Dündar Yenal, Hill Ruaraidh A, Bakhai Ameet, Dickson Rumona, Walley Tom
The University of Liverpool, Faculty of Medicine, Liverpool Reviews & Implementation Group, Liverpool, UK.
Scand Cardiovasc J. 2004 Aug;38(4):200-10. doi: 10.1080/14017430410032325.
To undertake a systematic review of the clinical effectiveness of routine percutaneous transluminal coronary angioplasty (PTCA) plus stenting vs PTCA alone.
MEDLINE; EMBASE; Science Citation Index; The Cochrane Library; cardiovascular journals and conference proceedings; Internet resources (including industry supported web pages); and reference lists of included studies and relevant reviews.
Study selection included published and unpublished randomized controlled trials (RCTs) comparing the use of coronary stents to PTCA. Outcome measures assessed included death, acute myocardial infarction (AMI), event rate (such as major cardiac adverse events (MACE) or other composite measures), and binary restenosis (BR). Data extraction and quality assessment were conducted according to internationally recognized methods. Data synthesis included meta-analysis of assessed outcomes, reported as odds ratios (ORs).
Fifty RCTs involving 16,500 patients met the inclusion criteria (39 full articles, 11 abstracts). Of these, 23 studies compared stenting with PTCA in patients with non-specific coronary artery disease (CAD), 11 compared stents with PTCA following AMI, 8 included patients with small coronary arteries and 8 included patients whose vessels had chronic total occlusion. There were no differences in rates of death or AMI. There were reductions in the rates of MACE (death, AMI or revascularization) with stents compared to PTCA (at 6 months, for non-specific group OR: 1.64, 95% CI 1.44-1.87; for AMI group OR: 2.36, 95% CI 1.92-2.89; for small vessel group OR: 1.38, 95% CI 1.10-1.74; at 12 months, for non-specific group OR: 1.31, 95% CI 1.11-1.55; for AMI OR: 2.26, 95% CI 1.47-3.46). Reporting of combined major adverse cardiac events was inconsistent across studies. Most events were revascularizations that may have been partly driven by protocol-required angiograms. Stents reduced BR rates at angiogram at 6 months compared to PTCA in all groups.
We found no differences in mortality or AMI, but the studies were not powered to identify changes in these endpoints. Coronary stenting is associated with reduced restenosis and combined adverse cardiac events, primarily revascularizations. However, the frequency of revascularization may have been distorted by protocol-dictated angiography.
对常规经皮冠状动脉腔内血管成形术(PTCA)加支架置入术与单纯PTCA的临床疗效进行系统评价。
MEDLINE;EMBASE;科学引文索引;考克兰图书馆;心血管杂志和会议论文集;互联网资源(包括行业支持的网页);以及纳入研究和相关综述的参考文献列表。
研究选择包括已发表和未发表的随机对照试验(RCT),比较冠状动脉支架与PTCA的使用情况。评估的结局指标包括死亡、急性心肌梗死(AMI)、事件发生率(如主要心脏不良事件(MACE)或其他综合指标)和二元再狭窄(BR)。数据提取和质量评估按照国际认可的方法进行。数据合成包括对评估结局的荟萃分析,以比值比(OR)报告。
50项涉及16,500例患者的RCT符合纳入标准(39篇全文,11篇摘要)。其中,23项研究比较了非特异性冠状动脉疾病(CAD)患者的支架置入术与PTCA,11项比较了AMI后支架与PTCA,8项纳入了小冠状动脉患者,8项纳入了血管慢性完全闭塞患者。死亡或AMI发生率无差异。与PTCA相比,支架置入术降低了MACE(死亡、AMI或血运重建)发生率(6个月时,非特异性组OR:1.64,95%CI 1.44 - 1.87;AMI组OR:2.36,95%CI 1.92 - 2.89;小血管组OR:1.38,95%CI ?1.10 - 1.74;12个月时,非特异性组OR:1.31,95%CI 1.11 - 1.55;AMI组OR:2.26,95%CI 1.47 - 3.46)。各研究中联合主要不良心脏事件的报告不一致。大多数事件是血运重建,可能部分由方案要求的血管造影驱动。与PTCA相比,支架在6个月时降低了所有组血管造影时的BR发生率。
我们发现死亡率或AMI无差异,但这些研究的样本量不足以识别这些终点的变化。冠状动脉支架置入术与再狭窄和联合不良心脏事件减少相关,主要是血运重建。然而,血运重建的频率可能因方案规定的血管造影而失真。