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来自瑞典冠状动脉造影和血管成形术登记处(SCAAR)的患者使用载有依维莫司的铂铬合金支架及管腔外可生物降解聚合物的实际临床结果。

Real-life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

作者信息

Sarno Giovanna, Lagerqvist Bo, Olivecrona Göran, Varenhorst Christoph, Danielewicz Mikael, Hambraeus Kristina, Lindholm Daniel, Råmunddal Truls, Witt Nils, James Stefan

机构信息

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

UCR, Uppsala Clinical Research Center, Uppsala, Sweden.

出版信息

Catheter Cardiovasc Interv. 2017 Nov 15;90(6):881-887. doi: 10.1002/ccd.27030. Epub 2017 May 22.

DOI:10.1002/ccd.27030
PMID:28544146
Abstract

BACKGROUND

No previous studies have evaluated the performance of the Synergy stent in a large real-life population.

OBJECTIVES

To describe the initial real-life experience with a novel everolimus eluting platinum chromium stent with abluminal biodegradable polymer (SYNERGY) in unselected patients from a nationwide registry.

METHODS

All implanted Synergy stents were compared with other new generation drug eluting stents (n-DES) with >1,000 implantations in Sweden between March 2013 and October 2015. Restenosis, definite stent thrombosis (ST), myocardial infarction (MI) and death rates were assessed using propensity score and Cox regression analyses.

RESULTS

A total of 7,886 of Synergy stents and 64,429 other n-DES (BioMatrix, N = 1,953; Orsiro, N = 4,946; Promus Element Plus, N= 2,543; Promus Premier, N= 20,414; Xience Xpedition, N= 7,971, Resolute/Resolute Integrity, N = 19,021; Ultimaster, N = 1,156; Resolute Onyx, N = 6,425) were implanted in 42,357 procedures. Restenosis and stent thrombosis occurred in 642 and 314 cases, respectively, in the overall population at 1 year. The cumulative rate of restenosis (1.1% vs. 1.0%, adjusted HR: 1.24 95% CI: 0.88-1.75; P = 0.21) and ST (0.4% vs. 0.5%, adjusted HR: 0.97; 95% CI: 0.63-1.50; P = 0.17) up to 1 year was low in both the Synergy group and the other n-DES group. Death occurred in 5.2% versus 4.5% (adjusted HR: 1.14; 95% CI: 0.96-1.36; P = 0.11) and MI in 3.2% versus 3.5%, (adjusted HR: 1.11; 95% CI: 0.93-1.33; P = 0.24) up to 1 year.

CONCLUSIONS

In a large real-life population the Synergy stent appears to be safe and effective with a low rate of restenosis and ST comparable with other n-DES. © 2017 Wiley Periodicals, Inc.

摘要

背景

此前尚无研究评估Synergy支架在大型真实世界人群中的性能。

目的

描述一种新型的载有依维莫司的铂铬合金支架且带有腔外可生物降解聚合物(SYNERGY)在全国登记处未筛选患者中的初始真实世界使用经验。

方法

将2013年3月至2015年10月期间在瑞典植入的所有Synergy支架与其他植入量超过1000例的新一代药物洗脱支架(n-DES)进行比较。使用倾向评分和Cox回归分析评估再狭窄、明确的支架血栓形成(ST)、心肌梗死(MI)和死亡率。

结果

在42357例手术中,共植入了7886枚Synergy支架和64429枚其他n-DES(BioMatrix,N = 1953;Orsiro,N = 4946;Promus Element Plus,N = 2543;Promus Premier,N = 20414;Xience Xpedition,N = 7971;Resolute/Resolute Integrity,N = 19021;Ultimaster,N = 1156;Resolute Onyx,N = 6425)。总体人群中术后1年时,再狭窄和支架血栓形成分别发生在642例和314例。Synergy组和其他n-DES组在1年内的再狭窄累积发生率(1.1%对1.0%,调整后HR:1.24,95%CI:0.88 - 1.75;P = 0.21)和ST累积发生率(0.4%对0.5%,调整后HR:0.97;95%CI:0.63 - 1.50;P = 0.17)均较低。1年内死亡率分别为5.2%对4.5%(调整后HR:1.14;95%CI:0.96 - 1.36;P = 0.11),MI发生率分别为3.2%对3.5%(调整后HR:1.11;95%CI:0.93 - 1.33;P = 0.24)。

结论

在大型真实世界人群中,Synergy支架似乎安全有效,再狭窄率和ST发生率较低,与其他n-DES相当。©2017威利期刊公司。

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