Kereiakes Dean J, Turco Mark A, Breall Jeffrey, Farhat Naim Z, Feldman Robert L, McLaurin Brent, Popma Jeffrey J, Mauri Laura, Zimetbaum Peter, Massaro Joseph, Cutlip Donald E
Christ Hospital Heart and Vascular Center, Cincinnati, Ohio, USA.
JACC Cardiovasc Interv. 2008 Jun;1(3):248-57. doi: 10.1016/j.jcin.2008.03.009.
We sought to evaluate the relative safety and efficacy of the novel Interceptor PLUS Coronary Filter System (Medtronic Vascular, Santa Rosa, California) compared with approved embolic-protection devices (e.g., GuardWire, Medtronic Vascular/FilterWire EZ, Boston Scientific, Natick, Massachusetts) during percutaneous coronary intervention (PCI) of degenerative saphenous vein grafts (SVG).
Percutaneous coronary intervention of degenerative SVG is associated with embolization of atherothrombotic debris and subsequent myocardial infarction in a significant portion of patients. The use of distal embolic-protection devices has previously been demonstrated to reduce major adverse cardiovascular events associated with PCI in these patients.
In this multicenter, randomized noninferiority trial, 797 patients undergoing PCI with stenting of SVG stenoses (de novo or restenotic) with reference vessel diameter 2.5 mm to 5.25 mm were randomly assigned 2:1 to either the Interceptor PLUS (n = 533) or control distal-protection devices (GuardWire [n = 191], FilterWire EZ [n = 73]) at the physician's discretion.
The trial primary clinical end point (composite occurrence of death, myocardial infarction, or urgent repeat revascularization through 30 days) was observed in 8% and 7.3% of Interceptor and control-treated patients, respectively (p = 0.025 for noninferiority; p = 0.77 for difference). Key secondary end points for device and procedural success were similar between randomly assigned treatment strategies.
The Interceptor PLUS Coronary Filter System is noninferior in safety and efficacy to 30 days when compared with the GuardWire and FilterWire EZ distal embolic protection devices.
我们旨在评估新型Interceptor PLUS冠状动脉滤器系统（美敦力血管公司，加利福尼亚州圣罗莎）与已获批准的栓子保护装置（如GuardWire，美敦力血管公司/FilterWire EZ，波士顿科学公司，马萨诸塞州纳蒂克）在退行性大隐静脉移植血管（SVG）经皮冠状动脉介入治疗（PCI）期间的相对安全性和有效性。
退行性SVG的经皮冠状动脉介入治疗在相当一部分患者中与动脉粥样硬化血栓碎片栓塞及随后的心肌梗死相关。先前已证明使用远端栓子保护装置可减少这些患者中与PCI相关的主要不良心血管事件。
在这项多中心、随机非劣效性试验中，797例接受SVG狭窄（初发或再狭窄）支架置入术且参考血管直径为2.5毫米至5.25毫米的PCI患者，由医生酌情将其按2:1随机分配至Interceptor PLUS组（n = 533）或对照远端保护装置组（GuardWire [n = 191]，FilterWire EZ [n = 73]）。
试验的主要临床终点（30天内死亡、心肌梗死或紧急再次血运重建的复合发生情况）在Interceptor组和对照组患者中的发生率分别为8%和7.3%（非劣效性p = 0.025；差异p = 0.77）。随机分配的治疗策略之间，装置和手术成功的关键次要终点相似。
与GuardWire和FilterWire EZ远端栓子保护装置相比，Interceptor PLUS冠状动脉滤器系统在30天的安全性和有效性方面非劣效。
