左侧对比右侧桡动脉入路行冠状动脉介入术有效性与安全性的Meta分析

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牛小伟, 杨翠玲, 贺生亮, 陈德, 燕东, 姚亚丽. 左侧对比右侧桡动脉入路行冠状动脉介入术有效性与安全性的Meta分析. 循证医学, 2013,13(6): 363-369
NIU Xiao-wei, YANG Cui-ling, HE Sheng-liang, CHEN De, YAN Dong, YAO Ya-li. Efficacy and Safety of Left versus Right Radial Approach for Percutaneous Coronary Procedures： A Meta-Analysis. Journal of Evidence-Based Medicine,2013, 13(6): 363-369 复制到剪切板

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左侧对比右侧桡动脉入路行冠状动脉介入术有效性与安全性的Meta分析

牛小伟^1a, 杨翠玲², 贺生亮^1a, 陈德^1a, 燕东^1a, 姚亚丽^1b

1.兰州大学 a. 第一临床医学院; b. 第一医院, 兰州 730000

2.西安交通大学医学院, 西安710061

通讯作者：姚亚丽,Tel： 0931-8625200; E-mail：yaoyalifs@yahoo.com

作者简介：牛小伟（1988-）,男,甘肃灵台人,硕士研究生,从事心血管病学研究。

摘要

目的评价左侧对比右侧桡动脉入路行冠状动脉介入术的有效性与安全性。方法计算机检索PubMed、EMBASE、Web of Science、Cochrane图书馆、中国生物医学文献数据库、中文科技期刊全文数据库、数字化期刊数据库和中国期刊全文数据库,时间从1989年至2013年2月。由两名研究人员独立地按照纳入与排除标准以及Cochrane 协作网推荐的方法筛选文献、评价质量,并采用RevMan 5.1软件进行 Meta 分析。结果共纳入13个研究,包括6 605例患者。Meta分析结果显示：右侧桡动脉入路组发生入路更改的可能性是左侧桡动脉入路组的1.37倍[相对危险度1.37, 95%可信区间（1.10,1.71）,P=0.005],左侧桡动脉入路有利于缩短手术时间[均数差0.73, 95%可信区间（0.09,1.36）,P=0.02]。两组在外周血管并发症、主要不良心脏事件方面差异无统计学意义（P>0.05）。结论左侧桡动脉入路组与右侧桡动脉入路组相比,具有较低的入路更改率及较短的手术操作时间,处于学习曲线期的术者使用左侧桡动脉入路完成冠状动脉介入术时更有优势。

关键词: 冠状动脉介入术; 桡动脉; Meta分析

中图分类号:R816.2 文献标识码:A

Efficacy and Safety of Left versus Right Radial Approach for Percutaneous Coronary Procedures： A Meta-Analysis

NIU Xiao-wei^1a, YANG Cui-ling², HE Sheng-liang^1a, CHEN De^1a, YAN Dong^1a, YAO Ya-li^1b

1.a. The First Clinical Medical College; b. The First Affiliated Hospital, Lanzhou University Lanzhou 730000, China

2. The Medical School, Xi＇an Jiaotong University, Xi＇an 710061, China

Abstract

Objective To assess the efficacy and safety of left （LRA） versus right radial approach （RRA） for coronary diagnostic or interventional procedures.Methods The databases were searched including PubMed, EMBASE, Cochrane Library, Web of Science, CBM, CNKI, VIP and Wanfang. Two reviewers extracted data independently according to the methods of Cochrane Collaboration. Statistical analysis was performed using Review Manager software （RevMan 5.1, Cochrane Collaboration, Oxford, UK）.Results13 trials with 6 605 patients were included in the meta-analysis. The results showed no significant difference in the risks of peripheral vascular complications and major adverse cardiac events comparing LRA with RRA （P>0.05）. However, in comparison with LRA, RRA arm was fraught with a significantly higher risk of failure leading to cross-overs to other access [risk ratio 1.37, 95% confidence interval （1.10,1.71）,P=0.005], and a prolonged procedural time [mean difference 0.73, 95% confidence interval （0.09,1.36）,P=0.02].Conclusions Compared with RRA, LRA could reduce the risk of other access cross-overs and the procedural time. LRA could be recommended to complete coronary intervention for operators during the learning curve phase.

