内科学
冠状动脉疾病
心脏病学
生物吸附支架
经皮冠状动脉介入治疗
西罗莫司
随机对照试验
药物洗脱支架
作者
Takeshi Kimura,Ken Kozuma,Kengo Tanabe,Sunao Nakamura,Masahisa Yamane,Toshiya Muramatsu,Shigeru Saito,Junji Yajima,Nobuhisa Hagiwara,Kazuaki Mitsudo,Jeffrey J. Popma,Patrick W. Serruys,Yoshinobu Onuma,Shih-Wa Ying,Sherry Cao,Peter Staehr,Wai Fung Cheong,Hajime Kusano,Gregg W. Stone
标识
DOI:10.1093/eurheartj/ehv435
摘要
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%); P non-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); P non-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][1].
[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01844284&atom=%2Fehj%2Fearly%2F2015%2F08%2F28%2Feurheartj.ehv435.atom
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