Effect of Technique on Outcomes Following Bioresorbable Vascular Scaffold Implantation Analysis From the ABSORB Trials
Effect of Technique on Outcomes Following Bioresorbable Vascular Scaffold Implantation Analysis From the ABSORB Trials
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DOI：
10.1016/j.jacc.2017.09.1106
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发表时间：
2017-12-12
影响因子：
24
通讯作者：
Serruys, Patrick W.
中科院分区：
文献类型：
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作者：
Stone, Gregg W.;Abizaid, Alexandre;Serruys, Patrick W.
背景：手术技术可能影响生物可吸收血管支架（BVS）植入后的临床结局。先前的研究表明，这种关系没有调整基线患者和病变特征，可能会影响术者选择的技术和结果。（心源性死亡，靶血管心肌梗死，或缺血驱动的靶病变血运重建）和支架血栓形成（ScT）BVS植入后3年内的发生率受术者技术的影响方法在2,973例患者中测定TLF和ScT率，来自5项前瞻性研究（ABSORB II、ABSORB中国、ABSORB日本、ABSORB III和ABSORB Extend）的149处经BVS治疗的冠状动脉病变。根据预先规定的最佳技术定义（预扩张、血管尺寸测量和后扩张）评估3年（0 - 1年和1 - 3年）的结局。多变量分析用于调整多达18个患者和病变特征的差异。（球囊与核心实验室衍生的参考血管直径比$1：1）、血管尺寸选择（参考血管直径$2.25 mm和# 3.75 mm）和后扩张分别在59.2%、81.6%和12.4%的患者中对所有经BVS治疗的病变进行了球囊扩张（使用非顺应性球囊，压力为18 atm，直径大于标称支架直径，但不大于> 0.5 mm）。在适当尺寸的血管中植入BVS是1年内（风险比[HR]：0.67; p = 0.01）和3年内（HR：0.72; p = 0.01）无TLF以及1年内无ScT（HR：0.36; p = 0.004）的独立预测因子。积极的预扩张是1 - 3年无ScT的独立预测因素（HR：0.44; p = 0.03），最佳后扩张是1 - 3年无TLF的独立预测因素（HR：0.55; p = 0.05）。结论在目前对主要ABSORB研究的大规模分析中，在对基线患者和病变特征进行多变量调整后，血管尺寸和操作者技术与3年随访期间的BVS相关结局密切相关。（ABSORBII随机对照试验[ABSORBII]; NCT 01425281; ABSORBIII随机对照试验[RCT] [ABSORB-III]; NCT 01751906; Absorb生物可吸收血管支架[Absorb BVS]系统在中国人群中的临床评价-ABSORB中国随机对照试验[RCT] [ABSORB中国]; NCT 01923740; ABSORB EXTEND临床研究[ABSORB EXTEND]; NCT 01023789; AVJ-301临床试验：AVJ-301 [Absorb BVS]在日本人群中的临床评价[ABSORB JAPAN]; NCT 01844284）（C）2017，美国心脏病学会基金会。
BACKGROUND Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes.OBJECTIVES This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre-and post-dilation parameters).METHODS TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and post-dilation). Multivariable analysis was used to adjust for differences in up to 18 patient and lesion characteristics.RESULTS Optimal pre-dilation (balloon to core laboratory-derived reference vessel diameter ratio $ 1: 1), vessel size selection (reference vessel diameter $ 2.25 mm and # 3.75 mm), and post-dilation (with a noncompliant balloon at $ 18 atm and larger than the nominal scaffold diameter, but not by > 0.5 mm larger) in all BVS-treated lesions were performed in 59.2%, 81.6%, and 12.4% of patients, respectively. BVS implantation in properly sized vessels was an independent predictor of freedom from TLF through 1 year (hazard ratio [HR]: 0.67; p = 0.01) and through 3 years (HR: 0.72; p = 0.01), and of freedom from ScT through 1 year (HR: 0.36; p = 0.004). Aggressive pre-dilation was an independent predictor of freedom from ScT between 1 and 3 years (HR: 0.44; p = 0.03), and optimal post-dilation was an independent predictor of freedom from TLF between 1 and 3 years (HR: 0.55; p = 0.05).CONCLUSIONS In the present large-scale analysis from the major ABSORB studies, after multivariable adjustment for baseline patient and lesion characteristics, vessel sizing and operator technique were strongly associated with BVS-related outcomes during 3-year follow-up. (ABSORBIIRandomized Controlled Trial [ABSORBII]; NCT01425281; ABSORBIII Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906; A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population-ABSORB CHINA Randomized Controlled Trial [RCT] [ABSORB CHINA]; NCT01923740; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND]; NCT01023789; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284) (C) 2017 by the American College of Cardiology Foundation.