Savage M P, Douglas J S, Fischman D L, Pepine C J, King S B, Werner J A, Bailey S R, Overlie P A, Fenton S H, Brinker J A, Leon M B, Goldberg S
Jefferson Medical College, Philadelphia, PA 19107, USA.
N Engl J Med. 1997 Sep 11;337(11):740-7. doi: 10.1056/NEJM199709113371103.
Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts.
A total of 220 patients with new lesions in aortocoronary-venous bypass grafts were randomly assigned to placement of Palmaz-Schatz stents or standard balloon angioplasty. Coronary angiography was performed during the index procedure and six months later.
As compared with the patients assigned to angioplasty, those assigned to stenting had a higher rate of procedural efficacy, defined as a reduction in stenosis to less than 50 percent of the vessel diameter without a major cardiac complication (92 percent vs. 69 percent, P<0.001), but they had more frequent hemorrhagic complications (17 percent vs. 5 percent, P<0.01). Patients in the stent group had a larger mean (+/-SD) increase in luminal diameter immediately after the procedure (1.92+/-0.30 mm, as compared with 1.21+/-0.37 mm in the angioplasty group; P<0.001) and a greater mean net gain in luminal diameter at six months (0.85+/-0.96 vs. 0.54+/-0.91 mm, P=0.002). Restenosis occurred in 37 percent of the patients in the stent group and in 46 percent of the patients in the angioplasty group (P=0.24). The outcome in terms of freedom from death, myocardial infarction, repeated bypass surgery, or revascularization of the target lesion was significantly better in the stent group (73 percent vs. 58 percent, P = 0.03).
As compared with balloon angioplasty, stenting of selected venous bypass-graft lesions resulted in superior procedural outcomes, a larger gain in luminal diameter, and a reduction in major cardiac events. However, there was no significant benefit in the rate of angiographic restenosis, which was the primary end point of the study.
冠状动脉搭桥手术后大隐静脉移植物狭窄的治疗是一项艰巨的挑战。本研究的目的是比较支架置入术与球囊血管成形术对大隐静脉移植物阻塞性疾病患者临床和血管造影结果的影响。
总共220例主动脉冠状动脉静脉搭桥移植物出现新病变的患者被随机分配接受Palmaz-Schatz支架置入或标准球囊血管成形术。在初次手术期间及6个月后进行冠状动脉造影。
与接受血管成形术的患者相比，接受支架置入术的患者手术成功率更高，手术成功率定义为狭窄程度降低至血管直径的50%以下且无重大心脏并发症（92%对69%，P<0.001），但出血并发症更常见（17%对5%，P<0.01）。支架组患者术后即刻管腔直径平均（±标准差）增加更大（1.92±0.30mm，血管成形术组为1.21±0.37mm；P<0.001），6个月时管腔直径平均净增加更大（0.85±0.96对0.54±0.91mm，P=0.002）。支架组37%的患者出现再狭窄，血管成形术组为46%（P=0.24）。支架组在无死亡、心肌梗死、再次搭桥手术或靶病变血运重建方面的结果明显更好（73%对58%，P = 0.03）。
与球囊血管成形术相比，对选定的静脉搭桥移植物病变进行支架置入术可带来更好的手术结果、更大的管腔直径增加以及主要心脏事件的减少。然而，在作为研究主要终点的血管造影再狭窄率方面没有显著益处。
