Baim Donald S, Wahr Dennis, George Barry, Leon Martin B, Greenberg Joel, Cutlip Donald E, Kaya Unsal, Popma Jeffrey J, Ho Kalon K L, Kuntz Richard E
Division of Cardiovascular Diseases, Brigham and Women's Hospital, Boston, Mass 02115, USA.
Circulation. 2002 Mar 19;105(11):1285-90.
Stents provide effective treatment for stenotic saphenous venous aorto-coronary bypass grafts, but their placement carries a 20% incidence of procedure-related complications, which potentially are related to the distal embolization of atherosclerotic debris. We report the first multicenter randomized trial to evaluate use of a distal embolic protection device during stenting of such lesions.
Of 801 eligible patients, 406 were randomly assigned to stent placement over the shaft of the distal protection device, and 395 were assigned to stent placement over a conventional 0.014-inch angioplasty guidewire (control group). The primary end point-a composite of death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days-was observed in 65 patients (16.5%) assigned to the control group and 39 patients (9.6%) assigned to the embolic protection device (P=0.004). This 42% relative reduction in major adverse cardiac events was driven by myocardial infarction (8.6% versus 14.7%, P=0.008) and "no-reflow" phenomenon (3% versus 9%, P=0.02). Clinical benefit was seen even when platelet glycoprotein IIb/IIIa receptor blockers were administered (61% of patients), with composite end points occurring in 10.7% of protection device patients versus 19.4% of control patients (P=0.008).
Use of this distal protection device during stenting of stenotic venous grafts was associated with a highly significant reduction in major adverse events compared with stenting over a conventional angioplasty guidewire. This demonstrates the importance of distal embolization in causing major adverse cardiac events and the value of embolic protection devices in preventing such complications.
支架为狭窄的大隐静脉主动脉 - 冠状动脉旁路移植血管提供了有效的治疗方法，但其置入会导致20%的与手术相关的并发症发生率，这些并发症可能与动脉粥样硬化碎片的远端栓塞有关。我们报告了第一项多中心随机试验，以评估在这类病变的支架置入过程中使用远端栓塞保护装置的情况。
在801例符合条件的患者中，406例被随机分配接受在远端保护装置杆部上方进行支架置入，395例被分配接受在传统的0.014英寸血管成形术导丝上进行支架置入（对照组）。对照组65例患者（16.5%）和栓塞保护装置组39例患者（9.6%）出现了主要终点事件，即30天内死亡、心肌梗死、急诊搭桥或靶病变血管重建的复合终点事件（P = 0.004）。主要不良心脏事件相对减少42%是由心肌梗死（8.6%对14.7%，P = 0.008）和“无复流”现象（3%对9%，P = 0.02）所致。即使在使用血小板糖蛋白IIb/IIIa受体阻滞剂的患者中（61%的患者）也观察到了临床益处，保护装置组患者复合终点事件发生率为10.7%，对照组为19.4%（P = 0.008）。
与在传统血管成形术导丝上进行支架置入相比，在狭窄静脉移植物支架置入过程中使用这种远端保护装置可使主要不良事件显著减少。这证明了远端栓塞在导致主要不良心脏事件中的重要性以及栓塞保护装置在预防此类并发症中的价值。
