介入心臟病學(xué)進(jìn)展培訓(xùn)教學(xué)課件

1、介入心臟病學(xué)進(jìn)展 Advances of Cardiovascular Interventions 內(nèi)容可降解血管內(nèi)支架 多聚物全降解藥物洗脫支架 ABSORB BVS 國(guó)內(nèi)研發(fā)的全降解藥物洗脫支架 金屬降解支架結(jié)構(gòu)性心臟病 經(jīng)導(dǎo)管主動(dòng)脈瓣置換術(shù)（TAVR） 經(jīng)導(dǎo)管二尖瓣修復(fù)術(shù) Parachute左心室隔離治療心梗后心衰藥物支架的未來(lái)-全降解藥物洗脫支架藥物洗脫支架（DES）通過(guò)抑制血管內(nèi)膜過(guò)度增生減少再狹窄。但延遲內(nèi)膜愈合，導(dǎo)致慢性炎癥，增加晚期、極晚期支架內(nèi)血栓形成。 支架在完成預(yù)防血管負(fù)性重構(gòu)及釋放抑制血管內(nèi)膜增生的藥物的功能之后（一般認(rèn)為在6個(gè)月以后），其在血管內(nèi)持久存在已無(wú)必要反而有

2、潛在危害，影響正常血管運(yùn)動(dòng)，及日后在相同部位的血管重建（PCI或CABG）并干擾CT、MRI檢查。因此全降解血管內(nèi)支架的研制具有極大吸引力。多聚物降解支架，其中BVS多聚物（PLLA）Everolimus (依羅莫司)降解支架臨床試驗(yàn)取得滿意結(jié)果。我國(guó)自行研制的多聚物降解支架的臨床試驗(yàn)正在進(jìn)行中 Everolimus/PDLLA (1:1) matrix coating7 mConformal coating Controlled drug release similar to Xience CoCr-EES PLLA BackboneSemi-crystallineCircumferenti

3、al sinusoidal rings connected by linear linksStrut thickness 150 mPlatinum markers in each end ringFullyBioresorbableAbsorb BVSDrug ElutionMechanical SupportMass lossOberhauser JP et al. EuroInt 2009;5:F15-2216243RevascularizationRestorationResorptionMonthsPhases of Absorb FunctionalityABSORB Cohort

4、 B 5 Years Follow-upABSORB Cohort B 5 Years Follow-upABSORB Cohort B 5 Years Follow-upABSORB Cohort B 5 Years Follow-upABSORB Cohort B 5 Years Follow-up1Atherosclerosis 2014;237:23e292 Images courtesy of S Windecker, ABSORB Cohort B 5 Yrs Metallic DES1Absorb-Treated Artery2Metallic DES vs. Absorb BV

5、SRepresentative Human images at 5 Years ABSORB II Study Design501 subjects Randomized 2:1 Absorb BVS:XIENCE / 46 sites (Europe and New Zealand)Clinical Follow-Up 24m6m12m36m30dQoL follow-upAngio, IVUS follow-upMSCT follow-up (Absorb arm only) 48m60mStudy ObjectiveRandomized against XIENCE control. F

6、irst Patient In: 28-Nov-2011Co-primary EndpointsVasomotion assessed by change in Mean Lumen Diameter between pre- and post-nitrate at 3 years (superiority)Minimum Lumen Diameter (MLD) at 3 years post nitrate minus MLD post procedure post nitrate (non-inferiority, reflex to superiority)TreatmentUp to

7、 2 de novo lesions in different epicardial vesselsPlanned overlapping allowed in lesions 48 mmDevice SizesDevice diameters: 2.5, 3.0, 3.5 mmDevice lengths: 12 (3.5 mm diameter only), 18, 28 mm Serruys PW, Lancet. 2015;385:43-54.ABSORB II 1-Year Patient FlowchartIntent To TreatN=501 Absorb BVSN=335N=

8、334N=331N=329(98.2%)XienceN=166N=166N=165N=164(98.8%)1 subject consent withdrawn3 subjects consent withdrawn2 subjects consent withdrawn1 subject diedBaseline30-day180-day1-year1 subject consent withdrawnAbsorb 364 LesionsXience 182 Lesions p valueLesion length obstruction mm13.8 6.5 13.8 6.6 1.00To

