Schroeder S, Baumbach A, Haase K K, Oberhoff M, Marholdt H, Herdeg C, Athanasiadis A, Karsch K R
Department of Internal Medicine, University of Tuebingen, Germany.
Am J Cardiol. 1999 Mar 15;83(6):875-9. doi: 10.1016/s0002-9149(98)01069-8.
Restenosis following percutaneous transluminal coronary angioplasty (PTCA) remains a serious problem in interventional cardiology. Recent trials using stent implantation have proposed a reduction in restenosis, presumably due to a higher initial luminal gain. This study was conducted to evaluate if the short- and long-term results following conventional PTCA may be favorable, if balloon dilation was performed according to measurements gained by intravascular ultrasound (IVUS) (vessel size adapted PTCA). The use of intracoronary stents might be omitted if comparable long-term results could be achieved by this modified technique of balloon angioplasty. This unicenter and nonrandomized pilot trial was initiated in January 1995 with 252 patients who had 271 lesions. IVUS was performed before and after intervention to determine the external elastic membrane (EEM) diameter at the lesion site. The balloon catheter was sized according to the EEM diameter measured by IVUS (EEM 10%). The mean balloon diameter was 4.1 +/- 0.5 mm, the dilation time 130 +/- 60 seconds with a balloon pressure of 7.0 +/- 2.0 atm. Clinical acute and 1-year long-term follow-up were obtained for all patients and follow-up angiography in 71% of patients. Acute events occurred postinterventionally in 5 patients (2%). The cumulative event rate during long-term follow-up was 14%. The angiographic restenosis rate (diameter stenosis >50%) after 1 year was 19%. Vessel size adapted PTCA using IVUS led to favorable acute and long-term results with a low restenosis rate and a low 1-year clinical event rate. Despite dissections that occur frequently using large balloon sizes, an increased rate of major complications did not occur, indicating a safe procedure and substantiating the philosophy of "therapeutic dissections." The results need to be verified in a randomized trial.
经皮腔内冠状动脉成形术（PTCA）后再狭窄仍是介入心脏病学中的一个严重问题。最近使用支架植入的试验表明再狭窄有所减少，推测这是由于初始管腔增益更高。本研究旨在评估，如果根据血管内超声（IVUS）获得的测量结果进行球囊扩张（血管大小适配性PTCA），传统PTCA后的短期和长期结果是否良好。如果这种改良的球囊血管成形术能取得可比的长期结果，那么冠状动脉内支架的使用或许可以省略。这项单中心、非随机的试点试验于1995年1月启动，纳入了252例患者的271处病变。在干预前后进行IVUS检查，以确定病变部位的外弹力膜（EEM）直径。根据IVUS测量的EEM直径（EEM的10%）选择球囊导管。球囊平均直径为4.1±0.5mm，扩张时间为130±60秒，球囊压力为7.0±2.0个大气压。对所有患者进行了临床急性和1年长期随访，71%的患者进行了随访血管造影。干预后有5例患者（2%）发生急性事件。长期随访期间的累积事件发生率为14%。1年后血管造影再狭窄率（直径狭窄>50%）为19%。使用IVUS的血管大小适配性PTCA产生了良好的急性和长期结果，再狭窄率低，1年临床事件发生率低。尽管使用大尺寸球囊时经常发生夹层，但并未出现主要并发症发生率增加的情况，这表明该手术安全，并证实了“治疗性夹层”的理念。结果需要在随机试验中得到验证。
