Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon
Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon
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DOI：
10.1016/j.jcin.2022.01.012
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发表时间：
2022-04-04
影响因子：
11.3
通讯作者：
Scheller, Bruno
中科院分区：
文献类型：
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作者：
Ahmad, Wan Azman Wan;Nuruddin, Amin Ariff;Scheller, Bruno
目的研究一种新型西罗莫司包衣球囊(SCB)，并与目前研究最多的紫杉醇包衣球囊(PCB)进行比较。背景：越来越多的临床证据表明，使用药物包衣球囊治疗冠状动脉病变是可行的。然而，目前尚不清楚紫杉醇是否仍是首选药物，或者西罗莫司是否是一种替代药物，类似于药物洗脱支架。方法70名冠状动脉新生病变患者参加了一项随机多中心试验，比较新型SCB(Sequent SCB，B.Braun Melsungen；4mug/mm(2))和PCB(Sequent Pest，B.Braun Melsungen；3mug/mm(2))。主要终点是6个月时的血管造影晚期管腔丢失(LLL)。次要终点包括主要心血管不良事件和个别临床终点，如心源性死亡、靶病变心肌梗死、临床驱动靶病变血运重建和二尖瓣狭窄。结果定量冠状动脉造影显示基线参数无差异。6个月后，PCB组节段内LL值为0.01+/-0.33 mm，SCB组为0.10+/-0.32 mm。SCB与PCB值的平均差值为0.08(95%CI：-0.07~0.24)。在预定义的0.35的范围内表现出非自卑性。然而，在PCB组中，LLL阴性的发生率更高(60%的病变比SCB组的32%；P=0.019)。两组之间12个月内的主要心血管不良事件也没有差异。结论首次在人类范围内比较了具有结晶涂层的新型SCB，与临床证明的PCB相比，在治疗新发冠状动脉疾病方面显示了类似的血管造影结果。然而，在多氯联苯治疗后，更常见的是晚期管腔扩大。(使用马来西亚西罗莫斯涂层球囊导管或紫杉醇涂层球囊导管治疗冠状动脉De-Novo狭窄[SCBDNMAL]；NCT04017364)(C)2022，美国心脏病学会基金会。
OBJECTIVES The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB).BACKGROUND There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents.METHODS Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4 mu g/mm(2)) with a PCB (SeQuent Please, B. Braun Melsungen; 3 mu g/mm(2)). The primary endpoint was angiographic late lumen loss (LLL) at 6 months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.RESULTS Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment LLL was 0.01 +/- 0.33 mm in the PCB group versus 0.10 +/- 0.32 mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95% CI: -0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P = 0.019). Major adverse cardiovascular events up to 12 months also did not differ between the groups.CONCLUSIONS This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364) (C) 2022 by the American College of Cardiology Foundation.