低中风险重度主动脉瓣狭窄患者经导管与外科主动脉瓣置换术的比较：系统评价与荟萃分析
Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis.
作者信息
Siemieniuk Reed A, Agoritsas Thomas, Manja Veena, Devji Tahira, Chang Yaping, Bala Malgorzata M, Thabane Lehana, Guyatt Gordon H
机构信息
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8 Department of Medicine, University of Toronto, Toronto, ON, Canada
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8 Division General Internal Medicine, and Division of Clinical Epidemiology, University Hospitals of Geneva, Geneva, Switzerland.
出版信息
BMJ. 2016 Sep 28;354:i5130. doi: 10.1136/bmj.i5130.
OBJECTIVE
To examine the effect of transcatheter aortic valve implantation (TAVI) versus surgical replacement of an aortic valve (SAVR) in patients with severe aortic stenosis at low and intermediate risk of perioperative death.
DESIGN
Systematic review and meta-analysis DATA SOURCES: Medline, Embase, and Cochrane CENTRAL.
STUDY SELECTION
Randomized trials of TAVI compared with SAVR in patients with a mean perioperative risk of death <8%.
REVIEW METHODS
Two reviewers independently extracted data and assessed risk of bias for outcomes important to patients that were selected a priori by a parallel guideline committee, including patient advisors. We used the GRADE system was used to quantify absolute effects and quality of evidence.
RESULTS
4 trials with 3179 patients and a median follow-up of two years were included. Compared with SAVR, transfemoral TAVI was associated with reduced mortality (risk difference per 1000 patients: -30, 95% confidence interval -49 to -8, moderate certainty), stroke (-20, -37 to 1, moderate certainty), life threatening bleeding (-252, -293 to -190, high certainty), atrial fibrillation (-178, -150 to -203, moderate certainty), and acute kidney injury (-53, -39 to -62, high certainty) but increased short term aortic valve reintervention (7, 1 to 21, moderate certainty), permanent pacemaker insertion (134, 16 to 382, moderate certainty), and moderate or severe symptoms of heart failure (18, 5 to 34, moderate certainty). Compared with SAVR, transapical TAVI was associated higher mortality (57, -16 to 153, moderate certainty, P=0.015 for interaction between transfemoral versus transapical TAVI) and stroke (45, -2 to 125, moderate certainty, interaction P=0.012). No study reported long term follow-up, which is particularly important for structural valve deterioration.
CONCLUSIONS
Many patients, particularly those who have a shorter life expectancy or place a lower value on the risk of long term valve degeneration, are likely to perceive net benefit with transfemoral TAVI versus SAVR. SAVR, however, performs better than transapical TAVI, which is of interest to patients who are not candidates for transfemoral TAVI.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42016042879.
目的
探讨经导管主动脉瓣植入术（TAVI）与外科主动脉瓣置换术（SAVR）在围手术期死亡风险为低到中度的严重主动脉瓣狭窄患者中的疗效。
设计
系统评价和荟萃分析
数据来源
Medline、Embase和Cochrane CENTRAL。
研究选择
对平均围手术期死亡风险<8%的患者进行TAVI与SAVR对比的随机试验。
综述方法
两名综述员独立提取数据，并评估由包括患者顾问在内的平行指南委员会预先选定的对患者重要的结局的偏倚风险。我们使用GRADE系统来量化绝对效应和证据质量。
结果
纳入4项试验，共3179例患者，中位随访时间为2年。与SAVR相比，经股动脉TAVI与死亡率降低相关（每1000例患者的风险差异：-30，95%置信区间-49至-8，中等确定性）、卒中（-20，-37至1，中等确定性）、危及生命的出血（-252，-293至-190，高确定性）、房颤（-178，-150至-203，中等确定性）和急性肾损伤（-53，-39至-62，高确定性），但短期主动脉瓣再次干预增加（7，1至21，中等确定性）、永久性起搏器植入（134，16至382，中等确定性）以及中度或重度心力衰竭症状（18，5至34，中等确定性）。与SAVR相比，经心尖TAVI与更高的死亡率相关（57，-16至153，中等确定性，经股动脉与经心尖TAVI之间的交互作用P=0.015）和卒中（45，-2至125，中等确定性，交互作用P=0.012）。没有研究报告长期随访情况，而这对于瓣膜结构退化尤为重要。
结论
许多患者，尤其是那些预期寿命较短或对长期瓣膜退化风险不太在意的患者，可能认为经股动脉TAVI相对于SAVR有净获益。然而对于那些不适合经股动脉TAVI的患者，SAVR的表现优于经心尖TAVI。
系统评价注册
PROSPERO CRD42016042879
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