les incontournables de 2019 the low-risk tavi ......mack m.j. et al , nejm 2019. tavr resulted in a...

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