生物可吸收支架与药物洗脱支架治疗心血管疾病的比较:临床试验meta分析
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摘要
目的比较生物可吸收支架与药物洗脱支架治疗心血管疾病的安全性和有效性。方法计算机检索中国生物医学文献服务系统(Sino Med)、万方、中国知网(CNKI)、维普(VIP)、Pub Med、Medline、Embase数据库,检索年限为1980年1月至2018年10月,筛选出符合纳入标准的临床试验研究文献,采用R 3.5.1软件计算评价指标比值比(OR)及95%置信区间(CI),评估生物可吸收支架与药物洗脱支架治疗心血管疾病的安全性和有效性。结果最终纳入22项研究,包含33 570名研究对象。在合并的心脏冠状动脉疾病的临床试验随访结果中,生物可吸收支架相对于药物洗脱支架,主要的安全性指标、有效性指标差异均无统计学意义(P均>0.05),其中心源性死亡率合并OR(95%CI)为1.01(0.88,1.16)、总体死亡率合并OR(95%CI)为0.97(0.88,1.08)、心肌梗死发生率合并OR(95%CI)为0.98(0.87,1.10)、靶病变血运重建率合并OR(95%CI)为0.99(0.89,1.09)、靶血管血运重建率合并OR(95%CI)为1.03(0.95,1.13)。针对生物可吸收支架的应用目的对各时期支架内血栓发生率的合并分析中,临床确诊或疑似支架内血栓发生率合并OR(95%CI)为0.80(0.65,0.99),差异有统计学意义(P=0.042);早期支架内血栓发生率合并OR(95%CI)为0.97(0.69,1.37),差异无统计学意义(P=0.906);晚期支架内血栓发生率合并OR(95%CI)为0.61(0.43,0.86),差异有统计学意义(P=0.004)。结论在冠心病的治疗中,不能认为生物可吸收支架与药物洗脱支架存在安全性或有效性的差异,但生物可吸收支架可降低支架内血栓尤其是晚期血栓的发生风险。
Objective To compare the safety and effectiveness of bioabsorbable stents and drug-eluting stents for cardiovascular disease. Methods We searched SinoMed, Wanfang data, Chinese National Knowledge Infrastructure(CNKI),VIP, PubMed, Medline and Embase databases to obtain the clinical trial studies published between Jan. 1980 and Oct. 2018 according to inclusion criteria. The odds ratio(OR) and 95% con?dence interval(95% CI) were calculated by the R 3.5.1 software to evaluate the safety and ef?cacy of bioabsorbable stents and drug-eluting stents in treatment of cardiovascular disease. Results A total of 22 studies with 33 570 subjects were included. Comparing the bioabsorbable stents with the drug-eluting stents, we found that OR(95% CI) for the main safety and effectiveness indicators were as follow: cardiac death(1.01 [0.88, 1.16], P>0.05), all-caused death(0.97 [0.88, 1.08], P>0.05), myocardial infarction(0.98 [0.87, 1.10], P>0.05),target lesion revascularization(0.99 [0.89, 1.09], P>0.05), and target vessel revascularization(1.03 [0.95, 1.13], P>0.05). The OR(95% CI) was(0.80 [0.65, 0.99], P=0.042) for the detection of con?rmed or suspected stent thrombosis,(0.97 [0.69, 1.37],P=0.906) for early stent thrombus, and(0.61 [0.43, 0.86], P=0.004) for late stent thrombus. Conclusion In the treatment of coronary heart disease, the results of this meta-analysis indicate that there are no differences in safety or ef?cacy between bioabsorbable stents and drug-eluting stents. However, bioabsorbable stents can decrease the risk of stent thrombus, especially for the late stent thrombus.