Key words: percutaneous coronary intervention; radial artery; meta-analysis

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自1989年Campeau医生首次报道经桡动脉入路行冠状动脉造影术以来^{[ 1]},随着器材的改进和操作技术的进步,桡动脉入路与传统的股动脉入路相比,已具有使患者痛苦小、住院时间短、外周血管并发症少等诸多优点^{[ 2, 3]},并被2013年《欧洲心脏病学会专家共识》推荐为冠状动脉介入术的首选入路^{[ 4]}。目前国内外的研究多集中于右侧桡动脉入路（right radial approach, RRA）,在临床中对左右侧桡动脉入路的选择也多取决于术者的个人选择^{[ 5]}。然而最近一项随机入组1 540例患者的TALENT研究表明^{[ 5]},与RRA相比,左侧桡动脉入路（left radial approach, LRA）不仅具有解剖学路径优势,还能缩短透视时间等。因此,有必要对LRA行冠状动脉介入术的有效性与安全性进行分析。本研究旨在利用Meta分析的方法,将比较RRA和LRA这两种入路方式的随机对照试验（randomized controlled trials, RCT）进行综合,以客观评价两者的临床价值。

1 资料与方法

1.1 纳入与排除标准

1.1.1 研究类型随机对照试验。

1.1.2 研究对象行冠状动脉造影术（coronary angiography, CAG）或经皮冠状动脉介入术（percutaneous coronary intervention, PCI）的患者。

1.1.3 干预措施试验组采用LRA,对照组采用RRA。

1.1.4 结局指标 ①入路更改：未能完整地经初始入路完成手术诊疗操作过程,而更改为股动脉或对侧桡动脉入路;②手术时间;③外周血管并发症：外周血管痉挛、闭塞、夹层、出血、血肿、假性动脉瘤、动静脉瘘、血栓或栓塞;④主要不良心脏事件（major adverse cardiac events, MACE）：包括死亡、心肌梗死、卒中、急诊PCI或急诊冠状动脉旁路移植术、休克、严重左心功能衰竭。

1.1.5 排除标准 ①仅有摘要,缺乏全文且联系作者未回复者;②作者、单位且报道的结果都相似的文献,仅纳入信息最全面者,并积极联系作者澄清;③对于同一试验报告不同结果的多个文献,仅收集有可用数据的研究。

1.2 检索策略

以“right radial artery, left radial artery, transradial, radial, coronary, coronary angiography, percutaneous coronary intervention”为英文检索词,以“左桡动脉、右桡动脉、桡动脉、冠状动脉、冠脉、冠状动脉造影、冠脉造影、冠状动脉介入术、冠脉介入”为中文检索词,采用自由词与主题词相结合的方法,计算机检索PubMed、EMBASE、Web of Science、Cochrane图书馆、中国生物医学文献数据库、中文科技期刊全文数据库、数字化期刊数据库和中国期刊全文数据库,检索时限从1989年至2013 年2月,并辅以追溯纳入文献的参考文献。

1.3 文献筛选和资料提取

1.4 方法学质量评价

根据 Cochrane Handbook 5.0.2推荐的“偏倚风险评估”工具对纳入研究进行方法学质量评价,包括：①随机分配方法;②隐蔽分组;③对研究对象、治疗方案实施者、研究结果测量者或统计人员采用盲法;④结果数据的完整性;⑤选择性报告研究结果;⑥其他偏倚来源。对上述6条做出“是”（低度偏倚）、“否”（高度偏倚）、“不清楚”（缺乏相关信息或偏倚情况不确定）的评价。

1.5 统计分析

两名研究人员独立输入数据,互相复核,准确无误且意见统一后,使用RevMan 5.1软件进行Meta分析。计量资料选用均数差（mean difference, MD）及其 95%可信区间（confidence interval, CI）,计数资料选用相对危险度（risk ratio, RR）及其95%CI。若研究仅提供观察指标的中位数和四分位间距时,根据Cochrane 系统评价手册中推荐的公式进行换算^{[ 6]}。采用χ²检验进行异质性分析,检验水准α=0.1;并用 I²判断异质性大小。如异质性较小（ I²≤50%, P≥0.1）,采用固定效应模型合并效应量;反之,若异质性较大（ I²>50%, P<0.1）,分析异质性产生的来源和原因,如仅有统计学异质性时,采用随机效应模型合并效应量,否则仅行描述性分析。对纳入研究数≥9的主要观察指标,绘制漏斗图判断发表偏倚。

