生物可吸收支架与药物洗脱支架在急性心肌梗死治疗中的安全性和有效性Meta分析Meta-analysis of efficacy and safety of the bioresorbable vascular scaffold versus drug-eluting stents treating acute myocardial infarction
柯俊松,杨文学,张鸿宇,黄俊,吕平,陈雲,徐凯
摘要(Abstract):
目的系统评价生物可吸收支架(BVS)与药物洗脱支架(DES)在治疗急性心肌梗死(AMI)中的安全性和有效性。方法计算机检索Pub Med、Cochrane Library、Embase、Web of Science及相关网站(www.clinicaltrials.gov)。纳入2006年1月至2020年1月关于BVS与DES治疗AMI安全性与有效性的研究。主要有效终点为靶病变血运重建,主要安全终点为明确/可能的支架内血栓形成。由两名研究者按照纳入与排除标准筛选文献,提取资料和评价文献质量。采用Stata 12.0统计软件进行Meta分析。结果最终纳入4个临床研究,其中2个为随机对照研究,2个为观察性研究,共1335例患者,其中BVS组709例,DES组626例。随访时间为12~36个月。Meta分析结果:BVS组与DES组靶病变血运重建(RR 1.59,95%CI0.82~3.10,P=0.337)、明确/可能的支架内血栓形成(RR 1.56,95%CI 0.70~3.46,P=0.685)的差异均无统计学意义。两组靶血管心肌梗死(RR 1.05,95%CI0.41~2.67,P=0.667)、全因死亡(RR 1.35,95%CI 0.52~3.45,P=0.871)、心原性死亡(RR 1.29,95%CI 0.59~2.80,P=0.778)、设备相关的复合终点(RR 1.37,95%CI 0.87~2.16,P=0.425)的差异均无统计学意义。结论 BVS治疗AMI的安全性与有效性可能不劣于DES。
关键词(KeyWords): 生物可吸收支架;药物洗脱支架;急性心肌梗死;Meta分析
基金项目(Foundation):
作者(Author): 柯俊松,杨文学,张鸿宇,黄俊,吕平,陈雲,徐凯
参考文献(References):
- [1]Zhang YJ,Zhu LL,Bourantas CV,et al.The impact of everolimus versus other rapamycin derivative-eluting stents on clinical outcomes in patients with coronary artery disease:A meta-analysis of 16randomized trials.J Cardiol,2014,64(3):185-193.
- [2]Serruys PW,Garciagarcia HM,Onuma Y.From metallic cages to transient bioresorbable scaff olds:change in paradigm of coronary revascularization in the upcoming decade?Eur Heart J,2012,33(1):16-25.
- [3]陆寒新,Karn SK,车文良,等.生物可吸收支架进展及前景.国际心血管病杂志,2016,43(2):75-78.
- [4]王效增,刘艳杰,郭忱,等.生物可吸收支架置入后影像学随访三年一例.中华心血管病杂志,2019,47(3):235-237.
- [5]Ali ZA,Serruys PW,Kimura T,et al.2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary a rtery disease:a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy.Lancet,2017,390(10096):760-772.
- [6]张立博,邓婧,魏向龙.生物可吸收支架在急性冠状动脉综合征中应用的Meta分析.中国介入心脏病学杂志,2018,26(7):390-399.
- [7]Cutlip D E,Windecker S,Mehran R,et al.Clinical end points in coronary stent trials:a case for standardized definitions.Circulation,2007,115(17):2344-2351.
- [8]Higgins JPT,Altman DG,G?tzsche PC,et al.The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials.BMJ,2011,343:d5928.
- [9]Peterson J,Welch V,Losos M,et al.The Newcastle-Ottawa scale(NOS) for assessing the quality of nonrandomised studies in metaanalyses.Ottawa:Ottawa Hospital Research Institute,2011.
