Savage M P, Fischman D L, Schatz R A, Teirstein P S, Leon M B, Baim D, Ellis S G, Topol E J, Hirshfeld J W, Cleman M W
Department of Medicine, Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania 19107.
J Am Coll Cardiol. 1994 Nov 1;24(5):1207-12. doi: 10.1016/0735-1097(94)90099-x.
The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary stent implantation.
Previous reports have shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting.
Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of angiographers utilizing an automated edge detection program. Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year.
Although there were no acute in laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean +/- SD of 5 +/- 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 +/- 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 +/- 0.39 mm at baseline to 1.65 +/- 0.51 mm after angioplasty and further increased to 2.55 +/- 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 +/- 0.71 mm. Restenosis, defined as > or = 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions.
Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.
本研究旨在探讨冠状动脉支架植入术后的长期临床及血管造影结果。
既往报道显示冠状动脉支架置入术后，最初良好的血管造影结果与随后的不良临床事件之间存在不一致。
对连续300例患者的自身冠状动脉选择性植入单枚Palmaz-Schatz支架。在基线、球囊血管成形术后、支架植入后及植入后6个月时进行血管造影。血管造影图像由一组血管造影师使用自动边缘检测程序进行分析。记录1年内的临床事件，包括死亡、心肌梗死、冠状动脉搭桥手术及再次血管成形术。
虽然术中无实验室血管急性闭塞，但14例患者（4.7%）在植入后平均±标准差5±3天发生支架血栓形成。286例符合条件的患者中有258例（90%）在支架植入后6.1±2.2个月进行了随访血管造影。最小管腔直径从基线时的0.80±0.39mm增加到血管成形术后的1.65±0.51mm，并在支架置入后进一步增加到2.55±0.49mm（p = 0.0001）。随访时管腔直径有0.85mm的晚期丢失，6个月时最终最小管腔直径为1.70±0.71mm。再狭窄定义为随访时直径狭窄≥50%，在既往未经治疗病变的患者中发生率为14%，在既往有血管成形术的患者中发生率为39%（p < 0.001）。300例患者1年后的临床事件包括死亡0.7%、心肌梗死3.7%、搭桥手术8%及再次血管成形术13%。所有接受治疗患者无任何不良临床事件的生存率为80%，既往未经治疗病变患者为87%。
在自身冠状动脉循环中选择性使用这种球囊扩张支架，经定量血管造影显示既往未经治疗病变的再狭窄率较低，临床结果良好，1年无事件生存率优异。
