Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter
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DOI：
10.1056/nejmoa061254
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发表时间：
2006-11-16
影响因子：
158.5
通讯作者：
Speck, Ulrich
中科院分区：
文献类型：
--
作者：
Scheller, Bruno;Hehrlein, Christoph;Speck, Ulrich
背景：冠状动脉支架内再狭窄的治疗因复发性支架内再狭窄的高发生率而受到阻碍。我们评估了紫杉醇涂层球囊在这种情况下的有效性和安全性。方法：我们在一项随机、双盲、多中心试验中招募了 52 名支架内再狭窄患者，以比较冠状动脉成形术中涂有紫杉醇（球囊表面积每平方毫米 3 微克）的球囊导管与未涂层球囊导管的效果。主要终点是血管造影所见的晚期管腔损失。次要终点包括再狭窄率（二元变量）和主要不良心脏事件。结果：两组中 80% 的患者存在多支血管疾病。定量冠状动脉造影显示基线测量没有显着差异。 6 个月时，血管造影显示，未涂层球囊组的平均 (+/-SD) 节段内晚期管腔损失为 0.74+/-0.86 毫米，而涂层球囊组为 0.03+/-0.48 毫米 (P=0.002)。未涂层球囊组中 23 名患者中共有 10 名 (43%) 出现再狭窄，而涂层球囊组中 22 名患者中只有 1 名 (5%) (P=0.002)。 12 个月时，未涂层球囊组的主要不良心脏事件发生率为 31%，涂层球囊组为 4%（P=0.01）。这种差异主要是由于未涂层球囊组中的 6 名患者需要进行靶病灶血运重建 (P=0.02)。结论：紫杉醇涂层球囊导管治疗冠状动脉支架内再狭窄可显着降低再狭窄的发生率。这些数据表明，通过局部药物递送抑制再狭窄可能不需要支架植入和在损伤部位持续释放药物。
Background: Treatment of coronary in-stent restenosis is hampered by a high incidence of recurrent in-stent restenosis. We assessed the efficacy and safety of a paclitaxel-coated balloon in this setting. Methods: We enrolled 52 patients with in-stent restenosis in a randomized, double-blind, multicenter trial to compare the effects of a balloon catheter coated with paclitaxel (3 microg per square millimeter of balloon surface area) with those of an uncoated balloon catheter in coronary angioplasty. The primary end point was late luminal loss as seen on angiography. Secondary end points included the rates of restenosis (a binary variable) and major adverse cardiac events. Results: Multivessel disease was present in 80% of patients in both groups. Quantitative coronary angiography revealed no significant differences in baseline measures. At 6 months, angiography showed that the mean (+/-SD) in-segment late luminal loss was 0.74+/-0.86 mm in the uncoated-balloon group versus 0.03+/-0.48 mm in the coated-balloon group (P=0.002). A total of 10 of 23 patients (43%) in the uncoated-balloon group had restenosis, as compared with 1 of 22 patients (5%) in the coated-balloon group (P=0.002). At 12 months, the rate of major adverse cardiac events was 31% in the uncoated-balloon group and 4% in the coated-balloon group (P=0.01). This difference was primarily due to the need for target-lesion revascularization in six patients in the uncoated-balloon group (P=0.02). Conclusions: Treatment of coronary in-stent restenosis with paclitaxel-coated balloon catheters significantly reduced the incidence of restenosis. These data suggest that the inhibition of restenosis by local drug delivery may not require stent implantation and sustained drug release at the site of injury.