导管主动脉瓣置换术后抗血小板药单用或双联治疗短期并发症有效性和安全性的Meta分析
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摘要
目的:系统评价单用抗血小板治疗方案对比双联抗血小板治疗方案治疗经导管主动脉瓣置换术(TAVI)后短期并发症的有效性和安全性,为临床治疗提供循证参考。方法:计算机检索PubMed、Cochrane临床对照试验注册中心、Web of Science、中国知网、万方数据、中国生物医学文献服务系统及中国临床试验注册中心,检索时限为自建库时起至2019年1月,收集单用抗血小板治疗方案对比双联抗血小板治疗方案治疗TAVI后短期并发症有效性(术后30 d全因死亡率、30 d脑卒中发生率及30 d心肌梗死发生率)与安全性(术后30 d出血事件发生率)的随机对照试验(RCT)与观察性研究,对符合纳入标准的研究进行资料提取后并采用Cochrane系统评价员手册5.1.0(RCT)和纽卡斯尔-渥太华(the Newcastle-Ottawa Scale,NOS)量表(观察性研究)进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入3项RCT和7项队列研究,合计3 188例患者。Meta分析结果显示,单用抗血小板治疗组患者TAVI后30 d全因死亡率[OR=0.48,95%CI(0.32,0.73),P<0.001]、30 d出血事件发生率[OR=0.43,95%CI(0.30,0.59),P<0.001]显著低于双联抗血小板治疗组的患者,差异均有统计学意义。但两组患者术后30 d脑卒中发生率[OR=0.63,95%CI(0.38,1.06),P=0.08]、30 d心肌梗死发生率[OR=1.09,95%CI(0.46,2.59),P=0.85]比较,差异均无统计学意义。结论:单用抗血小板治疗方案对比双联抗血小板治疗方案可降低TAVI后30 d全因死亡率和30 d出血事件发生率。
OBJECTIVE:To systematically evaluate effectiveness and safety of single antiplatelet therapy(SAPT)versus dual antiplatelet therapy(DAPT) on short-term complications after transcatheter aortic valve implantation(TAVI),and to provide evidence-based reference for clinical treatment. METHODS:Retrieved from PubMed,Cochrane clinical controlled trials registry,Web of Science,CNKI,Wanfang database,CBM and Chinese Clinical Trial Registry,RCTs and observational studies about effectiveness(all-cause mortality,incidence of stroke and incidence of myocardial infarction 30 days after operation) and safety(the incidence of bleeding events at 30 days after operation)of SAPT versus DAPT on short-term complications of TAVI were collected during the date of database establishment to Jan. 2019. After data extraction of included studies and quality evaluation with Cochrane system evaluator manual 5.1.0(for RCT) and the Newcastle-Ottawa Scale(NOS)(for observational studies),Meta-analysis was conducted by using Rev Man 5.3 statistical software. RESULTS:Totally 3 RCTs and 7 cohort studies were included,involving 3 188 patients. Results of Meta-analysis showed that the incidence of all-cause mortality 30 days after operation[OR=0.48,95% CI(0.32,0.73),P<0.001] and the incidence of bleeding events 30 days after operation [OR=0.43,95% CI(0.30,0.59),P<0.001] in SAPT group were significantly lower than DAPT group,with statistical significance. There was no statistical significance in the incidence of stroke 30 days after operation [OR=0.63,95% CI(0.38,1.06),P=0.08] or the incidence of myocardial infarction 30 days after operation[OR=1.09, 95% CI(0.46, 2.59), P=0.85] between 2 groups. CONCLUSIONS:Compared with DAPT,SAPT can decrease the incidence of all-cause mortality 30 days after TAVI and the incidence of bleeding events 30 days after TAVI.