9、tal device length mm21.1 8.820.9 7.40.74Pre-procedure RVD mm2.59 0.4 2.63 0.4 0.36Post- procedure RVD mm2.64 0.4 2.80 0.3 0.001Pre-procedure MLD mm 1.07 0.3 1.05 0.3 0.44Post-procedure in-device MLD mm2.22 0.3 2.50 0.3 0.001Acute gain in-device mm1.15 0.4 1.46 0.4 0.001Pre-procedure %DS % 59 1160 12

10、 0.30Post-procedure in-device DS % 16 710 5 0.001Post-procedural curvature cm-10.29 0.20.24 0.20.02Angiography Assessment Pre and Post ProcedureSerruys PW, Lancet. 2015;385:43-54. Conformability (Curvature, Angulation) in Absorb BVS and XienceAngulation=78 deg.Curvature= 0.85 cm-1Angulation=69 deg.C

11、urvature= 0.73 cm-1Angulation=122 deg.Curvature= 1.14 cm-1Angulation=61 deg.Curvature= 0.65 cm-1Pre device implantationPost device implantationAbsorbXienceCase:100353-1011 Case:103257-1018Serruys PW, Lancet. 2015;385:43-54.Cumulative incidence in percentageAbsorb 335 pts Xience166 pts p valueComposi

12、te of cardiac death, target vessel MI and clinically indicated target lesion revascularization (TLF, DoCE) 4.8 %3.0 %0.35Cardiac death0 %0 %1.00Target vessel MI4.2 %1.2 %0.07Clinically indicated TLR1.2 %1.8 %0.69All TLR1.2 %1.8 %0.69Composite of all death, all MI and all revascularization (PoCE) 7.3

13、 %9.1 %0.47All death0 %0.6 %0.33All MI4.5 %1.2 %0.06All revascularization3.6 %7.3 % 0.08Clinical OutcomesSerruys PW, Lancet. 2015;385:43-54.Cumulative incidence in percentageAbsorb 335 pts Xience166 pts p valueDefinite scaffold/stent thrombosis Acute (0-1 day) 0.3 (1pt)0.0NS Sub-acute (230 days) 0.3

14、 (1pt)0.0NS Late (31365 days) 0.00.0NSProbable scaffold/stent thrombosis Acute (0-1 day) 0.00.0NS Sub-acute (230 days) 0.00.0NS Late (31365 days) 0.3 (1pt)0.0NSDefinite scaffold/stent thrombosisSerruys PW, Lancet. 2015;385:43-54.6-Month FU Window12-Month FU Window16.4%25.6%BVS Angina EpisodeXIENCE A

15、ngina EpisodeCumulative Angina Rate16.4% vs. 25.6%, p=0.015Time to the First Occurrence of Angina(Worsening or Recurrent) and its Duration according to AE Reporting Cumulative Rate Excluding first 7 days Randomization Absorb:Xience 2:1Serruys PW, TCT 2015Serruys PW, TCT 20152130 d6 mo12 mo24 mo36 mo

16、48 mo60 moClinical follow-up:Prospective, multicenter, single-blind, trial2,000 patients randomized 2:1 Absorb BVS vs. Xience CoCr-EESABSORB III Study DesignNo routine angiographic follow-upEllis SG, NEJM onlineRandomized 2:1N=2008 (ITT)ABSORB N=1322ABSORBN=1312Xience N=67799.2% Complete98.7% Comple

17、teN=4 lost to follow-upN=6 withdrew consentN=6 lost to follow-upN=3 withdrew consentXienceN=68612-month Follow-upStudy Flow and Follow-upEllis SG, NEJM onlineNon-inferiority margin = 4.5%Difference = 1.7% -0.5%, 3.9%PNI = 0.007% Difference (ABSORB - Xience)Primary Endpoint1 Year TLF1-Year TLFABSORB

18、vs. Xience7.8% (102/1313) vs. 6.1% (41/677)Ellis SG, NEJM onlineNo. at Risk:AbsorbTLF (%)Xience Months Post Index Procedure20%100%80%60%40%0%01234567891011121322686125466112306511218643119663413Absorb BVS (n=1322)Xience CoCr-EES (n=686)Diff 95% CI =1.7% -0.5% to 3.9%Psuperiority=0.1620%15%10%5%0%012

19、34567891011137.7%6.0%12Target Lesion FailureEllis SG, NEJM online1-Year TLF ComponentsP=0.16P=0.29P=0.18P=0.50Ellis SG, NEJM onlineAbsorb(N=1322)Xience(N=686)p-valueDevice Thrombosis (def*/prob)1.54%0.74%0.13 - Early (0 to 30 days)1.06%0.73%0.46 - Late ( 30 to 1 year)0.46%0.00%0.10 - Definite* (1 ye

