A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan
A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan
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DOI：
10.1093/eurheartj/ehv435
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发表时间：
2015-12-14
影响因子：
39.3
通讯作者：
Stone, Gregg W.
中科院分区：
文献类型：
--
作者：
Kimura, Takeshi;Kozuma, Ken;Stone, Gregg W.
目的从理论上讲，与永久性金属药物洗脱支架(DESS)相比，生物可吸收血管支架(BVSS)具有更好的远期疗效。然而，在完全生物吸收之前，BVSS是否与金属DES一样安全和有效尚不清楚。方法和结果日本吸收是一项单盲、多中心、主动对照、随机试验，旨在支持日本监管部门对吸收BVS的批准。符合条件的患者在不同的心外膜血管中有一个或两个新生病变，按2：1的比例在日本的38个部位随机选择吸收BVS和钴铬血管洗脱支架(COCR-EESS)。主要终点是12个月时靶病变失败[TLF：心源性死亡、靶血管引起的心肌梗死或缺血驱动的靶病变血运重建术(ID-TLR)的复合体]，动力非劣势。主要的次要终点是13个月时的血管造影节段内晚期管腔丢失(LLL)。共有400名患者被随机分为BVSS组(266名患者，275个病灶)或COCR-EESS组(134名患者，137个病灶)。12个月时BVSS组和COCR-EESS组的总有效率分别为4.2%和3.8%[差值(单侧95%可信限)=0.39%(3.95%)；P非劣性t；0.0001]。术后12个月明确或可能的支架/支架血栓发生率为1.5%(P=1.0)，再狭窄的ID-TLR发生率较低(BVSS为1.1%，COCR-EESS为1.5%，P=1.0)。13个月时BVSS组和COCR-EESS组的节段内LLL值分别为0.13+/-0.30 mm和0.12+/-0.32 mm[差异(单侧95%可信区间上限)-0.01(0.07)，P非劣势0.0001]。结论在日本随机试验中，BVSS组和COCR-EESS组12个月的临床和13个月的血管造影结果相似。
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.