Albiero Remo, Silber Sigmund, Di Mario Carlo, Cernigliaro Carmelo, Battaglia Salvatore, Reimers Bernhard, Frasheri Arian, Klauss Volker, Auge Joseph M, Rubartelli Paolo, Morice Marie-Claude, Cremonesi Alberto, Schofer Joachim, Bortone Alessandro, Colombo Antonio
Columbus Hospital, Milan, Italy.
J Am Coll Cardiol. 2004 Mar 17;43(6):943-9. doi: 10.1016/j.jacc.2003.09.054.
The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR).
Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR.
The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative).
In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p < 0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar.
Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.
本试验旨在比较切割球囊血管成形术（CBA）与传统球囊血管成形术（即经皮腔内冠状动脉血管成形术[PTCA]）治疗冠状动脉支架内再狭窄（ISR）患者的效果。
回顾性研究表明，在治疗ISR方面，CBA可能优于传统PTCA。
再狭窄切割球囊评估试验（RESCUT）是一项多中心、随机、前瞻性欧洲试验，纳入了428例各种类型ISR（如局灶性、多灶性、弥漫性、增殖性）患者。
两组中，大多数ISR病变长度均短于20 mm。再狭窄支架的长度相似（CBA组：18.6±9.7 mm；PTCA组：18.3±8.7 mm）。CBA组用于治疗ISR的球囊数量较少：82.3%的CBA病例仅使用了一个球囊，而PTCA手术中这一比例为75%（p = 0.03）。CBA组球囊滑脱的发生率较低（CBA组为6.5%，PTCA组为25%；p < 0.01）。CBA组额外置入支架的需求有降低趋势（CBA组为3.9%，PTCA组为8.0%；p = 0.07）。在7个月的血管造影随访中，两组的二元再狭窄率无差异（CBA组为29.8%，PTCA组为31.4%；p = 0.82），复发再狭窄模式相似。7个月时的临床事件也相似。
与传统PTCA相比，切割球囊血管成形术并未降低复发性ISR和主要不良心脏事件的发生率。然而，CBA具有一些操作上的优势，如使用的球囊较少、额外置入支架的需求较低以及球囊滑脱的发生率较低。
