经导管主动脉瓣置换与外科主动脉瓣置换治疗主动脉瓣狭窄疗效的Meta分析
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摘要
背景:经导管主动脉瓣置换与外科主动脉瓣置换是治疗主动脉瓣狭窄的主要治疗方案,但研究者对2种方法的疗效、安全性和预后存在很大分歧。目的:应用循证医学手段探讨经导管主动脉瓣置换与外科主动脉瓣置换治疗主动脉瓣狭窄的疗效和预后。方法:在EMbase、Medline、Pu Mbed、维普等中、外数据库中查找经导管主动脉瓣置换与外科主动脉瓣置换治疗主动脉瓣狭窄的随机对照试验,利用Revman5.0对数据进行分析,比较两组短期(30d)和长期(1年)的死亡率、脑卒中发生率、心肌梗死发生率、出血发生率、肾损伤发生率和起搏器植入率。结果与结论:①共纳入8篇随机对照研究,包括6 147例主动脉瓣狭窄患者,研究组(n=3 136)进行经导管主动脉瓣置换组例,对照组(n=3 011)进行外科主动脉瓣置换;②两组术后30 d的死亡率、脑卒中发生率、心肌梗死发生率、出血发生率比较差异无显著性意义[OR=0.92,95%CI(0.74,1.13),Z=0.83,P> 0.05;OR=0.82,95%CI(0.49,1.38),Z=0.74,P>0.05;OR=0.63,95%CI(0.38,1.05),Z=1.77,P> 0.05;OR=0.50,95%CI(0.20,1.26),Z=1.47,P>0.05];研究组术后30 d的肾损伤发生率低于对照组[OR=0.43,95%CI(0.33,0.57),Z=5.89,P <0.01],起搏器植入率高于对照组[OR=4.77,95%CI(1.36,16.72),Z=2.94,P <0.01];③两组术后1年的死亡率、脑卒中发生率、心肌梗死发生率比较差异无显著性意义[OR=0.93,95%CI(0.81,1.07),Z=1.02,P> 0.05;OR=1.00,95%CI(0.81,1.23),Z=0.02,P> 0.05;OR=0.88,95%CI(0.61,1.28),Z=0.65,P> 0.05];研究组术后1年的起搏器植入率高于对照组[OR=3.47,95%CI(1.64,7.34),Z=3.26,P<0.01];④结果表明2种方法治疗主动脉瓣狭窄的疗效和预后相当,但经导管主动脉瓣置换治疗的手术创伤小、起搏器植入率较高。
BACKGROUND: Transcatheter aortic vavle replacement and surgical aortic vavle replacement are the main treatment for aortic stenosis.However, the efficacy and prognosis between the two methods were still inconsistent.OBJECTIVE: To investigate the efficacy and prognosis of transcatheter aortic vavle repalcement and surgical aortic vavle replacement in the treatment of aortic stenosis with evidence-based medicine.METHODS: We searched relevant literature from Chinese and English databases such as EMbase, Medline, Pub Med, and VIP to retrieve randomized controlled trial studies. Data were analyzed by Revman 5.0 to compare short-term(30 days) and long-term(1 year) mortality,incidence of stroke, incidence of myocardial infarction, incidence of hemorrhage, incidence of renal damage and rate of pacemaker implantation.RESULTS AND CONCLUSION: Eight randomized controlled trials involving 6 147 patients were included in the final analysis. Among these patients, 3 136 patients received transcatheter aortic valve replacement(study group) and 3 011 patients underwent surgical aortic valve replacement(control group). There were no significant differences in mortality, incidence of stroke, incidence of myocardial infarction, and incidence of hemorrhage between study and control groups at 30 days post-surgery [OR=0.92, 95%CI(0.74, 1.13), Z=0.83, P > 0.05; OR=0.82,95%CI(0.49, 1.38), Z=0.74, P > 0.05; OR=0.63, 95%CI(0.38, 1.05), Z=1.77, P > 0.05; OR=0.50, 95%CI(0.20, 1.26), Z=1.47, P > 0.05]. At 30 days post-surgery, the incidence of renal damage in the study group was significantly lower than that in the control group [OR=0.43, 95%CI(0.33,0.57), Z=5.89, P < 0.01], the rate of pacemaker implantation was significantly higher in the study group was significantly higher than that in the control group [OR=4.77, 95%CI(1.36, 16.72), Z=2.94, P < 0.01]. There were no significant differences in mortality, incidence of stroke, and incidence of myocardial infarction at 1 year post-surgery between study and control groups [OR=0.93, 95%CI(0.81, 1.07), Z=1.02, P > 0.05;OR=1.00, 95%CI(0.81, 1.23), Z=0.02, P > 0.05; OR=0.88, 95%CI(0.61, 1.28), Z = 0.65, P > 0.05]. At 1 year post-surgery, the rate of pacemaker implantation in the study group was significantly higher than that in the control group [OR=3.47, 95%CI(1.64, 7.34), Z=3.26, P < 0.01]. The results showed that the efficacy and prognosis of the two methods for the treatment of aortic stenosis were comparable, but the transcatheter aortic valve replacement treatment had less trauma and a higher rate of pacemaker implantation than the aortic valve replacement.
