生物可吸收支架与依维莫斯洗脱支架在经皮冠状动脉介入治疗中的安全性和有效性Meta分析
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摘要
目的:系统评价生物可吸收支架(BVS)与依维莫司洗脱支架(EES)在经皮冠状动脉介入治疗(PCI)中的安全性和有效性。方法:计算机检索Pub Med、MEDILINE、EMBASE、Cochrane library、知网、万方等数据库,检索时限从建库到2017-10。同时查阅会议摘要和相关网站,收集已公布随访数据的有关随机对照试验。根据改良Jadad量表评价文献质量并提取资料,运用Review Manager 5.3软件进行Meta分析。主要的有效性终点和安全性终点为靶病变失败和支架内血栓形成。结果:共纳入9篇随机对照研究,共包含6 721例患者,其中BVS组3 670例,EES组3 051例。随访时间为6~36个月。Meta分析结果:BVS组靶病变失败(RR=1.31,95%CI:1.08~1.58,P=0.005)、支架内血栓形成(RR=2.89,CI:1.85~4.53,P<0.0001)、缺血驱动靶病变血运重建(RR=1.44,95%CI:1.12~1.86,P=0.005)、靶血管心肌梗死(RR=1.74,95%CI:1.33~2.27,P<0.0001)及所有心肌梗死(RR=1.49,95%CI:1.16~1.91,P=0.002)均高于EES组;全因死亡(RR=0.87,95%CI:0.57~1.33,P=0.520),心原性死亡(RR=0.78,95%CI:0.54~1.11,P=0.160)及患者相关的复合终点(RR=1.10,95%CI:0.95~1.27,P=0.210),两组差异均无统计学意义。结论:在PCI中BVS与EES相比安全性和有效性较低。BVS的安全性和有效性仍然需要更长时间的、大量的临床研究来论证。
Objectives: To systemically review the safety and efficacy of bioresorbable vascular scaffold(BVS) versus everolimus eluting stent(EES) for percutaneous coronary intervention(PCI).Methods: The database searched includes Pub Med, Medline, MEDILINE, EMBASE, Cochrane library, CNKI and Wanfang. Database retrieval time was between database establishment time to October 2017. During the same time, authors accessed the conference summary and related websites to collect published randomized controlled trials of published data. To evaluate the quality of the literature according to the modified Jadad scale and extracted the data. Meta-analysis was performed using Review Manager 5.3 software.Results: Nine trials were included; 6 721 patients were randomized to receive BVS(n=3 670) or EES(n=3 051). Time offollow-up was ranged from 6 to 36 months. Compared with metallic EES, risk of target lesion failure(RR=1.31, 95%CI: 1.08-1.58; P=0.005) and in-stent thrombosis(RR=2.89, 95%CI: 1.85-4.53; P<0.0001), ischemia-driven target lesion revascularization(RR=1.44,95 % CI:1.12-1.86, P=0.005)、target-vessel myocardial infarction(RR=1.74, 95 % CI:1.33-2.27, P<0.0001) and all myocardial infarction(RR=1.49, 95% CI:1.16-1.91, P=0.002) were all significantly higher in BVS group than in EES group. There were no significant differences in all-cause death(RR=0.87, 95 % CI: 0.57-1.33, P=0.520), cardiovascular mortality(RR=0.78, 95% CI: 0.54-1.11, P=0.160) and composite endpoints(RR=1.10, 95% CI: 0.95-1.27, P=0.210) between the two groups. Conclusions: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk during the observation period.
Objectives: To systemically review the safety and efficacy of bioresorbable vascular scaffold(BVS) versus everolimus eluting stent(EES) for percutaneous coronary intervention(PCI).Methods: The database searched includes Pub Med, Medline, MEDILINE, EMBASE, Cochrane library, CNKI and Wanfang. Database retrieval time was between database establishment time to October 2017. During the same time, authors accessed the conference summary and related websites to collect published randomized controlled trials of published data. To evaluate the quality of the literature according to the modified Jadad scale and extracted the data. Meta-analysis was performed using Review Manager 5.3 software.Results: Nine trials were included; 6 721 patients were randomized to receive BVS(n=3 670) or EES(n=3 051). Time offollow-up was ranged from 6 to 36 months. Compared with metallic EES, risk of target lesion failure(RR=1.31, 95%CI: 1.08-1.58; P=0.005) and in-stent thrombosis(RR=2.89, 95%CI: 1.85-4.53; P<0.0001), ischemia-driven target lesion revascularization(RR=1.44,95 % CI:1.12-1.86, P=0.005)、target-vessel myocardial infarction(RR=1.74, 95 % CI:1.33-2.27, P<0.0001) and all myocardial infarction(RR=1.49, 95% CI:1.16-1.91, P=0.002) were all significantly higher in BVS group than in EES group. There were no significant differences in all-cause death(RR=0.87, 95 % CI: 0.57-1.33, P=0.520), cardiovascular mortality(RR=0.78, 95% CI: 0.54-1.11, P=0.160) and composite endpoints(RR=1.10, 95% CI: 0.95-1.27, P=0.210) between the two groups. Conclusions: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk during the observation period.
