Park S W, Lee C W, Hong M K, Kim J J, Cho G Y, Nah D Y, Park S J
Department of Medicine, Asan Medical Center, University of Ulsan, Seoul, Korea.
Eur Heart J. 2000 Nov;21(21):1785-9. doi: 10.1053/euhj.1999.1947.
Angioplasty of lesions in small coronary arteries remains a significant problem because of the increased risk of restenosis. The aim of this study was to compare the efficacy of elective coronary stent placement and optimal balloon angioplasty in small vessel disease.
One hundred and twenty patients with lesions in small coronary arteries (de novo, non-ostial lesion and reference diameter <3 mm) were randomly assigned to either balloon angioplasty or elective stent placement (7-cell NIR stent). The primary end-point was restenosis at 6 months follow-up. Optimal balloon angioplasty was defined as diameter stenosis less than or = 30% and the absence of major dissection after the angioplasty, and crossover to stenting was allowed.
Baseline clinical and angiographic characteristics were similar in the two groups. Procedure was successful in all patients, and in-hospital events did not occur in any patient. However, 12 patients in the angioplasty group were stented because of suboptimal results or major dissection. Postprocedural lumen diameter was significantly larger in the stent group than in the angioplasty group (2.44 +/- 0.36 mm vs 2.14 +/- 0.36, P<0.05, respectively), but late loss was greater in the stent group (1.12 +/- 0.67 mm vs 0.63 +/- 0.48, P<0.01, respectively). The angiographic restenosis rate was 30.9% in the angioplasty group, and 35.7% in the stent group (P = ns). Clinical follow-up was available in all patients (15.9 +/- 5.7 months) and clinical events during the follow-up were similar in both groups.
These results suggest that optimal balloon angioplasty with provisional stenting may be a reasonable approach for treatment of lesions in small coronary arteries.
由于再狭窄风险增加，小冠状动脉病变的血管成形术仍然是一个重大问题。本研究的目的是比较选择性冠状动脉支架置入术与最佳球囊血管成形术治疗小血管疾病的疗效。
120例小冠状动脉病变（初发、非开口病变且参考直径<3mm）患者被随机分为球囊血管成形术组或选择性支架置入术组（7细胞NIR支架）。主要终点是6个月随访时的再狭窄。最佳球囊血管成形术定义为血管成形术后直径狭窄小于或等于30%且无严重夹层，并允许交叉至支架置入术。
两组的基线临床和血管造影特征相似。所有患者手术均成功，且无患者发生院内事件。然而，血管成形术组有12例患者因结果不理想或严重夹层而置入了支架。术后支架组的管腔直径明显大于血管成形术组（分别为2.44±0.36mm和2.14±0.36mm，P<0.05），但支架组的晚期管腔丢失更大（分别为1.12±0.67mm和0.63±0.48mm，P<0.01）。血管成形术组的血管造影再狭窄率为30.9%，支架组为35.7%（P=无统计学意义）。所有患者均有临床随访（15.9±5.7个月），两组随访期间的临床事件相似。
这些结果表明，采用临时支架置入术的最佳球囊血管成形术可能是治疗小冠状动脉病变的合理方法。
