The National Heart and Lung Institute, Imperial College London, London, United Kingdom.
Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
J Am Coll Cardiol. 2017 Jul 4;70(1):60-74. doi: 10.1016/j.jacc.2017.05.028.
Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion.
This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling.
In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements.
The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. -1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling.
Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281).
尽管先前的观察性研究记录了生物可吸收血管支架（BVS）植入后的晚期管腔扩大和扩张性重塑，但尚未以随机方式将其与金属支架进行比较。
本研究旨在比较 Absorb BVS 或 Xience 金属药物洗脱支架（DES）植入后的血管重塑模式，并确定重塑的独立预测因素。
在 ABSORB II 随机试验中，通过静脉内超声在术后和 3 年随访时对 383 个病变（n=359）进行了研究。根据 3 年内血管和管腔面积的变化，我们将血管重塑模式分为 9 种类型，这些类型超出了管腔和血管面积测量的可重复性。
与 DES 相比，BVS 导致平均血管面积的相对变化明显更大（6.7±12.6%比 2.9±11.5%；p=0.003）；2 个臂之间的平均管腔面积的相对变化明显不同（1.4±19.1%比-1.9±10.5%，分别；p=0.031）。多变量分析表明，使用 BVS、女性、球囊-动脉比>1.25、扩张指数≥0.8、既往经皮冠状动脉介入治疗和低密度脂蛋白胆固醇水平较高是扩张性重塑的独立预测因素。此外，在 BVS 臂中，术前存在坏死核心是扩张性重塑的独立决定因素。
与金属 DES 相比，BVS 更频繁且强烈地发生血管壁扩张性重塑，并且可以通过患者基线特征和围手术期因素来确定。必须在进一步的大型临床研究中研究观察到的管腔和血管重塑的临床效果，以优化生物可吸收支架治疗的患者和病变的临床结果。（ABSORB II 随机对照试验；NCT01425281）。
