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 honoraria or consultation fees: Abbott, Boston Scientific, Edwards Lifesciences, Medtronic

PARTNER 3 TRIAL

PARTNER 3 TRIAL Objective: to compare TAVR with SAVR in patients with AS at low risk for death with surgery Mack M.J. et al , NEJM 2019

PARTNER 3 TRIAL 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, stroke or rehospitalization at 1 year Mack M.J. et al , NEJM 2019

PARTNER 3 TRIAL 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 Mack M.J. et al , NEJM 2019

PARTNER 3 TRIAL AT TAVR AT SAVR n= 496 n= 454 Mean age 73 y Mean STS Score 1,9 % Concomitant coronary revascularization 6,5 % 12,8 % 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 TAVR resulted in a lower rate of stroke than surgery 0,6 % vs 2,4 % p=0,02 TAVR resulted in a lower risk of poor treatment outcome (death or a low KCCQ score) 3,9 % vs 30,6 % p<0,001 No significant difference of 30-d PPM 6,5 % vs 4,0 % p=0,09 Mack M.J. et al , NEJM 2019

PARTNER 3 TRIAL Echocardiographic findings (30 days) AT TAVR AT SAVR n= 496 n= 454 Mean AVA / Mean AV gradient 1,7 cm2 / 12,8 mmHg P < 0,05 1,8 cm2 / 11,2 mmHg Moderate / Severe PAR 0,8 % 0 % Mack M.J. et al , NEJM 2019

EVOLUT LOW RISK TRIAL

EVOLUT LOW RISK TRIAL Objective: to compare TAVR with SAVR in patients with AS at low risk for death with surgery Popma J. et al , NEJM 2019

EVOLUT LOW RISK TRIAL 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

EVOLUT LOW RISK TRIAL 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) Popma J. et al , NEJM 2019

EVOLUT LOW RISK TRIAL AT TAVR AT SAVR n= 725 n= 678 Mean age 74 y Mean STS Score 1,9 % Ev R 74,1 %, Ev Pro 22,3 % 99 % TF access Popma J. et al , NEJM 2019

EVOLUT LOW RISK TRIAL TAVR with SEV non inferior to SAVR with regard to the primary outcome Popma J. et al , NEJM 2019

EVOLUT LOW RISK TRIAL 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

EVOLUT Low Risk Trial Popma J. et al , NEJM 2019

EVOLUT Low Risk Trial Echocardiographic findings AT TAVR AT SAVR n= 725 n= 678 Moderate / Severe PAR (30 days) 3,5 % 0,5 % Severe Patient Prosthesis Mismatch 1,2 % 8,2 % 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 ? 1,1 % PARTNER 3 1,3 % Evolut Low Risk Hamm CW et al ,Eur Heart J 2013

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 2022 ESC VHD updated guidelines 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 A requiring revascularization, the Heart Team should favor TAVI by transfemoral access

BACK UP SLIDES

Low Risk TAVI Trial meta-analysis 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 Kolte D.. et al , JACC 2019