Legrand V M, Garcia E J, Grube E, Khalife K, Bonnier H, Commeau P, Przewlocki T, Macaya C, Witkowski A
Department of Cardiology, C.H.U. de Liège, Liège, Belgium.
Catheter Cardiovasc Interv. 2001 Nov;54(3):276-82. doi: 10.1002/ccd.1284.
The objectives of the Race Car study were to assess the safety and efficacy of the Medtronic AVE S670 stent, a new-generation stent with a modular design consisting of interconnected sinusoidal rings allowing improved flexibility with good conformability and scaffolding. A total of 285 stents were implanted in 267 patients with (un)stable angina pectoris who underwent angioplasty of a single de novo lesion in a native coronary artery with a diameter between 3.0 and 4.0 mm. Available stent lengths were 9, 12, and 15 mm. The primary endpoint was the 6-month restenosis rate. Secondary endpoints were device and procedural success and major adverse cardiac event (MACE)-free survival at 1 and 6 months. All patients received the study stents and no other stents were used (angiographic success: 100%). Eight patients experienced a MACE during hospital admission (Q-wave MI in 2, non-Q-wave MI in 4, TLR in 2). A procedural success was obtained in 97% of the patients. There were no additional events at 1 month. The clinical endpoints encountered at 6 months were Q-wave MI in 1, bypass surgery in 3, and repeat angioplasty in 25 (MACE-free survival: 86.5%). Quantitative angiographic results were the minimum lumen diameter increased from 1.05 +/- 0.32 before to 2.73 +/- 0.39 mm after stent implantation. At follow-up, the loss in diameter was 0.74 +/- 0.50 mm. The loss index was 0.45 +/- 0.31 and restenosis rate was 13.4%. This study has demonstrated that the S670 stent in patients with (un)stable angina pectoris requiring intervention of a single lesion has a low acute and 6-month major event rate and a low angiographic restenosis rate.
“赛车”研究的目的是评估美敦力AVE S670支架的安全性和有效性。该支架是新一代模块化设计的支架，由相互连接的正弦环组成，具有更好的柔韧性、贴合性和支撑性。共有285枚支架植入了267例（不）稳定型心绞痛患者体内，这些患者在直径为3.0至4.0毫米的天然冠状动脉中接受了单处初发病变的血管成形术。可用的支架长度为9毫米、12毫米和15毫米。主要终点是6个月时的再狭窄率。次要终点是器械和手术成功率以及1个月和6个月时无主要不良心脏事件（MACE）的生存率。所有患者均接受了研究支架，未使用其他支架（血管造影成功率：100%）。8例患者在住院期间发生了MACE（2例为Q波心肌梗死，4例为非Q波心肌梗死，2例为靶病变血运重建）。97%的患者手术成功。1个月时无其他事件发生。6个月时遇到的临床终点为1例Q波心肌梗死、3例搭桥手术和25例再次血管成形术（无MACE生存率：86.5%）。定量血管造影结果显示，最小管腔直径从支架植入前的1.05±0.32毫米增加到术后的2.73±0.39毫米。随访时，直径损失为0.74±0.50毫米。损失指数为0.45±0.31，再狭窄率为13.4%。这项研究表明，对于需要对单处病变进行干预的（不）稳定型心绞痛患者，S670支架具有较低的急性和6个月主要事件发生率以及较低的血管造影再狭窄率。
