摘要
目的系统评价国内经桡动脉路径行冠状动脉造影及介入治疗的可行性、安全性。
背景国外已完成多个比较不同动脉路径进行冠状动脉介入诊疗的循证医学研究,进一步证实经桡动脉途径在保证较高手术成功率的同时,周围血管并发症明显少于经股动脉途径。由于国人桡动脉内径较细小,经桡动脉途径冠状动脉介入诊疗是否适于国人尚需进一步明确。
方法计算机网络检索中国生物医学文献数据库、MEDLINE、EMBASE、Cochrane图书馆,检索年限为1989年~2008年。收集所有相关国内随机和非随机对照试验,质量评价后用Revman4.2.3软件进行Meta分析。
结果未能获得国内随机对照试验,共纳入9个前瞻性对照研究,累计样本量2389例。结果显示:1、CAG成功率:3个试验(n=1013)的Meta分析结果显示,经桡动脉途径冠状动脉造影(TRA)成功率与经股动脉途径冠状动脉造影(TFA)相似[RR=0.98,95%CI(0.95,1.00)];2、PCI成功率:6个试验(n=1441)的Meta分析结果显示,经桡动脉途径冠状动脉介入手术(TRI)成功率与经股动脉途径冠状动脉造影(TFI)相似[RR=0.99,95%CI(0.97,1.01)];3、住院期间主要不良心脏事件(MACE):4个试验报道为0,有1个试验报道TRI组3例、TFI组有2例因术后出现急性冠脉闭塞死亡,其余试验未见相关研究。4、插管操作失败率:8个试验(n=2236)的Meta分析结果显示,经桡动脉途径的失败率要高于经股动脉途径,其差异有统计学意义[RR=1.59,95%CI(1.02,2.47)];5、外周血管并发症:9个试验(n=2389)的Meta分析结果显示,经桡动脉途径组的外周血管并发症明显少于经股动脉组,其差异有统计学意义[RR=0.50,95%CI(0.29,0.86)];6、住院时间:5个试验(n=1293)的Meta分析结果显示,经桡动脉途径组的住院时间明显少于经股动脉组,统计学有显著差异[WMD=-2.68,95%CI(-3.55,-1.81)]。另外造影剂使用量、X线曝光时间、动脉穿刺时间、手术时间,在多个研究合并效应量后没有统计学意义。
结论国人在经桡动脉途径行冠心病介入诊疗与经股动脉途径行冠心病介入诊疗同样安全可行的。经桡动脉途径外周血管并发症少,尤其是出血性血管并发症,且卧床和住院时间短,是经股动脉途径所不可比拟的。但经桡动脉途径行冠心病介入诊疗操作难度较大,对术者技能要求高。此外,进一步提高经桡动脉介入器材的操作性能以及桡动脉易发生痉挛和闭塞的难题还有待解决。
Background Overseas evidence based medicine researches about comparison of different approaches for percutaneous coronary diagnostic and interventional procedures have been finished, which confirmed that the radial approach can guarantee high success rate and reduce local vascular complications compared with the femoral approach. However, the inner diameter of Chinese radial arteries is small, so it is quite necessary to make sure that if the radial approach is also suit for Chinese people for coronary angiography and percutaneous coronary intervention.
Objective To systematically review the feasibility and safety of coronary angiography (CAG) and percutaneous coronary intervention (PCI) through the radial approach in China.
Methods The papers from 1989 to 2008 were retrieved from biomedicine bibliographic database of China (CBM), MEDLINE, EMBASE, and Cochrane, which were about randomized controlled trials (RCT) and non-randomized controlled trials to compare the radial approach with the femoral approach. Software of Revman4.2.3 was used to carry out Meta-analysis after the quality of the papers was evaluated.