Objective To compare the safety and effectiveness of bioabsorbable stents and drug-eluting stents for cardiovascular disease. Methods We searched SinoMed, Wanfang data, Chinese National Knowledge Infrastructure(CNKI),VIP, PubMed, Medline and Embase databases to obtain the clinical trial studies published between Jan. 1980 and Oct. 2018 according to inclusion criteria. The odds ratio(OR) and 95% con?dence interval(95% CI) were calculated by the R 3.5.1 software to evaluate the safety and ef?cacy of bioabsorbable stents and drug-eluting stents in treatment of cardiovascular disease. Results A total of 22 studies with 33 570 subjects were included. Comparing the bioabsorbable stents with the drug-eluting stents, we found that OR(95% CI) for the main safety and effectiveness indicators were as follow: cardiac death(1.01 [0.88, 1.16], P>0.05), all-caused death(0.97 [0.88, 1.08], P>0.05), myocardial infarction(0.98 [0.87, 1.10], P>0.05),target lesion revascularization(0.99 [0.89, 1.09], P>0.05), and target vessel revascularization(1.03 [0.95, 1.13], P>0.05). The OR(95% CI) was(0.80 [0.65, 0.99], P=0.042) for the detection of con?rmed or suspected stent thrombosis,(0.97 [0.69, 1.37],P=0.906) for early stent thrombus, and(0.61 [0.43, 0.86], P=0.004) for late stent thrombus. Conclusion In the treatment of coronary heart disease, the results of this meta-analysis indicate that there are no differences in safety or ef?cacy between bioabsorbable stents and drug-eluting stents. However, bioabsorbable stents can decrease the risk of stent thrombus, especially for the late stent thrombus.
引文
[1]LV J,WU Y,ZHANG X,JING T,ZHANG L,TONGS,et al.Comparison of the safety and efficacy of biodegradable polymer drug-eluting stents versus durable polymer drug-eluting stents:a meta-analysis[J/OL].Eur JMed Res,2015,20:21.doi:10.1186/s40001-015-0110-z.
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[3]BUSZMAN P P,ORLIK B,TRELA B,MILEWSKI K,KOZLOWSKI M,PRUSKI M J,et al.Comparable clinical safety and efficacy of biodegradable versus durable polymer paclitaxel eluting stents despite shorter dual antiplatelet therapy:insights from a multicenter,propensity scorematched registry[J/OL].Catheter Cardiovasc Interv,2013,82:E155-E162.doi:10.1002/ccd.24732.
[4]WINDECKE R S,SERRUYS P W,WANDE L S,BUSZMAN P,TRZNADEL S,LINKE A,et al.Biolimuseluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation(LEADERS):a randomised noninferiority trial[J].Lancet,2008,372:1163-1173.
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[9]VON BIRGELEN C,KOK M M,VAN DER HEIJDENL C,DANSE P W,SCHOTBORGH C E,SCHOLTE M,et al.Very thin strut biodegradable polymer everolimuseluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease(BIO-RESORT):a three-arm,randomised,non-inferiority trial[J].Lancet,2016,388:2607-2617.
[10]RAUNGAARD B,JENSEN L O,TILSTED H H,CHRISTIANSEN E H,MAENG M,TERKELSEN C J,et al.Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention(SORT OUTⅥ):a randomised non-inferiority trial[J].Lancet,2015,385:1527-1535.
[11]PILGRIM T,PICCOLO R,HEG D,ROFFI M,TULLERD,MULLER O,et al.Ultrathin-strut,biodegradablepolymer,sirolimus-eluting stents versus thin-strut,durable-polymer,everolimus-eluting stents for percutaneous coronary revascularisation:5-year outcomes of the BIOSCIENCE randomised trial[J].Lancet,2018,392:737-746.
[12]PILGRIM T,PICCOLO R,HEG D,ROFFI M,TULLERD,VUILLIOMENET A,et al.Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimuseluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction[J/OL].EuroIntervention,2016,12:e1343-e1354.doi:10.4244/EIJY15M12_09.
[13]SMITS P C,HOFMA S,TOGNI M,VAZQUEZN,VALDE S M,VOUDRI S V,et al.Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent(COMPAREⅡ):a randomised,controlled,non-inferiority trial[J].Lancet,2013,381:651-660.
[14]TEEUWEN K,SPOORMANS E M,BENNETT J,DUBOIS C,DESMET W,UGHI G J,et al.Optical coherence tomography findings:insights from the“randomised multicentre trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions”(PRISONⅣ)trial[J/OL].EuroIntervention,2017,13:e522-e530.doi:10.4244/EIJ-D-17-00261.
[15]KUFNER S,SORGES J,MEHILLI J,CASSESE S,REPP J,WIEBE J,et al.Randomized trial of polymerfree sirolimus-and probucol-eluting stents versus durable polymer zotarolimus-eluting stents:5-year results of the ISAR-TEST-5 trial[J].JACC Cardiovasc Interv,2016,9:784-792.
[16]HAN Y,XU B,JING Q,LU S,YANG L,XU K,et al.Arandomized comparison of novel biodegradable polymer-and durable polymer-coated cobalt-chromium sirolimus-eluting stents[J].JACC Cardiovasc Interv,2014,7:1352-1360.
