LES INCONTOURNABLES DE 2019 THE LOW-RISK TAVI TRIALS: PARTNER 3, - - PowerPoint PPT Presentation
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
Nicolas Dumonteil
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
Mack M.J. et al , NEJM 2019
Objective: to compare TAVR with SAVR in patients with AS at low risk for death with surgery
Mack M.J. et al , NEJM 2019
Hypothesis: Non-inferiority (pre specified margin of 6%) and superiority testing
performed in the as-treated population ? Composite outcome of death, stroke or rehospitalization at 1 year
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
AT TAVR n= 496 AT SAVR n= 454 Mean STS Score 1,9 % Mean age 73 y 6,5 % 12,8 % Concomitant coronary revascularization
Mack M.J. et al , NEJM 2019
TF TAVR with S3 superior to SAVR with regard to the primary outcome
Mack M.J. et al , NEJM 2019
Key secondary endpoints at 30 days
Mack M.J. et al , NEJM 2019
TAVR resulted in a lower rate of stroke than surgery
0,6 % vs 2,4 % p=0,02
No significant difference of 30-d PPM
6,5 % 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
Echocardiographic findings (30 days)
Mack M.J. et al , NEJM 2019
AT TAVR n= 496 AT SAVR n= 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
Popma J. et al , NEJM 2019
Objective: to compare TAVR with SAVR in patients with AS at low risk for death with surgery
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
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 TAVR n= 725 AT SAVR n= 678 Mean STS Score 1,9 % Mean age 74 y
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
Popma J. et al , NEJM 2019
Key secondary endpoints
TAVR resulted in a lower rate of disabling stroke than surgery
0,6 % 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 use
17,4 % vs 6,1 % at 30 days p <0,001
Popma J. et al , NEJM 2019
Popma J. et al , NEJM 2019
Echocardiographic findings
AT TAVR n= 725 AT SAVR n= 678
3,5 % 0,5 % Moderate / Severe PAR (30 days) 1,2 % 8,2 % Severe Patient Prosthesis Mismatch
Popma J. et al , NEJM 2019
Were surgical outcomes of poor quality ?
Hamm CW et al ,Eur Heart J 2013
1,1 % PARTNER 3 1,3 % Evolut Low Risk
Can I extrapolate those results to all-comers ? Bicuspid Aortic Valves (BAV) excluded from low risk TAVI trials
Can I extrapolate those results to all-comers ? Complex coronary artery disease excluded from 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
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 ?
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
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
A
Kolte D.. et al , JACC 2019
All cause death at 1 year after TAVR and SAVR 2.1% vs. 3.5%
RR: 0.61; 95% CI: 0.39 to 0.96; p= 0.03