2 结果

2.1 文献筛选流程与结果

初检到相关文献870篇,根据纳入与排除标准,通过阅读文题和摘要并进一步阅读全文后,最终纳入13篇文献^{[ 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18]}。文献检索流程见图1。

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	图1 文献检索流程及结果

2.2 纳入研究的概况

所有研究都报道基线资料可比,入路桡动脉Allen试验阳性。共纳入6 605例患者,其中RRA组3 292例,LRA组3 313例。各研究样本量差异较大（40~1 467例）,4个研究纳入例数大于500例^{[ 5, 9, 12, 17]}。9个研究报道了术者的操作水平^{[ 5, 7, 8, 9, 10, 11, 12, 13, 14]}。各研究的主要特征及病人的基本资料见表1。纳入研究的方法学质量评价见表2。

表1 纳入研究的基本特征

表2 纳入研究的方法学质量评价

2.3 Meta分析结果

2.3.1 入路更改 13个研究均报告了入路更改率或人数,共6 605例患者。异质性检验显示各研究间无统计学异质性（ P=0.58, I²=0%）,采用固定效应模型进行Meta分析,结果显示RRA组与LRA组差异有统计学意义[RR=1.37,95%CI（1.10,1.71）, P=0.005]（图2）,RRA组发生入路更改的可能性是LRA组的1.37倍。

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	图2 RRA 组与LRA 组入路更改发生率比较的Meta 分析

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	图3 RRA 组与LRA 组手术时间比较的Meta 分析

2.3.2 手术时间 13个研究均以分钟为单位报告了手术时间,共6 605例患者。异质性检验显示各研究间统计学异质性较大（ P<0.000 1, I²=71%）,采用随机效应模型合并。Meta分析结果显示RRA组与LRA组差异有统计学意义[MD=0.73,95%CI（0.09,1.36）, P=0.02]（图3）,RRA组的手术时间长于LRA组。

2.3.3 外周血管并发症 10个研究^{[ 5, 7, 9, 10, 12, 13, 15, 16, 17, 18]}报告了外周血管并发症的发生率或人数,共5 801例患者。异质性检验显示各研究间统计学异质性较小（ P=0.39, I²=6%）,采用固定效应模型进行Meta分析,结果显示RRA组与LRA组差异无统计学意义[RR=0.94, 95%CI（0.76,1.16）, P=0.57]（图4）。

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	图4 RRA组与LRA组外周血管并发症发生率比较的Meta分析

2.3.4 主要不良心脏事件纳入的4个研究^{[ 5, 10, 12, 17]}报告了MACE发生率或人数,共3 630例患者。异质性检验显示各研究间无统计学异质性（ P=0.56, I²=0%）,采用固定效应模型进行合并。Meta分析结果显示RRA组与LRA组差异无统计学意义[RR=1.41, 95%CI（0.28,7.11）, P=0.68]（图5）。

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	图5 RRA组与LRA组MACE发生率比较的Meta分析

