Kerkmeijer Laura S, Kalkman Deborah N, Woudstra Pier, Menown Ian B A, Suryapranata Harry, den Heijer Peter, Iñiguez Andrés, Van't Hof Arnoud W J, Erglis Andrejs, Arkenbout Karin E, Muller Philippe, Koch Karel T, Tijssen Jan G, Beijk Marcel A M, de Winter Robbert J
Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Craigavon Cardiac Centre, Craigavon, United Kingdom.
Cardiovasc Revasc Med. 2020 May;21(5):567-570. doi: 10.1016/j.carrev.2019.09.015. Epub 2019 Oct 25.
Data of long-term safety and efficacy of the COMBO dual-therapy stent is lacking. REMEDEE Registry evaluated the COMBO stent and showed low clinical event rates up to 3 year. We report the clinical outcomes at 4-year follow-up of this registry.
The REMEDEE Registry is a prospective, multicenter registry with minimal exclusion criteria, evaluating clinical outcomes after treatment with the COMBO stent. A 1000 patients were enrolled between June 2013 and March 2014. Target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR), at 4-year follow-up was the primary focus of this analysis.
Four-year follow-up data were obtained in 97.3% of patients. TLF was present in 117 patients (11.9%). Cardiac death occurred in 45 patients (4.6%), TV-MI was observed in 25 patients (2.6%) and TLR was performed in 73 patients (7.5%). Of the 7.5% TLR at 4 years, 1.5% were beyond 2 years. Definite ST was seen in 7 patients (0.7%) and probable ST in 1 (0.1%). No definite or probable ST occurred between 3 and 4 years follow-up. At 4-year follow-up, 93.1% of patients were free of ischemic symptoms.
This registry showed excellent 4-year results after COMBO stent placement, with no ST beyond 3 years.
COMBO双药涂覆支架的长期安全性和有效性数据尚缺。REMEDEE注册研究对COMBO支架进行了评估，显示长达3年的临床事件发生率较低。我们报告该注册研究4年随访的临床结果。
REMEDEE注册研究是一项前瞻性、多中心注册研究，排除标准极少，旨在评估COMBO支架治疗后的临床结果。2013年6月至2014年3月期间共纳入1000例患者。本分析的主要重点是4年随访时的靶病变失败（TLF），其定义为心源性死亡、靶血管心肌梗死（TV-MI）和靶病变血运重建（TLR）的复合终点。
97.3%的患者获得了4年随访数据。117例患者（11.9%）出现TLF。45例患者（4.6%）发生心源性死亡，25例患者（2.6%）观察到TV-MI，73例患者（7.5%）进行了TLR。在4年时7.5%的TLR中，1.5%发生在2年之后。7例患者（0.7%）出现明确的支架内血栓（ST），1例患者（0.1%）出现可能的ST。在3至4年随访期间未发生明确或可能的ST。4年随访时，93.1%的患者无缺血症状。
该注册研究显示COMBO支架置入术后4年结果优异，3年后无ST发生。
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