[17]BYRNE R A,KASTRATI A,KUFNER S,MASSBERGS,BIRKMEIER K A,LAUGWITZ K L,et al.Randomized,non-inferiority trial of three limus agenteluting stents with different polymer coatings:the Intracoronary Stenting and Angiographic Results:Test Efficacy of 3 Limus-Eluting Stents(ISAR-TEST-4)Trial[J].Eur Heart J,2009,30:2441-2449.
[18]WIJNS W,VROLIX M,VERHEYE S,SCHOORS D,SLAGBOOM T,GOSSELINK M,et al.Randomised study of a bioabsorbable polymer-coated sirolimuseluting stent:results of the DESSOLVEⅡtrial[J].EuroIntervention,2015,10:1383-1390.
[19]GAO R L,XU B,LANSKY A J,YANG Y J,MA C S,HAN Y L,et al.A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimuseluting stent with a durable polymer everolimuseluting stent:clinical and angiographic follow-up of the TARGETⅠtrial[J].EuroIntervention,2013,9:75-83.
[20]WINDECKER S,HAUDE M,NEUMANN F J,STANGLK,WITZENBICHLER B,SLAGBOOM T,et al.Comparison of a novel biodegradable polymer sirolimuseluting stent with a durable polymer everolimus-eluting stent:results of the randomized BIOFLOW-Ⅱtrial[J/OL].Circ Cardiovasc Interv,2015,8:e001441.doi:10.1161/CIRCINTERVENTIONS.114.001441.
[21]NATSUAK I M,KOZUM A K,MORIMOT O T,KADOTA K,MURAMATSU T,NAKAGAWA Y,et al.Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent:a randomized,controlled,noninferiority trial[J].J Am Coll Cardiol,2013,62:181-190.
[22]LEE J Y,PARK D W,KIM Y H,AHN J M,KIM W J,KANG S J,et al.Comparison of biolimus A9-eluting(Nobori)and everolimus-eluting(Promus Element)stents in patients with de novo native long coronary artery lesions:a randomized Long Drug-Eluting StentⅤtrial[J].Circ Cardiovasc Interv,2014,7:322-329.
[23]PURICEL S,ARROYO D,CORPATAUX N,BAERISWYLG,LEHMANN S,KALLINIKOU Z,et al.Comparison of everolimus-and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds[J].J Am Coll Cardiol,2015,65:791-801.
[24]KAISER C,GALATIUS S,JEGER R,GILGEN N,SKOV JENSEN J,NABER C,et al.Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents:main results of the Basel Stent Kosten-Effektivit?ts Trial-PROspective Validation ExaminationⅡ(BASKET-PROVEⅡ),a randomized,controlled noninferiority2-year outcome trial[J].Circulation,2015,131:74-81.
[25]WIJNS W,VALDES-CHAVARRI M,RICHARDT G,MORENO R,í?IGUEZ-ROMO A,BARBATO E,et al.Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation:final five-year results of the CENTURYⅡrandomised clinical trial[J/OL].EuroIntervention,2018,14:e343-e351.doi:10.4244/EIJ-D-18-00358.
[26]CHEVALIER B,SILBER S,PARK S,GARCIA E,SCHULER G,SURYAPRANATA H,et al.Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Libertépaclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries:the NOBORI 1 trial―phase 2[J].Circ Cardiovasc Interv,2009,2:188-195.
[27]ZHANG Q I,QIU J P,KIRTANE A J,ZHU T Q,ZHANGR Y,YANG Z K,et al.Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention:results of the RESOLVE Study[J].J Interv Cardiol,2014,27:131-141.
[28]NAVARESE E P,KOWALEWSKI M,CORTESE B,KANDZARI D,DIAS S,WOJAKOWSKI W,et al.Short and long-term safety and efficacy of polymer-free vs.durable polymer drug-eluting stents.A comprehensive meta-analysis of randomized trials including 6 178patients[J].Atherosclerosis,2014,233:224-231.
[29]ZHU L,LV Y N,WANG L Y.Stent thrombosis with biodegradable polymer drug-eluting stents versus durable polymer sirolimus-eluting stents:an update metaanalysis[J].Cardiology,2015,130:96-105.
[30]LUPI A,GABRIO S G,ROGNONI A,LAZZEROM,FATTORI R,SHEIBAN I,et al.Meta-analysis of bioabsorbable versus durable polymer drug-eluting stents in 20,005 patients with coronary artery disease:an update[J/OL].Catheter Cardiovasc Interv,2014,83:E193-E206.doi:10.1002/ccd.25416.
