使用薄支架生物可吸收聚合物药物洗脱支架治疗长冠状动脉病变：多中心随机CENTURY II研究经验
Long Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study.
作者信息
Lesiak Maciej, Araszkiewicz Aleksander, Grajek Stefan, Colombo Antonio, Lalmand Jacques, Carstensen Steen, Namiki Atsuo, Tobaru Tetsuya, Merkely Béla, Moreno Raul, Barbato Emanuele, Wijns William, Saito Shigeru
机构信息
Department of Cardiology, University of Medical Sciences, Poznan, Poland.
Cardiac Cath Lab and Interventional Cardiology Unit EMO GVM Centro Cuore, Columbus and San Raffaele Hospital, Milan, Italy.
出版信息
J Interv Cardiol. 2016 Feb;29(1):47-56. doi: 10.1111/joic.12262.
OBJECTIVES
To assess performance of new, bioresorbable polymer sirolimus-eluting stent (BP-SES), in patients with long coronary lesions (LL) and to compare it to permanent polymer everolimus-eluting stent (PP-EES).
BACKGROUND
LL have been associated with worse clinical outcomes in percutaneous coronary interventions (PCI). The impact of lesion length on the outcomes of drug eluting stent (DES) implantations is not as clear.
METHODS
In the frame of a randomized, multicentre CENTURY II study, out of 1119 patients enrolled, 182 patients had LL (defined as ≥25 mm), and were assigned randomly to treatment with BP-SES (101) or PP-EES (81). Primary endpoint was target lesion failure (TLF, composite of cardiac death, target vessel related myocardial infarction [MI], and target lesion revascularization [TLR]) at 9 months. All data were 100% monitored and adverse events were adjudicated by an independent clinical event committee.
RESULTS
The baseline patient and lesion characteristics were similar in the 2 study arms. At 9-months, the rates of cardiac death (2.0% vs 1.2%; P = 0.70), MI (3.0% vs 4.9%; P = 0.49) and clinically driven TLR (2.0% vs 3.7%; P = 0.48) and TLF (6.9% vs 8.6%; P = 0.67) were similar for BP-SES and PP-EES, respectively. There was no stent thrombosis (ST) in BP-SES group up to 9 months, while 1 case (1.2%) of ST was recorded in PP-EES group (P = 0.44).
CONCLUSIONS
Patients with LL showed similar clinical outcomes when treated with Ultimaster BP-SES and Xience PP-EES.
目的
评估新型生物可吸收聚合物西罗莫司洗脱支架（BP-SES）在长冠状动脉病变（LL）患者中的性能，并将其与永久性聚合物依维莫司洗脱支架（PP-EES）进行比较。
背景
在经皮冠状动脉介入治疗（PCI）中，LL与较差的临床结局相关。病变长度对药物洗脱支架（DES）植入结局的影响尚不清楚。
方法
在一项随机、多中心的CENTURY II研究框架内，在纳入的1119例患者中，182例患者患有LL（定义为≥25毫米），并被随机分配接受BP-SES（101例）或PP-EES（81例）治疗。主要终点是9个月时的靶病变失败（TLF，包括心源性死亡、靶血管相关心肌梗死[MI]和靶病变血运重建[TLR]的复合终点）。所有数据均进行100%监测，不良事件由独立的临床事件委员会判定。
结果
两个研究组的基线患者和病变特征相似。在9个月时，BP-SES和PP-EES的心源性死亡发生率（2.0%对1.2%；P = 0.70）、MI发生率（3.0%对4.9%；P = 0.49）、临床驱动的TLR发生率（2.0%对3.7%；P = 0.48）和TLF发生率（6.9%对8.6%；P = 0.67）分别相似。BP-SES组至9个月时无支架血栓形成（ST），而PP-EES组记录到1例（1.2%）ST（P = 0.44）。
结论
LL患者接受Ultimaster BP-SES和Xience PP-EES治疗时临床结局相似。
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