涂药球囊治疗膝下动脉病变安全性和有效性Meta分析
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摘要
目的比较涂药球囊(DCB)和普通球囊(UCB)治疗膝下动脉病变的安全性和有效性。方法中国人民解放军总医院全面检索PubMed、EMBASE、Cochrane Library和Clinicaltrials.gov数据库,检索时限均为自建库起至2018-06-30。纳入DCB与UCB治疗膝下动脉病变的随机对照研究。对1年随访的主要截肢率、全因病死率、晚期管腔丢失、靶病变血运重建进行Meta分析。采用Revman 5.3和R软件进行分析,效应值采用均差或相对危险度表示。结果纳入4项随机对照研究,590例受试者和841处病变。Meta分析结果显示:在1年主要截肢率和1年全因病死率的安全性指标方面两组未见显著性差异(P>0.05)。在1年晚期管腔丢失和1年靶病变血运重建的有效性指标方面显著优于UCB组(P<0.05)。结论 DCB组在治疗有效性方面显著优于UCB组,两者在安全性上差异无统计学意义。尚需更多长期随访的随机对照试验予以印证。
Objective To assess the safety and efficacy of drug-coated balloons(DCBs) compared with uncoated balloons(UCBs) for infrapopliteal arterial occlusive disease. Methods The electronic databases of Medline, Embase,Cochrane library, and ClinicalTrials.gov to compare DCBs vs. UCBs for infrapopliteal arterial occlusive disease were searched. All data were pooled with relative risk or mean difference, and Meta-analysis was performed on late lumen loss(LLL,twelve months), target lesion revascularization(TLR,twelve months), major amputation(twelve months), and all caused-mortality(twelve months). Meta-analysis was carried out using Revman version 5.3 and R statics package.Results Four random controlled trials were included. The analysis found a significant reduction of LLL at 12 months and TLR at 1 years in DCB groups compared with UCB groups(P<0.05). No significant difference was found in amputation rate at 1 year and all caused mortality at 1 year(P>0.05). Conclusion DCBs improve the treatment efficacy of infrapopliteal arterial occlusive disease by significantly decreasing LLL and TLR. More RCTs with long-time follow up were warranted.
Objective To assess the safety and efficacy of drug-coated balloons(DCBs) compared with uncoated balloons(UCBs) for infrapopliteal arterial occlusive disease. Methods The electronic databases of Medline, Embase,Cochrane library, and ClinicalTrials.gov to compare DCBs vs. UCBs for infrapopliteal arterial occlusive disease were searched. All data were pooled with relative risk or mean difference, and Meta-analysis was performed on late lumen loss(LLL,twelve months), target lesion revascularization(TLR,twelve months), major amputation(twelve months), and all caused-mortality(twelve months). Meta-analysis was carried out using Revman version 5.3 and R statics package.Results Four random controlled trials were included. The analysis found a significant reduction of LLL at 12 months and TLR at 1 years in DCB groups compared with UCB groups(P<0.05). No significant difference was found in amputation rate at 1 year and all caused mortality at 1 year(P>0.05). Conclusion DCBs improve the treatment efficacy of infrapopliteal arterial occlusive disease by significantly decreasing LLL and TLR. More RCTs with long-time follow up were warranted.
引文
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[12] Cassese S,Ndrepepa G,Liistro F,et al.Drug-coated balloonsfor revascularization of infrapopliteal arteries:A Meta-analysisof randomized trials[J].JACC Cardiovasc Interv,2016,9(10):1072-1080.
[2] Lupi A,Rognoni A,Secco GG,et al.Drug eluting balloon versusdrug eluting stent in percutaneous coronary interventions:in-sights from a meta-analysis of 1462 patients[J].Int J Cardiol,2013,168(5):4608-4616.
[3] Jongsma H,Bekken JA,Vries JPPMD,et al.Drug-eluting bal-loon angioplasty versus uncoated balloon angioplasty in patientswith femoropopliteal arterial occlusive disease[J].J Vasc Surg,2016,64(5):1503-1514.
[4] Jia X,Zhang J,Zhuang B,et al.Acotec drug-coated ballooncatheter:randomized, multicenter, controlled clinical study infemoropopliteal arteries:evidence from the acoart i trial[J].JACC Cardiovasc Interv,2016,9(18):1941-1949.
[5] Zeller T,Beschorner U,Pilger E,et al.Paclitaxel-coated balloonin infrapopliteal arteries:12-month results from the biolux P-IIrandomized trial(biotronik's-first in man study of the passeo-18lux drug releasing pta balloon catheter vs. the uncoated passeo-18 pta balloon catheter in subjects requiring revascularization ofinfrapopliteal arteries)[J].JACC Cardiovasc Interv,2015,8(12):1614-1622.
[6] Zeller T,Baumgartner I,Scheinert D,et al.Drug-eluting balloonversus standard balloon angioplasty for infrapopliteal arterial re-vascularization in critical limb ischemia:12-month results fromthe IN.PACT DEEP randomized trial[J].J Am Coll Cardiol,2014,64(15):1568-1576.
[7] Siablis D,Kitrou PM,Spiliopoulos S,et al.Paclitaxel-coated bal-loon angioplasty versus drug-eluting stenting for the treatment ofinfrapopliteal long-segment arterial occlusive disease:theIDEAS randomized controlled trial[J].JACC Cardiovasc Interv,2014,7(9):1048-1056.
[8] Fanelli F,Cannavale A,Corona M,et al.The"DEBELLUM"--lower limb multilevel treatment with drug eluting balloon--ran-domized trial:1-year results[J].J Cardiovasc Surg(Torino),2014,55(2):207-216.
[9] Liistro F,Porto I,Angioli P,et al.Drug-eluting balloon in pe-ripheral intervention for below the knee angioplasty evaluation(DEBATE-BTK):a randomized trial in diabetic patients withcritical limb ischemia[J].Circulation,2013,128(6):615-621.
[10] Moher D,Liberati A,Tetzlaff J,et al.Preferred reporting itemsfor systematic reviews and meta-analyses:the PRISMA State-ment[J].Open Med,2009,3(3):e123-130.
[11] Kayssi A,Al-Atassi T,Oreopoulos G,et al.Drug-eluting bal-loon angioplasty versus uncoated balloon angioplasty for pe-ripheral arterial disease of the lower limbs[J].Cochrane Data-base Syst Rev,2016,8:CD011319.
[12] Cassese S,Ndrepepa G,Liistro F,et al.Drug-coated balloonsfor revascularization of infrapopliteal arteries:A Meta-analysisof randomized trials[J].JACC Cardiovasc Interv,2016,9(10):1072-1080.