2.3.5 漏斗图对入路更改率进行漏斗图分析,结果提示发表偏倚较小（图6）。

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	图6 入路更改率的漏斗图

3 讨论

Meta分析结果显示：在入路更改率及手术时间方面,LRA组均优于RRA组;在外周血管并发症、MACE发生率方面,二组差异无统计学意义。

随着介入技术的不断进步,桡动脉入路目前已成为冠状动脉介入术的首选路径^{[ 4]}。但在临床和研究中大多都采用RRA,由于桡动脉管径较小、易痉挛以及越来越常见的锁骨下动脉迂曲等解剖学变异^{[ 19]},都显示出单一RRA的不足,需要积极探索新的介入途径以保证经前臂动脉介人诊疗的成功率。LRA相对于RRA的优势主要在于其解剖学路径的特点：①左锁骨下动脉经主动脉弓远端进入升主动脉根部的角度大而平滑,而右锁骨下动脉经头臂干、主动脉弓近端进入升主动脉根部时形成“S”形迂曲^{[ 20]}。故经LRA行CAG或PCI时导丝和导管旋转、调整的次数较少,使其操作更为方便,有利于缩短手术时间^{[ 5]}。②右锁骨下动脉经头臂干进入主动脉弓处,血管迂曲成角常见^{[ 20]}。在TALENT研究中^{[ 5]},对桡动脉入路更改的多因素分析表明,锁骨下动脉迂曲为其主要原因（比值比18.5, 95%CI 6.4~54.0, P<0.001）,锁骨下动脉迂曲的独立预测因素为年龄>70岁（比值比2.6, 95%CI 1.8~3.7, P<0.001）和RRA（比值比2.7, 95%CI 1.9~4.0, P<0.001）。Sciahbasi等^{[ 21]}的研究发现LRA组较少的血管迂曲成角还可以缩短学习曲线周期,对初学者更有利。本研究提示RRA组发生入路更改的可能性为LRA组的1.37倍,且由于处于学习曲线期的术者对桡动脉入路的解剖学异常处理经验较欠缺,故对于经验不丰富的术者采用LRA时一次成功率可能会较RRA高。LRA的劣势在于操作距离的增加,即在CAG和PCI术中,患者的左侧桡动脉在身体的左侧偏上,不利于站在右侧偏下的术者进行桡动脉穿刺,特别是对体型肥胖的患者。本研究发现LRA组与RRA组相比缩短了手术时间,这与一项纳入1 052例患者的前瞻性、观察性PREVAIL研究结果一致^{[ 22]}。说明在手术台上对患者左上肢予以合适的固定后,LRA行CAG或PCI时并不会给术者的操作过程带来明显的位置不便。

本研究结果提示与RRA相比,LRA没有增加外周血管并发症、MACE发生率,提示LRA与RRA行冠状动脉介入术时具有同样的安全性,可以作为常规入路。

本研究存在一些不足之处：①纳入研究中未包括会议论文摘要和读者来信,这可能导致发表偏倚。②纳入研究中所使用的大多数导管为Judkins型,其设计有利于LRA的操作,这可能对结果有一定影响。③手术入路更改率、手术时间与术者的操作水平密切相关,本次Meta分析纳入的研究中有9个研究报告了术者每年的手术量>100例,各研究间术者的手术经验也不同^{[ 5, 7, 8, 9, 10, 11, 12, 13, 14]}。但基于LRA解剖学的优势,其对于经验不丰富的术者会有更低的入路更改率的结论仍较可靠。④纳入的研究中有7个研究报告了正确的随机方法^{[ 5, 9, 11, 12, 13, 14, 17]},5个研究报告了分配隐藏^{[ 5, 9, 11, 13, 14]}。1个研究按照住院号进行了随机分配^{[ 10]}。各研究均未报告盲法,虽然纳入研究的干预措施涉及手术,对患者和术者的盲法难以实现,但仍可对结果测量者和统计分析人员施盲,尽可能地减少测量偏倚。

在本研究的主要指标入路更改率中,纳入的样本量大,各个研究一致性高,漏斗图提示发表偏倚较小,较稳定可靠的结果已表明,LRA能很好地完成CAG或PCI。因此,未来更多有关此方面的设计、实施和报告良好的高质量RCT应更多地关注尺动脉入路^{[ 23]},进一步丰富经前臂动脉介入治疗的手段。此外也可以进一步地探索使用其它设计的造影导管时经左右侧入路行冠状动脉介入术的差异。

综上所述,LRA与RRA相比,具有较低的入路更改率及较短的手术操作时间,处于学习曲线期的术者使用LRA完成冠状动脉介入术时更有优势。

The authors have declared that no competing interests exist.