OBJECTIVE:To systematically evaluate effectiveness and safety of single antiplatelet therapy(SAPT)versus dual antiplatelet therapy(DAPT) on short-term complications after transcatheter aortic valve implantation(TAVI),and to provide evidence-based reference for clinical treatment. METHODS:Retrieved from PubMed,Cochrane clinical controlled trials registry,Web of Science,CNKI,Wanfang database,CBM and Chinese Clinical Trial Registry,RCTs and observational studies about effectiveness(all-cause mortality,incidence of stroke and incidence of myocardial infarction 30 days after operation) and safety(the incidence of bleeding events at 30 days after operation)of SAPT versus DAPT on short-term complications of TAVI were collected during the date of database establishment to Jan. 2019. After data extraction of included studies and quality evaluation with Cochrane system evaluator manual 5.1.0(for RCT) and the Newcastle-Ottawa Scale(NOS)(for observational studies),Meta-analysis was conducted by using Rev Man 5.3 statistical software. RESULTS:Totally 3 RCTs and 7 cohort studies were included,involving 3 188 patients. Results of Meta-analysis showed that the incidence of all-cause mortality 30 days after operation[OR=0.48,95% CI(0.32,0.73),P<0.001] and the incidence of bleeding events 30 days after operation [OR=0.43,95% CI(0.30,0.59),P<0.001] in SAPT group were significantly lower than DAPT group,with statistical significance. There was no statistical significance in the incidence of stroke 30 days after operation [OR=0.63,95% CI(0.38,1.06),P=0.08] or the incidence of myocardial infarction 30 days after operation[OR=1.09, 95% CI(0.46, 2.59), P=0.85] between 2 groups. CONCLUSIONS:Compared with DAPT,SAPT can decrease the incidence of all-cause mortality 30 days after TAVI and the incidence of bleeding events 30 days after TAVI.
引文
[1]MEREDITH AM IT,WALTERS DL,DUMONTEIL N,et al.Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system:30-day primary endpoint results from the RE-PRISEⅡstudy[J].J Am Coll Cardiol,2014,64(13):1339-1348.
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[4]KAPPETEIN AP,HEAD SJ,GENEREUX P,et al.Updated standardized endpoint definitions for transcatheter aortic valve implantation:the valve academic research consortium-2 consensus document[J].J Thorac Cardiovasc Surg,2013,145(1):6-23.
[5]HIGGINS JPT,GREEN S,EDITOR.Cochrane handbook for systematic reviews of interventions version 5.1.0[J/OL].[2019-01-02].http://handbook.cochrane.org/.
[6]WELLS GSB,O’CONNELL D,PETERSON J,et al.The Newcastle-Ottawa scale(NOS)for assessing the quality of nonrandomised studies in meta-analyses[J/OL].[2019-01-03].http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
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[8]RODES-CABAU J,MASSON JB,WELSH RC,et al.Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon-expandable valve:the ARTE(aspirin versus aspirin+clopidogrel following transcatheter aortic valve implantation)randomized clinical trial[J].JACCCardiovasc Interv,2017,10(13):1357-1365.
[9]STABILE E,PUCCIARELLI A,COTA L,et al.SAT-TAVI(single antiplatelet therapy for TAVI)study:a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation[J].Int JCardiol,2014,174(3):624-627.
[10]USSIA GP,SCARABELLI M,MULE M,et al.dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation[J].Am J Cardiol,2011,108(12):1772-1776.
[11]GUREVICH S,OESTREICH B,KELLY RF,et al.Routine use of anticoagulation after transcatheter aortic valve replacement:Initial safety outcomes from a single-center experience[J].Cardiovasc Revasc Med,2018,19(5 Pt B):621-625.
[12]ICHIBORI Y,MIZOTE I,MAEDA K,et al.Clinical outcomes and bioprosthetic valve function after transcatheter aortic valve implantation under dual antiplatelet therapy vs.aspirin alone[J].Circ J,2017,81(3):397-404.
[13]D’ASCENZO F,BENEDETTO U,BIANCO M,et al.Which is the best antiaggregant or anticoagulant therapy after TAVI?A propensity-matched analysis from the ITERregistry the management of DAPT after TAVI[J].Euro Intervention,2017,13(12):e1392-e1400.
