defined as a reduction in Thrombolysis In Myocardial Infarction flow grade 0 or 1.
Post-procedural SBO was observed in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital myocardial infarction (6.5% in SBO group vs. 0.5% in non-SBO group, p < 0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (odds ratio: 2.09; 95% confidence interval: 1.18 to 3.68). By stratified analysis, BVS demonstrated a higher incidence of post-procedural SBO compared with EES only in small side branches with a reference vessel diameter ≤0.5 mm (10.5% vs. 3.9%, p = 0.03 between the groups, p for interaction = 0.08).
Bioresorbable vascular scaffold was associated with a higher incidence of post-procedural SBO compared with EES. This effect was more pronounced with small side branches with a reference vessel diameter ≤0.5 mm. (ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold [BVS] System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions: NCT01023789).
本研究旨在探讨 Absorb（雅培血管，加利福尼亚州圣克拉拉）生物可吸收血管支架（BVS）置入后小分支闭塞（SBO）的发生率和临床后果。
金属支架的较厚支架可能导致 SBO 发生率更高。
我们对 435 名患者的 435 个侧支血管（纳入 ABSORB-EXTEND 单臂试验的患者）和 237 名患者的 682 个侧支血管（纳入 SPIRIT（评估一种研究器械的临床试验。依维莫司洗脱金属支架在治疗原发性冠状动脉病变患者中的应用）第一和第二试验的依维莫司洗脱金属支架（EES）患者）进行了血管造影后评估，与支架植入部位或 5mm 近端和远端边缘内起源的任何可见侧支血管均纳入血管造影评估。SBO 定义为血栓溶解心肌梗死血流分级 0 或 1 级的降低。
BVS 组有 73 个侧支（6.0%）发生术后 SBO，EES 组有 28 个侧支（4.1%）（p=0.09）。术后 SBO 患者与院内心肌梗死发生率增加显著相关（SBO 组 6.5%，非 SBO 组 0.5%，p<0.01）。多变量分析显示，BVS 是术后 SBO 的独立预测因素（比值比：2.09；95%置信区间：1.18 至 3.68）。分层分析显示，BVS 与 EES 相比，仅在参考血管直径≤0.5mm 的小侧支中，术后 SBO 的发生率更高（10.5%比 3.9%，两组间 p=0.03，交互作用 p=0.08）。
与 EES 相比，生物可吸收血管支架术后 SBO 的发生率更高。这种影响在参考血管直径≤0.5mm 的小侧支中更为明显。（ABSORB EXTEND 临床研究：对原发性冠状动脉病变患者的 Absorb 生物可吸收血管支架系统临床评估的延续：NCT01023789）。