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[14]	Dominici M, Diletti R, Milici C, et al. Operator exposure to X-ray in left and right radial access during percutaneous coronary procedures: OPERA rand omised study[J]. Heart, 2013, 99(7): 480-484. [本文引用:1] [JCR: 5.014]
[15]	陈灿, 陈亮波, 黄石安, 等. 经左桡动脉途径行冠脉介入治疗的可行性研究[J]. 中国介入影像与治疗学, 2008, 4(6): 460-462. [本文引用:1]
[16]	贺剑. 经左、右桡动脉途径行冠状动脉造影的对比分析[J]. 中国煤炭工业医学杂志, 2010, 13(8): 1103-1103. [本文引用:1]
[17]	熊永红, 惠永明, 张骥, 等. 经左侧桡动脉途径冠状动脉介入治疗的临床分析[J]. 中国循证心血管医学杂志, 2011, 3(2): 124-126. [本文引用:3]
[18]	聂斌, 张维君, 杨清, 等. 经左桡动脉与右桡动脉入路冠状动脉造影术安全性和有效性比较[J]. 中国医药, 2012, 7(8): 913-915. [本文引用:1]
[19]	Nie B, Zhou YJ, Li GZ, et al. Clinical study of arterial anatomic variations for transradial coronary procedure in Chinese population[J]. Chin Med J (Engl), 2009, 122(18): 2097-2102. [本文引用:1]
[20]	Cha KS, Kim MH, Kim HJ. Prevalence and clinical predictors of severe tortuosity of right subclavian artery in patients undergoing transradial coronary angiography[J]. Am J Cardiol, 2003, 92(10): 1220-1222. [本文引用:2] [JCR: 3.209]
[21]	Sciahbasi A, Romagnoli E, Trani C, et al. Evaluation of the “learning curve” for left and right radial approach during percutaneous coronary procedures[J]. Am J Cardiol, 2011, 108(2): 185-188. [本文引用:1] [JCR: 3.209]
[22]	Pelliccia F, Trani C, Biondi-Zoccai GGL, et al. Comparison of the feasibility and effectiveness of transradial coronary angiography via right versus left radial artery approaches (from the PREVAIL study)[J]. Am J Cardiol, 2012, 110(6): 771-775. [本文引用:1] [JCR: 3.209]
[23]	deAndrade PB, Tebet MA, Nogueira EF, et al. Transulnar approach as an alternative access site for coronary invasive procedures after transradial approach failure[J]. Am Heart J, 2012, 164(4): 462-467. [本文引用:1] [JCR: 4.497]

1989

0.0

Campeau

Percutaneous radial artery approach for coronary angiography[J]. Cathet Cardiovasc Diagn, 1989, 16(1): 3-7.

Montreal Heart Institute, Montreal, Quebec, Canada *Montreal Heart Institute, 5000 East Belanger Street. Montreal. Quebec, HIT 1C8, Canada

Percutaneous entry into the distal radial artery and selective coronarography using a French 5 sheath and preshaded catheters were attempted in 100 patients with a normal Allen test. Cannulation of the radial artery was not possible in ten patients, and selective catheterization of the coronary arteries was unsuccessful in two. Manipulation of catheters presented no problem, and arterial spasm was rarely observed, only before the use of a 23-cm-long sheath. Only two complications without symptoms were observed: arterial dissection of the brachial artery in one patient and occlusion of the radial artery in another. With experience, this approach may become as effective and possibly safer than the transbrachial entry.

... 自1989年Campeau医生首次报道经桡动脉入路行冠状动脉造影术以来^[1],随着器材的改进和操作技术的进步,桡动脉入路与传统的股动脉入路相比,已具有使患者痛苦小、住院时间短、外周血管并发症少等诸多优点^[2,3],并被2013年《欧洲心脏病学会专家共识》推荐为冠状动脉介入术的首选入路^[4] ...

2013

0.0

2011

39.06

0.0

2013

3.173

0.0

... 随着介入技术的不断进步,桡动脉入路目前已成为冠状动脉介入术的首选路径^[4] ...

2011

4.497

0.0

Sciahbasi

, Romagnoli

, Burzotta

, et al. Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study[J]. Am Heart J, 2011, 161(1): 172-179.

<ul><li id="af0005">aUO Cardiologia, Policlinico Casilino—ASL RM B, Rome, Italy</li><li id="af0010">bUniversità Cattolica del Sacro Cuore di Roma, Italy</li><li id="af0015">cUniversità degli studi dell'Aquila, Italy</li></ul>

... 目前国内外的研究多集中于右侧桡动脉入路（right radial approach, RRA）,在临床中对左右侧桡动脉入路的选择也多取决于术者的个人选择^[5] ...