[14]CZERWINSKA-JELONKIEWICZ K,ZEMBALA M,DABROWSKI M,et al.Can TAVI patients receive aspirin monotherapy as patients after surgical aortic bioprosthesis implantation?Data from the Polish registry-POL-TAVI[J].Int J Cardiol,2017.DOI:10.1016/j.ijcard.2016.11.095.
[15]DURAND E,BLANCHARD D,CHASSAING S,et al.comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation[J].Am J Cardiol,2014,113(2):355-360.
[16]POLIACIKOVA P,COCKBURN J,DE BELDER A,et al.Antiplatelet and antithrombotic treatment after transcatheter aortic valve implantation:comparison of regimes[J].JInvasive Cardiol,2013,25(10):544-548.
[17]FIGINI F,LATIB A,MAISANO F,et al.Managing patients with an indication for anticoagulant therapy after transcatheter aortic valve implantation[J].Am J Cardiol,2013,111(2):237-242.
[18]汪浩,孟凡华,马翔,等.Meta分析:经导管主动脉瓣置入术后抗血小板治疗的有效性和安全性[J].中国介入心脏病学杂志,2016,24(9):515-520.
[19]HASSELL ME,HILDICK-SMITH D,DURAND E,et al.Antiplatelet therapy following transcatheter aortic valve implantation[J].Heart,2015,101(14):1118-1125.
[20]VAN MIEGHEM NM,EL FAQUIR N,RAHHAB Z,et al.Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation[J].JACCCardiovasc Interv,2015,8(5):718-724.
[21]SIONTIS GC,JUNI P,PILGRIM T,et al.Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR:a meta-analysis[J].JAm Coll Cardiol,2014,64(2):129-140.
[22]朱齐丰.经导管主动脉瓣置换术后止血指标变化及术后血小板减少的相关因素、预后分析[D].杭州:浙江大学,2017.
[23]KIBLER M,MARCHANDOT B,MESSAS N,et al.Primary hemostatic disorders and late major bleeding after transcatheter aortic valve replacement[J].J Am Coll Cardiol,2018,72(18):2139-2148.
[24]GIANNINI F,BALDETTI L,GALLONE G,et al.Transcatheter valve replacement in Asia Pacific:current practice and perspectives[J].J Am Coll Cardiol,2018,72(24):3189-3199.
[25]AHMAD Y,DEMIR O,RAJKUMAR C,et al.Optimal antiplatelet strategy after transcatheter aortic valve implantation:a meta-analysis[J].Open Heart,2018,5(1):e000748.
[2]BAUMGARTNER H,FALK V,BAX JJ,et al.2017 ESC/EACTS guidelines for the management of valvular heart disease[J].Rev Esp Cardiol(Engl Ed),2018,71(2):110.
[3]NISHIMURA RA,OTTO CM,BONOW RO,et al.2017AHA/ACC focused update of the 2014 AHA/ACC Guideline for the management of patients with valvular heart disease:a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice guidelines[J].Circulation,2017,135(25):e1159-e1195.
[4]KAPPETEIN AP,HEAD SJ,GENEREUX P,et al.Updated standardized endpoint definitions for transcatheter aortic valve implantation:the valve academic research consortium-2 consensus document[J].J Thorac Cardiovasc Surg,2013,145(1):6-23.
[5]HIGGINS JPT,GREEN S,EDITOR.Cochrane handbook for systematic reviews of interventions version 5.1.0[J/OL].[2019-01-02].http://handbook.cochrane.org/.
[6]WELLS GSB,O’CONNELL D,PETERSON J,et al.The Newcastle-Ottawa scale(NOS)for assessing the quality of nonrandomised studies in meta-analyses[J/OL].[2019-01-03].http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.
[7]MOHER D,SHAMSEER L,CLARKE M,et al.Preferred reporting items for systematic review and meta-analysis protocols(PRISMA-P)2015 statement[J].Syst Rev,2015.DOI:10.1186/2046-4053-4-1.
[8]RODES-CABAU J,MASSON JB,WELSH RC,et al.Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon-expandable valve:the ARTE(aspirin versus aspirin+clopidogrel following transcatheter aortic valve implantation)randomized clinical trial[J].JACCCardiovasc Interv,2017,10(13):1357-1365.
[9]STABILE E,PUCCIARELLI A,COTA L,et al.SAT-TAVI(single antiplatelet therapy for TAVI)study:a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation[J].Int JCardiol,2014,174(3):624-627.
[10]USSIA GP,SCARABELLI M,MULE M,et al.dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation[J].Am J Cardiol,2011,108(12):1772-1776.
[11]GUREVICH S,OESTREICH B,KELLY RF,et al.Routine use of anticoagulation after transcatheter aortic valve replacement:Initial safety outcomes from a single-center experience[J].Cardiovasc Revasc Med,2018,19(5 Pt B):621-625.
[12]ICHIBORI Y,MIZOTE I,MAEDA K,et al.Clinical outcomes and bioprosthetic valve function after transcatheter aortic valve implantation under dual antiplatelet therapy vs.aspirin alone[J].Circ J,2017,81(3):397-404.
[13]D’ASCENZO F,BENEDETTO U,BIANCO M,et al.Which is the best antiaggregant or anticoagulant therapy after TAVI?A propensity-matched analysis from the ITERregistry the management of DAPT after TAVI[J].Euro Intervention,2017,13(12):e1392-e1400.
[14]CZERWINSKA-JELONKIEWICZ K,ZEMBALA M,DABROWSKI M,et al.Can TAVI patients receive aspirin monotherapy as patients after surgical aortic bioprosthesis implantation?Data from the Polish registry-POL-TAVI[J].Int J Cardiol,2017.DOI:10.1016/j.ijcard.2016.11.095.
[15]DURAND E,BLANCHARD D,CHASSAING S,et al.comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation[J].Am J Cardiol,2014,113(2):355-360.
[16]POLIACIKOVA P,COCKBURN J,DE BELDER A,et al.Antiplatelet and antithrombotic treatment after transcatheter aortic valve implantation:comparison of regimes[J].JInvasive Cardiol,2013,25(10):544-548.
[17]FIGINI F,LATIB A,MAISANO F,et al.Managing patients with an indication for anticoagulant therapy after transcatheter aortic valve implantation[J].Am J Cardiol,2013,111(2):237-242.
[18]汪浩,孟凡华,马翔,等.Meta分析:经导管主动脉瓣置入术后抗血小板治疗的有效性和安全性[J].中国介入心脏病学杂志,2016,24(9):515-520.
[19]HASSELL ME,HILDICK-SMITH D,DURAND E,et al.Antiplatelet therapy following transcatheter aortic valve implantation[J].Heart,2015,101(14):1118-1125.
[20]VAN MIEGHEM NM,EL FAQUIR N,RAHHAB Z,et al.Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation[J].JACCCardiovasc Interv,2015,8(5):718-724.
[21]SIONTIS GC,JUNI P,PILGRIM T,et al.Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR:a meta-analysis[J].JAm Coll Cardiol,2014,64(2):129-140.
[22]朱齐丰.经导管主动脉瓣置换术后止血指标变化及术后血小板减少的相关因素、预后分析[D].杭州:浙江大学,2017.
[23]KIBLER M,MARCHANDOT B,MESSAS N,et al.Primary hemostatic disorders and late major bleeding after transcatheter aortic valve replacement[J].J Am Coll Cardiol,2018,72(18):2139-2148.
[24]GIANNINI F,BALDETTI L,GALLONE G,et al.Transcatheter valve replacement in Asia Pacific:current practice and perspectives[J].J Am Coll Cardiol,2018,72(24):3189-3199.
[25]AHMAD Y,DEMIR O,RAJKUMAR C,et al.Optimal antiplatelet strategy after transcatheter aortic valve implantation:a meta-analysis[J].Open Heart,2018,5(1):e000748.
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