主页 > 医学讨论 >
【文摘发布】ISAR-PEACE 试验结果：雌激素能增强雷
Results of the ISAR-PEACE Randomized Trial
来源：J Am Coll Cardiol, 2007; 49:1265-1271
Tom Adriaenssens, MD, Julinda Mehilli, MD*, Rainer Wessely, MD, Gjin Ndrepepa, MD, Melchior Seyfarth, MD, Anna Wieczorek, Birgit Blaich, PhD, Raisuke Iijima, MD, Jürgen Pache, MD, Adnan Kastrati, MD1 and Albert Schömig, MD2
Objectives: This study aimed to assess the efficacy of a rapamycin plus 17-ß-estradiol–eluting stent versus a rapamycin-eluting stent in patients with coronary artery disease.
Background: Estradiol promotes rapid re-endothelialization of coronary stents in animal models, but it is not known whether combining this drug with rapamycin represents an improved drug-eluting stent technology in terms of reduced lumen renarrowing.
Methods: In this randomized study, we enrolled 502 patients with de novo lesions in native coronary arteries who were randomly assigned to receive either a polymer-free, estradiol plus rapamycin-eluting stent (ERES) (n = 252) or a polymer-free, rapamycin-eluting stent (RES) (n = 250). The primary end point was in-stent late lumen loss in the follow-up angiography. Secondary end points were binary angiographic restenosis, target lesion revascularization, combined incidence of death and myocardial infarction, and incidence of stent thrombosis during 1 year after randomization. The study was designed to test for the superiority of the ERES compared with the RES with respect to in-stent late lumen loss.
Results: Late lumen loss (0.52 ± 0.58 mm vs. 0.51 ± 0.58 mm, p = 0.83), the incidence of binary angiographic restenosis (17.6% vs. 16.9%, p = 0.85), the incidence of target lesion revascularization (14.3% vs. 13.2%, p = 0.72), the combined incidence of death and myocardial infarction (7.9% vs. 8.0%, p = 0.98), and the incidence of stent thrombosis (0.8% vs. 1.2%, p = 0.99) were not significantly different between the ERES group and the RES group.
Conclusions: No apparent beneficial effect is obtained by adding estradiol to a polymer-free rapamycin-eluting stent during the first year after the procedure. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 放弃了 认领该文编译，48小时后若未提交译文，请其他战友自由认领 Does Addition of Estradiol Improve the Efficacy of a Rapamycin-Eluting Stent?
Results of the ISAR-PEACE Randomized Trial
ISAR-PEACE 试验结果：雌激素能增强雷帕霉素支架的有效性吗？
来源：J Am Coll Cardiol, 2007; 49:1265-1271
Objectives: This study aimed to assess the efficacy of a rapamycin plus 17-ß-estradiol–eluting stent versus a rapamycin-eluting stent in patients with coronary artery disease.
目的：该研究的目的是评价联合应用雌二醇和雷帕霉素的药物洗脱支架与单独雷帕霉素支架在冠心病治疗上的效果。
Background: Estradiol promotes rapid re-endothelialization of coronary stents in animal models, but it is not known whether combining this drug with rapamycin represents an improved drug-eluting stent technology in terms of reduced lumen renarrowing.
背景：动物实验中，雌二醇可以促进冠脉支架的快速再内皮化，但是联合应用雌二醇和雷帕霉素的药物洗脱支架是否在减少管腔再狭窄方面更加有效，尚不得而知。
Methods: In this randomized study, we enrolled 502 patients with de novo lesions in native coronary arteries who were randomly assigned to receive either a polymer-free, estradiol plus rapamycin-eluting stent (ERES) (n = 252) or a polymer-free, rapamycin-eluting stent (RES) (n = 250). The primary end point was in-stent late lumen loss in the follow-up angiography. Secondary end points were binary angiographic restenosis, target lesion revascularization, combined incidence of death and myocardial infarction, and incidence of stent thrombosis during 1 year after randomization. The study was designed to test for the superiority of the ERES compared with the RES with respect to in-stent late lumen loss.
方法：在该项随机试验中，共入选502名冠脉存在新发病变的患者，随机接受应用雌二醇的雷帕霉素支架（252例）和单纯雷帕霉素支架（250例）。首要终点为血管造影随访发现支架内晚期管腔狭窄程度，次要终点为二次造影发现血管再狭窄，靶病变的再血管化，以及死亡和心梗发生率和1年内支架内血栓发生率。试验的设计就是为了比较联合雌二醇组是否在支架内管腔狭窄方面优于单独雷帕霉素组。
Results: Late lumen loss (0.52 ± 0.58 mm vs. 0.51 ± 0.58 mm, p = 0.83), the incidence of binary angiographic restenosis (17.6% vs. 16.9%, p = 0.85), the incidence of target lesion revascularization (14.3% vs. 13.2%, p = 0.72), the combined incidence of death and myocardial infarction (7.9% vs. 8.0%, p = 0.98), and the incidence of stent thrombosis (0.8% vs. 1.2%, p = 0.99) were not significantly different between the ERES group and the RES group.
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-04-23 05:11
医学,生命科学网