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.

中文翻译：

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小型冠状血管的经皮治疗和结果：SCAAR报告。

目的本研究的目的是调查在小冠状血管中接受药物涂层球囊（DCB）或新一代药物洗脱支架（n-DES）的经皮冠状动脉介入治疗（PCI）的新病变患者的结局。背景技术尽管从一些随机临床试验和荟萃分析中获得了可用的证据，但尚未建立用于小血管冠状动脉疾病患者的PCI的最佳装置。方法该研究纳入了自2009年4月至2017年7月在瑞典接受PCI的所有小冠状动脉病变患者，所有这些患者均从头开始病变。小冠状动脉定义为直径≤2.5 mm的器械。主要结果是在3年的随访中再狭窄和明确的目标病变血栓形成。次要结局是全因死亡和心肌梗塞的发生。结果研究人群包括14,788例患者：1,154例接受DCB治疗，13,634例接受n-DES治疗。总体而言，使用2,503个DCB和33,038个n-DES进行了35,541个PCI。倾向得分调整后的回归分析显示，与n-DES组相比，DCB组的再狭窄风险显着更高（调整后的危险比[HR]：2.027； 95％置信区间[CI]：1.537至2.674）。相反，未检测到目标病变血栓形成的风险差异（校正后的HR：0.741； 95％CI：0.412至1.331）。在各组中，全因死亡（调整后的HR：1.178； 95％CI：0.992至1.399）和心肌梗塞（调整后的HR：1.251； 95％CI：0.960至1.629）的风险在两组之间具有可比性。