紫杉醇洗脱球囊、紫杉醇洗脱支架与药物洗脱支架置入后再狭窄患者的球囊血管成形术（ISAR-DESIRE 3）：一项随机、开放标签试验。
Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial.
机构信息
Deutsches Herzzentrum, Technische Universität, Munich, Germany.
出版信息
Lancet. 2013 Feb 9;381(9865):461-7. doi: 10.1016/S0140-6736(12)61964-3. Epub 2012 Dec 1.
BACKGROUND
The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients.
METHODS
In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6-8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324.
FINDINGS
We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5] vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; p(non-inferiority)=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (p(non-inferiority)=0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; p(superiority)<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups.
INTERPRETATION
By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent.
FUNDING
Deutsches Herzzentrum.
背景
对于先前接受过药物洗脱支架治疗的患者，管理再狭窄的最佳方法尚不清楚。我们研究了紫杉醇洗脱球囊（PEB）、紫杉醇洗脱支架（PES）和单纯球囊血管成形术在这些患者中的疗效。
方法
在这项随机、开放标签试验中，我们在德国的三个中心招募了年龄大于 18 岁的患者，这些患者在植入任何雷帕霉素洗脱支架后至少有 50%的再狭窄。患者通过密封的不透明信封以 1:1:1 的比例（根据中心分层）随机分配接受 PEB、PES 或单纯球囊血管成形术，信封内包含计算机生成的序列。患者和研究者未对治疗分配进行设盲，但事件和血管造影由设盲的个体进行评估。主要终点是 6-8 个月时随访血管造影的直径狭窄率。主要分析按意向治疗进行。这项试验在 ClinicalTrials.gov 注册，编号为 NCT00987324。
结果
我们共纳入了 402 名患者，其中 137 名（34%）被分配至 PEB 组，131 名（33%）至 PES 组，134 名（33%）至单纯球囊血管成形术组。338 名（84%）患者获得了 6-8 个月时的随访血管造影。PEB 在直径狭窄率方面不劣于 PES（38.0%[21.5] 与 37.4%[21.8]；差值 0.6%，单侧 95%CI 4.9%；p（非劣效性）=0.007；非劣效性边界为 7%）。意向治疗分析结果一致（p（非劣效性）=0.011）。PEB 和 PES 均优于单纯球囊血管成形术（54.1%[25.0]；p（优越性）均<0.0001）。各组之间的死亡率、心肌梗死或靶病变血栓形成发生率无差异。
结论
通过避免再次植入支架的需要，PEB 可能是药物洗脱支架植入后再狭窄患者的一种有用治疗方法。
资金来源
德国心脏中心。
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