Kunadian Babu, Dunning Joel, Vijayalakshmi Kunadian, Thornley Andrew R, de Belder Mark A
Department of Cardiology, The James Cook University Hospital, Marton Road, Middlesbrough, United Kingdom.
Catheter Cardiovasc Interv. 2007 Mar 1;69(4):488-96. doi: 10.1002/ccd.20990.
Failure to achieve adequate myocardial reperfusion often occurs during PCI in patients with STEMI. This is in part due to atheromatous and thrombotic distal embolization. Several anti-embolic devices have been developed to protect against distal embolization during percutaneous coronary interventions (PCI) to improve myocardial reperfusion and enhance event free survival. Evidence from current studies has not shown a consistent benefit, but anti-embolic devices continue to be used.
We conducted a systemic overview (meta-analysis) of randomized trials of thrombectomy or distal protection devices versus standard PCI to evaluate the effects of reducing distal embolization during PCI for native vessel acute myocardial infarction (AMI). We identified randomized trials by searching PubMed, OVID, the Cochrane databases, references of articles, and abstracts of conference proceedings (all from September 2000 to October 2005). Each trial tested the hypothesis that anti-embolic therapy would result in better clinical or angiographic results than standard PCI alone.
Fourteen trials (n = 2630) were identified comparing a distal protection device or a thrombectomy device (n = 1320) versus standard PCI (n = 1310). When the studies were combined, primary endpoints of death or reinfarction were not improved by the use of anti-embolic devices (4% [52/1309] vs. 4.5% [59/1303], odds ratio [OR] 0.82 [95% CI 0.55 to 1.24, P= 0.35]). In subgroup analysis, analyzing the class of device separately, use of thrombectomy devices (4.4% [33/758 vs. 4.2% [32/763], OR 0.98 CI 0.53 to 1.83, P = 0.95]), and the use of distal protection device 3.5% [19/551] vs. 5% [27/540], OR 0.68 CI 0.37 to 1.23, P = 0.20]) during PCI for native vessel AMI did not improve the clinical outcome of death or reinfarction. The secondary endpoints of death, reinfarction, and major adverse cardiac events did not improve with the use of anti-embolic devices.
The combined experience from randomized trials suggests that the use of anti-embolic devices does not decrease early mortality or reinfarction during PCI for native vessel AMI. Whether their use improves longer term outcomes is unknown. Further research is needed to clarify the indication and optimal devices for anti-embolic protection.
ST段抬高型心肌梗死（STEMI）患者在经皮冠状动脉介入治疗（PCI）期间常出现心肌再灌注不足的情况。这部分归因于动脉粥样硬化和血栓形成导致的远端栓塞。已经研发了多种抗栓塞装置，以在经皮冠状动脉介入治疗（PCI）期间预防远端栓塞，从而改善心肌再灌注并提高无事件生存率。目前研究的证据并未显示出一致的益处，但抗栓塞装置仍在使用。
我们对血栓切除术或远端保护装置与标准PCI的随机试验进行了系统综述（荟萃分析），以评估在原发性血管急性心肌梗死（AMI）的PCI过程中减少远端栓塞的效果。我们通过检索PubMed、OVID、Cochrane数据库、文章参考文献和会议论文摘要（均为2000年9月至2005年10月期间）来确定随机试验。每项试验都检验了抗栓塞治疗比单纯标准PCI能产生更好的临床或血管造影结果这一假设。
确定了14项试验（n = 2630），比较了远端保护装置或血栓切除装置（n = 1320）与标准PCI（n = 1310）。当合并这些研究时，使用抗栓塞装置并未改善死亡或再梗死的主要终点（4% [52/1309] 对 4.5% [59/1303]，优势比 [OR] 0.82 [95% CI 0.55至1.24，P = 0.35]）。在亚组分析中，分别分析装置类别，在原发性血管AMI的PCI过程中，使用血栓切除装置（4.4% [33/758] 对 4.2% [32/763]，OR 0.98 CI 0.53至1.83，P = 0.95]）以及使用远端保护装置（3.5% [19/551] 对 5% [27/540]，OR 0.68 CI 0.37至1.23，P = 0.20]）均未改善死亡或再梗死的临床结局。使用抗栓塞装置也未改善死亡、再梗死和主要不良心脏事件的次要终点。
随机试验的综合经验表明，在原发性血管AMI的PCI过程中，使用抗栓塞装置并不能降低早期死亡率或再梗死率。其使用是否能改善长期结局尚不清楚。需要进一步研究以明确抗栓塞保护的适应证和最佳装置。