... 然而最近一项随机入组1 540例患者的TALENT研究表明^[5],与RRA相比,左侧桡动脉入路（left radial approach, LRA）不仅具有解剖学路径优势,还能缩短透视时间等 ...

... 1 文献筛选流程与结果初检到相关文献870篇,根据纳入与排除标准,通过阅读文题和摘要并进一步阅读全文后,最终纳入13篇文献^{[5,7,8,9,10,11,12,13,14,15,16,17,18]} ...

... 各研究样本量差异较大（40~1 467例）,4个研究纳入例数大于500例^[5,9,12,17] ...

... 9个研究报道了术者的操作水平^{[5,7,8,9,10,11,12,13,14]} ...

... 3 外周血管并发症 10个研究^{[5,7,9,10,12,13,15,16,17,18]}报告了外周血管并发症的发生率或人数,共5 801例患者 ...

... 4 主要不良心脏事件纳入的4个研究^[5,10,12,17]报告了MACE发生率或人数,共3 630例患者 ...

... 故经LRA行CAG或PCI时导丝和导管旋转、调整的次数较少,使其操作更为方便,有利于缩短手术时间^[5] ...

... 在TALENT研究中^[5],对桡动脉入路更改的多因素分析表明,锁骨下动脉迂曲为其主要原因（比值比18 ...

... 100例,各研究间术者的手术经验也不同^{[5,7,8,9,10,11,12,13,14]} ...

... ④纳入的研究中有7个研究报告了正确的随机方法^{[5,9,11,12,13,14,17]},5个研究报告了分配隐藏^{[5,9,11,13,14]} ...

0.0

... 若研究仅提供观察指标的中位数和四分位间距时,根据Cochrane 系统评价手册中推荐的公式进行换算^[6] ...

2004

0.0

Kawashima

, Endoh

, Terashima

, et al. Effectiveness of right or left radial approach for coronary angiography[J]. Catheter Cardiovasc Interv, 2004, 61(3): 333-337.

1Heart Center, Sendai Kosei Hospital, Sendai, Japan 2Faculty of Medical Science and Welfare, Tohoku Bunka Gakuen University, Sendai, Japan *Heart Center, Sendai Kosei Hospital, 4-15 Hirose-machi, Aoba-ku, Sendai 980-0873, Japan

The transradial approach for catheterization is becoming increasingly more popular. At present, the choice of the right or left radial artery depends on the operator's preference. We examined how the laterality influenced the effectiveness of the approach. Employing Judkins-type catheters, we performed coronary angiography in 232 patients with the left approach and in 205 patients with the right approach. Although access time did not differ between the two groups of patients, the duration of catheter manipulation was shorter in the left- than in the right-approach group (11.7 ± 5.9 vs. 9.8 ± 4.4 min; P < 0.001). Because of the shorter duration of catheter manipulation, the total procedural duration was shorter in the left-approach group (13.7 ± 6.4 vs. 11.4 ± 4.8 min; P < 0.001). The fluoroscopy time was shorter in the left- than in the right-approach group (3.7 ± 2.5 vs. 5.0 ± 3.3 min; P < 0.001). The amount of contrast material did not differ between the groups (79 ± 27 vs. 83 ± 25 ml). The rate of guidewire usage to engage the coronary ostium was higher in the right- than in the left-approach group because of the severe tortuosity of the right subclavian artery (20/205 vs. 0/232; P < 0.001). Thus, for operators with significant experience, the left radial approach may provide increased procedural efficacy for coronary angiography compared to the right radial approach. Catheter Cardiovasc Interv 2004;61:333–337. © 2004 Wiley-Liss, Inc.

... 3 外周血管并发症 10个研究^{[5,7,9,10,12,13,15,16,17,18]}报告了外周血管并发症的发生率或人数,共5 801例患者 ...

2006

3.204

0.0

Fernand ez-Portales

, Valdesuso

, Carreras

, et al. Right versus left radial artery approach for coronary angiography. Differences observed and the learning curve[J]. Rev Esp Cardiol, 2006, 59(10): 1071-1074.

2009

3.204

0.0

Santas

, Bodi

, Sanchis

, et al. The left radial approach in daily practice. A rand omized study comparing femoral and right and left radial approaches[J]. Rev Esp Cardiol, 2009, 62(5): 482-490.