BACKGROUND: Transcatheter aortic vavle replacement and surgical aortic vavle replacement are the main treatment for aortic stenosis.However, the efficacy and prognosis between the two methods were still inconsistent.OBJECTIVE: To investigate the efficacy and prognosis of transcatheter aortic vavle repalcement and surgical aortic vavle replacement in the treatment of aortic stenosis with evidence-based medicine.METHODS: We searched relevant literature from Chinese and English databases such as EMbase, Medline, Pub Med, and VIP to retrieve randomized controlled trial studies. Data were analyzed by Revman 5.0 to compare short-term(30 days) and long-term(1 year) mortality,incidence of stroke, incidence of myocardial infarction, incidence of hemorrhage, incidence of renal damage and rate of pacemaker implantation.RESULTS AND CONCLUSION: Eight randomized controlled trials involving 6 147 patients were included in the final analysis. Among these patients, 3 136 patients received transcatheter aortic valve replacement(study group) and 3 011 patients underwent surgical aortic valve replacement(control group). There were no significant differences in mortality, incidence of stroke, incidence of myocardial infarction, and incidence of hemorrhage between study and control groups at 30 days post-surgery [OR=0.92, 95%CI(0.74, 1.13), Z=0.83, P > 0.05; OR=0.82,95%CI(0.49, 1.38), Z=0.74, P > 0.05; OR=0.63, 95%CI(0.38, 1.05), Z=1.77, P > 0.05; OR=0.50, 95%CI(0.20, 1.26), Z=1.47, P > 0.05]. At 30 days post-surgery, the incidence of renal damage in the study group was significantly lower than that in the control group [OR=0.43, 95%CI(0.33,0.57), Z=5.89, P < 0.01], the rate of pacemaker implantation was significantly higher in the study group was significantly higher than that in the control group [OR=4.77, 95%CI(1.36, 16.72), Z=2.94, P < 0.01]. There were no significant differences in mortality, incidence of stroke, and incidence of myocardial infarction at 1 year post-surgery between study and control groups [OR=0.93, 95%CI(0.81, 1.07), Z=1.02, P > 0.05;OR=1.00, 95%CI(0.81, 1.23), Z=0.02, P > 0.05; OR=0.88, 95%CI(0.61, 1.28), Z = 0.65, P > 0.05]. At 1 year post-surgery, the rate of pacemaker implantation in the study group was significantly higher than that in the control group [OR=3.47, 95%CI(1.64, 7.34), Z=3.26, P < 0.01]. The results showed that the efficacy and prognosis of the two methods for the treatment of aortic stenosis were comparable, but the transcatheter aortic valve replacement treatment had less trauma and a higher rate of pacemaker implantation than the aortic valve replacement.
引文
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[12] Reardon MJ,Kleiman NS,Adams DH,et al.Outcomes in the randomized corevalve US pivotal high-risk trial in patients with a society of thoracic surgeons risk score of 7%or less.JAMA Cardiol.2016;1(8):945-949.
[13] Gargiulo G,Sannino A,Capodanno D,et al.Transcatheter aortic valve implantation versus surgical aortic valve replacement a systematic review and meta-analysis.Ann Intern Med. 2016;165(5):334-344.
[14] Siemieniuk RA,Agoritsas T,Manja V,et al.Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk:systematic review and meta-analysis.BMJ.2016;354:i5130.
[15]郭丽娜,施仲伟.经导管Edwards-Sapien主动脉瓣植入术临床应用[J].国际心血管病杂志, 2011,38(4):209-212.
[16]李昕,刘世栋,朱鹏冲,等.经导管主动脉瓣置入术的研究进展[J].国际心血管病杂志,2018,45(1):8-11.
