Tanaka Shinichiro, Watanabe Sachiro, Matsuo Hitoshi, Segawa Tomonori, Iwama Makoto, Hirose Takeshi, Takahashi Haruki, Ono Koji, Warita Shunichiro, Kojima Tai, Minatoguchi Shinya, Fujiwara Hisayoshi
Second Department of Internal Medicine, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan.
Heart Vessels. 2008 Jan;23(1):1-8. doi: 10.1007/s00380-007-1000-2. Epub 2008 Feb 14.
The recent SCORES trial demonstrated that lower dilatation pressures seen with self-expanding (SE) stents may be associated with lower rates of target lesion revascularization (TLR). To determine whether SE stents with low-pressure dilatation are as safe and effective as balloon expandable (BE) stents. We randomly assigned 254 patients with 279 coronary lesions to groups receiving either SE with low-pressure dilatation <12 atm (n = 143) or conventional BE stents (n = 136). Thereafter, acute results and long-term outcomes were compared. Baseline patient and angiographic characteristics were similar in two groups. The incidence of procedural complications, such as slow flow, side branch occlusion, and edge dissection were significantly lower in the SE group than in the BE group (overall: SE, 17; BE, 35; P < 0.01), and the occurrence of myocardial infarction tended to be lower in SE than in BE (SE, 1; BE, 4; not significant). Although acute gain was significantly smaller with SE than BE (SE, 2.21 +/- 0.65 mm; BE, 2.42 +/- 0.62; P < 0.01), probably due to gradual expansion of the SE stent, nearly identical minimum luminal diameters on follow-up angiography (SE, 2.14 +/- 0.92 mm vs. BE, 2.22 +/- 0.93; not significant) and similar angiographic restenosis (SE, 18.1% vs. BE, 20.5%). and TLR rates (SE, 16.1% vs. BE, 14.0%) were apparent. This prospective randomized trial demonstrates that SE stents with low-pressure dilatation is safe and effective strategy for treating coronary arterial stenosis.
近期的SCORES试验表明，自膨胀（SE）支架较低的扩张压力可能与较低的靶病变血运重建（TLR）率相关。为确定低压扩张的SE支架是否与球囊扩张（BE）支架一样安全有效。我们将254例有279处冠状动脉病变的患者随机分为接受<12个大气压低压扩张的SE支架组（n = 143）或传统BE支架组（n = 136）。此后，比较了急性结果和长期预后。两组患者的基线特征和血管造影特征相似。SE组手术并发症（如慢血流、边支闭塞和边缘夹层）的发生率显著低于BE组（总体情况：SE组17例，BE组35例；P < 0.01），SE组心肌梗死的发生率也倾向于低于BE组（SE组1例，BE组4例；无显著性差异）。尽管SE支架的急性血管增益显著小于BE支架（SE组为2.21±0.65 mm；BE组为2.42±0.62；P < 0.01），这可能是由于SE支架的逐渐扩张所致，但随访血管造影显示两组的最小管腔直径几乎相同（SE组为2.14±0.92 mm，BE组为2.22±0.93；无显著性差异），血管造影再狭窄率（SE组为18.1%，BE组为20.5%）和TLR率（SE组为16.1%，BE组为14.0%）也相似。这项前瞻性随机试验表明，低压扩张的SE支架是治疗冠状动脉狭窄的一种安全有效的策略。