Results In this field, RCT of China was not found, and 9 perspective controlled trials (n=2389) were included. (l)Meta-analysis of 3 trials (n=1013) showed that the success rate of CAG was similar for the radial versus femoral approach [RR=0.98, 95%CI(0.95, 1.00)]. (2)Meta-analysis of 6 trials (n=1441) showed that the success rate of PCI was similar for the radial versus femoral approach [RR=0.99, 95%CI (0.97, 1.01)]. (3)None of the major adverse cardiovascular events (MACE) was found in 4 trials. In one trial, 3 cases of transradial intervention (TRI) group and 2 cases of transfemoral intervention (TFI) group died of acute coronary obstruction. The other trials did not carry out research of this part. (4)Meta-analysis of 8 trials (n=2236) showed that the radial approach had a higher proportion of intubation failures than that of the transfemoral approach [RR=1.59, 95%CI (1.02, 2.47)]. (5)Meta-analysis of 9 trials (n=2389) showed that the rate of local vascular complications of TRI group was lowered than that of the TFI group [RR=0.50, 95%CI (0.29, 0.86)]. (6)Meta-analysis of 5 trials (n=1293) showed that the length of stay of TRI group was shorter than that of TFI group[WMD=-2.68, 95%CI (-3.55, -1.81)].(7) The doses of contrast agent, exposure time of X ray, time for arteriopuncture, time for PCI showed no significant differences between the TRI group and the TFI group.
Conclusions In Chinese, the radial approach for coronary procedures appears as a safe alternative to femoral access. The lower rate of local vascular complications, especially hemorrhagic complications, the shorter time of lying in bed and staying in hospital through make the radial approach superior to the femoral approach. But it is more difficult to carry out PCI through radial approach. Moreover, it is necessary to improve the operability of equipment and supplies for radial approach and reduce the rate of arteriospasm and obstruction of radial artery.
引文
[1]Campeau L.Percutaneous radial artery approach for coronary angiography.Cathet Cardiovasc Diagn 1989;16:3-7.
[2]Kiemeneij F,Laarman GJ.Percutaneous transradial artery approachfor coronary stent implantation.Cathet Cardiovasc Diagn 1993;30:173-8.
[3]Kiemeneij F,Laarman GJ,odekerken D,Et Al.A randomized comparison of percutaneous transluminal coronary angioplsty by the radial,brachial and femoral approaches:the access sudy.J Am Coil Cardiol,1997,29:1269-1275
[4]Pierfrancesco Agostoni,Giuseppe G.L,Biondi-Zoccai etc.Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures systematic overview and Meta-analysis of randomized trials.Journal of the American College of Cardiology,Vol.44,No.2,2004:349-356
[5]Saito S,Ikei H,Hosokawa G,et al.Influence of he radio artery inner diameter and sheath outer diameer on radial artery flow after transradial coronary intervention Caheer cardiovasc Interv,1999,46(2):173-178
[6]贾三庆,郭春艳,滕一星.成人右侧桡动脉舒张期最大内径分布调查.中国介入心脏病学杂志,2004,Vol 12,Nol 3:162
[7]韩雅玲,荆全明,王守力,等1经桡动脉冠心病介入治疗165例报告[J]1中国实用内科杂志,2003,23(4):214-215
[8]庞明杰,张宏等.经桡动脉入径直接经皮冠状动脉介入治疗急性心肌梗 死的临床研究[J]1华西医学,2005;20(2):333-334
[9]赵全明,王现青,田军,等.经皮穿刺桡动脉冠状动脉照影术304例[J].中国介入心脏病学杂志,2002,10(3):1322134.
[10]姚民,乔树宾,王东方,等.使用5F造影导管经桡动径路冠状动脉造影689例体会[J].中华循环杂志,2002,17(4):374.
[11]张伟.经桡动脉、股动脉不同路径行冠状动脉造影术的临床观察[J].中国实用内科杂志,2003,23(4):243.
[12]Khan K,T e r R ie t G,G lanville J,Sow don A,Kle ijnen J.U n2de rtak ing system atic review s of research on effectiveness.C R Dgu idance fo r carrying out o r commission ing review s,2 nd edn.C R D R ep o rt 4.Yo rk,N H S C en tre fo r R eview s and D issem i2nation(C R D),U n ive rsity of York,2000.
