Maehara Akiko, Mintz Gary S, Lansky Alexandra J, Witzenbichler Bernhard, Guagliumi Giulio, Brodie Bruce, Kellett Mirle A, Parise Helen, Mehran Roxana, Stone Gregg W
Columbia University Medical Center, New York, NY 10022, USA.
Circulation. 2009 Nov 10;120(19):1875-82. doi: 10.1161/CIRCULATIONAHA.109.873893. Epub 2009 Oct 26.
Vascular responses to drug-eluting stents in ST-segment elevation myocardial infarction are unknown. In the prospective, multicenter Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset were randomized 3:1 to TAXUS EXPRESS paclitaxel-eluting stents (PES) or EXPRESS bare metal stents (BMS).
A formal intravascular ultrasound substudy enrolled 464 patients with baseline and 13-month follow-up imaging at 36 centers. Overall, 446 lesions in 402 patients were suitable for standard qualitative and quantitative analyses, which were performed at an independent blinded core laboratory. The primary prespecified end point was the in-stent percent net volume obstruction at follow-up. Median stent length measured 23.4 mm (first and third quartiles, 18.5 and 31.9 mm). PES compared with BMS significantly reduced 13-month percent net volume obstruction (6.5% [first and third quartiles, 2.2% and 10.8%] versus 15.6% [first and third quartiles, 7.2% and 28.8%]; P<0.0001). PES compared with BMS also resulted in more late-acquired stent malapposition (29.6% versus 7.9%; P=0.0005) resulting from positive vessel remodeling. Plaque and/or thrombus protrusion through stent struts was initially present in 70.4% of PES and 64.8% of BMS; all resolved during follow-up. New aneurysm formation, stent fracture, and subclinical thrombus were uncommon, although seen only in PES.
PES compared with BMS significantly reduce neointimal hyperplasia in patients with ST-segment elevation myocardial infarction but also result in a high frequency of late-acquired stent malapposition as a result of positive vessel remodeling. Ongoing long-term follow-up is required to establish the clinical significance of these findings. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.
药物洗脱支架在ST段抬高型心肌梗死中的血管反应尚不清楚。在一项前瞻性、多中心的急性心肌梗死血管重建和支架置入术疗效协调研究（HORIZONS-AMI）试验中，症状发作12小时内的ST段抬高型心肌梗死患者按3:1随机分为TAXUS EXPRESS紫杉醇洗脱支架（PES）组或EXPRESS裸金属支架（BMS）组。
一项正式的血管内超声亚研究纳入了36个中心的464例患者，进行了基线和13个月随访成像。总体而言，402例患者的446处病变适合进行标准的定性和定量分析，这些分析在一个独立的盲法核心实验室进行。预先设定的主要终点是随访时支架内净体积阻塞百分比。支架中位长度为23.4 mm（第一和第三四分位数分别为18.5和31.9 mm）。与BMS相比，PES显著降低了13个月时的净体积阻塞百分比（6.5%[第一和第三四分位数分别为2.2%和10.8%]对15.6%[第一和第三四分位数分别为7.2%和28.8%]；P<0.0001）。与BMS相比，PES还导致因血管正向重塑而出现更多的晚期获得性支架贴壁不良（29.6%对7.9%；P=0.0005）。70.4%的PES和64.8%的BMS最初存在斑块和/或血栓通过支架小梁突出的情况；所有这些在随访期间均消失。新的动脉瘤形成、支架断裂和亚临床血栓并不常见，尽管仅在PES中出现。
与BMS相比，PES显著减少了ST段抬高型心肌梗死患者的内膜增生，但也因血管正向重塑导致晚期获得性支架贴壁不良的发生率较高。需要持续的长期随访来确定这些发现的临床意义。临床试验注册——网址：http://www.clinicaltrials.gov。唯一标识符：NCT00433966。
