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急性冠状动脉综合征患者接受COMBO支架治疗后的临床结局评估。

Evaluation of clinical outcomes after COMBO stent treatment in patients presenting with acute coronary syndrome.

作者信息

Kalkman Deborah N, Woudstra Pier, Lu Huangling, Menown Ian B A, den Heijer Peter, Suryapranata Harry, Iñiguez Andrés, Arkenbout Karin E, Van't Hof Arnoud W J, Muller Philippe, Erglis Andrejs, Tijssen Jan G, Beijk Marcel A M, de Winter Robbert J

机构信息

Academic Medical Center - University of Amsterdam, Amsterdam, The Netherlands.

Craigavon Cardiac Centre, Craigavon, United Kingdom.

出版信息

Catheter Cardiovasc Interv. 2017 Aug 1;90(2):E31-E37. doi: 10.1002/ccd.26915. Epub 2017 Feb 1.

Abstract

BACKGROUND

Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications after percutaneous coronary intervention with stent placement compared to patients with stable angina (SA) treated in an elective setting. The novel pro-healing COMBO stent is a bio-engineered drug eluting stent designed to promote vessel healing. Therefore, the stent may reduce this difference in clinical outcomes between elective and ACS-patients and prevent late stent thrombosis.

METHODS AND RESULTS

The European, prospective, multicenter, 1000 all-comers patient REMEDEE registry evaluates clinical outcomes after COMBO stent placement in ACS- and elective patients. The primary endpoint at 12 months is target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization. A total of 49.9% (n = 498) of patients presented with acute coronary syndrome. TLF was 7.1% in ACS patients, definite and probable stent thrombosis was observed in 0.5% of ACS patients and in all within 9 days post stenting. We found no significant difference in TLF between ACS and non-ACS patients and a low overall rate of TLF.

CONCLUSIONS

The COMBO stent is a safe and efficient device for patients presenting with ACS. Low ST rate and only early stent thrombosis were observed. © 2017 Wiley Periodicals, Inc.

摘要

背景

与择期治疗的稳定型心绞痛(SA)患者相比,急性冠状动脉综合征(ACS)患者在接受经皮冠状动脉介入治疗并置入支架后发生并发症的风险更高。新型促愈合COMBO支架是一种生物工程药物洗脱支架,旨在促进血管愈合。因此,该支架可能会缩小择期患者与ACS患者在临床结局上的差异,并预防晚期支架血栓形成。

方法与结果

欧洲前瞻性多中心、纳入1000例各类患者的REMEDEE注册研究评估了COMBO支架置入ACS患者和择期患者后的临床结局。12个月时的主要终点是靶病变失败(TLF),这是一个综合了心源性死亡、靶血管心肌梗死和靶病变血运重建的指标。共有49.9%(n = 498)的患者表现为急性冠状动脉综合征。ACS患者的TLF为7.1%,在0.5%的ACS患者中观察到明确和可能的支架血栓形成,且均发生在支架置入后9天内。我们发现ACS患者和非ACS患者之间的TLF无显著差异,且TLF的总体发生率较低。

结论

COMBO支架对于ACS患者是一种安全有效的器械。观察到较低的ST发生率且仅发生早期支架血栓形成。© 2017威利期刊公司

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