Mauri Laura, Bonan Raoul, Weiner Bonnie H, Legrand Victor, Bassand Jean-Pierre, Popma Jeffrey J, Niemyski Paulette, Prpic Ross, Ho Kalon K L, Chauhan Manish S, Cutlip Donald E, Bertrand Olivier F, Kuntz Richard E
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Am J Cardiol. 2002 Nov 15;90(10):1079-83. doi: 10.1016/s0002-9149(02)02773-x.
The cutting balloon (CB) is a specialized device designed to create discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Such controlled dilatation theoretically reduces the force needed to dilate an obstructive lesion compared with standard percutaneous transluminal coronary angioplasty (PTCA). We report a multicenter, randomized trial comparing the incidence of restenosis after CB angioplasty versus conventional balloon angioplasty in 1,238 patients. Six hundred seventeen patients were randomized to CB treatment, and 621 to PTCA. The mean reference vessel diameter was 2.86 +/- 0.49 mm, mean lesion length 8.9 +/- 4.3 mm, and prevalence of diabetes mellitus in patients was 13%. The primary end point, the 6-month binary angiographic restenosis rate, was 31.4% for CB and 30.4% for PTCA (p = 0.75). Acute procedural success, defined as the attainment of <50% diameter stenosis without in-hospital major adverse cardiac events, was 92.9% for CB and 94.7% for PTCA (p = 0.24). Freedom from target vessel revascularization was slightly higher in the CB arm (88.5% vs 84.6%, log-rank p = 0.04). Five coronary perforations occurred in the CB arm only (0.8% vs 0%, p = 0.03). At 270 days, rates of myocardial infarction, death, and total major adverse cardiac events for CB and PTCA were 4.7% versus 2.4% (p = 0.03), 1.3% versus 0.3% (p = 0.06), and 13.6% versus 15.1% (p = 0.34), respectively. In summary, the proposed mechanism of controlled dilatation did not reduce the rate of angiographic restenosis for the CB compared with conventional balloon angioplasty. CB angioplasty should be reserved for difficult lesions in which controlled dilatation is believed to provide a better acute result compared with balloon angioplasty alone.
切割球囊（CB）是一种专门设计的器械，用于在球囊充盈时在动脉粥样硬化的目标冠状动脉节段制造离散的纵向切口。与标准经皮腔内冠状动脉成形术（PTCA）相比，这种可控扩张理论上可减少扩张阻塞性病变所需的力量。我们报告了一项多中心随机试验，比较了1238例患者接受CB血管成形术后与传统球囊血管成形术后再狭窄的发生率。617例患者被随机分配接受CB治疗，621例接受PTCA治疗。平均参考血管直径为2.86±0.49mm，平均病变长度为8.9±4.3mm，患者糖尿病患病率为13%。主要终点，即6个月时的二元血管造影再狭窄率，CB组为31.4%，PTCA组为30.4%（p = 0.75）。急性手术成功率定义为直径狭窄<50%且无院内主要不良心脏事件，CB组为92.9%，PTCA组为94.7%（p = 0.24）。CB组免于靶血管血运重建的比例略高（88.5%对84.6%，对数秩检验p = 0.04）。仅CB组发生了5例冠状动脉穿孔（0.8%对0%，p = 0.03）。在270天时，CB组和PTCA组的心肌梗死、死亡及总的主要不良心脏事件发生率分别为4.7%对2.4%（p = 0.03）、1.3%对0.3%（p = 0.06）、13.6%对15.1%（p = 0.34）。总之，与传统球囊血管成形术相比，CB可控扩张的拟议机制并未降低血管造影再狭窄率。CB血管成形术应保留用于那些认为与单纯球囊血管成形术相比可控扩张能提供更好急性效果的复杂病变。
