Comparison of In Vivo Acute Stent Recoil Between the Bioresorbable Everolimus-Eluting Coronary Scaffolds (Revision 1.0 and 1.1) and the Metallic Everolimus-Eluting Stent
Comparison of In Vivo Acute Stent Recoil Between the Bioresorbable Everolimus-Eluting Coronary Scaffolds (Revision 1.0 and 1.1) and the Metallic Everolimus-Eluting Stent
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DOI：
10.1002/ccd.22864
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发表时间：
2011-07-01
影响因子：
2.3
通讯作者：
Ormiston, John A.
中科院分区：
文献类型：
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作者：
Onuma, Yoshinobu;Serruys, Patrick W.;Ormiston, John A.
目的：使用生物可吸收依维莫司洗脱支架（BVS版本1.0，Abbott Vascular）的ABSORB队列A试验证明，BVS的急性回缩略高于金属支架。为了增强支架的机械强度，开发了具有改良支柱设计的新型BVS支架（版本1.1），并在ABSOR B队列B试验中进行了测试。本研究旨在评价和比较ABSOR B队列A中BVS版本1.0和ABSOR B队列B中BVS版本1.1的体内急性支架回缩与XIENCE V（R）依维莫司洗脱金属支架（EES、SPIRIT I和II）的历史回缩。方法：在ABSOR B队列B试验中，10家临床试验机构入组了101例有1处或2处新发病变的患者。在ABSORB队列A中，对27例接受BVS 1.0治疗的患者进行了分析，并与EES进行了比较。通过定量冠状动脉造影评估的急性绝对回缩定义为最高压力下最后一次充盈球囊的平均直径（X）与最后一次球囊回缩后即刻支架的平均管腔直径（Y）之间的差值。急性回缩百分比定义为（X-Y）/X，并以百分比表示。结果：在入组ABSOR B队列B试验的101例患者中，88例患者可用于急性回缩的完整分析。BVS 1.1（0.19 +/- 0.18 mm）的绝对反冲在数值上高于金属EES（vs. 0.13 +/- 0.21 mm），与BVS 1.0（0.20 +/- 0.21 mm）相似，但差异未达到统计学显著性（P = 0.40）。急性回缩百分比表现出相同的趋势（EES：4.3% +/-7.1%，BVS 1.0：6.9% +/-7.0%，BVS 1.1：6.7% +/-6.4%，P = 0.22）。在多变量回归模型中，高球囊/动脉比（>1.1）（OR 1.91 [1.34-2.71]）预测高绝对回缩（>0.27 mm），而（较大）术前MLD具有保护作用（OR 0.84 [0.72-0.99]）。支架/骨架类型不是急性回缩的预测因子。结论：BVS 1.1的平均体内急性支架回缩略高于金属EES。然而，支架/支架类型不能预测高急性回缩，而植入尺寸过小的血管或使用尺寸过大的器械可能会混淆结果。(C)2011 Wiley-Liss，Inc.
Objectives: The ABSORB cohort A trial using the bioresorbable everolimus-eluting scaffold (BVS revision 1.0, Abbott Vascular) demonstrated a slightly higher acute recoil with BVS than with metallic stents. To reinforce the mechanical strength of the scaffold, the new BVS scaffold (revision 1.1) with modified strut design was developed and tested in the ABSORB cohort B trial. This study sought to evaluate and compare the in vivo acute scaffold recoil of the BVS revision 1.0 in ABSORB cohort A and the BVS revision 1.1 in ABSORB cohort B with the historical recoil of the XIENCE V (R) everolimuseluting metal stent (EES, SPIRIT I and II). Methods: In the ABSORB cohort B trial, 101 patients with one or two de-novo lesions were enrolled at 10 sites. In ABSORB cohort A, 27 patients treated with a BVS 1.0 were analyzed and compared with EES. Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage. Results: Out of 101 patients enrolled in the ABSORB cohort B trial, 88 patients are available for complete analysis of acute recoil. Absolute recoil of BVS 1.1 (0.19 +/- 0.18 mm) was numerically higher than metallic EES (vs. 0.13 +/- 0.21 mm) and similar to BVS 1.0 (0.20 +/- 0.21 mm) but the differences did not reach statistical significance (P = 0.40). The acute percent recoil demonstrated the same trend (EES: 4.3% +/- 7.1%, BVS 1.0: 6.9% +/- 7.0%, BVS 1.1: 6.7% +/- 6.4%, P = 0.22). In the multivariate regression model, high balloon/artery ratio (>1.1) (OR 1.91 [1.34-2.71]) was the predictive for high absolute recoil (>0.27 mm) while (larger) preprocedural MLD was protective (OR 0.84 [0.72-0.99]). The stent/scaffold type was not a predictor of acute recoil. Conclusions: The average in vivo acute scaffold recoil of the BVS 1.1 is slightly higher than the metallic EES. However, the scaffold/stent type was not predictive of high acute recoil, while implantation in undersized vessels or usage of oversized devices might confound the results. (C) 2011 Wiley-Liss, Inc.