随机比较西罗莫司洗脱和依维莫司洗脱冠状动脉支架治疗完全闭塞性冠状动脉病变：依维莫司洗脱支架治疗慢性完全闭塞病变随机试验的结果。
Randomized comparison of sirolimus-eluting and everolimus-eluting coronary stents in the treatment of total coronary occlusions: results from the chronic coronary occlusion treated by everolimus-eluting stent randomized trial.
机构信息
Hospital Universitario La Paz, 28046 Madrid, Spain.
出版信息
Circ Cardiovasc Interv. 2013 Feb;6(1):21-8. doi: 10.1161/CIRCINTERVENTIONS.112.000076. Epub 2013 Feb 12.
BACKGROUND
Patients with coronary total occlusions are at especially high risk for restenosis and new revascularizations. Sirolimus-eluting stents dramatically improved the clinical outcome of this subset of patients in randomized trials, but other drug-eluting stents, mainly the everolimus-eluting stent (currently the most frequently used stent), have not yet been evaluated in patients with coronary total occlusions. The objective was to compare the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent in patients with coronary total occlusions.
METHODS AND RESULTS
A total of 207 patients with coronary total occlusions and estimated time since occlusion >2 weeks were randomized to everolimus- or sirolimus-eluting stent. The primary end point was in-stent late loss at 9-month angiographic follow-up (noninferiority trial). Clinical follow-up was performed at 1 and 12 months. In-stent late loss at 9 months was 0.29±0.60 versus 0.13±0.69 mm in patients allocated to sirolimus- and everolimus-eluting stent, respectively. The observed difference in in-stent late loss between both groups was -0.16 mm (95% confidence interval, 0.04 to -0.36 mm; P for noninferiority <0.01). The rate of binary angiographic restenosis was 10.8% and 9.1% in patients allocated to sirolimus- and everolimus-eluting stent, respectively (P=0.709), whereas the rate of vessel reocclusion was 3.2% and 1.1%, respectively (P=0.339). At 12 months, the rate of major adverse events was 15.9% versus 11.1% with sirolimus- and everolimus-eluting stent, respectively (P=0.335), and probable or definitive stent thrombosis occurred in 3.0% and 0.0% of patients, respectively (P=0.075).
CONCLUSIONS
In patients with coronary total occlusions, everolimus-eluting stent is as effective as sirolimus-eluting stent.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00793221.
背景
患有冠状动脉完全闭塞的患者尤其有再狭窄和新血运重建的风险。雷帕霉素洗脱支架在随机试验中显著改善了这部分患者的临床结局，但其他药物洗脱支架，主要是依维莫司洗脱支架（目前使用最广泛的支架），尚未在冠状动脉完全闭塞的患者中进行评估。本研究的目的是比较第二代依维莫司洗脱支架和第一代西罗莫司洗脱支架在冠状动脉完全闭塞患者中的疗效。
方法和结果
共纳入 207 例冠状动脉完全闭塞且闭塞时间超过 2 周的患者，随机接受依维莫司或西罗莫司洗脱支架治疗。主要终点是 9 个月血管造影随访时的支架内晚期管腔丢失（非劣效性试验）。临床随访在 1 个月和 12 个月进行。支架内晚期管腔丢失在 9 个月时分别为 0.29±0.60mm 和 0.13±0.69mm，分别接受西罗莫司和依维莫司洗脱支架治疗的患者。两组间支架内晚期管腔丢失的观察差异为-0.16mm（95%置信区间，0.04 至-0.36mm；P 值＜0.01，非劣效性检验）。接受西罗莫司和依维莫司洗脱支架治疗的患者的血管造影再狭窄率分别为 10.8%和 9.1%（P=0.709），血管再闭塞率分别为 3.2%和 1.1%（P=0.339）。在 12 个月时，主要不良事件发生率分别为 15.9%和 11.1%，接受西罗莫司和依维莫司洗脱支架治疗的患者（P=0.335），可能或确定的支架血栓形成发生率分别为 3.0%和 0.0%（P=0.075）。
结论
在冠状动脉完全闭塞的患者中，依维莫司洗脱支架与西罗莫司洗脱支架同样有效。
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