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首页> 外文期刊>The New England journal of medicine >Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.
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Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.

机译：紫杉醇涂层球囊导管治疗冠状动脉支架内再狭窄。

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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. (ClinicalTrials.gov number, NCT00106587 [ClinicalTrials.gov].).
机译：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而受到阻碍。我们在这种情况下评估了紫杉醇涂层球囊的疗效和安全性。方法：我们在一项随机，双盲，多中心试验中招募了52例支架内再狭窄患者，以比较涂有紫杉醇的球囊导管（每平方毫米球囊表面积3微克）与未涂层的球囊导管的效果。在冠状动脉成形术中。如血管造影所见，主要终点是晚期管腔丢失。次要终点包括再狭窄率（二进制变量）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无明显差异。在第6个月时，血管造影显示，未包囊的气球组的节段内晚期腔平均损失（+/- SD）为0.74 +/- 0.86 mm，包囊的气球组为0.03 +/- 0.48 mm（P = 0.002）。未包囊的气球组中有23例患者中有10例（43％）发生再狭窄，相比之下，包囊的气球组中22例患者中有1例（5％）（P = 0.002）。在12个月时，未包被的气球组的主要不良心脏事件发生率为31％，包被的气球组为4％（P = 0.01）。这种差异主要是由于在未包被的气球组中有六名患者需要进行靶病变血运重建（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。 （ClinicalTrials.gov编号，NCT00106587 [ClinicalTrials.gov]。）。

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