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经皮冠状动脉小血管病变的治疗及结果:SCAAR 报告。

Percutaneous Treatment and Outcomes of Small Coronary Vessels: A SCAAR Report.

机构信息

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

Department of Cardiology, Linköping University, Linköping, Sweden; Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.

出版信息

JACC Cardiovasc Interv. 2020 Apr 13;13(7):793-804. doi: 10.1016/j.jcin.2019.10.062. Epub 2020 Feb 12.

Abstract

OBJECTIVES

The aim of this study was to investigate the outcomes of patients with de novo lesions in small coronary vessels undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs) or newer-generation drug-eluting stents (n-DES).

BACKGROUND

Notwithstanding the available evidence from a few randomized clinical trials and meta-analyses, the best device for PCI in patients with small-vessel coronary artery disease is not yet established.

METHODS

The study included all consecutive patients with de novo lesions in small coronary vessels undergoing PCI in Sweden from April 2009 to July 2017. A small coronary vessel was defined by a device diameter ≤2.5 mm. The primary outcomes were restenosis and definite target lesion thrombosis at 3-year follow-up. The secondary outcomes were the occurrence of all-cause death and myocardial infarction.

RESULTS

The study population included 14,788 patients: 1,154 treated with DCBs and 13,634 with n-DES. Overall, 35,541 PCIs were performed using 2,503 DCBs and 33,038 n-DES. The propensity score-adjusted regression analysis showed a significantly higher risk for restenosis in the DCB group compared with the n-DES group (adjusted hazard ratio [HR]: 2.027; 95% confidence interval [CI]: 1.537 to 2.674). Conversely, no difference in the risk for target lesion thrombosis (adjusted HR: 0.741; 95% CI: 0.412 to 1.331) was detected. The risk for all-cause death (adjusted HR: 1.178; 95% CI: 0.992 to 1.399) and myocardial infarction (adjusted HR: 1.251; 95% CI: 0.960 to 1.629) was comparable between groups.

CONCLUSIONS

Because of the significantly higher risk for restenosis up to 3 years, this research suggests that DCBs are not an equally effective alternative to n-DES for percutaneous treatment of small coronary vessels.

摘要

目的

本研究旨在探讨接受药物涂层球囊(DCB)或新一代药物洗脱支架(n-DES)经皮冠状动脉介入治疗(PCI)的新发小血管病变患者的治疗结局。

背景

尽管有几项随机临床试验和荟萃分析的证据,但在小血管冠状动脉疾病患者中进行 PCI 的最佳器械尚未确定。

方法

本研究纳入了 2009 年 4 月至 2017 年 7 月期间在瑞典接受新发小血管病变 PCI 的所有连续患者。小血管定义为器械直径≤2.5mm。主要结局是 3 年随访时的再狭窄和明确的靶病变血栓形成。次要结局是全因死亡和心肌梗死的发生。

结果

研究人群包括 14788 例患者:1154 例接受 DCB 治疗,13634 例接受 n-DES 治疗。总共进行了 35541 例 PCI,其中使用了 2503 个 DCB 和 33038 个 n-DES。经倾向评分调整的回归分析显示,DCB 组的再狭窄风险显著高于 n-DES 组(调整后的危险比 [HR]:2.027;95%置信区间 [CI]:1.537 至 2.674)。相反,两组之间靶病变血栓形成的风险无差异(调整后的 HR:0.741;95%CI:0.412 至 1.331)。全因死亡(调整后的 HR:1.178;95%CI:0.992 至 1.399)和心肌梗死(调整后的 HR:1.251;95%CI:0.960 至 1.629)的风险在两组之间相当。

结论

由于再狭窄的风险在 3 年内显著增加,本研究表明,与 n-DES 相比,DCB 不是治疗小血管病变的一种同等有效的经皮治疗替代方法。

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