REGULATE-PCI解讀：新型抗凝劑REG1與比伐盧定的心血管獲益比較課件

陳燦教授2015.07.16新型抗凝劑REG1（REG1AnticoagulationSystem）與比伐盧定（Bivalirudin）的心血管獲益比較TheREGULATE-PCIRandomizedClinicalTrial試驗(yàn)主要參與組織AcademicLeadershipExecutiveCommitteeJohnAlexander(co-PI)MichaelLincoff(co-PI)RoxanaMehran(co-PI)PaulArmstrongGabrielStegChristophBodeSteveZelenkofske(Regado)SteeringCommittee:A.Levinson(USA),R.Becker(USA),V.Hasselblad(USA),K.Huber(Austria,P.R.Sinnaeve(Belgium),M.Aschermann(CzechRepublic),P.Laanmets(Estonia),B.Merkely(Hungary),V.Guetta(Israel),M.Valgimigli(Italy),J.H.Cornel(Netherlands),J.D.Kasprzak(Poland),J.Morais(Portugal),B.Alekyan(Russia),V.Fridrich(Slovakia),J.Lopez/Sendon(Spain),R.Stables(UK),M.G.Cohen(USA),T.Povsic(USA)OperationsProjectManagement:DCRI,C5R,Regado,PAREXELUSSiteManagement:DCRI,C5RCNSiteManagement:CVCROWSiteManagement:PAREXELDataManagement:DCRIStatistics:DCRISafety:DCRIClinicalEventCommittee:DCRIIXRS:ClinPhonePerceptiveInformatics)StudyDrug:Catalent/PAREXELDSMB:StanfordU.–RobertHarrington(chair)背景該研究注冊(cè)情況：REG-1由pegnivacogin

和拮抗劑

anivamersen組成TheREG1Anti-CoagulationSystemanivamersen(RB007)pegnivacogin(RB006)FactorIXa特異性結(jié)合IXa因子31nucleotides

+40kDaPEGt1/2>24hrtmax<5minpegnivacogin

中和pegnivacogin15nucleotidest1/2<5mintmax~immediateanivamersen+REG1是一種快速起效、可預(yù)測(cè)劑量反應(yīng)、高效的抗凝劑TheREGULATE-PCI

RandomizedClinicalTrialRandomized,open-label,active-controlled,superiority,

phase3trialtotestthehypothesisthatnearcompleteFIXainhibitionwithPegnivacoginduringPCIwouldprovideagreaterreductioninischemiceventsthanbivalirudinwithoutincreasedbleedingasaresultofanticoagulantreversalwithAnivamersen.研究設(shè)計(jì)經(jīng)CAG后需要PCI患者隨機(jī)分組REG1組

Bivalirudin組Pegnivacogin1mg/kgBival藥丸Bival輸注PCI劑量PCI術(shù)后Anivamersen0.5mg/kg鞘管拔出后隨訪評(píng)估4-10d隨訪30d最初結(jié)局(Day3)事件終點(diǎn)

(在3天和30天評(píng)估)主要療效終點(diǎn)主要安全終點(diǎn)次要終點(diǎn)3天時(shí)死亡非致死性心梗非致死性卒中緊急TLR3天時(shí)出血發(fā)生率（與CABG無關(guān)的BARC3或5）3天時(shí)主要終點(diǎn)的組分，30天復(fù)合主要終點(diǎn)，30天出血終點(diǎn)過敏不良事件的發(fā)生率和嚴(yán)重程度參與國家共17個(gè)國家225家醫(yī)院參與前五名人選人群基本信息支架類型3天終點(diǎn)比較主要終點(diǎn)死亡率MI發(fā)生率中風(fēng)發(fā)生率TLR支架內(nèi)血栓形成P=1.00P=0.36P=0.69P=0.71P=0.06P<0.0130天終點(diǎn)比較主要終點(diǎn)死亡率MI發(fā)生率中風(fēng)發(fā)生率TLR支架內(nèi)血栓形成出血安全性終點(diǎn)比較30天出血發(fā)生率3天出血發(fā)生率主要終點(diǎn)主要終點(diǎn)