Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Am J Cardiol. 2013 Nov 1;112(9):1328-34. doi: 10.1016/j.amjcard.2013.06.010. Epub 2013 Jul 24.
Even in the drug-eluting stent era, restenosis has remained an unresolved issue, particularly in the treatment of complex coronary lesions. In this study, patient-level data from 3 randomized trials (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus [DECLARE-DIABETES] and Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Long Native Coronary Lesions [DECLARE-LONG] I and II) were pooled to estimate the differential antirestenotic efficacy of add-on cilostazol according to the implanted drug-eluting stent in patients at high risk for restenosis. A total of 1,399 patients underwent sirolimus-eluting stent (SES; n = 450), paclitaxel-eluting stent (n = 450), and zotarolimus-eluting stent (n = 499) implantation and received triple-antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol, n = 700) and dual-antiplatelet therapy (aspirin and clopidogrel, n = 699). Randomization of antiplatelet regimen was stratified by stent type. In-stent late loss after TAT was significantly lower than that after dual-antiplatelet therapy, regardless of implanted stent type. However, the incidence of in-segment restenosis after TAT was significantly lower with SES (0.5% vs 6.7%, p = 0.014) and zotarolimus-eluting stent (12.2% vs 20.0%, p = 0.028) implantation but not paclitaxel-eluting stent implantation (14.4% vs 20.0%, p = 0.244). A significant interaction was present between stent type and antiplatelet regimen for the risk for in-segment restenosis (p = 0.004). Post hoc analysis using bootstrap resampling methods showed that the relative risk reduction for in-segment restenosis after TAT was most prominent with SES implantation. In conclusion, add-on cilostazol effectively reduced restenosis in patients at high risk for restenosis, particularly in those receiving SES, suggesting the sustainable utility of add-on cilostazol therapy in newer generation drug-eluting stents with comparable efficacy with that of SES.
即使在药物洗脱支架时代,再狭窄仍然是一个未解决的问题,尤其是在复杂冠状动脉病变的治疗中。在这项研究中,来自 3 项随机试验(药物洗脱支架治疗后西洛他唑治疗降低糖尿病患者的晚期再狭窄[DECLARE-DIABETES]和药物洗脱支架治疗后西洛他唑治疗降低长原发性冠状动脉病变患者的晚期再狭窄[DECLARE-LONG]I 和 II)的患者水平数据被汇总,以根据植入的药物洗脱支架估算高再狭窄风险患者中附加西洛他唑的差异抗再狭窄疗效。共有 1399 例患者接受西罗莫司洗脱支架(SES;n=450)、紫杉醇洗脱支架(n=450)和佐他莫司洗脱支架(n=499)植入,并接受三联抗血小板治疗(TAT;阿司匹林、氯吡格雷和西洛他唑,n=700)和双联抗血小板治疗(阿司匹林和氯吡格雷,n=699)。抗血小板方案的随机分组按支架类型分层。TAT 后支架内晚期丢失明显低于双联抗血小板治疗,与植入支架类型无关。然而,TAT 后节段内再狭窄的发生率明显低于 SES(0.5%比 6.7%,p=0.014)和佐他莫司洗脱支架(12.2%比 20.0%,p=0.028)植入,但紫杉醇洗脱支架植入则不然(14.4%比 20.0%,p=0.244)。支架类型和抗血小板方案对节段内再狭窄风险的交互作用有显著差异(p=0.004)。使用 bootstrap 重采样方法的事后分析显示,TAT 后节段内再狭窄的相对风险降低与 SES 植入最为显著。总之,附加西洛他唑可有效降低高危再狭窄患者的再狭窄,尤其是接受 SES 植入的患者,这表明在与 SES 疗效相当的新一代药物洗脱支架中,附加西洛他唑治疗具有可持续的应用价值。