在冠状动脉疾病患者中评估依维莫司洗脱 Absorb 生物可吸收支架与依维莫司洗脱金属支架的随机试验：ABSORB 日本。
A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan.
机构信息
Department of Cardiovascular Medicine, Kyoto University Hospital, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
Teikyo University Hospital, Tokyo, Japan.
出版信息
Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.
AIMS
Theoretically, bioresorbable vascular scaffolds (BVSs) may provide superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown.
METHODS AND RESULTS
ABSORB Japan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. cobalt-chromium everolimus-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure [TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR)] at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001]. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001).
CONCLUSION
In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs.
CLINICAL REGISTRATION
ClinicalTrials.gov, number NCT01844284.
目的
从理论上讲，生物可吸收血管支架（BVS）可能比永久性金属药物洗脱支架（DES）提供更优异的长期结果。然而，在完全吸收之前，BVS 是否与金属 DES 一样安全有效尚不清楚。
方法和结果
ABSORB Japan 是一项单盲、多中心、主动对照、随机试验，旨在支持 Absorb BVS 在日本获得监管批准。在日本的 38 个地点，将符合条件的患有一个或两个不同心外膜血管内新病变的患者以 2:1 的比例随机分为 Absorb BVS 组和钴铬依维莫司洗脱支架（CoCr-EES）组。主要终点为 12 个月时的靶病变失败（TLF：由靶血管相关的心脏死亡、心肌梗死和缺血驱动的靶病变血运重建（ID-TLR）组成），以非劣效性为基础。主要次要终点为 13 个月时的血管造影节段晚期管腔丢失（LLL）。共 400 名患者被随机分配至 BVS 组（266 名患者，275 个病变）或 CoCr-EES 组（134 名患者，137 个病变）。12 个月时的 TLF 为 BVS 组 4.2%，CoCr-EES 组 3.8%[差异（单侧上 95%置信限）=0.39%（3.95%）；P<0.0001，非劣效性<0.0001]。两组患者的 12 个月时的明确/可能的支架/支架血栓形成发生率均为 1.5%（P=1.0），再狭窄导致的 ID-TLR 也不常见（BVS 组为 1.1%，CoCr-EES 组为 1.5%，P=1.0）。血管造影随访率为 96.0%，13 个月时的节段内 LLL 为 BVS 组 0.13±0.30mm，CoCr-EES 组 0.12±0.32mm[差异（单侧上 95%置信限）=0.01（0.07）；P<0.0001，非劣效性<0.0001]。
结论
在 ABSORB Japan 随机试验中，BVS 的 12 个月临床结果和 13 个月血管造影结果与 CoCr-EES 相当。
临床试验注册
ClinicalTrials.gov，编号 NCT01844284。
Zotero 插件