[31]EL-HAYEK G,BANGALOR E S,CASSO D A,DEVIREDDY C,JABER W,KUMAR G,et al.Metaanalysis of randomized clinical trials comparing biodegradable polymer drug-eluting stent to secondgeneration durable polymer drug-eluting stents[J].JACCCardiovasc Interv,2017,10:462-473.
[2]CHRISTIANSEN E H,JENSEN L O,THAYSSEN P,TILSTED H H,KRUSELL L R,HANSEN K N,et al.Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention(SORT OUTⅤ):a randomised noninferiority trial[J].Lancet,2013,381:661-669.
[3]BUSZMAN P P,ORLIK B,TRELA B,MILEWSKI K,KOZLOWSKI M,PRUSKI M J,et al.Comparable clinical safety and efficacy of biodegradable versus durable polymer paclitaxel eluting stents despite shorter dual antiplatelet therapy:insights from a multicenter,propensity scorematched registry[J/OL].Catheter Cardiovasc Interv,2013,82:E155-E162.doi:10.1002/ccd.24732.
[4]WINDECKE R S,SERRUYS P W,WANDE L S,BUSZMAN P,TRZNADEL S,LINKE A,et al.Biolimuseluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation(LEADERS):a randomised noninferiority trial[J].Lancet,2008,372:1163-1173.
[5]KEREIAKES D J,MEREDITH I T,WINDECKERS,LEE JOBE R,MEHTA S R,SAREMBOCK I J,et al.Efficacy and safety of a novel bioabsorbable polymer-coated,everolimus-eluting coronary stent:the EVOLVEⅡRandomized Trial[J/OL].Circ Cardiovasc Interv,2015,8.pii:e002372.doi:10.1161/CIRCINTERVENTIONS.114.002372.
[6]NATSUAKI M,KOZUMA K,MORIMOTO T,KADOTAK,MURAMATSU T,NAKAGAWA Y,et al.Five-year outcome of a randomised trial comparing second-generation drug-eluting stents using either biodegradable polymer or durable polymer:the NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial(NEXT)[J].EuroIntervention,2018,14:815-818.
[7]BYRNE R A,KASTRAT I A,MASSBER G S,WIECZOREK A,LAUGWITZ K L,HADAMITZKY M,et al.Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus versus sirolimuseluting stents in patients with coronary artery disease:3-year outcomes from a randomized clinical trial[J].J Am Coll Cardiol,2011,58:1325-1331.
[8]BYRNE R A,KUFNER S,TIROCH K,MASSBERG S,LAUGWITZ K L,BIRKMEIER A,et al.Randomised trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis:2-year follow-up results[J].Heart,2009,95:1489-1494.
[9]VON BIRGELEN C,KOK M M,VAN DER HEIJDENL C,DANSE P W,SCHOTBORGH C E,SCHOLTE M,et al.Very thin strut biodegradable polymer everolimuseluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease(BIO-RESORT):a three-arm,randomised,non-inferiority trial[J].Lancet,2016,388:2607-2617.
[10]RAUNGAARD B,JENSEN L O,TILSTED H H,CHRISTIANSEN E H,MAENG M,TERKELSEN C J,et al.Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention(SORT OUTⅥ):a randomised non-inferiority trial[J].Lancet,2015,385:1527-1535.
[11]PILGRIM T,PICCOLO R,HEG D,ROFFI M,TULLERD,MULLER O,et al.Ultrathin-strut,biodegradablepolymer,sirolimus-eluting stents versus thin-strut,durable-polymer,everolimus-eluting stents for percutaneous coronary revascularisation:5-year outcomes of the BIOSCIENCE randomised trial[J].Lancet,2018,392:737-746.
[12]PILGRIM T,PICCOLO R,HEG D,ROFFI M,TULLERD,VUILLIOMENET A,et al.Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimuseluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction[J/OL].EuroIntervention,2016,12:e1343-e1354.doi:10.4244/EIJY15M12_09.
[13]SMITS P C,HOFMA S,TOGNI M,VAZQUEZN,VALDE S M,VOUDRI S V,et al.Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent(COMPAREⅡ):a randomised,controlled,non-inferiority trial[J].Lancet,2013,381:651-660.
