General Hospital of Shenyang Military Region, Shenyang, China.
Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
JACC Cardiovasc Interv. 2014 Dec;7(12):1352-60. doi: 10.1016/j.jcin.2014.09.001. Epub 2014 Nov 12.
The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES.
No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type.
In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis.
At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: -1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55).
In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381).
本研究旨在验证假设，即新型可生物降解聚合物涂层钴铬（CoCr）雷帕霉素洗脱支架（BP-SES）在安全性和疗效方面不劣于耐用聚合物（DP）-SES。
没有随机试验比较过类似 CoCr 平台上的 BP-SES 与 DP-SES 的安全性和疗效，因此无法隔离聚合物类型的影响。
在这项在中国 32 个地点进行的前瞻性、单盲、随机试验中，2737 名适合进行冠状动脉支架置入术的患者以 2:1 的比例接受 BP-SES 或 DP-SES 治疗。主要终点是 12 个月时的靶病变失败（TLF），即心脏死亡、靶血管心肌梗死或临床指征靶病变血运重建的复合终点。次要终点包括 TLF 成分和确定/可能的支架血栓形成。
在 12 个月时，BP-SES（6.3%）和 DP-SES（6.1%）组的主要终点 TLF 差异为 0.25%（95%置信区间：-1.67%至 2.17%，非劣效性 p 值=0.0002），表明 BP-SES 不劣于 DP-SES。单个 TLF 成分（心脏死亡：0.7%比 0.6%，p=0.62；靶血管心肌梗死：3.6%比 4.3%，p=0.39；临床指征靶病变血运重建：2.6%比 2.2%，p=0.50）和较低的确定/可能的支架血栓形成率（0.4%比 0.6%，p=0.55）也相似。
在这项大规模的真实世界试验中，BP-SES 在 1 年 TLF 方面不劣于 DP-SES。[评估 Tivoli®DES 和 Firebird®DES 治疗冠状动脉血运重建的安全性和有效性；NCT01681381]