[17] Arora S, Misenheimer JA,Ramaraj R.Transcatheter aortic valve replacement:comprehensive review and present status.Tex Heart Inst J.2017;44(1):29-38.
[18] Fischer-Rasokat U,Renker M,Liebetrau C,et al. 1-yearsurvival after TAVR of patients with low-flow, low-gradient and high-gradient aortic valve stenosis in matched study populations.JACC Cardiovasc Interv. 2019;12(8):752-763.
[19] Elmaraezy A,Ismail A,Abushouk AI.Efficacy and safety of transcatheter aortic valve replacement in aortic stenosis patients at low to moderate surgical risk:a comprehensive meta-analysis.BMC Cardiovasc Disord.2017;17(1):234.
[20] Mack MJ,Leon MB,Thourani VH,et al.Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med.2019;380(18):1695-1705.
[21] Guedeney P,TchétchéD,Petronio AS,et al.Impact of coronary artery disease and percutaneous coronary intervention in women undergoing transcatheter aortic valve replacement:From the WIN-TAVI registry.Catheter Cardiovasc Interv. 2019;93(6):1124-1131.
[22] Solomonica A,Choudhury T,Bagur R.Newer-generation of Edwards transcatheter aortic valve systems:SAPIEN 3, Centera, and SAPIEN 3 Ultra.Expert Rev Med Devices.2019;16(2):81-87.
[23] Goodall G,Lamotte M,Ramos M,et al.Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients.J Med Econ.2019;22(4):289-296.
[24] Baron SJ,Wang K,House JA,et al.Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at intermediate risk. Circulation. 2019;139(7):877-888.
[25] Kapadia SR,Huded CP,Kodali SK,et al.Stroke after surgical versus transfemoral transcatheter aortic valve replacement in the PARTNER Trial.J Am Coll Cardiol. 2018;72(20):2415-2426.
[26] Chen S,Redfors B,Ben-Yehuda O,et al.Transcatheter versus surgical aortic valve replacement in patients with prior cardiac surgery in the Randomized PARTNER 2A Trial.JACC Cardiovasc Interv. 2018;11(21):2207-2216.
[27] Abdelghani M,Allali A,Kaur J,et al.Impact of prosthesis-iteration evolution and sizing practice on the incidence of prosthesis-patient mismatch after transcatheter aortic valve replacement.Catheter Cardiovasc Interv. 2019;93(5):971-979.
[28] Still S,Szerlip M,Mack M.TAVR Vs. SAVR in intermediate-risk patients:what influences our choice of therapy.Curr Cardiol Rep.2018;20(10):82.
[29] St?hli BE,Reinthaler M,Leistner DM,et al.Transcatheter aortic vavle replacement and concomitant mitral regulation.Front Cardiovasc Med.2018;5:74.
[30] Indolfi C,Bartorelli AL,Berti S,et al.Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis:expert opinion of the Italian Society of Cardiology and GISE.J Cardiovasc Med(Hagerstown).2018,19(5):197-210.
[2] Liu Z,Kidney E,Bem D,et al.Transcatheter aortic valve implantation for aortic stenosis in high surgical risk patients:A systematic review and meta-analysis.PLoS One. 2018;13(5):e0196877.
[3] Wang Y,Zhou Y,Zhang L,et al.Midterm outcome of transcatheter versus surgical aortic valve replacement in low to intermediate risk patients:a meta-analysis of randomized controlled trials. J Cardiol.2018;71(6):534-539.
[4] Svenssin LG,Blackstone EH,Rajeswaran J,et al.Comprehensive analysis of mortality among patients undergoing TAVR results of the PARTNER Trial.J Am Coll Cardiol.2014;64(2):158-168.
[5] Smith CR,Leon MB,Mack MJ,et al.Transcatheter versus surgical aortic-valve replacement in high-risk patient.N Engl J Med. 2011;364(23):2187-2198.
[6] Thyregod HG,Steinbruchel DA,Ihlemann N,et al.Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis 1-year results from the all-comers notion randomized clinical trial J Am Coll Cardiol.2015;57(5):276-280.
[7] S?ndergaard L,Steinbrüchel DA,Ihlemann N,et al.Two-year outcomes in patients with severe aortic valve stenosis randomized to transcatheter versus surgical aortic valve replacement the all-comers nordic aortic valve intervention randomized clinical trial.Circ Cardiovasc Interv.2016;9(6):e003665.