[13]Deeks JJ,Dinnes J,D'Amico R,et al.Evaluating non-randomised intervention studies.Health Technol Assess,2003,7(27):1-173
[14]傅向华,马宁,刘君.经桡动脉与股动脉入径直接经皮冠状动脉介入治疗急性心肌梗死的对比研究.中华心血管病杂志,2003,Vol.31 No.8:573-577
[15]柳景华,范煜东,王学英.经桡动脉途径和经股动脉途径行冠状动脉介入检查及治疗的前瞻性临床研究.介入放射学杂志,2004,Vol.12,Suppl (2):115
[16]胡信群,,沈向前,周胜华等.经桡动脉与经股动脉途径冠状动脉造影的比较.中南大学学报(医学版),2005,30(4):475-476
[17]荆全民,韩雅玲,王守力等.老年冠心病经桡动脉穿刺介入治疗的可行性研究.中国实用内科杂志,2005,25(1):33-35
[18]吴艳梅,陈丽娜,张超峰.桡动脉与股动脉入径经皮冠状动脉介入治疗冠心病的对比研究.白求恩军医学院学报,2005,3(1):88-90
[19]虞准,彭晓玲,胡春华等.经肱动脉、桡动脉及股动脉途径行冠状动脉PCI的比较研究.中国全科医学,2006,9(17):1417-1418
[20]王平,王国祥.经桡动脉穿刺行冠脉造影的可行性研究.四川医学,,2007,28(14):382-383
[21]潘震华,王柏颖,王满庆.经桡动脉入路急诊冠状动脉介入治疗的临床研究.黑龙江医药,2007,20(3):216-217
[22]肖华,李志良,陈爱华.经皮桡动脉入路直接冠状动脉介入治疗急性心肌梗死.第二军医大学学报,2007,28(2):175.178
[23]刘建平.非随机研究的系统评价.中国循证医学,2001,1,(3):137-139
[24]Grinfeld L,Berrocal D,Rojas Matas C,Magni J,Belardi J.What is the most effective vascular approach for a diagnostic cardiac catheter-ization?A randomized trial using the femoral,brachial or radial approaches(abstr).J Am Coil Cardiol 1996;27 Suppl A:901.
[25]Louvard Y,Lefevre T,Allain A,Morice MC.Coronary angiography through the radial or the femoral approach:the CARAFE study.Cathet Cardiovasc Intervent 2001;52:181-7.
[26]Louvard Y,Sabatier R,Benamer H,et al.A randomized comparison of transradial and transfemoral approaches for coronary angiography and PTCA in octogenarians (abstr). Am J Cardiol 2003;92 Suppl6A:17L.
[27] Saito S, Tanaka S, Hiroe Y, et al. Comparative study on transradialapproach vs. transfemoral approach in primary stent implantation for patients with acute myocardial infarction: results of the Test for Myocardial Infarction by Prospective Unicenter Randomization for Access Sites(TEMPURA) trial. Cathet Cardiovasc Intervent 2003;59:26-33.
[28] Kiemeneij F. Percutaneous transradial artery approach for coronary stent implantation [J]. Cathet Cardiovasc Diagn ,1993 ,30 (3): 173.
[29] Kiemeneij F , Lasman GJ , Odekerken D , et al , A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches : the access study[J] . J Am Coll Cardiol, 1997,29 (6): 1269.
[30] KIEMENEU F.Outpatient coronary stent implantation J.JACC,1997,29:323-327
[31] Yokoyama N, Takeshita S, Ochiai M, et al.Anatomic variations of he radial artery in patiens undergoing transradial coronary intervention. Cahet cardiovasc intervent,2000,49:357-362
[32] Hudelo C,Maillard L,Quilliet L, et al1Comparison of coronary angiogra2 phy by the left radial, and right femoral app roach with 4 French heters [J] lArchMal CoeurVaiss, 2000; 93 (7): 813291"
[33] Valsecchi O, Vassileva A, musumeci G, et al.Failure of transradial approach during coronary intervenions: Anaomic considerations. Cahet rdiovasc Intervent,2006,67:870-878
[34]乔树宾,高润霖.经桡动脉进行冠状动脉腔内成形术和支架置入术[J].中华心血管病杂志,2002,30:63-64.
[35]Koga S,Ikeda S,Futagawa K,et al.The use of a hydrophilic2coated catheter during transradial cardiac catheterization is associated with a low incidence of radial artery spasm[J].Int J Cardiol,2004,96:255-258.