- [10]Byrne RA,Alfonso F,Schneider S,et al.Prospective,randomized trial of bioresorbable scaffolds vs.everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction:the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial.Eur Heart J,2019,40(2):167-176.
- [11]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-TROFIⅡtrial.Eur Heart J,2016,37(3):229-240.
- [12]Katagiri Y,Onuma Y,Asano T,et al.Three-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaff old and a durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction (TROFI IItrial).Euro Intervention,2018,14(11):e1224-e1226.
- [13]Fam JM,Felix C,van Geuns RJ,et al.Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction:a propensitymatched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study.Euro Intervention,2016,12(1):30-37.
- [14]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-EXAMINATION Study(bioresorbable vascular scaff old-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction).JACC Cardiovasc Interv,2015,8(1 Part B):189-197.
- [15]Brugaletta S,Gori T,Low AF,et al.ABSORB bioresorbable vascular scaff old vs.everolimus-eluting metallic stent in ST-segment elevation myocardial infarction (BVS EXAMINATION study):2-Year results from a propensity score matched comparison.Int JCardiol,2016,214:483-484.
- [16]Je?ewski MP,Kubisa MJ,Eyileten C,et al.Bioresorbable vascular scaff olds-dead end or still a rough diamond?J Clin Med,2019,8(12):2167.
- [17]Souteyrand G,Amabile N,Mangin L,et al.Mechanisms of stent thrombosis analysed by optical coherence tomography:insights from the national PESTO French registry.Eur Heart J,2016,37(15):1208-1216.
- [18]Ke J,Zhang H,Huang J,et al.Mid-term outcomes of bioresorbable vascular scaff olds vs second-generation drug-eluting stents in patients with acute coronary syndromes:A systematic review and metaanalysis.Medicine,2020,99(10):e19458.
- [19]Everaert B,Wykrzykowska JJ,Koolen J,et al.Recommendations for the use of bioresorbable vascular scaffolds in percutaneous coronary interventions:2017 revision.Neth Heart J,2017,25(7-8):419-428.
- [20]Danzi GB,Bernelli C,Cerrato E.Outcomes of optimised implantation technique with bioresorbable scaffolds:A pooled analysis of ABSORB-Ⅳand COMPARE-ABSORB trials.Cardiovasc Revasc Med,2020,21(4):559-561.
- [21]Puricel S,Cuculi F,Weissner M,et al.Bioresorbable coronary scaff old thrombosis:multicenter comprehensive analysis of clinical presentation,mechanisms,and predictors.J Am Coll Cardiol,2016,67(8):921-931.
- [22]吕续成,沈雳,洪斌,等.生物可吸收支架内血的光学相干断层成像发现及原因分析.中国介入心脏病学杂志,2017,25(10):589-593.
- [23]Ali ZA,Gao RR,Kimura TT,et al.Three-year outcomes with the absorb bioresorbable scaffold:individual-patient-data metaanalysis from the ABSORB randomized trials.Circulation,2017,137(5):464-479.
- [24]Ali ZA,Serruys PW,Kimura T,et al.2-year outcomes with the Absorb bioresorbable scaff old for treatment of coronary artery disease:a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy.Lancet,2017,390(10096):760-772.
- [25]Picard F,de Hemptinne Q,Avram R,et al.Bioresorbable vascular scaffold during ST-elevation myocardial infarction:a systematic review.Can J Cardiol,2017,33(4):515-524.
- [26]Goel S,Pasam RT,Chava S,et al.Three to four years outcomes of the absorb bioresorbable vascular scaff old versus second‐generation drug‐eluting stent:A meta‐analysis.Catheter Cardiovasc Interv,2020,95(2):216-223.
- [27]Ielasi A,Campo G,Cortese B,et al.One-year results following a pre-specified ABSORB implantation strategy in ST-elevation myocardial inf arction (BVS STEMI STRATEGY-IT study).Cardiovasc Revasc Med,2019,20(8):700-704.