20、ar)1.38%0.74%0.21 - Probable (1 year )0.15%0.00%0.55*One “definite ST” in the Absorb arm by ITT was in a pt that was treated with XienceDevice Thrombosis to 1 YearEllis SG, NEJM onlineABSORB ChinaInclusion: Up to 2 de novo lesions in separate native coronary arteries Lesion length 24 mm, RVD 2.5 mm

21、- 3.75 mm, %DS 50% - 100% Exclusion: AMI, EF 30%, eGFR 30 mL/min/1.73m2, LMCA, ostial lesion, excessive vessel tortuosity, heavy calcification, myocardial bridge, bifurcation with side branch 2 mm Primary Endpoint: In-Segment Late Loss at 1 Yearin the Per-Treatment-Evaluable (PTE) Population*1: 1 Ra

22、ndomizationProspective, randomized, active control, open-label, multicenter study in 480 subjects enrolled from 24 sites in ChinaAbsorb BVSTreat with single study deviceDiameters: 2.5, 3.0. 3.5 mmLengths: 8, 12, 18, 28 mmXIENCE VTreat with single study deviceDiameters: 2.5, 3.0. 3.5 mmLengths: 8, 12

23、, 18, 28 mm* Treated with only the study device (Absorb BVS or XIENCE V), without major pre-specified protocol deviationsGao R, JACC onlinePatient Flow and Follow-up (ITT) Absorb BVS(N=238)Randomized(N=480)Absorb BVS(N=241)XIENCE V(N=239)1-Year Clinical F/U(N=475; 99.0%)Withdrawal = 32 = WithdrawalX

24、IENCE V(N=237)Absorb BVS(N=208)1-Year Angio F/U(N=407; 84.8%)XIENCE V(N=199)ITT = 480 subjects (Absorb BVS: 241 and XIENCE V: 239)PTE = 460 subjects (Absorb BVS: 228 and XIENCE V: 232)Gao R, JACC onlinePrimary Endpoint:In-Segment Late Loss at 1 Year (PTE) Gao R, JACC onlineIn-Segment Late Loss PTE P

25、opulationAbsorb BVS:0.19 0.03 (n=212)XIENCE V: 0.13 0.03 (n=208)PNI = 0.01Summary results are adjusted using generalized estimating equations for cases in which 2 lesions were present in a single patient and presented as least square mean standard error.Cumulative Percent of LesionsITT PopulationAbs

26、orb BVS: 0.18 0.03 (n=221)XIENCE V: 0.13 0.03 (n=213) PNI = 0.01Cumulative Percent of LesionsIn-Segment Late Loss (mm)In-Segment Late Loss (mm) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%-1.5-1-0.500.511.522.533.5 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%-1.5-1-0.500.511.522.533.5Gao R, JACC onlin

27、e1-Year Target Lesion FailureTLF = cardiac death, TV-MI, or ID-TLRTLF (%) 0 1 2 3 4 5 6 7 8 9 10Time After Index Procedure (Days)060120180240300360420HR 95% CI=0.79 0.31,2.00p=0.62 (Log rank test) 3.4% 4.2% = -0.8%Absorb BVSXIENCE VNumber at risk060120180240300365Absorb BVS238235235235234234232XIENC

28、E V237234234233229229226Gao R, JACC onlineOne-Year Scaffold/Stent ThrombosisAbsorb BVS(N=241)XIENCE V(N=239)P-ValueAll (0 - 365 days)0.4% (1/238)0.0% (0/232)1.0 Definite 0.0% (0/238)0.0% (0/232)1.0 Probable 0.4% (1/238)0.0% (0/232)1.0Early (0 30 days)0.4% (1/238) 0.0% (0/236) 1.0Late (31- 365 days)0

29、.0% (0/238)0.0% (0/232) 1.0There was only one ST case reported in the Absorb BVS arm (subacute, probable)Gao R, JACC onlineKimura T, Eur Heart J. 2015 Sep 1. pii: ehv435.Kimura T, Eur Heart J. 2015 Sep 1. pii: ehv435.Kimura T, Eur Heart J. 2015 Sep 1. pii: ehv435.Kimura T, Eur Heart J. 2015 Sep 1. p

