Nordmann A J, Bucher H, Hengstler P, Harr T, Young J
Basel Institute for Clinical Epidemiology, University Hospital Basel, Hebelstrasse 10, Basel, Switzerland, 4031.
Cochrane Database Syst Rev. 2005 Apr 18;2005(2):CD005313. doi: 10.1002/14651858.CD005313.
Balloon angioplasty following myocardial infarction (MI) reduces death, non-fatal MI and stroke compared to thrombolytic reperfusion. However up to 50% of patients experience restenosis and 3% to 5% recurrent myocardial infarction. Therefore, primary stenting may offer additional benefits compared to balloon angioplasty in patients with acute myocardial infarction.
To examine whether primary stenting compared to primary balloon angioplasty reduces clinical outcomes in patients with acute myocardial infarction.
We searched MEDLINE, EMBASE, Pascal, Index medicus and The Cochrane Controlled Trials Register (The Cochrane Library) from 1979 to March 2002.
Randomised controlled trials of primary stenting or balloon angioplasty prior to the invasive procedure; intervention in native coronary arteries within 24 hours after onset of symptoms of myocardial infarction; report of death or reinfarction; and follow-up of at least 1 month. Trials were excluded when randomisation occurred after an invasive procedure and if they exclusively included patients with cardiogenic shock.
Two reviewers independently selected and extracted data from identified trials. Outcomes included mortality, reinfarction, coronary artery bypass grafting, target vessel revascularization, need for vascular repair or blood transfusion. Peto odds ratios were calculated. To explore the stability of the overall treatment effect various sensitivity analyses were performed.
We included nine trials of 4433 participants. Odds ratios for mortality after stenting compared to balloon angioplasty at 30 days, 6 and 12 months were 1.16 (95% CI 0.78 to 1.73), 1.27 (95% CI 0.89 to 1.83), and 1.06 (95% CI 0.77 to 1.45). At 30 days, 6 and 12 months odds ratios for reinfarction after stenting compared to balloon angioplasty were 0.52 (95% CI 0.31 to 0.87), 0.67 (95% CI 0.45 to 1.00), and 0.67 (95% CI 0.45-0.98) and odds ratio for target vessel revascularization after stenting compared to balloon angioplasty were 0.45 (95%CI 0.34 to 0.60), 0.42 (95% CI 0.35 to 0.51), and 0.47 (95% CI 0.38 to 0.57). The odds ratio for post-interventional bleeding complications after stenting compared to balloon angioplasty was 1.34 (95% CI 0.95 to 1.88; test of heterogeneity p > 0.1).
AUTHORS' CONCLUSIONS: There is no evidence to suggest that primary stenting reduces mortality when compared to balloon angioplasty. Stenting seems to be associated with a reduced risk of reinfarction and target vessel revascularization, but potential confounding due to unbalanced post-interventional antithrombotic/anticoagulant therapies can not be ruled out on basis of this review.
与溶栓再灌注相比，心肌梗死（MI）后进行球囊血管成形术可降低死亡、非致命性心肌梗死和中风的发生率。然而，高达50%的患者会出现再狭窄，3%至5%会发生复发性心肌梗死。因此，对于急性心肌梗死患者，与球囊血管成形术相比，直接支架置入术可能会带来更多益处。
探讨与直接球囊血管成形术相比，直接支架置入术是否能改善急性心肌梗死患者的临床预后。
我们检索了1979年至2002年3月期间的MEDLINE、EMBASE、Pascal、医学索引和Cochrane对照试验注册库（Cochrane图书馆）。
侵入性操作前直接支架置入术或球囊血管成形术的随机对照试验；在心肌梗死症状发作后24小时内对自身冠状动脉进行干预；报告死亡或再梗死情况；以及至少随访1个月。当随机分组在侵入性操作后进行，以及试验仅纳入心源性休克患者时，将试验排除。
两名综述作者独立从纳入的试验中选择并提取数据。结局包括死亡率、再梗死、冠状动脉旁路移植术、靶血管血运重建、血管修复或输血需求。计算Peto比值比。为探究总体治疗效果的稳定性，进行了各种敏感性分析。
我们纳入了9项试验，共4433名参与者。与球囊血管成形术相比，支架置入术后30天、6个月和12个月的死亡率比值比分别为1.16（95%可信区间0.78至1.73）、1.27（95%可信区间0.89至1.83）和1.06（95%可信区间0.77至1.45）。与球囊血管成形术相比，支架置入术后30天、6个月和12个月的再梗死比值比分别为0.52（95%可信区间0.31至0.87）、0.67（95%可信区间0.45至1.00）和0.67（95%可信区间0.45至0.98），支架置入术后靶血管血运重建的比值比分别为0.45（95%可信区间0.34至0.60）、0.42（95%可信区间0.35至0.51）和0.47（95%可信区间0.38至0.57）。与球囊血管成形术相比，支架置入术后介入后出血并发症的比值比为1.34（95%可信区间0.95至1.88；异质性检验p>0.1）。
没有证据表明与球囊血管成形术相比，直接支架置入术能降低死亡率。支架置入术似乎与再梗死和靶血管血运重建风险降低相关，但基于本综述不能排除介入后抗血栓/抗凝治疗不平衡导致的潜在混杂因素。
