研究显示两种聚合物支架的风险相似

在2年的随访期间，发现生物可降解biolimus洗脱支架与永久性依维莫司洗脱支架同样安全和有效，且靶病变血运重建、死亡或心肌梗死发生率无显著差异。这一结果来自NEXT(NOBORI Biolimus-洗脱支架与XIENCE/PROMUS依维莫司洗脱支架的比较试验)，是由日本Saiseikai Fukuoka全科医院的Masahiro Natsuaki医生牵头进行的一项为期3年的随机试验。研究者3月31日在美国心脏病学会(ACC)年会上展示了这项研究结果，并同期发表于JAMA杂志(doi:10.1001/jama.2014.3584)。

Natsuaki医生指出，NEXT是首项报告超过1年结局的随机试验。“之前的荟萃分析将数种不同的生物可降解药物洗脱支架作为一个分类，汇总的不同试验中入选患者的风险特性不同，并且年龄差异较大，此外，还存在一些对临床实践的改变，例如双联抗血小板治疗的持续时间改变。”而在NEXT研究中，2年时，BP-BES和DP-EES治疗组分别有69%和70%的患者继续接受双联抗血小板治疗。

NEXT研究旨在通过衡量靶病变血运重建和BP-DES是否较DP-EES有更高的死亡或MI风险（短期研究和荟萃分析中曾有这种提示），确定生物可降解聚合物biolimu洗脱支架(BP-BES)相对于永久性聚合物依维莫司洗脱支架(DP-EES)的非劣效性。Natsuaki医生及其同事将近100个治疗中心的3,235例患者随机分配到BP-BES(n=1,617)或DP-EES(n=1,618)治疗组，全部患者中的98%完成了随访。

结果显示，这两种支架治疗者的死亡和MI发生率相似（BP-BES和DP-EES组分别为7.8%和7.7%，达到非劣效性，P=0.003），并且两组患者对靶病变血运重建的需求相似(两组分别为6.2%和6%；达到非劣效性，P＜0.001)。

研究者结论称，生物可降解biolimus洗脱支架与永久性依维莫司洗脱支架置入后2年内的靶病变血运重建、死亡或心肌梗死发生率无统计学差异。

NEXT研究是由研究中使用的生物可降解支架的生产商日本Terumo公司资助的。两位研究者披露担任日本Terumo公司和日本雅培血管产品公司（研究中使用的永久性聚合物支架的生产商）的顾问。

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By: JENNIE SMITH, Cardiology News Digital Network

Biodegradable biolimus-eluting stents are as safe and effective as durable everolimus-eluting stents at 2 years’ follow-up, with no significant differences seen in rates of target lesion revascularization, mortality, or myocardial infarction.

The findings come from NEXT (NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial), a 3-year randomized trial led by Dr. Masahiro Natsuaki of Saiseikai Fukuoka (Japan) General Hospital. They were presented March 31 at the annual meeting of the American College of Cardiology and published simultaneously in JAMA (doi:10.1001/jama.2014.3584).

NEXT aims to determine the noninferiority of the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES) as measured by target lesion revascularization and whether BP-DES carries a risk for excess mortality or MI compared with DP-EES, as shorter studies and meta-analyses have suggested.

Dr. Natsuaki and colleagues randomized 3,235 patients from nearly 100 treatment centers to BP-BES (n = 1,617) or DP-EES (n = 1,618), with 98% of all patients completing follow-up.

Mortality and MI were comparable for both stents (7.8% for BP-BES vs. 7.7% for DP-EES; noninferiority, P = .003), and the need for target lesion revascularization was also comparable for both stents (6.2% vs. 6%; noninferiority, P less than .001).

Dr. Natsuaki and colleagues noted that "2 years is not long enough to confirm the long-term safety of BP-BES, and the study was underpowered for the interim analysis. Follow-up at 3 years will be important."

NEXT is the first randomized trial to report outcomes longer than 1 year, Dr. Natsuaki said, which could be why these results differ from those of previous studies. In addition, previous meta-analyses pooled "several different biodegradable drug-eluting stents as a class, different risk profiles of enrolled patients across trials, and the wide variation in the ages of the trials, with changes in clinical practices such as duration of dual antiplatelet therapy." In NEXT, dual antiplatelet therapy continued in 69% of BP-BES patients and 70% of DP-EES patients at 2 years.

The researchers said that patients with MI were underrepresented in their sample and that "event rates were less than expected."

NEXT was sponsored by Terumo Japan, the maker of the biodegradable stents used in the study. Two investigators disclosed that they serve as advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.