引文
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[12]SabatéM,Windecker S,I?iguez A,et al.Everolimus-eluting bioresorbable stent vs.durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction:results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial[J].Euro Heart J,2016,37:229-240.DOI:10.1093/eurheartj/ehv500.
[13]Applegate RJ,Sacrinty MT,Little WC,et al.Incidence of coronary stent thrombosis based on academic research consortium definitions[J].JACC,2008,102(6):683-688.DOI:10.1016/j.amjcard.2008.04.050.
[14]袁晋青,徐波,高润霖,等.药物洗脱支架与金属裸支架对冠状动脉临界病变的远期疗效[J].中国循环杂志,2010,25(1):11-13.DOI:10.3969/j.issn.1000-3614.2010.01.005.
[15]Kereiakes DJ,Onuma Y,Serruys PW,et al.Bioresorbable vascular scaffolds for coronary revascularization[J].Circulation,2016,134(2):168-182.DOI:10.1161/CIRCULATIONAHA.116.021539.
[16]陈纪言,董豪坚.生物可吸收支架的循证医学证据和展望[J].中国循环杂志,2014(8):561-563.DOI:10.3969/j.issn.1000-3614.2014.08.001.
[17]Cassese S,Byrne RA,Ndrepepa G,et al.Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents:a meta-analysis of randomised controlled trials[J].Lancet,2015,387(10018):537-544.DOI:10.1016/S0140-6736(15)00979-4.
[18]Kang SH,Chae IH,Park JJ,et al.Stent thrombosis with drug-eluting stents and bioresorbable scaffolds:evidence from a network metaanalysis of 147 trials[J].JACC,2016,9(12):1203-1212.DOI:10.1016/j.jcin.2016.03.038.
[19]Otsuka F,Cheng Q,Yahagi K,et al.Acute thrombogenicity of a durable polymer everolimus-eluting stent relative to contemporary drug-eluting stents with biodegradable polymer coatings assessed ex vivo in a swine shunt model[J].JACC,2015,8(9):1248-1260.DOI:10.1016/j.jcin.2015.03.029.
[20]Stone GW,Gao R,Kimura T,et al.1-year outcomes with the absorb bioresorbable scaffold in patients with coronary artery disease:a patient-level,pooled meta-analysis[J].Lancet,2016,387(10025):1277-1289.DOI:10.1016/S0140-6736(15)01039-9.
[21]庞思,潘道蓉,朱灏,等.生物可吸收支架与钴铬合金依维莫司洗脱支架治疗冠心病的Meta分析[J].中国循环杂志,2016,31(1):15-19.DOI:10.3969/j.issn.1000-3614.2016.01.004.
[22]Sorrentino S,Giustino G,Mehran R,et al.Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents[J].JACC,2017,69(25):3055-3066.DOI:10.1016/j.jacc.2017.04.011.
[23]Ali ZA,Serruys PW,Kimura T,et al.2-year outcomes with the absorb bioresorbable scaffold for treatment of coronary artery disease:a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy[J].Lancet,2017,390(10096):760-772.DOI:10.1016/S0140-6736(17)31470-8.
[24]Elias J,van Dongen IM,Kraak RP,et al.Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease:a weighted meta-analysis of seven randomised controlled trials including 5577patients[J].Neth Heart J,2017,25(7-8):429-438.DOI:10.1007/s12471-017-1008-x.
[2]Ellis SG,Kereiakes DJ,Metzger DC,et al.Everolimus-eluting bioresorbable scaffolds for coronary artery disease[J].N Engl J Med,2015,373(20):1905-1915.DOI:10.1056/NEJMoa1509038.
[3]Zhang Y,Gao R,Xu B,et al.Bioresorbable scaffolds for coronary artery disease:current status and future prospective[J].Chin Med J,2014,127(6):1141-1148.DOI:10.3760/cma.j.issn.0366-6999.20140015.
[4]Ellis SG.Everolimuseluting bioresorbable vascular scaffolds in patients with coronary artery disease:ABSORBⅢtrial 2-year results[C].Washington,DC,2017.http://www.tctmd.com/.
[5]Gao R.ABSORB-China:two-year clinical inpatients with coronary artery disease randomized to the absorb bioresorbable vascular scaffoldversus metallic drug-eluting stents[C].Washington,DC,2016.https://www.tctmd.com/slide/absorb-china-two-year-clinicaloutcomes-prospective-randomized-trial-everolimus-eluting.
[6]Onuma Y,Sotomi Y,Shiomi H,et al.Two-year clinical,angiographic,and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimuseluting metallic stent:insights from the randomised ABSORB Japan trial[J].Euro Intervention,2016,12(9):1090-1101.DOI:10.4244/EIJY16M09_01.
