Davidson C J, Laskey W K, Hermiller J B, Harrison J K, Matthai W, Vlietstra R E, Brinker J A, Kereiakes D J, Muhlestein J B, Lansky A, Popma J J, Buchbinder M, Hirshfeld J W
Northwestern Memorial Hospital, Chicago, IL 60611, USA.
Circulation. 2000 May 9;101(18):2172-7. doi: 10.1161/01.cir.101.18.2172.
Previous in vitro and in vivo studies have suggested an association between thrombus-related events and type of contrast media. Low osmolar contrast agents appear to improve the safety of diagnostic and coronary artery interventional procedures. However, no data are available on PTCA outcomes with an isosmolar contrast agent.
A multicenter prospective randomized double-blind trial was performed in 856 high-risk patients undergoing coronary artery intervention. The objective was to compare the isosmolar nonionic dimer iodixanol (n=405) with the low osmolar ionic agent ioxaglate (n=410). A composite variable of in-hospital major adverse clinical events (MACE) was the primary end point. A secondary objective was to evaluate major angiographic and procedural events during and after PTCA. The composite in-hospital primary end point was less frequent in those receiving iodixanol compared with those receiving ioxaglate (5.4% versus 9.5%, respectively; P=0.027). Core laboratory defined angiographic success was more frequent in patients receiving iodixanol (92.2% versus 85. 9% for ioxaglate, P=0.004). There was a trend toward lower total clinical events at 30 days in patients randomized to iodixanol (9.1% versus 13.2% for ioxaglate, P=0.07). Multivariate predictors of in-hospital MACE were use of ioxaglate (P=0.01) and treatment of a de novo lesion (P=0.03).
In this contemporary prospective multicenter trial of PTCA in the setting of acute coronary syndromes, there was a low incidence of in-hospital clinical events for both treatment groups. The cohort receiving the nonionic dimer iodixanol experienced a 45% reduction in in-hospital MACE when compared with the cohort receiving ioxaglate.
先前的体外和体内研究表明血栓相关事件与造影剂类型之间存在关联。低渗造影剂似乎可提高诊断和冠状动脉介入手术的安全性。然而，关于等渗造影剂用于经皮冠状动脉腔内血管成形术（PTCA）的结果尚无数据。
对856例接受冠状动脉介入治疗的高危患者进行了一项多中心前瞻性随机双盲试验。目的是比较等渗非离子二聚体碘克沙醇（n = 405）与低渗离子型造影剂碘克酸（n = 410）。住院期间主要不良临床事件（MACE）的复合变量为主要终点。次要目的是评估PTCA期间及之后的主要血管造影和手术事件。与接受碘克酸的患者相比，接受碘克沙醇的患者住院期间复合主要终点事件的发生率更低（分别为5.4%和9.5%；P = 0.027）。核心实验室定义的血管造影成功在接受碘克沙醇的患者中更为常见（碘克沙醇组为92.2%，碘克酸组为85.9%，P = 0.004）。随机接受碘克沙醇的患者在30天时总临床事件有降低趋势（碘克酸组为13.2%，碘克沙醇组为9.1%，P = 0.07）。住院期间MACE的多变量预测因素为使用碘克酸（P = 0.01）和治疗新发病变（P = 0.03）。
在这项针对急性冠状动脉综合征患者进行的当代前瞻性多中心PTCA试验中，两个治疗组的住院临床事件发生率均较低。与接受碘克酸的队列相比，接受非离子二聚体碘克沙醇的队列住院期间MACE减少了45%。
