Brilakis Emmanouil S, Lichtenwalter Christopher, de Lemos James A, Roesle Michele, Obel Owen, Haagen Donald, Saeed Bilal, Gadiparthi Chiranjeevi, Bissett Joseph K, Sachdeva Rajesh, Voudris Vassilios V, Karyofillis Panagiotis, Kar Biswajit, Rossen James, Fasseas Panayotis, Berger Peter, Banerjee Subhash
Veterans Affairs North Texas Healthcare System, Dallas, TX, USA.
J Am Coll Cardiol. 2009 Mar 17;53(11):919-28. doi: 10.1016/j.jacc.2008.11.029.
The aim of this study was to compare the frequency of angiographic restenosis and clinical events between a paclitaxel-eluting stent (PES) and a similar bare-metal stent (BMS) in saphenous vein graft (SVG) lesions.
There are conflicting and mostly retrospective data on outcomes after drug-eluting stent implantation in SVGs.
Patients requiring SVG lesion stenting were randomized to BMS or PES. The primary study end point was binary in-segment restenosis at 12-month follow-up quantitative coronary angiography. Secondary end points included death, myocardial infarction, ischemia-driven target vessel and lesion revascularization, and target vessel failure.
Eighty patients with 112 lesions in 88 SVGs were randomized to a BMS (39 patients, 43 grafts, 55 lesions) or PES (41 patients, 45 grafts, 57 lesions). Binary angiographic restenosis occurred in 51% of the BMS-treated lesions versus 9% of the PES-treated lesions (relative risk: 0.18; 95% confidence interval [CI]: 0.07 to 0.48, p < 0.0001). During a median follow-up of 1.5 years the PES patients had less target lesion revascularization (28% vs. 5%, hazard ratio: 0.38; 95% CI: 0.15 to 0.74, p = 0.003) and target vessel failure (46% vs. 22%, hazard ratio: 0.65; 95% CI: 0.42 to 0.96, p = 0.03), a trend toward less target vessel revascularization (31% vs. 15%, hazard ratio: 0.66; 95% CI: 0.39 to 1.05, p = 0.08) and myocardial infarction (31% vs. 15%, hazard ratio: 0.67; 95% CI: 0.40 to 1.08, p = 0.10), and similar mortality (5% vs. 12%, hazard ratio: 1.56; 95% CI: 0.72 to 4.11, p = 0.27).
In SVG lesions, PES are associated with lower rates of angiographic restenosis and target vessel failure than BMS.
本研究旨在比较紫杉醇洗脱支架（PES）与类似裸金属支架（BMS）在隐静脉桥（SVG）病变中的血管造影再狭窄频率和临床事件。
关于在SVG中植入药物洗脱支架后的结果，存在相互矛盾且大多为回顾性的数据。
需要对SVG病变进行支架置入的患者被随机分配至BMS或PES组。主要研究终点是在12个月随访定量冠状动脉造影时的节段内二元再狭窄。次要终点包括死亡、心肌梗死、缺血驱动的靶血管和病变血运重建以及靶血管失败。
88条SVG中有112处病变的80例患者被随机分配至BMS组（39例患者，43条移植物，55处病变）或PES组（41例患者，45条移植物，57处病变）。BMS治疗的病变中51%发生二元血管造影再狭窄，而PES治疗的病变中为9%（相对风险：0.18；95%置信区间[CI]：0.07至0.48，p<0.0001）。在中位随访1.5年期间，PES组患者的靶病变血运重建较少（28%对5%，风险比：0.38；95%CI：0.15至0.74，p = 0.003）和靶血管失败较少（46%对22%，风险比：0.65；95%CI：0.42至0.96，p = 0.03），靶血管血运重建有减少趋势（31%对15%，风险比：0.66；95%CI：0.39至1.05，p = 0.08）和心肌梗死有减少趋势（31%对15%，风险比：0.67；95%CI：0.40至1.08，p = 0.10），且死亡率相似（5%对12%，风险比：1.56；95%CI：0.72至4.11，p = 0.27）。
在SVG病变中，与BMS相比，PES与较低的血管造影再狭窄率和靶血管失败率相关。