[7]Serruys PW,Chevalier B,Sotomi Y,et al.Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis(ABSORB II):a 3 year,randomised,controlled,single-blind,multicentre clinical trial[J].Lancet,2016,388(10059):2479-2491.DOI:10.1016/S0140-6736(16)32050-5.
[8]Wykrzykowska JJ,Kraak RP,Hofma SH,et al.Bioresorbable scaffolds versus metallic stents in routine PCI[J].N Engl J Med,2017,376(24):2319-2328.DOI:10.1056/NEJMoa1614954.
[9]Brugaletta S,Gori T,Low AF,et al.Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction:1-year results of a propensity score matching comparison:the BVS-examinationstudy(bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction)[J].JACC Cardiovasc Interv,2015,8(3):503.DOI:10.1016/j.jcin.2014.10.005.
[10]Cortese B,Ielasi A,Romagnoli E,et al.Clinical comparison with shortterm follow-up of bioresorbable vascular scaffold versus everolimuseluting stent in primary percutaneous coronary interventions[J].JACC,2015,116(5):705-710.DOI:10.1016/j.amjcard.2015.05.049.
[11]Puricel S.Comparison of everolimus andbiolimus-eluting coronary stents with everolimus eluting bioresorbable vascular scaffolds:2-year out comes of the EVERBIO II trial[C].San Francisco,California,2015.https://www.tctmd.com/slide/new-randomized-trial-data-2-yearoutcomes-everbio-ii.
[12]SabatéM,Windecker S,I?iguez A,et al.Everolimus-eluting bioresorbable stent vs.durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction:results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial[J].Euro Heart J,2016,37:229-240.DOI:10.1093/eurheartj/ehv500.
[13]Applegate RJ,Sacrinty MT,Little WC,et al.Incidence of coronary stent thrombosis based on academic research consortium definitions[J].JACC,2008,102(6):683-688.DOI:10.1016/j.amjcard.2008.04.050.
[14]袁晋青,徐波,高润霖,等.药物洗脱支架与金属裸支架对冠状动脉临界病变的远期疗效[J].中国循环杂志,2010,25(1):11-13.DOI:10.3969/j.issn.1000-3614.2010.01.005.
[15]Kereiakes DJ,Onuma Y,Serruys PW,et al.Bioresorbable vascular scaffolds for coronary revascularization[J].Circulation,2016,134(2):168-182.DOI:10.1161/CIRCULATIONAHA.116.021539.
[16]陈纪言,董豪坚.生物可吸收支架的循证医学证据和展望[J].中国循环杂志,2014(8):561-563.DOI:10.3969/j.issn.1000-3614.2014.08.001.
[17]Cassese S,Byrne RA,Ndrepepa G,et al.Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents:a meta-analysis of randomised controlled trials[J].Lancet,2015,387(10018):537-544.DOI:10.1016/S0140-6736(15)00979-4.
[18]Kang SH,Chae IH,Park JJ,et al.Stent thrombosis with drug-eluting stents and bioresorbable scaffolds:evidence from a network metaanalysis of 147 trials[J].JACC,2016,9(12):1203-1212.DOI:10.1016/j.jcin.2016.03.038.
[19]Otsuka F,Cheng Q,Yahagi K,et al.Acute thrombogenicity of a durable polymer everolimus-eluting stent relative to contemporary drug-eluting stents with biodegradable polymer coatings assessed ex vivo in a swine shunt model[J].JACC,2015,8(9):1248-1260.DOI:10.1016/j.jcin.2015.03.029.
[20]Stone GW,Gao R,Kimura T,et al.1-year outcomes with the absorb bioresorbable scaffold in patients with coronary artery disease:a patient-level,pooled meta-analysis[J].Lancet,2016,387(10025):1277-1289.DOI:10.1016/S0140-6736(15)01039-9.
[21]庞思,潘道蓉,朱灏,等.生物可吸收支架与钴铬合金依维莫司洗脱支架治疗冠心病的Meta分析[J].中国循环杂志,2016,31(1):15-19.DOI:10.3969/j.issn.1000-3614.2016.01.004.
[22]Sorrentino S,Giustino G,Mehran R,et al.Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents[J].JACC,2017,69(25):3055-3066.DOI:10.1016/j.jacc.2017.04.011.
[23]Ali ZA,Serruys PW,Kimura T,et al.2-year outcomes with the absorb bioresorbable scaffold for treatment of coronary artery disease:a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy[J].Lancet,2017,390(10096):760-772.DOI:10.1016/S0140-6736(17)31470-8.
[24]Elias J,van Dongen IM,Kraak RP,et al.Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease:a weighted meta-analysis of seven randomised controlled trials including 5577patients[J].Neth Heart J,2017,25(7-8):429-438.DOI:10.1007/s12471-017-1008-x.