[36]Saito S,Tanaka S,Hiroe Y,et al.Usefulness of hydrophilic coating on arterial sheath introducer in transradial coronary interventions.CathetCardiovasc Intervent 2002;56:328-32.
[37]He GW,Yang CQ.Use of verapamil and nitroglycerin solution in preparation of radial artery for coronary grafting.Ann Thorac Surg 1996;61:610-4.
[38]Kiemeneij F,Vajifdar BU,Eccleshall SC,Laarman G,Slagboom T,van der Wieken R.Evaluation of a spasmolytic cocktail to prevent radial artery spasm during coronary procedures.Cathet Cardiovasc Intervent 2003;58:281-4.
[39]Mintz GS,Popma JJ,Picharel AD,et al.Arterial remodeling after coronary angioplasty.A serial interavascular ultrasound study[J]1Circulation,1996,94:351
[40]Kikuchi Y,Endou N,Tershima M,et al.Incidence of radial artery occlusion after transradial coronary intervention in the Japanese population[J]1 Jan J Inter Cardiol,2000,15:3431
[41] Nagai S, Abe S, Sato T, et al. Ultrasonic assessment of vascular complications in coronary angiography and angiolpasty after transradial appoach[J]. Am J Cardiol, 1999, 83 (2): 1802186.
[42] Splauding C, lefevre T, Funck F, et al. left radial approach for coronary angiography:results of a prospective study. Cathet Cardiovasc Dign, 1996,39(4):365-370
[43] Gioia G, Comito C, Moreyra AE. Coronary rotational atherectomy via transradial approach: a study using radial artery intravascular ultrasound. Cathet Cardiovasc Intervent 2000;51:234-8.
[44] Wu SS, Galani RJ, Bahro A, Moore JA, Burket MW, Cooper CJ. 8 French transradial coronary interventions: clinical outcome and late effects on the radial artery and hand function. J Invasive Cardiol 2000;12:605-9.
[45] Saito S, Tanaka S, Hiroe Y, et al. Angioplasty for chronic total occlusion by using tapered-tip guidewires. Catheter Cardiovasc Interv. 2003 ,59(3):305-311
1 Waksman R, King SB 3rd, Douglas JS, Shen Y, Ewing H, Mueller L, et al. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol 1995; 75:886-889
2 Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989; 16:3-7
3 Kiemeneij F, Laarman GJ. Percutaneous transradial artery approach for coronary stent implantation. Cathet Cardiovasc Diagn 1993; 30:173-178
4 Kiemeneij F, Laarman GJ, odekerken D, Et Al. A randomized comparison of percutaneous transluminal coronary angioplsty by the radial, brachial and femoral approaches: the access sudy. J Am Coll Cardiol, 1997,29:1269-1275
5 Yokoyama N, Takeshita S, Ochiai M, et al. Anatomic variations of he radial artery in patiens undergoing transradial coronary intervention. Cahet cardiovasc intervent,2000,49:357-362
6 Valsecchi O, Vassileva A, musumeci G, et al. Failure of transradial approach during coronary intervenions: Anaomic considerations. Cahet Cardiovasc Intervent, 2006,67:870-878
7 Saito S, Ikei H, Hosokawa G, et al. Influence of he radio artery inner diameter and sheath outer diameer on radial artery flow after transradial coronary intervention Caheer cardiovasc Interv, 1999, 46(2): 173-178
8 Yoo BS, Yoon J, Ko JY, et al. Anatomical consideration of the radial artery for transradial coronary procedures: arterial diameter, branching anomaly and vessel tortuosity. Int J Cardiol. 2005,101 (3):421-427
9 Fukuda N, Iwahara S, Harada A, et al. Vasospasms of the radial artery after the transradial approach for coronary angiography and angioplasty.Jpn Heart J. 2004,45(5):723-731
10 Varenne O, Jegou A, Cohen R, et al. Prevention of arterial spasm during percutaneous coronary interventions through radial artery: the SPASM study. Catheter Cardiovasc Interv, 2006,68(2):231-235
11 Chen CW, Lin CL, Lin TK, et al. A simple and effective regimen for prevention of radial artery spasm during coronary catheterization. Cardiology. 2006,105(1):43-47
12 Ruiz-Salmeron RJ, Mora R, Masotti M, et al. Assessment of the efficacy of phentolamine to prevent radial artery spasm during cardiac catheterization procedures: a randomized study comparing phentolamine vs. verapamil. Catheter Cardiovasc Interv. 2005 ,66(2): 192-198
13 Koga S, Ikeda S, Futagawa K, et al. The use of a hydrophilic-coated catheter during transradial cardiac catheterization is associated with a low incidence of radial artery spasm. Int J Cardiol. 2004,96(2):255-258
14 Gilchrist IC. Is the Allen's test accurate for patients considered for transradial coronary angiography? J Am Coll Cardiol. 2006, 48(6): 1287.