30、ii: ehv435.Summary of ABSORB BVS Studies4 ABSORB BVS trials in 3,389 randomized patients demonstrated similar results for BVS and CoCr-EES for the PoCE and the DoCE at 1 year Non-significant trend toward greater device thrombosis at 1 year with BVS compared to CoCr-EES was present (13% vs. 06% respe

31、ctively, RR 209 092, 475, P=008.The outcomes will improve over time with optimized operator technique, experience and device iteration.內(nèi)容可降解血管內(nèi)支架 多聚物全降解藥物洗脫支架 ABSORB BVS 國(guó)內(nèi)研發(fā)的全降解藥物洗脫支架 金屬降解支架結(jié)構(gòu)性心臟病 經(jīng)導(dǎo)管主動(dòng)脈瓣置換術(shù)（TAVR） 經(jīng)導(dǎo)管二尖瓣修復(fù)術(shù) Parachute左心室隔離治療心梗后心衰XINSORB ScaffoldP-DL-LA polymer carrying sirolimusRx.

32、& balloon expandable1. PLLA bioresorbable compositions2. 150 m thickness3. Radial strength similar to BMS4. Sirolimus-eluting5. Available size: 2.75mm, 3.0mm and 3.5mm in diameter; 12mm, 15mm, 18mm, 23mm and 28mm in lengthSirolimusGe JB, TCT 2014FIM EvaluationPost-procedure 30days 90days 180days 270

33、days 365daysClinical FU (N=30)Angiographic FU (N=30)Study objective: Prospective, bi-centers, first-in-human clinical trialPI: Prof. Junbo GEEnd point: Primary point: MACE at 30 days FU and LLL at 180 days FU Secondary point: instantly device / procedure success, in-stent / in-segment restenosis, an

34、d TLRTreatment: Single de novo lesion with %DS50% and 100%, TIMI grade 1. Diameter of lesion 2.75mm 3.0mm Length of lesion must 14mm.Device sizes: Scaffold diameter: 3.0mm Scaffold lengths: 12, 15, 18mmGe JB, TCT 20146-month Angiographic FU (n=27)proximalIn-scaffolddistalDiameter of reference vessel

35、 (mm) After procedure3.040.292.920.292.670.35 6-month follow-up2.830.362.740.342.530.40 P value0.020.040.19Minimal luminal diameter (mm) After procedure2.850.342.620.252.470.38 6-month follow-up2.680.432.440.292.370.45 P value0.110.020.36Acute gain (mm)1.430.43Late luminal loss (mm)0.170.300.180.210

36、.100.32Diameter stenosis (%) After procedure6.85.610.04.27.27.1 6-month follow-up6.45.710.66.67.47.5 P value0.780.700.89In-scaffold LLL = 0.170.12 mmPeri-scaffold LLL = 0.130.24 mmClinical FUMACE = 0 6-month FUNo ARC confirmed/probable STGe JB, TCT 20146-month OCT FU (n=19)1mmExcellent intimal heali

37、ngLuminal area = 6.56 1.12 mm2 Scaffold area = 7.37 1.03 mm2 In-scaffold area obstruction = 11.3 4.2%Neointimal area = 0.83 0.48 mm2Neointimal thickness = 0.22 0.05mmNo stent thrombusGe JB, TCT 201400NeoVasTM- Bioresorbable Sirolimus-Eluting Scaffold Scaffold Material:- Bioresorbable Poly L-Lactic A

38、cid (PLLA) Coating Carrier:- Bioresorbable Poly Lactic Acid (PDLLA) Sirolimus:- 15.3g/mmRadiopaque Markers:- Platinum Han YL, Late Breaking Trial at CIT 2015Clinical Follow-up6 months9 months1 year30 days2 years3 years4 years5 yearsBaselineStudy DesignProspective, Two-Center, First-in-Man Study30 Su

39、bjectsObjectiveTo investigate the feasibility, preliminary safety and efficacy of the novel bioresorbable scaffold NeoVasTM in patients with de novo coronary artery diseasePrimary EndpointTLF (composite of cardiac death, TV-MI, iTLR) at 30 daysSecondary EndpointsLate lumen loss, minimal lumen diamet

40、er, diameter stenosis, binary restenosis by angiographic F/UMinimal/ mean vessel area, lumen area and scaffold area by IVUS assessmentIncomplete scaffold apposition, proportion of covered struts and thickness of struts coverage by OCT assessmentMSCT F/UAngio, IVUS, OCT F/UAngio, IVUS, OCT F/UAngio,