[8] Nielsen HH,Klaaborg KE,Nissen H,et al.A prospective, randomised trial of transapical transcatheter aortic valve implantation vs.surgical aortic valve replacement in operable elderly patients with aortic stenosis:the STACCATO trial. Euro Intervention. 2012;8(3):383-389.
[9] Adams DH,Popma JJ,Reardon MJ,et al.Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis.N Engl J Med. 2014;371(10):967-968.
[10] Leon ML,Smith CR,Mack MJ,et al.Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med.2016;374(17):1609-1620.
[11] Reardon MJ,Van NM,Popma J,et al.Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med.2017;376(14):1321-1331.
[12] Reardon MJ,Kleiman NS,Adams DH,et al.Outcomes in the randomized corevalve US pivotal high-risk trial in patients with a society of thoracic surgeons risk score of 7%or less.JAMA Cardiol.2016;1(8):945-949.
[13] Gargiulo G,Sannino A,Capodanno D,et al.Transcatheter aortic valve implantation versus surgical aortic valve replacement a systematic review and meta-analysis.Ann Intern Med. 2016;165(5):334-344.
[14] Siemieniuk RA,Agoritsas T,Manja V,et al.Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk:systematic review and meta-analysis.BMJ.2016;354:i5130.
[15]郭丽娜,施仲伟.经导管Edwards-Sapien主动脉瓣植入术临床应用[J].国际心血管病杂志, 2011,38(4):209-212.
[16]李昕,刘世栋,朱鹏冲,等.经导管主动脉瓣置入术的研究进展[J].国际心血管病杂志,2018,45(1):8-11.
[17] Arora S, Misenheimer JA,Ramaraj R.Transcatheter aortic valve replacement:comprehensive review and present status.Tex Heart Inst J.2017;44(1):29-38.
[18] Fischer-Rasokat U,Renker M,Liebetrau C,et al. 1-yearsurvival after TAVR of patients with low-flow, low-gradient and high-gradient aortic valve stenosis in matched study populations.JACC Cardiovasc Interv. 2019;12(8):752-763.
[19] Elmaraezy A,Ismail A,Abushouk AI.Efficacy and safety of transcatheter aortic valve replacement in aortic stenosis patients at low to moderate surgical risk:a comprehensive meta-analysis.BMC Cardiovasc Disord.2017;17(1):234.
[20] Mack MJ,Leon MB,Thourani VH,et al.Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med.2019;380(18):1695-1705.
[21] Guedeney P,TchétchéD,Petronio AS,et al.Impact of coronary artery disease and percutaneous coronary intervention in women undergoing transcatheter aortic valve replacement:From the WIN-TAVI registry.Catheter Cardiovasc Interv. 2019;93(6):1124-1131.
[22] Solomonica A,Choudhury T,Bagur R.Newer-generation of Edwards transcatheter aortic valve systems:SAPIEN 3, Centera, and SAPIEN 3 Ultra.Expert Rev Med Devices.2019;16(2):81-87.
[23] Goodall G,Lamotte M,Ramos M,et al.Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients.J Med Econ.2019;22(4):289-296.
[24] Baron SJ,Wang K,House JA,et al.Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at intermediate risk. Circulation. 2019;139(7):877-888.
[25] Kapadia SR,Huded CP,Kodali SK,et al.Stroke after surgical versus transfemoral transcatheter aortic valve replacement in the PARTNER Trial.J Am Coll Cardiol. 2018;72(20):2415-2426.
[26] Chen S,Redfors B,Ben-Yehuda O,et al.Transcatheter versus surgical aortic valve replacement in patients with prior cardiac surgery in the Randomized PARTNER 2A Trial.JACC Cardiovasc Interv. 2018;11(21):2207-2216.
[27] Abdelghani M,Allali A,Kaur J,et al.Impact of prosthesis-iteration evolution and sizing practice on the incidence of prosthesis-patient mismatch after transcatheter aortic valve replacement.Catheter Cardiovasc Interv. 2019;93(5):971-979.
[28] Still S,Szerlip M,Mack M.TAVR Vs. SAVR in intermediate-risk patients:what influences our choice of therapy.Curr Cardiol Rep.2018;20(10):82.
[29] St?hli BE,Reinthaler M,Leistner DM,et al.Transcatheter aortic vavle replacement and concomitant mitral regulation.Front Cardiovasc Med.2018;5:74.
[30] Indolfi C,Bartorelli AL,Berti S,et al.Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis:expert opinion of the Italian Society of Cardiology and GISE.J Cardiovasc Med(Hagerstown).2018,19(5):197-210.