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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.1361

摘要内容如下：

重要性

药物涂层球囊为冠状动脉支架内再狭窄的治疗提供了一种潜在有益的治疗策略。然而，在美国以前没有评估或批准用于冠状动脉循环。

目的

评估在接受经皮冠状动脉介入治疗的支架内再狭窄患者中，紫杉醇涂层球囊是否优于未涂层球囊。

设计、设置和参与者

多中心随机临床试验Agent IDE于2021年5月至2022年8月在全美40个中心纳入600例支架内再狭窄（病变长度<26 mm，参考血管直径>2.0 mm至≤4.0 mm）患者，2023年10月2日完成为期1年的临床随访。

干预措施

参与者以2:1的比例随机接受紫杉醇包衣（n=406）或未包衣（n=194）球囊治疗。

主要成果和措施

1年靶病变失败的主要终点（定义为缺血驱动的靶病变血运重建、靶血管相关心肌梗死或心源性死亡的复合终点）的优越性得到了检验。

结果

在600名随机分组的患者中（平均年龄68岁；女性157人[26.2%]；42名黑人[7%]，35名西班牙裔[6%]），574名（95.7%）完成了1年的随访。紫杉醇涂层球囊组1年的主要终点发生率为17.9%，而未涂层球囊组为28.6%，符合优越性标准（风险比[HR]，0.59[95%CI，0.42-0.84]；双面P=.003）。靶病变血运重建（13.0%vs 24.7%）；HR，0.50[95%CI，0.34-0.74]；P=.001）和靶血管相关心肌梗死（5.8%vs 11.1%；HR，0.51[95%CI，0.28-0.92]；P=.02）在接受紫杉醇涂层球囊治疗的患者中发生率较低。心源性死亡率分别为2.9%和1.6%（HR，1.75[95%CI，0.49-6.28]；P=.38），分别在有涂层和无涂层球囊组中。

结论和相关性

在因支架内再狭窄而接受冠状动脉血管成形术的患者中，紫杉醇涂层球囊在靶病变失败的复合终点方面优于无涂层球囊。紫杉醇涂层球囊是冠状动脉支架内再狭窄患者的有效治疗选择。

试用注册

ClinicalTrials.gov标识符：NCT04647253。

英文原文如下：

Abstracts

Importance  Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States.

Objective  To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention.

Design, Setting, and Participants  AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023.

Interventions  Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon.

Main Outcomes and Measures  The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority.

Results  Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively.

Conclusions and Relevance  Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis.

Trial Registration  ClinicalTrials.gov Identifier: NCT04647253.

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