Vermeersch Paul, Agostoni Pierfrancesco, Verheye Stefan, Van den Heuvel Paul, Convens Carl, Bruining Nico, Van den Branden Frank, Van Langenhove Glenn
Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Antwerp, Belgium.
J Am Coll Cardiol. 2006 Dec 19;48(12):2423-31. doi: 10.1016/j.jacc.2006.09.021. Epub 2006 Nov 28.
We sought to compare, in a randomized fashion, sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVGs).
Sirolimus-eluting stents reduce restenosis and repeated revascularization in native coronary arteries compared with BMS. However, randomized data in SVG are absent.
Patients with SVG lesions were randomized to SES or BMS. All were scheduled to undergo 6-month coronary angiography. The primary end point was 6-month angiographic in-stent late lumen loss. Secondary end points included binary angiographic restenosis, neointimal volume by intravascular ultrasound and major adverse clinical events (death, myocardial infarction, target lesion, and vessel revascularization).
A total of 75 patients with 96 lesions localized in 80 diseased SVGs were included: 38 patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. In-stent late loss was significantly reduced in SES (0.38 +/- 0.51 mm vs. 0.79 +/- 0.66 mm in BMS, p = 0.001). Binary in-stent and in-segment restenosis were reduced, 11.3% versus 30.6% (relative risk [RR] 0.37; 95% confidence interval [CI] 0.15 to 0.97, p = 0.024) and 13.6% versus 32.6% (RR 0.42; 95% CI 0.18 to 0.97, p = 0.031), respectively. Median neointimal volume was 1 mm(3) (interquartile range 0 to 13) in SES versus 24 (interquartile range 8 to 34) in BMS (p < 0.001). Target lesion and vessel revascularization rates were significantly reduced, 5.3% versus 21.6% (RR 0.24; 95% CI 0.05 to 1.0, p = 0.047) and 5.3% versus 27% (RR 0.19; 95% CI 0.05 to 0.83, p = 0.012), respectively. Death and myocardial infarction rates were not different.
Sirolimus-eluting stents significantly reduce late loss in SVG as opposed to BMS. This is associated with a reduction in restenosis rate and repeated target lesion and vessel revascularization procedures. (The RRISC Study; http://clinicaltrials.gov/ct/show; NCT00263263).
我们试图以随机方式比较雷帕霉素洗脱支架（SES）与裸金属支架（BMS）在隐静脉移植物（SVG）中的应用效果。
与BMS相比，雷帕霉素洗脱支架可减少天然冠状动脉中的再狭窄和重复血管重建。然而，SVG中的随机数据尚不存在。
患有SVG病变的患者被随机分配至SES或BMS组。所有患者均计划接受6个月的冠状动脉造影。主要终点是6个月时血管造影的支架内晚期管腔丢失。次要终点包括二元血管造影再狭窄、血管内超声测量的新生内膜体积以及主要不良临床事件（死亡、心肌梗死、靶病变和血管再血管化）。
总共纳入了75例患者，其96处病变位于80条病变的SVG中：38例患者接受了60枚SES用于47处病变，而37例患者接受了54枚BMS用于49处病变。SES组的支架内晚期丢失显著减少（0.38±0.51mm vs. BMS组的0.79±0.66mm，p = 0.001）。支架内和节段内的二元再狭窄减少，分别为11.3%对30.6%（相对风险[RR]0.37；95%置信区间[CI]0.15至0.97，p = 0.024）和13.6%对32.6%（RR 0.42；95%CI 0.18至0.97，p = 0.031）。SES组新生内膜体积中位数为1mm³（四分位间距0至13），而BMS组为24（四分位间距8至34）（p < 0.001）。靶病变和血管再血管化率显著降低，分别为5.3%对21.6%（RR 0.24；95%CI 0.05至1.0，p = 0.047）和5.3%对27%（RR 0.19；95%CI 0.05至0.83，p = 0.012）。死亡和心肌梗死率无差异。
与BMS相比，雷帕霉素洗脱支架可显著减少SVG中的晚期丢失。这与再狭窄率以及重复的靶病变和血管再血管化手术的减少相关。（RRISC研究；http://clinicaltrials.gov/ct/show；NCT00263263）
