BA9™系列 | Biolimus A9(BA9™)——为血管介入药械而生
 BiolimusA9(BA9TM)——柏盛国际的独门秘籍




BA9™系列




在长达近20年的药物洗脱支架(DES)的发展过程中, Sirolimus(雷帕霉素)是DES应用最广泛的药物。雷帕霉素通过控制蛋白质的转化,从而抑制血管内平滑肌细胞迁移、增生和生长。无论是作为DES开山鼻祖的Cypher支架,还是全球第一款可降解涂层药物洗脱支架——EXCEL(爱克塞尔),使用雷帕霉素药物的冠脉支架植入体内后都能明显抑制过度平滑肌增生,有效抑制新生内膜增殖,从而降低裸金属支架植入后带来的支架内再狭窄的风险。


Biolimus A9(BA9)是蓝帆医疗旗下柏盛国际的专利药物。作为一款专为血管介入治疗药械特别研发的雷帕霉素衍生物。在涉及近两万例病例的all comer试验中,使用BA9药物的支架与其他limus类支架显示出在安全性和有效性方面具有非劣效性的结果。1-8


BA9与雷帕霉素相比,具有十倍于雷帕霉素的亲脂性,可以使BA9更容易被组织吸收;长约20天的药物半衰期,可以使BA9在血管壁组织中储存的时间(超过180天)9更长,发挥更持久的抑制细胞增殖的效果。


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比雷帕霉素更少的损失


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更长的半衰期可以提供更持久的药物作用

            R.Tzafriri, poster presentation - EuroPCR 2017






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       BA9TM药物支架挽救更多患者生命





BA9™系列










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超过51000病例数据的研究显示,专为血管介入药械设计的BA9支架对复杂PCI患者(HBR、STEMI、ACS、LM、CTO、分叉、高syntax评分)带来更多获益。


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使用BioFreedom支架的LEADERS FREE试验显示,在伴有高出血风险(HBR)的 ACS患者中,应用BioFreedom BA9TM DCS显著降低心血管死亡率。


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LEADERS系列研究中,应用BA9 TM药物的可降解涂层DES的BioMatrix系列支架与雷帕霉素DES比较中,显示在高syntax评分、AMI患者中可以显著降低心血管死亡。


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在所有all-comer的试验中(3年随访),BA9 TM DES极晚期支架血栓发生率最低 。


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LEADERS FREE研究显示,在高出血风险(HBR)人群中需要超短DAPT治疗的情况下,使用BA9 DCS的患者有更少的心梗和支架血栓发生率。


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参考文献:

[1] Evald H. Christiansen, et al."TCT-643 Very LateStent Thrombosis after Revascularization with Biolimus-Eluting BiodegradablePolymer-Coated Nobori Stent versus Durable Polymer-Coated Sirolimus-ElutingStents from the SORT OUT V Trial." Journal of the American College of Cardiology 64.11(2014): doi:10.1016/j.jacc.2014.07.711.

[2] Raungaard Bent, et al."Comparison ofDurable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-ElutingCoronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomesin the Randomized SORT OUT VI Trial.." JACC. Cardiovascular interventions 10.3(2017): doi:10.1016/j.jcin.2016.11.007.

 [3] Julia Ellert,et al."TCT-90 Clinical Outcomes Three Year After Revascularization With aBiodegradable Polymer Ultra-thin Strut Sirolimus-eluting Stent and aBiodegradable Polymer Biolimus-eluting Stent. From the SORT OUT VIItrial.." Journal of the AmericanCollege of Cardiology 72.13(2018):doi:10.1016/j.jacc.2018.08.1186.

 [4] Maeng Michael, etal."Everolimus-Eluting Versus Biolimus-Eluting Stents With BiodegradablePolymers in Unselected Patients Undergoing Percutaneous Coronary Intervention:A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIIITrial).." JACC. Cardiovascularinterventions 12.7(2019): doi:10.1016/j.jcin.2018.12.036.

 [5] Natsuaki Masahiro, et al."Five-yearoutcome of a randomised trial comparing second-generation drug-eluting stentsusing either biodegradable polymer or durable polymer: the NOBORIbiolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial(NEXT).." EuroIntervention : journal ofEuroPCR in collaboration with the Working Group on Interventional Cardiology ofthe European Society of Cardiology 14.7(2018): doi:10.4244/EIJ-D-17-01050.

[6] Chevalier Bernard, et al."Five-yearclinical outcome of the Nobori drug-eluting coronary stent system in thetreatment of patients with coronary artery disease: final results of the NOBORI1 trial.." EuroIntervention : journal ofEuroPCR in collaboration with the Working Group on Interventional Cardiology ofthe European Society of Cardiology 11.5(2015): doi:10.4244/EIJY14M12_13.

 [7] Yoon ChangHwan, et al."BioMatrixversus Orsiro biodegradable polymer stents in all-comer patients with coronaryartery disease: the multicentre, randomised BIODEGRADE trial.." EuroIntervention : journal of EuroPCR in collaboration with the WorkingGroup on Interventional Cardiology of the European Society of Cardiology 16.17(2021): doi:10.4244/EIJ-D-20-00185.

 [8] Windecker Stephan, et al."FINAL TWO-YEARRESULTS FROM THE RANDOMIZED ONYX ONE TRIAL IN HIGH BLEEDING RISK PATIENTSTREATED WITH 1-MONTH DAPT." Journal of the AmericanCollege of Cardiology 77.18S1(2021):doi:10.1016/S0735-1097(21)02258-0.

[9]  Norio Tada,et al. Polymer-free biolimus a9-coatedstent demonstrates more sustained intimal inhibition, improved healing, andreduced inflammation compared with a polymer-coated sirolimus-eluting cypherstent in a porcine model Circ Cardiovasc Interv.2010;3:174-183

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