15 Yap CH, Kenny JF. Transradial angiography may deleteriously affect patency of radial artery grafts. BMJ. 2004, 329(7473): 1046
16 Spaulding, Lefevre-T, Funck-F, et al. Left radial approach for coronary angiography: results of a prospective study[J]. cahet-cardiovasc-diagn, 1996,39(1):360-370
17 Louvard Y, Krol M, Pezzano M, et al. feasibility of routine ransradial coronary angiograghy: A single operaoros experience[J]. J invasive cardiol,1999,11(9);543-548
18 andrew AR, nicholas MR, Richand JS. Radial arery access for coronary angiography and percutaneous coronary intervenion. BMJ,2004,329:443-446
19 Cantor WJ, Puley G, Natarajan MK, et al. Radial versus femoral access for emergent percutaneous coronary intervention with adjunct glycoprotein Ilb/IIIa inhibition in acute myocardial infarction—the RADIAL-AMI pilot randomized trial. Am Heart J. 2005,150(3):543-549
20 Louvard Y, Benamer H, Garot P, et al. Comparison of transradial and transfemoral approaches for coronary angiography and angioplasty in octogenarians (the OCTOPLUS study). Am J Cardiol. 2004 ,94(9):1177-1180.
21 Kiemeneij F, Laarman GJ, Slagboom T, e al. Outpatient coronary stent implantation. j Am Coll Cardiol,1997,29(2):323-327
22 Slagboom T, Kiemeneij F, Laarman GJ, et al. Outpatient coronary angioplasty: feasible and safe. Catheter Cardiovasc Interv. 2005 ,64(4):421-427
23 Wiper A, Kumar S, MacDonald J, et al. Day case transradial coronary angioplasty: a four-year single-center experience. Catheter Cardiovasc Interv. 2006, 68(4):549-553
24 Mann JT, Cubeddu MG,. Schneider JE, et al. Right radial access for PTCA:a prospective study demonstrates reduced complications and hospital changes. J invasive Cardiol, 1996,8:40-44
25 Martial Hamon, Trans-radial approch for cardiovascular interventions. Eurpa Stehoscope Media,2003,80-83
26 Lim PO, Dzavik V. Balloon crush: treatment of bifurcation lesions using the crush stenting technique as adapted for transradial approach of percutaneous coronary intervention. Catheter Cardiovasc Interv. 2004,63(4):412-416
27 Jim MH, Ho HH, Miu R, et al. Modified crush tachnique with double kissing balloon inflation (sleeve tachnique): A novel technique for coronary bifurcation lesions. Catheterization and Cardiovascular Interventions,2006,67:403-409
28 Brunei P, lefevre T, Darremont O, et al. provisional T-stenting and kissing balloon in the treatment of coronary bifurcation lesions:resuls of the french multicenter 'TULIP" study. Catheterization and cardiovascular Inervention,2006,68:67-73
29 Yang YJ, Xu B, Chen JL, et al. Comparison of immediate and followup results between transradial and transfemoral approach for percutaneous coronary intervention in true bifurcational lesions. Chin Med J (Engl). 2007 ,120(7):539-544
30 Christoferson RD, lehmann KG, Martin GV, et al. Effect of chronic total coronary occlusion on treatment strategy.Am J Cardiol, 2005,95(9): 1088-1091
31 Saito S, Tanaka S, Hiroe Y, et al. Angioplasty for chronic total occlusion by using tapered-tip guidewires. Catheter Cardiovasc Interv. 2003 ,59(3):305-311
32 Kim JY, Lee SH, Choe HM, et al. The feasibility of percutaneous transradial coronary intervention for chronic total occlusion. Yonsei Med J. 2006,47(5):680-687
33 Lenzen MJ, Boersmal E, Bertrand ME, et al. Management and outcome of patients with established coronary artery disease:the Euro Heart Survey on coronary revascularization Eur Heart J, 2005,26b: 1169-1179
