Unverdorben Martin, Vallbracht Christian, Cremers Bodo, Heuer Hubertus, Hengstenberg Christian, Maikowski Christian, Werner Gerald S, Antoni Diethmar, Kleber Franz X, Bocksch Wolfgang, Leschke Matthias, Ackermann Hanns, Boxberger Michael, Speck Ulrich, Degenhardt Ralf, Scheller Bruno
Institut für Klinische Forschung, Herz- und Kreislaufzentrum, Rotenburg, Germany.
Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.
Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care.
One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 microg/mm2) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38+/-0.61 mm in the drug-eluting stent group versus 0.17+/-0.42 mm (P=0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P=0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (P=0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P=0.15).
Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation.
与普通球囊血管成形术相比，使用紫杉醇涂层球囊导管治疗支架内再狭窄在6个月时显示出惊人的低晚期管腔丢失，并且在长达2年的时间里主要不良心脏事件较少。我们将紫杉醇涂层球囊与作为当前护理标准的紫杉醇洗脱支架的疗效和安全性进行了比较。
131例冠状动脉支架内再狭窄患者被随机分配接受紫杉醇涂层球囊（3微克/平方毫米）或紫杉醇洗脱支架治疗。主要纳入标准包括直径狭窄≥70%且长度≤22毫米，血管直径为2.5至3.5毫米。主要终点是血管造影节段内晚期管腔丢失。定量冠状动脉造影显示基线参数无差异。在6个月随访时，药物洗脱支架组节段内晚期管腔丢失为0.38±0.61毫米，而药物涂层球囊组为0.17±0.42毫米（P = 0.03），导致二元再狭窄率在59例中有12例（20%），而在57例中有4例（7%；P = 0.06）。在12个月时，主要不良心脏事件发生率分别为22%和9%（P = 0.08）。这种差异主要是由于涂层球囊组有4例患者（6%）需要进行靶病变血管重建，而支架组有10例患者（15%）（P = 0.15）。
使用紫杉醇涂层球囊治疗冠状动脉支架内再狭窄至少与紫杉醇洗脱支架一样有效且耐受性良好。对于支架内再狭窄的治疗，抑制再狭窄不需要再次植入支架。
