Background:Patients at high-bleeding risk (HBR) undergoing percutaneous coronary intervention represent a challenging patient population. The use of drug-coated balloon (DCB) allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents (DES) and reduces thrombotic risk due to the absence of a permanent implant. The present analysis aimed to investigate if the effect of DCB versus DES differed between patients with and without HBR treated with percutaneous coronary intervention in small coronary arteries.Methods:This prespecified subgroup analysis of a multicenter, randomized, noninferiority trial included 758 patients with de novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention, randomized to DCB (n=382) or second-generation DES (n=376). Patients were followed over 3 years for major adverse cardiac events.Results:Of the 758 patients randomized, 155 (20%) had HBR; these patients had higher mortality at 3 years (hazard ratio [95% CI], 3.09 [1.78–5.36]; P<0.001). Rates of major bleeding events were overall low but tended to be lower after DCB versus DES (1.6% versus 3.7%; P=0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%). There was no difference in major adverse cardiac events between DCB and DES regardless of bleeding risk (HBR, hazard ratio: 1.16 [0.51–2.62]; P=0.719 versus non-HBR, 0.96 [0.62–1.49]; P=0.863).Conclusions:DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk. In patients treated with DCB, there was a trend towards a reduction of severe bleeding events at 3 years.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01574534.

中文翻译：

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BASKET-SMALL 2 试验中用于有和无高出血风险患者的小冠状动脉疾病的药物涂层球囊

背景：接受经皮冠状动脉介入治疗的高出血风险 (HBR) 患者代表了具有挑战性的患者群体。与药物洗脱支架 (DES) 相比，使用药物涂层球囊 (DCB) 可以缩短双重抗血小板治疗的持续时间，并且由于没有永久性植入物而降低了血栓形成的风险。本分析旨在调查小冠状动脉经皮冠状动脉介入治疗接受和不接受 HBR 的患者之间 DCB 与 DES 的效果是否不同。方法：这项预先指定的多中心、随机、非劣效性试验的亚组分析包括 758 名新发患者冠状血管病变 <3 mm 和经皮冠状动脉介入治疗的适应症，随机分配至 DCB (n=382) 或第二代 DES (n=376)。对患者的主要心脏不良事件进行了 3 年以上的随访。结果：在随机分组的 758 名患者中，155 名（20%）患有 HBR；这些患者的 3 年死亡率较高（风险比 [95% CI]，3.09 [1.78–5.36]；P <0.001)。大出血事件的发生率总体较低，但 DCB 与 DES 后往往较低（1.6% 与 3.7%；P = 0.064），HBR 患者的发生率相似（4.5% 与 3.4%），但 DCB 与 DES 的发生率较低接受过 HBR 治疗的患者（0.9% 对 3.8%）。无论出血风险如何，DCB 和 DES 的主要心脏不良事件均无差异（HBR，风险比：1.16 [0.51–2.62]；P = 0.719 与非 HBR，0.96 [0.62–1.49]；P=0.863)。结论：无论出血风险如何，DCBs 与当前一代 DES 治疗冠状动脉 <3 mm 的冠状动脉同样安全有效。在接受 DCB 治疗的患者中，3 年时严重出血事件有减少的趋势。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01574534。