34 GAO RL, XU B, CHEN JL, et al. Prognosis of unprotected left main coronary artery stenting and the facters affecting the outcomes inChinese.Chinese Medical Journal,2006,119:14-20
35 park SJ, Kim Yh, Lee BK, et al.Sirolimus-eluting Stent Implanted for unprotected left main Coronary Artery Stenosis.Comparison With Bare Metal Stent implantation. J Am Coll Cardiol, 2005,45:351-356
36 Colombo A, Stankovic G, Bonizzoni E, et al. Sirolimus-eluting stent implantation for unprotected left main coronary artery stenosis;Comparison with bare metal stent implantation. Circulation,2005,111:791-795
37 Valgimigli m, van Mieghem CA, Ong AT, et al. Short-and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease. Circulation,2005,111:1383-1389
38 Migliorini A, Moschi G, Giurlani L, et al. Drug-Eluting Stent Supported Percutaneous Coronary Intervention for Unprotected Left Main Disease. Catheterization and Cardiovascular Interventions,2006,68:225-230
39 Wood F, Bazemore E, Schneider JE, et al. Technique of left main stenting is dependent on lesion location and distal branch protection. Catheterization and cardiovascular Intervention,2005,65:499-503
40 Rigattieri S, Ferraiuolo G, Palamara A, et al. Transradial unprotected left main coronary artery stenting in an octogenarian with severe angina and Leriche syndrome. Am J Geriatr Cardiol. 2006,15(4):235-238
41 ziakas A, Klinke P, Mildenberger R, et al. Comparison of the Radial and Femoral Approaches in Left Main PCI: A Retrospective Study. The Journal of Invasive Cardiology,2004,16:129-132
42 Louvard Y, Ludwig J,Lefevre T,et al. Transradial approach for coronary angioplasty in the setting of acute myocardial infarction: a dualcenter registry. Catheter cardiovasc Interv,2002,55:206-211
43 Philippe F, Larrazet , Meziane T, et al. Comparison of transradial vs transfemoral approach in the treatment of acute myocardial infarction with primary angioplasty and abciximab. Catheter Cardiovasc Interv,2004,61:67-73
44 Lo TS, Hall IR, Jaumdally R, et al. Transradial rescue angioplasty for failed thrombolysis in acute myocardial infarction: reperfusion with reduced vascular risk. Heart. 2006,92(8):1153-1154
45 Saito s, Tanaka S, Hiroe Y, et al.Comparative study on transradial approach vs. transfemoral approach in primary stent implantation for patients with acute myocardial infarction:results of test for myocardial infarction by prospective unicenter randomization for access sites(TEMPURA) trial. Cathet Cardiovas Intervent,2003,59:26-33
46 Dahm JB, Vogelgesang D, Humme A, et al. A randomized trial of 5 VS 6 French transradial percuteneous coronary inerventions.Caheter Cardiovasc Inerv,2002,57(2):172-176
47 Saio S,Ikei I, Hosokawa G, Tanaka S. ET al.Influence of he raio between radial inner diameter and sheath outer diameter on radial artery flow afer transradial coronary intervention. Cathet Cardiovasc Interven, 1999,46:173-178
48 Splauding C, lefevre T, Funck F, et al. left radial approach for coronary angiography:results of a prospective study. Cathet Cardiovasc Dign, 1996,39(4):365-370
49 Lund C, Nes RB, Ugelstad TP, et al. Cerebral emboli during left heart catheterization may cause acute brain injury. Eur Heart J. 2005 ,26(13):1269-1275
50 Hall IR, Lo TS, Nolan J. Deep vein thrombosis in the arm following transradial cardiac catheterization: an unusual complication related to hemostatic technique. Catheter Cardiovasc Interv. 2004, 62(3):346-348