Introduction and objectives

The right radial (RRA) approach has been incorporated into daily clinical practice as a valid alternative to the femoral (FA) approach. The left radial (LRA) approach is seldom used and few data are available from randomized studies comparing this approach with F and RR approaches.

Methods

We randomized 1005 consecutive patients referred to a tertiary-care hospital for cardiac catheterization to different approaches. Procedures were performed by three interventional cardiologists experienced in transradial catheterization. There were no exclusion criteria. The primary end-point was the percentage of procedures completed using the assigned approach. Secondary endpoints were the percentage completed in the absence of contraindications to any approach, the duration of the procedure, and the incidence of vascular complications.

Results

More procedures were completed with the FA approach (LRA, 71%; FA, 92%; RRA, 68%; P<.001). The success rate in the absence of contraindications to any approach (n=907) was greater with the FA approach, with no difference between LRA and RRA approaches (LRA, 80%; FA, 96%; RRA, 82%; P<.001). The canalization time was greater with the LRA approach (P<.001), the time required for diagnosis was shorter with the FA approach (P<.001) and compression was faster with the radial approach (P<.001). There was no difference in the total duration of diagnostic procedures (P=.22) or interventions (P=.9). The incidence of vascular complications was lower with the radial approach (P=.03).

Conclusions

The left radial approach is as valid an alternative to the femoral approach as the right radial approach.

Introducción y objetivos

El acceso radial derecho (RD) se ha incorporado a la práctica clínica diaria como una alternativa válida al acceso femoral (AF). La vía radial izquierda (RI) se utiliza en menos centros y hay pocos datos de trabajos aleatorizados que la comparen con el AF y el RD.

Métodos

Se aleatorizó a 1.005 pacientes consecutivos remitidos a un hospital terciario para cateterismo cardiaco. Realizaron los procedimientos tres hemodinamistas expertos en cateterismo transradial. No se aplicaron criterios de exclusión. Como objetivo primario se analizó la tasa de finalización por la vía asignada y como objetivos secundarios, la tasa de finalización en ausencia de contraindicaciones para alguna vía, los tiempos del procedimiento y la incidencia de complicaciones vasculares.

Resultados

Se finalizaron más casos por vía femoral (RI, 71%; AF, 92%; RD, 68%; p < 0,001). El éxito en ausencia de contraindicaciones para alguna vía (n = 907) fue mayor en la AF, sin diferencias entre RI y RD (RI, 80%; AF, 96%; RD, 82%; p < 0,001). El tiempo de canalización fue mayor por RI (p < 0,001), el diagnóstico se acortó por AF (p < 0,001) y la compresión fue más rápida por radial (p < 0,001). No hubo diferencias en el tiempo total del procedimiento diagnóstico (p = 0,22) ni en el de intervencionismo (p = 0,9). La incidencia de complicaciones vasculares fue menor por radial (p = 0,01).

Conclusiones

El acceso RI es una alternativa tan válida como el RD al AF.

... 各研究样本量差异较大（40~1 467例）,4个研究纳入例数大于500例^[5,9,12,17] ...

... ④纳入的研究中有7个研究报告了正确的随机方法^{[5,9,11,12,13,14,17]},5个研究报告了分配隐藏^{[5,9,11,13,14]} ...

2011

3.209

0.0

... 4 主要不良心脏事件纳入的4个研究^[5,10,12,17]报告了MACE发生率或人数,共3 630例患者 ...

... 1个研究按照住院号进行了随机分配^[10] ...

2013

5.509

0.0

... ④纳入的研究中有7个研究报告了正确的随机方法^{[5,9,11,12,13,14,17]},5个研究报告了分配隐藏^{[5,9,11,13,14]} ...

2012

0.0

Norgaz

, Gorgulu

, Dagdelen

A rand omized study comparing the effectiveness of right and left radial approach for coronary angiography[J]. Catheter Cardiovasc Interv, 2012, 80(2): 260-264.

Cardiology Department, Acibadem University, Istanbul, Turkey *Acibadem Universitesi, Kocaeli Acibadem Hastanesi, Yeni Mahalle Inkilap Cad 9, Izmit 41100 Kocaeli, Turkey

Objectives

Our aim was to compare the effectiveness between right radial approach (RRA) and left radial approach (LRA) by means of a randomized study in a large unselected patient population undergoing diagnostic coronary angiography.