[14]TEEUWEN K,SPOORMANS E M,BENNETT J,DUBOIS C,DESMET W,UGHI G J,et al.Optical coherence tomography findings:insights from the“randomised multicentre trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions”(PRISONⅣ)trial[J/OL].EuroIntervention,2017,13:e522-e530.doi:10.4244/EIJ-D-17-00261.
[15]KUFNER S,SORGES J,MEHILLI J,CASSESE S,REPP J,WIEBE J,et al.Randomized trial of polymerfree sirolimus-and probucol-eluting stents versus durable polymer zotarolimus-eluting stents:5-year results of the ISAR-TEST-5 trial[J].JACC Cardiovasc Interv,2016,9:784-792.
[16]HAN Y,XU B,JING Q,LU S,YANG L,XU K,et al.Arandomized comparison of novel biodegradable polymer-and durable polymer-coated cobalt-chromium sirolimus-eluting stents[J].JACC Cardiovasc Interv,2014,7:1352-1360.
[17]BYRNE R A,KASTRATI A,KUFNER S,MASSBERGS,BIRKMEIER K A,LAUGWITZ K L,et al.Randomized,non-inferiority trial of three limus agenteluting stents with different polymer coatings:the Intracoronary Stenting and Angiographic Results:Test Efficacy of 3 Limus-Eluting Stents(ISAR-TEST-4)Trial[J].Eur Heart J,2009,30:2441-2449.
[18]WIJNS W,VROLIX M,VERHEYE S,SCHOORS D,SLAGBOOM T,GOSSELINK M,et al.Randomised study of a bioabsorbable polymer-coated sirolimuseluting stent:results of the DESSOLVEⅡtrial[J].EuroIntervention,2015,10:1383-1390.
[19]GAO R L,XU B,LANSKY A J,YANG Y J,MA C S,HAN Y L,et al.A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimuseluting stent with a durable polymer everolimuseluting stent:clinical and angiographic follow-up of the TARGETⅠtrial[J].EuroIntervention,2013,9:75-83.
[20]WINDECKER S,HAUDE M,NEUMANN F J,STANGLK,WITZENBICHLER B,SLAGBOOM T,et al.Comparison of a novel biodegradable polymer sirolimuseluting stent with a durable polymer everolimus-eluting stent:results of the randomized BIOFLOW-Ⅱtrial[J/OL].Circ Cardiovasc Interv,2015,8:e001441.doi:10.1161/CIRCINTERVENTIONS.114.001441.
[21]NATSUAK I M,KOZUM A K,MORIMOT O T,KADOTA K,MURAMATSU T,NAKAGAWA Y,et al.Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent:a randomized,controlled,noninferiority trial[J].J Am Coll Cardiol,2013,62:181-190.
[22]LEE J Y,PARK D W,KIM Y H,AHN J M,KIM W J,KANG S J,et al.Comparison of biolimus A9-eluting(Nobori)and everolimus-eluting(Promus Element)stents in patients with de novo native long coronary artery lesions:a randomized Long Drug-Eluting StentⅤtrial[J].Circ Cardiovasc Interv,2014,7:322-329.
[23]PURICEL S,ARROYO D,CORPATAUX N,BAERISWYLG,LEHMANN S,KALLINIKOU Z,et al.Comparison of everolimus-and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds[J].J Am Coll Cardiol,2015,65:791-801.
[24]KAISER C,GALATIUS S,JEGER R,GILGEN N,SKOV JENSEN J,NABER C,et al.Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents:main results of the Basel Stent Kosten-Effektivit?ts Trial-PROspective Validation ExaminationⅡ(BASKET-PROVEⅡ),a randomized,controlled noninferiority2-year outcome trial[J].Circulation,2015,131:74-81.
[25]WIJNS W,VALDES-CHAVARRI M,RICHARDT G,MORENO R,í?IGUEZ-ROMO A,BARBATO E,et al.Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation:final five-year results of the CENTURYⅡrandomised clinical trial[J/OL].EuroIntervention,2018,14:e343-e351.doi:10.4244/EIJ-D-18-00358.
[26]CHEVALIER B,SILBER S,PARK S,GARCIA E,SCHULER G,SURYAPRANATA H,et al.Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Libertépaclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries:the NOBORI 1 trial―phase 2[J].Circ Cardiovasc Interv,2009,2:188-195.
[27]ZHANG Q I,QIU J P,KIRTANE A J,ZHU T Q,ZHANGR Y,YANG Z K,et al.Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention:results of the RESOLVE Study[J].J Interv Cardiol,2014,27:131-141.
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