les incontournables de 2019 the low-risk tavi ......mack m.j. et al , nejm 2019. tavr resulted in a...
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LES INCONTOURNABLES DE 2019
THE LOW-RISK TAVI TRIALS: PARTNER 3, EVOLUT
Nicolas Dumonteil
POTENTIAL CONFLICTS OF INTEREST
Speaker's name : Nicolas Dumonteil
☑ I have the following potential conflicts of interest to declare:
Receipt of honoraria or consultation fees: Abbott, Boston Scientific, Edwards Lifesciences, Medtronic
PARTNER 3 TRIAL
PARTNER 3 TRIAL
Mack M.J. et al , NEJM 2019
Objective:
to compare TAVR with SAVR
in patients with AS
at low risk for death with surgery
PARTNER 3 TRIAL
Mack M.J. et al , NEJM 2019
Hypothesis:
Non-inferiority (pre specified margin of 6%) and superiority testingof TAVR vs SAVR
performed in the as-treated population ?
Composite outcome of death, stroke or rehospitalization at 1 year
PARTNER 3 TRIAL
Mack M.J. et al , NEJM 2019
Methods:
low risk : heart team agreement, STS score < 4 %
randomized 1:1 to TF TAVR (SAPIEN 3) vs SAVR (bioprosthesis)
concomitant coronary revascularization possible
systematic neurological assessment at baseline and 30 days
PARTNER 3 TRIAL
AT TAVRn= 496
AT SAVRn= 454
Mean STS Score 1,9 %
Mean age 73 y
6,5 % 12,8 %
Concomitant coronary revascularization
Mack M.J. et al , NEJM 2019
PARTNER 3 TRIAL
TF TAVR with S3 superior to SAVR with regard to the primary outcome
Mack M.J. et al , NEJM 2019
PARTNER 3 TRIAL
Key secondary endpoints at 30 days
Mack M.J. et al , NEJM 2019
TAVR resulted in a lower rate of stroke than surgery0,6 % vs 2,4 % p=0,02
No significant difference of 30-d PPM6,5 % vs 4,0 % p=0,09
TAVR resulted in a lower risk of poor treatment outcome (death or a low KCCQ score)
3,9 % vs 30,6 % p<0,001
PARTNER 3 TRIAL
Echocardiographic findings (30 days)
Mack M.J. et al , NEJM 2019
AT TAVRn= 496
AT SAVRn= 454
0,8 % 0 %
Moderate / Severe PAR
1,7 cm2 / 12,8 mmHg 1,8 cm2 / 11,2 mmHg
Mean AVA / Mean AV gradient
P < 0,05
EVOLUT LOW RISK TRIAL
EVOLUT LOW RISK TRIAL
Popma J. et al , NEJM 2019
Objective:
to compare TAVR with SAVR
in patients with AS
at low risk for death with surgery
EVOLUT LOW RISK TRIAL
Popma J. et al , NEJM 2019
Hypothesis:
Non-inferiority (pre specified margin of 6%) and superiority testing of TAVR vs SAVR
performed in the as- treated population ?
Composite outcome of death or disabling stroke at 24 months
EVOLUT LOW RISK TRIAL
Popma J. et al , NEJM 2019
Methods:
low risk : heart team agreement, STS score < 3 %
randomized 1:1 to TAVR (CV, Ev R, Ev Pro) vs SAVR (bioprosthesis)
concomitant coronary revascularization possible
systematic neurological assessment at baseline and 30 days
Bayesian statistical methods (analysis when 850 patients reached 12-month follow-up)
AT TAVRn= 725
AT SAVRn= 678
Mean STS Score 1,9 %
Mean age 74 y
EVOLUT LOW RISK TRIAL
Popma J. et al , NEJM 2019
Ev R 74,1 %, Ev Pro 22,3 %
99 % TF access
TAVR with SEV non inferior to SAVR with regard to the primary outcome
EVOLUT LOW RISK TRIAL
Popma J. et al , NEJM 2019
Key secondary endpoints
TAVR resulted in a lower rate of disabling stroke than surgery0,6 % vs 2,4 % p=0,02
TAVR resulted in a lower rates of AKI, bleeding events and AF than surgery
TAVR resulted higher incidence of PPM use17,4 % vs 6,1 % at 30 days p <0,001
EVOLUT LOW RISK TRIAL
Popma J. et al , NEJM 2019
EVOLUT Low Risk Trial
Popma J. et al , NEJM 2019
Echocardiographic findings
AT TAVRn= 725
AT SAVRn= 678
3,5 % 0,5 %
Moderate / Severe PAR (30 days)
1,2 % 8,2 %
Severe Patient Prosthesis Mismatch
EVOLUT Low Risk Trial
Popma J. et al , NEJM 2019
LOW RISK TAVI TRIALS
How do this apply to my everyday practice ?
LOW RISK TAVI TRIALS
Were surgical outcomes of poor quality ?
Hamm CW et al ,Eur Heart J 2013
1,1 % PARTNER 3
1,3 % Evolut Low Risk
LOW RISK TAVI TRIALS
Can I extrapolate those results to all-comers ?
Bicuspid Aortic Valves (BAV) excluded from low risk TAVI trials
LOW RISK TAVI TRIALS
Can I extrapolate those results to all-comers ?
Complex coronary artery disease excluded from low risk TAVI trials
LOW RISK TAVI TRIALS
Can I extrapolate those results to all-comers ?
Only favorable anatomies for safe TF TAVI included in low risk TAVI trials
LOW RISK TAVI TRIALS
Distinguish low surgical risk from life expectancy
Mean age in low risk TAVI trials : 74 years
If patients with longer life-expectancy treated by TAVI, what about :
Long term durability ?
Long term impact of PM, of mild PAR ?
Impact of THV on coronary artery disease management ?
Management of failed bioprostheses ?
CONCLUSION
TAVI low risk trials provide new evidences to expand this therapy to low risk patients,
from 74 years of mean age and beyond,
with selected anatomy highly favorable for a TF TAVI procedure
with a S3 or Evolut valve
CONCLUSION
In patients suffering from severe AS, from 70 years of age, with favorable anatomical
conditions shown by CT scan evaluation, and non complex coronary artery disease
requiring revascularization, the Heart Team should favor TAVI by transfemoral access
2022 ESC VHD updated guidelines
A
BACK UP SLIDES
Low Risk TAVI Trial meta-analysis
Kolte D.. et al , JACC 2019
All cause death at 1 year after TAVR and SAVR2.1% vs. 3.5%RR: 0.61; 95% CI: 0.39 to 0.96; p= 0.03