Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents - The SISR randomized trial
Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents - The SISR randomized trial
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DOI：
10.1001/jama.295.11.1264
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发表时间：
2006-03-15
影响因子：
120.7
通讯作者：
Cohen, SA
中科院分区：
文献类型：
--
作者：
Holmes, DR;Teirstein, P;Cohen, SA
背景尽管血管近距离放射治疗是唯一被批准的治疗裸金属支架植入后再狭窄的方法，但药物洗脱支架现在也被使用。两种方法的相对优点的数据有限。目的比较西罗莫司洗脱支架与血管近距离放射治疗治疗在裸金属支架内再狭窄患者中的安全性和有效性。2003年2月至2004年7月在26个学术和社区医疗中心入组的384例支架内再狭窄患者的随机试验。所提供的数据代表了截至2005年6月30日的所有随访。介入血管近距离放射治疗（n = 125）或西罗莫司洗脱支架（n = 259）。主要结果测量术后9个月靶血管衰竭（心源性死亡、心肌梗死或靶血管血运重建）。血管近距离放射治疗和西罗莫司洗脱支架患者的病变长度相似（平均值[SD]分别为16.76 [8.55] mm vs 17.22 [7.97] mm; P = 0.61）。血管近距离放射治疗组的手术成功率为99.2%（124/125），西罗莫司洗脱支架组为97.3%（250/257）（P = 0.28）。血管近距离放射治疗的靶血管失败率为21.6%（27/125），西罗莫司洗脱支架的靶血管失败率为12.4%（32/259）（相对风险[RR]，1.7; 95%置信区间[CI]，1.1-2.8; P = 0.02）。19.2%（24/125）的血管近距离放射治疗组和8.5%（22/259）的西罗莫司洗脱支架组需要靶病变血运重建（RR，2.3 [ 95% CI，1.3-3.9]; P = 0.004）。在随访血管造影时，血管近距离放射治疗组和西罗莫司洗脱支架组的分析节段二元血管造影再狭窄率分别为29.5%（31/105）和19.8%（45/227）（RR，1.5 [ 95% CI，1.0-2.2]; P = 0.07）。与血管近距离治疗组相比，西罗莫司洗脱支架组在6个月随访时的最小管腔直径较大（平均值[ SD]，1.52 [0.63] mm vs 1.80 [ 0.63] mm; P <0.001），反映了分析段的净管腔增益更大结论西罗莫司洗脱支架治疗裸金属支架内再狭窄的临床疗效和血管造影结果上级近距离放射治疗。
Context Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited.Objective To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare-metal stent.Design, Setting, and Patients Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005.Interventions Vascular brachytherapy (n = 125) or the sirolimus-eluting stent (n = 259).Main Outcome Measure Target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months postprocedure.Results Baseline patient characteristics were well matched. Lesion length was similar between vascular brachytherapy and sirolimus-eluting stent patients (mean [SD], 16.76 [8.55] mm vs 17.22 [7.97] mm, respectively; P = .61). Procedural success was 99.2% (124/125) in the vascular brachytherapy group and 97.3% (250/257) in the sirolimus-eluting stent group (P = .28). The rate of target vessel failure was 21.6% (27/125) with vascular brachytherapy and 12.4% (32/259) with the sirolimus-eluting stent (relative risk [RR], 1.7; 95% confidence interval [CI], 1.1-2.8; P = .02). Target lesion revascularization was required in 19.2% (24/125) of the vascular brachytherapy group and 8.5% (22/259) of the sirolimus-eluting stent group (RR, 2.3 [ 95% CI, 1.3-3.9]; P = .004). At follow-up angiography, the rate of binary angiographic restenosis for the analysis segment was 29.5% (31/105) for the vascular brachytherapy group and 19.8% (45/227) for the sirolimus-eluting stent group (RR, 1.5 [ 95% CI, 1.0-2.2]; P = .07). Compared with the vascular brachytherapy group, minimal lumen diameter was larger in the sirolimus-eluting stent group at 6-month follow-up (mean [ SD], 1.52 [0.63] mm vs 1.80 [ 0.63] mm; P < .001), reflecting greater net lumen gain in the analysis segment (0.68 [0.60] vs 1.0 [0.61] mm; P < .001) due to stenting and no edge restenosis.Conclusion Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent.