卵圆孔未闭封堵术与药物治疗隐源性卒中疗效和安全性的meta分析
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摘要
目的:比较卵圆孔未闭(patent foramen ovale,PFO)封堵术与药物治疗对隐源性卒中患者的临床疗效及安全性。方法:系统检索PubMed、Embase、Cochrane图书馆、中国知网、万方及维普数据库,筛选研究PFO封堵术治疗隐源性卒中患者临床疗效及安全性的随机对照试验(randomized controlled trial,RCT),采用Stata12.0软件进行meta分析。结果:总共纳入5项RCT研究,共计3 440例患者。结果显示,与药物治疗组相比,PFO封堵组脑卒中复发率显著降低(RR=0.43,95%CI:0.20～0.91,P=0.027,I2=58.8%),但一过性脑缺血发作风险并没有降低(RR=0.78,95%CI:0.53～1.15,P=0.212,I2=0.0%)。安全性方面,与药物相比,PFO封堵术不降低全因死亡(RR=0.81,95%CI:0.39～1.66,P=0.559,I2=0.0%)、大出血(RR=0.97,95%CI:0.42～2.26,P=0.949,I2=34.6%)风险,但增加新发心房颤动的风险(RR=4.45,95%CI:2.16～9.60,P<0.000 1,I2=25.0%)。结论:PFO封堵术能明显降低隐源性卒中患者脑卒中复发风险,但不能降低一过性脑缺血发作、死亡或大出血风险,且增加新发心房颤动的风险。
Objective:To compare the clinical efficacy and safety of closure of patent foramen ovale(PFO)with medical therapy in patients with cryptogenic stroke.Method:PubMed,Embase,Cochrane library,CNKI,Wanfang and Weipu databases were systematically searched for publications until April 1 st,2018 to identify the randomized controlled trials(RCTs)that compared the effects of PFO closure with medical therapy in patients with cryptogenic stroke.Stata 12.0 software was used to make meta analysis.Result:A total of 5 studies with 3 440 patients that fulfilled the criteria were included in the study.The pooled data indicated that PFO closure significantly reduced the risk of recurrent stroke(RR=0.43,95%CI:0.20-0.91,P=0.027,I2=58.8%).However,it did not significantly reduced the incidence of transient ischaemic attack(RR=0.78,95%CI:0.53-1.15,P=0.212,I2=0.0%),allcause mortality(RR=0.81,95%CI:0.39-1.66,P=0.559,I2=0.0%)and major bleeding(RR=0.97,95%CI:0.42-2.26,P=0.949,I2=34.6%).Moreover,PFO closure enhanced the incidence of newly detected atrial fibrillation(RR=4.45,95%CI:2.16-9.60,P<0.000 1,I2=25.0%).Conclusion:Closure of PFO can reduce the recurrence of stroke but increase the risk of atrial fibrillation in patients with cryptogenic stroke.
Objective:To compare the clinical efficacy and safety of closure of patent foramen ovale(PFO)with medical therapy in patients with cryptogenic stroke.Method:PubMed,Embase,Cochrane library,CNKI,Wanfang and Weipu databases were systematically searched for publications until April 1 st,2018 to identify the randomized controlled trials(RCTs)that compared the effects of PFO closure with medical therapy in patients with cryptogenic stroke.Stata 12.0 software was used to make meta analysis.Result:A total of 5 studies with 3 440 patients that fulfilled the criteria were included in the study.The pooled data indicated that PFO closure significantly reduced the risk of recurrent stroke(RR=0.43,95%CI:0.20-0.91,P=0.027,I2=58.8%).However,it did not significantly reduced the incidence of transient ischaemic attack(RR=0.78,95%CI:0.53-1.15,P=0.212,I2=0.0%),allcause mortality(RR=0.81,95%CI:0.39-1.66,P=0.559,I2=0.0%)and major bleeding(RR=0.97,95%CI:0.42-2.26,P=0.949,I2=34.6%).Moreover,PFO closure enhanced the incidence of newly detected atrial fibrillation(RR=4.45,95%CI:2.16-9.60,P<0.000 1,I2=25.0%).Conclusion:Closure of PFO can reduce the recurrence of stroke but increase the risk of atrial fibrillation in patients with cryptogenic stroke.
引文
[1] Fisher DC,Fisher EA,Budd JH,et al.The incidence of patent foramen ovale in 1,000consecutive patients.A contrast transesophageal echocardiography study[J].Chest,1995,107(6):1504-1509.
[2] Hart RG,Diener HC,Coutts SB,et al.Embolic strokes of undetermined source:the case for a new clinical construct[J].Lancet Neurol,2014,13(4):429-438.
[3]程志明,李冬梅,李杨.卵圆孔未闭封堵术对隐源性脑卒中预防作用[J].临床军医杂志,2018,46(2):235-240.
[4] Handke M,Harloff A,Olschewski M,et al.Patent foramen ovale and cryptogenic stroke in older patients[J].N Engl J Med,2007,357(22):2262-2268.
[5] Meier B,Kalesan B,Mattle HP,et al.Percutaneous closure of patent foramen ovale in cryptogenic embolism[J].N Engl J Med,2013,368(12):1083-1091.
[6] Furlan AJ,Reisman M,Massaro J,et al.Closure or medical therapy for cryptogenic stroke with patent foramen ovale[J].N Engl J Med,2012,366(11):991-999.
[7] Carroll JD,Saver JL,Thaler DE,et al.Closure of patent foramen ovale versus medical therapy after cryptogenic stroke[J].N Engl J Med,2013,368(12):1092-1100.
[8] Schuchlenz HW,Weihs W,Berghold A,et al.Secondary prevention after cryptogenic cerebrovascular events in patients with patent foramen ovale[J].Int J Cardiol,2005,101(1):77-82.
[9] Capodanno D,Milazzo G,Vitale L,et al.Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke:a systematic review and comprehensive meta-analysis of 2,303patients from three randomised trials and 2,231patients from 11observational studies[J].EuroIntervention,2014,9(11):1342-1349.
[10]Sondergaard L,Kasner SE,Rhodes JF,et al.Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke[J].N Engl J Med,2017,377(11):1033-1042.
[11]Saver JL,Carroll JD,Thaler DE,et al.Long-term outcomes of patent foramen ovale closure or medical therapy after stroke[J].N Engl J Med,2017,377(11):1022-1032.
[12]Mas JL,Derumeaux G,Guillon B,et al.Patent foramen ovale closure or anticoagulation vs.antiplatelets after stroke[J].N Engl J Med,2017,377(11):1011-1021.
[13]Chen L,Luo S,Yan L,et al.A systematic review of closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and cryptogenic stroke or transient ischemic attack[J].J Neurol Sci,2014,337(1-2):3-7.
[14]Kwong JS,Lam YY,Yu CM.Percutaneous closure of patent foramen ovale for cryptogenic stroke:a meta-analysis of randomized controlled trials[J].Int J Cardiol,2013,168(4):4132-4138.
[15]Khan AR,Bin Abdulhak AA,Sheikh MA,et al.Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke:a systematic review and meta-analysis[J].JACC Cardiovasc Interv,2013,6(12):1316-1323.
[16]Kernan WN,Ovbiagele B,Black HR,et al.Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack:aguideline for healthcare professionals from the American Heart Association/American Stroke Association[J].Stroke,2014,45(7):2160-2236.
[17] Wolfrum M,Froehlich GM,Knapp G,et al.Stroke prevention by percutaneous closure of patent foramen ovale:a systematic review and meta-analysis[J].Heart,2014,100(5):389-395.
[18]Udell JA,Opotowsky AR,Khairy P,et al.Patent foramen ovale closure vs medical therapy for stroke prevention:meta-analysis of randomized trials and review of heterogeneity in meta-analyses[J].Can J Cardiol,2014,30(10):1216-1224.
[19]Nagaraja V,Raval J,Eslick GD,et al.Is transcatheter closure better than medical therapy for cryptogenic stroke with patent foramen ovale?A meta-analysis of randomised trials[J].Heart Lung Circ,2013,22(11):903-909.
[20]Li J,Liu J,Liu M,et al.Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack[J].Cochrane Database Syst Rev,2015,(9):CD009938.
[21]Ando T,Holmes AA,Pahuja M,et al.Meta-analysis comparing patent foramen ovale closure versus medical therapy to prevent recurrent cryptogenic stroke[J].Am J Cardiol,2018,121(5):649-655.
[2] Hart RG,Diener HC,Coutts SB,et al.Embolic strokes of undetermined source:the case for a new clinical construct[J].Lancet Neurol,2014,13(4):429-438.
[3]程志明,李冬梅,李杨.卵圆孔未闭封堵术对隐源性脑卒中预防作用[J].临床军医杂志,2018,46(2):235-240.
[4] Handke M,Harloff A,Olschewski M,et al.Patent foramen ovale and cryptogenic stroke in older patients[J].N Engl J Med,2007,357(22):2262-2268.
[5] Meier B,Kalesan B,Mattle HP,et al.Percutaneous closure of patent foramen ovale in cryptogenic embolism[J].N Engl J Med,2013,368(12):1083-1091.
[6] Furlan AJ,Reisman M,Massaro J,et al.Closure or medical therapy for cryptogenic stroke with patent foramen ovale[J].N Engl J Med,2012,366(11):991-999.
[7] Carroll JD,Saver JL,Thaler DE,et al.Closure of patent foramen ovale versus medical therapy after cryptogenic stroke[J].N Engl J Med,2013,368(12):1092-1100.
[8] Schuchlenz HW,Weihs W,Berghold A,et al.Secondary prevention after cryptogenic cerebrovascular events in patients with patent foramen ovale[J].Int J Cardiol,2005,101(1):77-82.
[9] Capodanno D,Milazzo G,Vitale L,et al.Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke:a systematic review and comprehensive meta-analysis of 2,303patients from three randomised trials and 2,231patients from 11observational studies[J].EuroIntervention,2014,9(11):1342-1349.
[10]Sondergaard L,Kasner SE,Rhodes JF,et al.Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke[J].N Engl J Med,2017,377(11):1033-1042.
[11]Saver JL,Carroll JD,Thaler DE,et al.Long-term outcomes of patent foramen ovale closure or medical therapy after stroke[J].N Engl J Med,2017,377(11):1022-1032.
[12]Mas JL,Derumeaux G,Guillon B,et al.Patent foramen ovale closure or anticoagulation vs.antiplatelets after stroke[J].N Engl J Med,2017,377(11):1011-1021.
[13]Chen L,Luo S,Yan L,et al.A systematic review of closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and cryptogenic stroke or transient ischemic attack[J].J Neurol Sci,2014,337(1-2):3-7.
[14]Kwong JS,Lam YY,Yu CM.Percutaneous closure of patent foramen ovale for cryptogenic stroke:a meta-analysis of randomized controlled trials[J].Int J Cardiol,2013,168(4):4132-4138.
[15]Khan AR,Bin Abdulhak AA,Sheikh MA,et al.Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke:a systematic review and meta-analysis[J].JACC Cardiovasc Interv,2013,6(12):1316-1323.
[16]Kernan WN,Ovbiagele B,Black HR,et al.Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack:aguideline for healthcare professionals from the American Heart Association/American Stroke Association[J].Stroke,2014,45(7):2160-2236.
[17] Wolfrum M,Froehlich GM,Knapp G,et al.Stroke prevention by percutaneous closure of patent foramen ovale:a systematic review and meta-analysis[J].Heart,2014,100(5):389-395.
[18]Udell JA,Opotowsky AR,Khairy P,et al.Patent foramen ovale closure vs medical therapy for stroke prevention:meta-analysis of randomized trials and review of heterogeneity in meta-analyses[J].Can J Cardiol,2014,30(10):1216-1224.
[19]Nagaraja V,Raval J,Eslick GD,et al.Is transcatheter closure better than medical therapy for cryptogenic stroke with patent foramen ovale?A meta-analysis of randomised trials[J].Heart Lung Circ,2013,22(11):903-909.
[20]Li J,Liu J,Liu M,et al.Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack[J].Cochrane Database Syst Rev,2015,(9):CD009938.
[21]Ando T,Holmes AA,Pahuja M,et al.Meta-analysis comparing patent foramen ovale closure versus medical therapy to prevent recurrent cryptogenic stroke[J].Am J Cardiol,2018,121(5):649-655.
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