... 各研究样本量差异较大（40~1 467例）,4个研究纳入例数大于500例^[5,9,12,17] ...

... 4 主要不良心脏事件纳入的4个研究^[5,10,12,17]报告了MACE发生率或人数,共3 630例患者 ...

2012

0.0

Freixa

, Trilla

, Feldman

, et al. Right versus left transradial approach for coronary catheterization in octogenarian patients[J]. Catheter Cardiovasc Interv, 2012, 80(2): 267-272.

Thorax Institute, Division of Cardiology, Interventional Cardiology Program, Hospital Clinic of Barcelona, Barcelona, Spain *Hospital Clinic, University of Barcelona, Villarroel 170, Barcelona 08036, Catalonia, Spain

Objectives: The aim of the study was to evaluate if the left radial approach (LRA) confers any additional advantage compared to the right radial approach (RRA) in octogenarian patients who undergo a coronary diagnostic procedure. Background: Octogenarians, an increasing segment of patients in our society, present a higher risk of access-site complications related to invasive coronary catheterization. Transradial approach has been shown to be an effective alternative to reduce vascular complications. Although some studies have suggested that elderly people might benefit from a LRA, the advantages of using the left or right radial access remain not clear. Methods: One hundred octogenarian patients undergoing a transradial coronary angiogram with normal Allen test and without previous history of coronary artery by-pass grafting were randomized to either LRA (n = 50) or RRA (n = 50). The primary end-points of the study were procedural and fluoroscopy times. Results: Mean age was 82.6 years (80–88) and 59% were males. Procedural and fluoroscopy times were similar among study groups. Crossover was required in two patients (4%) with RRA and five patients (10%) with LRA (P = 0.24). Subclavian tortuosity was more frequent in the right side (32% vs. 6% in the left side; P = 0.002) but this difference did not translate into longer procedural or fluoroscopy times or higher cross-over, procedural difficulty or wire manipulation. Conclusions: In our series of octogenarian patients, the LRA was a valid alternative for diagnostic procedures but its usage was not associated with a significant reduction in procedural and fluoroscopy times compared to the RRA. © 2012 Wiley Periodicals, Inc.

2013

5.014

0.0

2008

0.0

2010

0.0

2011

0.0

... 各研究样本量差异较大（40~1 467例）,4个研究纳入例数大于500例^[5,9,12,17] ...

... 4 主要不良心脏事件纳入的4个研究^[5,10,12,17]报告了MACE发生率或人数,共3 630例患者 ...

... ④纳入的研究中有7个研究报告了正确的随机方法^{[5,9,11,12,13,14,17]},5个研究报告了分配隐藏^{[5,9,11,13,14]} ...

2012

0.0

2009

0.0

... 但在临床和研究中大多都采用RRA,由于桡动脉管径较小、易痉挛以及越来越常见的锁骨下动脉迂曲等解剖学变异^[19],都显示出单一RRA的不足,需要积极探索新的介入途径以保证经前臂动脉介人诊疗的成功率 ...

2003

3.209

0.0

... 形迂曲^[20] ...

... ②右锁骨下动脉经头臂干进入主动脉弓处,血管迂曲成角常见^[20] ...

2011

3.209

0.0

... Sciahbasi等^[21]的研究发现LRA组较少的血管迂曲成角还可以缩短学习曲线周期,对初学者更有利 ...

2012

3.209

0.0

... 本研究发现LRA组与RRA组相比缩短了手术时间,这与一项纳入1 052例患者的前瞻性、观察性PREVAIL研究结果一致^[22] ...

2012

4.497

0.0

deAndrade

, Tebet

, Nogueira

, et al. Transulnar approach as an alternative access site for coronary invasive procedures after transradial approach failure[J]. Am Heart J, 2012, 164(4): 462-467.

<ul><li id="af0005">Santa Casa de Marília, Marília, São Paulo, Brazil</li></ul>

... 因此,未来更多有关此方面的设计、实施和报告良好的高质量RCT应更多地关注尺动脉入路^[23],进一步丰富经前臂动脉介入治疗的手段 ...