vom Dahl Jürgen, Haager Philipp K, Grube Eberhard, Gross Michael, Beythien Christian, Kromer Eckhard P, Cattelaens Norbert, Hamm Christian W, Hoffmann Rainer, Reineke Thorsten, Klues Heinrich G
Medizinische Klinik I, Universitätsklinikum der RWTH Aachen, Aachen, Germany.
Am J Cardiol. 2002 Apr 1;89(7):801-5. doi: 10.1016/s0002-9149(02)02188-4.
Experimental studies suggest a reduced neointimal tissue proliferation in vascular stainless steel stents coated with gold. This prospective multicenter trial evaluated the impact of gold coating on neointimal tissue proliferation in patients undergoing elective stent implantation. The primary end point was the in-stent tissue proliferation measured by intravascular ultrasound at 6 months comparing stents of identical design with or without gold coating (Inflow). Two hundred four patients were randomized to receive uncoated (group A, n = 101) or coated (group B, n = 103) stents. Baseline parameters did not differ between the groups. Stent length and balloon size were comparable, whereas inflation pressure was slightly higher in group A (14 +/- 3 vs 13 +/- 3 atm, p = 0.013). Procedural success was similar (A, 97%; B, 96%). The acute angiographic result was better for group B (remaining stenosis 4 +/- 12% vs 10 +/- 11%, p = 0.002). Six-month examinations revealed more neointimal proliferation in group B. By ultrasound, the neointimal volume within the stent was 47 +/- 25 versus 41 +/- 23 mm(3) (p = 0.04), with a ratio of neointimal volume-to-stent volume of 0.45 +/- 0.12 versus 0.40 +/- 0.12 (p = 0.003). The angiographic minimal luminal diameter was smaller in group B (1.47 +/- 0.57 vs 1.69 +/- 0.70 mm, p = 0.04), with a higher late luminal loss of 1.17 +/- 0.51 versus 0.82 +/- 0.56 mm (p = 0.001). Thus, gold coating of the tested stent type resulted in more neointimal tissue proliferation.
实验研究表明，涂有金的血管不锈钢支架中新生内膜组织增殖减少。这项前瞻性多中心试验评估了金涂层对择期支架植入患者新生内膜组织增殖的影响。主要终点是在6个月时通过血管内超声测量相同设计的有或没有金涂层（流入型）支架的支架内组织增殖情况。204例患者被随机分为接受未涂层（A组，n = 101）或涂层（B组，n = 103）支架。两组之间的基线参数无差异。支架长度和球囊大小相当，而A组的膨胀压力略高（14±3对13±3个大气压，p = 0.013）。手术成功率相似（A组，97%；B组，96%）。B组的急性血管造影结果更好（残余狭窄4±12%对10±11%，p = 0.002）。6个月的检查显示B组有更多的新生内膜增殖。通过超声检查，支架内新生内膜体积为47±25与41±23立方毫米（p = 0.04），新生内膜体积与支架体积之比为0.45±0.12与0.40±0.12（p = 0.003）。B组的血管造影最小管腔直径较小（1.47±0.57对1.69±0.70毫米，p = 0.04），晚期管腔丢失更高，为1.17±0.51与0.82±0.56毫米（p = 0.001）。因此，所测试的支架类型的金涂层导致更多的新生内膜组织增殖。
