Download presentation
Presentation is loading. Please wait.
1
Late breaking news in heart valve disease
C. Bouleti
5
Primary endpoint Device success (VARC definition)
Successful vascular access, delivery and deployment of the device Correct position of the device Aortic valve area > 1.2 cm2, mean aortic gradient < 20 mmHG or V max < 3 m/s, AR<3 Only 1 valve implanted in the proper anatomical location
10
Baseline patient characteristics
12
Baseline TTE
13
Procedural factors: valve size
14
Procedural details
15
Immediate results: AR
16
Primary endpoint: device success
18
Clinical outcome at 30 days
19
Clinical outcome at 30 days
21
JAMA
23
CoreValve US Pivotal Trial High Risk Results
24
CoreValve US Pivotal Trial
Primary Endpoint: All-cause mortality at 1 year 24 (Adams et al. N Engl J Med online March 29)
25
Study Device and Access Routes
4 valve sizes (18-29 mm annular range) Transfemoral Subclavian Direct Aortic 18Fr delivery system 25 25 25 25
26
Primary Endpoint: All-cause mortality at 1 year
Non-inferiority Testing: TAVR with the CoreValve prosthesis was non-inferior to SAVR for 1 year all-cause mortality with a 7.5% non-inferiority margin Superiority Testing: If the primary endpoint was met at the one-sided 0.05 level, a subsequent test for superiority was performed at the one-sided 0.05 level 26
27
Hierarchical Testing of Secondary Endpoints
Δ mean gradient baseline to 1 year (non-inferior) Δ effective orifice area baseline to 1 year (non-inferior) Δ NYHA class baseline to 1 year (non-inferior) Δ KCCQ baseline to 1 year (non-inferior) Difference in MACCE* rate at hospital discharge or 30 days, whichever is later (superiority) Δ SF-12 baseline to 30 days (inequality) * Major adverse cardiovascular and cerebrovascular events, defined as a composite of all-cause mortality, myocardial infarction, all stroke, or aortic-valve reintervention 27
28
Participating Sites 28
29
Inclusion Criteria NYHA functional class II or greater
Severe aortic stenosis: AVA ≤ 0.8 cm2 or AVAI ≤ 0.5 cm2/m2 AND mean gradient > 40 mm Hg or peak velocity > 4 m/sec at rest or with dobutamine stress echocardiogram Risk of death at 30 days after surgery was ≥ 15% and the risk of death or irreversible complications within 30 days was < 50% Surgical risk assessment included consideration of STS Predicted Risk of Mortality estimate and other risk factors not captured in the STS risk model 29
30
Exclusion Criteria Recent active GI bleed (< 3 mos), stroke (< 6 mos), or MI (≤ 30 days) Any interventional procedure with bare metal stents (< 30 days) and drug eluting stents (< 6 months) Creatinine clearance < 20 mL/min Significant untreated coronary artery disease LVEF < 20% Life expectancy < 1 year due to co-morbidities 30
31
Study Disposition
32
Baseline Demographics
32
33
Baseline Demographics
33
34
Primary Endpoint: 1 Year All-cause Mortality
ACC 2014 19.1% 4.5% Surgical 14.2% P = 0.04 for superiority 3.3% Transcatheter 34
35
All Stroke 35
36
Hierarchical Testing of Secondary Endpoints
Δ mean gradient baseline to 1 year (non-inferior; P<0.001) Δ effective orifice area baseline to 1 year (non-inferior; P<0.001) Δ NYHA class baseline to 1 year (non-inferior; P<0.001) Δ KCCQ baseline to 1 year (non-inferior; P=0.006) Difference in MACCE rate at hospital discharge or 30 days, whichever is later (superiority; P=0.103) Δ SF-12 baseline to 30 days (inequality; nominal P<0.001) 36
37
1 Year MACCE 37
38
Other Endpoints 38
39
NYHA Class Survivors 39
40
Paravalvular Regurgitation
40
41
Subgroup Analysis for 1 Year Mortality
41
42
Subgroup Analysis for 1 Year Mortality
42
43
Conclusion We assessed the safety and effectiveness of TAVR with the CoreValve prosthesis compared to surgical valve replacement in symptomatic patients with severe aortic stenosis at increased surgical risk One-year survival was superior in patients that underwent transcatheter replacement with CoreValve as compared with surgical AVR 43
44
DONC… Si SAPIEN XT > COREVALVE (CHOICE)
ET QUE COREVALVE > CHIRURGIE (COREVALVE US PIVOTAL TRIAL) ALORS ….
45
DONC… …. SAPIEN > CHIRURGIE
46
DONC… ... SAPIEN > CHIRURGIE
47
All Cause Mortality in PARTNER A TAVI vs AVR
The primary analysis reveals no difference in mortality between TAVR and AVR with a hazard ratio of The two year KM estimates of mortality are 35% for AVR and 33.9% for TAVR. (Kodali et al. NEJM 2012;366: ) Months 47
48
PARTNER-A: population
Mêmes critères d’inclusion (surface Ao, NYHA≥ 2, mortalité estimée à 30 jours >15%) Mais STS 12% versus 7% ES logistic 29% versus 18% pop à plus haut risque dans PARTNER
49
PARTNER-A: procedure Voie d’abord: 30% de transapical Valve ancienne génération (Sapien)
50
PARTNER-A: stroke Recueil retrospectif des stroke Vs Prospectif pour CoreValve trial Plus de stroke retrouvés (TAVI 6% et chir 3% dans PARTNER Vs 9% et 13% dans CoreValve Trial ) “When you look harder you find more”
51
Conclusion La place importante du TAVI est confirmée par des études randomisées avec niveaux de preuve élevés En passe de donner de meilleurs résultats que la chirurgie ? Interprétation des études doit être prudente et attention aux comparaisons
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.