41、IVUS, OCT F/UMSCT F/UAngio, IVUS, OCT F/ULate Lumen LossPatrick W. Serruys, et al. Evaluation of the Second Generation of a Bioresorbable Everolimus Drug-Eluting Vascular Scaffold for Treatment of De Novo Coronary Artery Stenosis. Circulation. 2010, 122: 2301-2312. John A Ormiston, et al. A bioabsor

42、bable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008, 371:899-907.Han YL, Late Breaking Trial at CIT 201530 Days6 MonthsITT, n=31PPS, n=30ITT, n=31PPS, n=30All-Cause Death, % (n)0 (0)0 (0)0 (0)0

43、 (0) Cardiac Death, % (n)0 (0)0 (0)0 (0)0 (0) Non-Cardiac Death, % (n)0 (0)0 (0)0 (0)0 (0)Myocardial Infarction, % (n)0 (0)0 (0)0 (0)0 (0) Target Vessel MI, % (n)0 (0)0 (0)0 (0)0 (0)Any Revascularization, % (n)0 (0)0 (0)3.2 (1) 0 (0) TVR (non-TL) , % (n)0 (0)0 (0)0 (0) 0 (0) TLR, % (n)0 (0)0 (0)3.2

44、(1) 0 (0) Ischemia-Driven TLR, % (n)0 (0)0 (0)3.2 (1) 0 (0)TLF, % (n)0 (0)0 (0)3.2 (1) 0 (0)PoCE, % (n)0 (0)0 (0)3.2 (1) 0 (0)Def/Prob Stent Thrombosis, % (n)0 (0)0 (0)0 (0)0 (0)Clinical Outcomes Han YL, Late Breaking Trial at CIT 2015Firesorb ( MicroPort)Second generation of BRS 100-120 m thickness

45、LCX lesionScaffold positioningBaseline and ImplantationFinal ResultFinal ResultFinal ResultEvidence of Degradation6 month f/uEvidence of Degradation內(nèi)容可降解血管內(nèi)支架 多聚物全降解藥物洗脫支架 ABSORB BVS 國(guó)內(nèi)研發(fā)的全降解藥物洗脫支架 金屬降解支架結(jié)構(gòu)性心臟病 經(jīng)導(dǎo)管主動(dòng)脈瓣置換術(shù)（TAVR） 經(jīng)導(dǎo)管二尖瓣修復(fù)術(shù) Parachute左心室隔離治療心梗后心衰HaodeHaude M, Lancet onlineHaude M, Lance

46、t onlineHaude M, Lancet onlineM. Peuster et al. / Biomaterials 27 (2006) 49554962M. Peuster et al. / Heart 2001;86:56356928d12months18monthsWaksman R, J Interven Cardiol 2008;21:1520)Pure iron is corrodible with good biocompatibility but corrosion is too slow !Gao R, Zhang D, TCT 2013Pure Iron Stent

47、Nitrided Iron Bioabsorbable StentStentGlow discharge NitridingDispersive Fe4N Galvanic CorrosionPrecipitation StrengtheningIncreased mechanical strength ( Co-Cr)Decreased strut thickness(70 5m)Faster corrosionFe-N( 200,000 transcatheter aortic valves will have been implantedaround the world!Leon M,

48、TVT 2015Leon M, TVT 2015Leon M, TVT 2015Leon M, TVT 2015Leon M, TVT 2015Leon M, TVT 2015Leon M, TVT 2015Leon M, TVT 2015Leon M, TVT 2015Leon M, TVT 2015Study Disposition of CoreValve US Clinical TrialCoreValve US clinical trial ACC 2014Baseline Demographics85CoreValve US clinical trial ACC 201419.1%

49、4.5%Surgical14.2%P = 0.04 for superiority3.3%TranscatheterPrimary Endpoint: 1 Year All-cause MortalityACC 201486All Stroke871 Year MACCE88Valve TechnologySAPIENSAPIEN XTSAPIEN 3Sheath CompatibilityAvailable Valve Sizes 23 mm26 mm 20 mm23 mm26 mm29 mmSAPIEN Platforms in PARTNERDevice Evolution22-24F1

