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Circulation:罗非罗昔林和佐他莫司洗脱支架在冠状动脉疾病中的安全性和有效性

2017-10-03 MedSci MedSci原创

具有耐久弹性体聚合物的抗增生剂ridaforolimus的新型钴合金基冠状动脉支架用于治疗冠状动脉疾病患者的安全性和有效性尚未确定。一项前瞻性国际1:1的随机试验在76个中心进行,纳入了经皮冠状动脉介入治疗的1919名患者,评价罗非罗昔林洗脱支架(RESs)和缓释佐佐罗莫斯洗脱支架的安全性和有效性。纳入标准允许近期心肌梗死、全闭塞、分叉病变和其他复杂状况的患者。结果显示,两组患者间基线临床和血管造

具有耐久弹性体聚合物的抗增生剂罗非罗昔林的新型钴合金基冠状动脉支架用于治疗冠状动脉疾病患者的安全性和有效性尚未确定。

一项前瞻性国际1:1的随机试验在76个中心进行,纳入了经皮冠状动脉介入治疗的1919名患者,评价罗非罗昔林洗脱支架(RESs)和缓释佐他莫司洗脱支架的安全性和有效性。纳入标准允许近期心肌梗死、全闭塞、分叉病变和其他复杂状况的患者。

结果显示,两组患者间基线临床血管造影特征相似。总体而言,患者的平均年龄为63.4岁,32.5%为糖尿病,39.7%为急性冠状动脉综合征。12个月时,两个装置的靶病变失败的主要终点(心源性死亡、靶血管相关性心肌梗死和靶病变血运重建的复合终点)为5.4%(单侧95%置信区间上限1.8%,Pnoninferiority = 0.001)。两组中明确/可能的支架内血栓形成率较低(0.4%RES VS. 佐他莫司洗脱支架组0.6%,P = 0.75);RES和佐他莫司洗脱支架组13个月血管造影支架内晚期管腔损失分别为0.22±0.41 mm和0.23±0.39 mm(Pnoninferiority = 0.004),血管内超声新生内膜增生百分比分别为8.10±5.81和8.85± 7.77(Pnoninferiority = 0.01)。

总之,本研究结果表明,12个月时靶病变失败的主要终点,与佐他莫司洗脱支架相比,新型RESs符合非优劣标准,并具有相似的晚期管腔损失量。这些发现支持RESs在患者中应用的安全性和有效性。

原始出处:


David E. Kandzari, Pieter C. Smits, Michael P. Love, et al., Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery DiseasePrimary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis). Circulation. 2017;136:1304-1314, originally published August 9, 2017.

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    2017-10-03 131****1460

    学习了受益匪浅

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    2017-10-03 1e0e5697m83(暂无匿称)

    henhao

    0

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