de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es G A
Department of Cardiology, Thoraxcenter, Rotterdam, The Netherlands.
Eur Heart J. 1998 Aug;19(8):1214-23. doi: 10.1053/euhj.1998.1012.
A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate.
The study was designed to be multicentred, prospective, and observational.
One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100 mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients). At quantitative coronary angiography, the minimal lumen diameter (mean+/-SD) increased from 1.12+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8.3%. When the two patients with documented stent thrombosis are included, the restenosis rate amounts to 97%.
These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved. The exact role of intravascular ultrasound in the achievement of these results needs to be established by appropriately designed studies. In the meantime, intravascular ultrasound coupled with the Palmaz-Schatz stent incorporating a spiral bridge, may have contributed considerably to the immediate angiographic outcome, which in turn may explain the favourable clinical and angiographic outcome at 6 months.
开展一项研究以验证血管内超声引导下无需后续抗凝治疗的支架置入术的安全性和可行性，及其对6个月再狭窄率的影响。
该研究设计为多中心、前瞻性观察性研究。
纳入161例稳定型心绞痛且有新发冠状动脉病变的患者。4例患者植入Palmaz-Schatz（带螺旋桥）支架失败。这4例患者中有1例在搭桥手术后3天死亡。另外2例患者未进行血管内超声评估。其余155例患者中有125例（81%）因满足支架最佳扩张的所有三项标准而接受阿司匹林治疗（100mg×每日-1）。其余38例患者中至少有一项标准未满足的22例（25%）接受阿司匹林和醋硝香豆素治疗（3个月，国际标准化比值2.5 - 3.5），而16例患者仅接受阿司匹林治疗。有2例患者（1.3%）发生支架血栓形成，为此进行了再次血管成形术。住院期间，无死亡或Q波心肌梗死发生。5例患者（3.2%）发生非Q波心肌梗死。在随访期（198±38天，除1例患者外所有患者随访完整），1例患者（0.6%）发生Q波心肌梗死，1例（0.6%）接受搭桥手术，9例患者（5.7%）进行了再次血管成形术。9例患者中有2例再次血管成形术涉及另一病变。因此，随访期间靶病变血管重建率为4.5%（7例患者）。在定量冠状动脉造影中，最小管腔直径（平均值±标准差）从支架置入前的1.12±0.34mm增加到置入后的2.89±0.35mm。144例患者（92%）在6个月时进行了再次血管造影。随访时最小管腔直径为2.12±0.67mm。12例患者（8.3%）记录有再狭窄（直径狭窄50%或以上）。若将2例记录有支架血栓形成的患者包括在内，再狭窄率达97%。
这些数据证实，在选定患者中，若能实现支架最佳扩张，可不使用全身抗凝而安全地植入支架。血管内超声在取得这些结果中的确切作用需要通过适当设计的研究来确定。同时，血管内超声结合带有螺旋桥的Palmaz-Schatz支架可能对即刻血管造影结果有很大贡献，这反过来可能解释了6个月时良好的临床和血管造影结果。