50、6-20F14-16F23 mm26 mm29 mm. Thourani VH, ACC 2016The PARTNER 2A and S3i TrialsStudy DesignIntermediate Risk Symptomatic Severe Aortic StenosisIntermediate Risk ASSESSMENT by Heart Valve TeamP2 S3in = 1078ASSESSMENT: Optimal Valve Delivery Access TA/TAo TAVRSAPIEN 3Transapical /Transaortic (TA/TAo)TF

51、 TAVRSAPIEN 3Transfemoral (TF)P2An = 2032ASSESSMENT: Transfemoral AccessTransapical / TransAortic (TA/TAo)Transfemoral (TF)1:1 Randomization1:1 RandomizationYesNoTF TAVR SAPIEN XTSurgical AVRSurgical AVR VS VSTA/Tao TAVRSAPIEN 3. Thourani VH, ACC 2016The PARTNER 2A and S3i TrialsStudy DesignIntermed

52、iate Risk Symptomatic Severe Aortic StenosisIntermediate Risk ASSESSMENT by Heart Valve TeamTF TAVRSAPIEN 3TA/TAo TAVRSAPIEN 3P2 S3in = 1078ASSESSMENT: Optimal Valve Delivery Access Transapical /Transaortic (TA/TAo)Transfemoral (TF)Surgical AVRSurgical AVRP2An = 2032ASSESSMENT: Transfemoral AccessTr

53、ansapical / TransAortic (TA/TAo)Transfemoral (TF)1:1 Randomization1:1 RandomizationYesNoTF TAVR SAPIEN XT VS VSTA/Tao TAVRSAPIEN 3Primary Endpoint: All-Cause Mortality, All Stroke, or Mod/Sev AR at One Year (Non-inferiority Propensity Score Analysis) Severe AS: Echo-derived AVA 0.8 cm2 (or AVA index

54、 40 mmHg or peak jet velocity 4.0 m/s Cardiac Symptoms: NYHA Functional Class IIIntermediate Risk: Determined by a multi-disciplinary Heart Team Using a guideline STS between 4-8%*, and Adjudicated by case review committee The PARTNER 2A and S3i TrialsInclusion Criteria* PARTNER 2A used guideline ST

55、S 4%. Thourani VH, ACC 2016Time-to-Event Curves for the Primary Composite End Point (Partner2)Leon B, NEJM 2016 2016;Apr 2:Epub ahead of print.Subgroup Analyses of Death from Any Cause or Disabling Stroke (Partner2) Leon B, NEJM 2016 2016;Apr 2:Epub ahead of print.Clinical End Points at 30 Days, 1 Y

56、ear, and 2 Years (Partner2) Leon B, NEJM 2016 2016;Apr 2:Epub ahead of print.The PARTNER 2A and S3i TrialsStudy DesignIntermediate Risk Symptomatic Severe Aortic StenosisIntermediate Risk ASSESSMENT by Heart Valve TeamTF TAVRSAPIEN 3TA/TAo TAVRSAPIEN 3P2 S3in = 1078ASSESSMENT: Optimal Valve Delivery

57、 Access Transapical /Transaortic (TA/TAo)Transfemoral (TF)Surgical AVRSurgical AVRP2An = 2032ASSESSMENT: Transfemoral AccessTransapical / TransAortic (TA/TAo)Transfemoral (TF)1:1 Randomization1:1 RandomizationYesNoTF TAVR SAPIEN XT VS VSTA/Tao TAVRSAPIEN 3Primary Endpoint: All-Cause Mortality, All S

58、troke, or Mod/Sev AR at One Year (Non-inferiority Propensity Score Analysis)Non-hierarchical composite of all-cause mortality, all stroke, or moderate aortic regurgitation at one yearPropensity score analysis of the valve implant (VI) populations from S3i compared to the surgical arm of the PARTNER

59、2A trialAll patients followed for at least 1 yearEvent rates by Kaplan-Meier estimatesNon-inferiority trial design followed by superiority testing for the primary endpoint and components The PARTNER 2A and S3i TrialsPrimary EndpointCharacteristicTAVR(n = 1077)Surgery(n = 944)p-valueAge - yrs81.9 6.6

60、81.6 6.80.23Male - %61.755.00.002BMI - kg/m228.7 6.128.4 6.20.32Median STS Score - % 5.2 4.3, 6.35.4 4.4, 6.70.0002NYHA Class III or IV - %72.576.10.07Baseline Patient CharacteristicsDemographics (AT)mean SD, median IQR. Thourani VH, ACC 2016Characteristic (%)TAVR(n = 1077)Surgery(n = 944)p-valueCAD