Nicolas M Van Mieghem MD PhD For the SURTAVI Trial Investigators 0 Disclosure Statement of Financial Interests Within the past 12 months I have had a financial interestarrangement or affiliation with the organizations list below ID: 932289
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Slide1
5-Year Clinical and Echocardiographic Outcomes from the Randomized SURTAVI Trial
Nicolas M. Van Mieghem, MD, PhDFor the SURTAVI Trial Investigators
0
Slide2Disclosure Statement of Financial Interests
Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) list below
1
Financial Relationship
Company
Research grants
Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Daiichi Sankyo, Abiomed, PulseCath BV, Pie MedicalMedtronic personnel performed all statistical analyses and assisted with the graphical display of the data presented
Faculty disclosure information can be found on the app
Slide3Background
Early randomized TAVR trials enrolled patients at high operative risk with reserved long-term prognosis.1,2TAVR with balloon-expandable valves in intermediate-risk patients at 5 years was associated with higher rates of readmission and similar hemodynamics compared to surgery.3
Limited long-term data exists comparing surgery with self-expanding supra-annular TAVR
2
1
Gleason TGG, et al. J Am Coll Cardiol 2018; 72: 2687-96; 2Mack MJ et al. Lancet 2015;385:2477-84; 3Makkar R. et al, N Engl J Med 2020; 82: 799-809.
Slide4SURTAVI Trial Design
Intermediate Surgical Risk Risk of Operative Mortality ≥3% to <15%
TAVR
Surgery
TAVR + PCI
Surgery + CABG
TAVR onlySurgery only
Heart Team Evaluation
Screening Committee Confirmed Eligibility
Baseline Neurological Assessments
Randomization
Stratified by Need for Revascularization
Slide5CoreValve
Bioprosthesis
(84%)
23-, 26-, 29-, 31 mm
Evolut
R Valve (16%)23-, 26-, 29 mmStudy ValvesVascular access93.6% Iliofemoral2.3% Subclavian4.1% Direct aortic
Slide6Study Methods
Central screening committee confirmed patient eligibilityClinical events committee adjudicated serious adverse events per VARC-21 Core laboratory assessed echocardiographic outcomes at baseline, discharge, 1, 2 and 5 yearsStatistical MethodsPrimary analysis on modified intention to treat (MITT) cohort defined as undergoing an attempted implant of the assigned therapyAdverse events reported as Kaplan-Meier estimates and compared with log-rank test Post-hoc landmark analysis of key outcomes between 2 and 5 years
5
1
Kappetein AP, et al. Eur Heart J 2012; 33: 2403-18.
Slide7Study Flow
Randomized
N= 1746
TAVR
N=879
SAVR
N=8675 YearsDead = 250Lost to follow-up = 14
Withdrawal = 78
Follow-up 93.7%
5 Years
Dead = 206
Lost to follow-up = 21
Withdrawal = 194
Follow-up 95.5%
TAVR MITT cohort
N=864
Surgery MITT cohort
N=796
Slide8Key Clinical Outcomes
All-cause mortality or disabling strokeValve durabilityCore-laboratory-assessed echocardiographyEffective orifice areaMean gradientValve regurgitationEndocarditisThrombosisValve-related reinterventions and rehospitalizations
Quality of life
Kansas City Cardiomyopathy Questionnaire
New York Heart Association class
Slide9Baseline Characteristics
Mean ± SD or no. (%)
TAVR
N=864
Surgery
N=796Age, years
79.9 ± 6.279.7 ± 6.1Female42.445.0STS-PROM, %
4.4 ± 1.5
4.5 ± 1.6
NYHA Class III,IV
60.2
58.2
Prior CABG
15.7
17.2
Prior PCI
21.3
21.2
Cerebrovascular disease
17.5
16.3
Peripheral vascular disease
30.8
29.9
Diabetes mellitus
34.3
34.8
Chronic lung disease/COPD
35.4
33.5
Pre-existing pacemaker
10.1
9.9
Prior atrial fibrillation/flutter
28.1
26.5
Falls in past 6 months
11.8
12.7
5-Meter gait speed > 6 seconds
51.8
52.9
8
Slide10Baseline Characteristics
Mean ± SD or no. (%)
TAVR
N=864
Surgery
N=796Age, years
79.9 ± 6.279.7 ± 6.1Female42.445.0STS-PROM, %
4.4 ± 1.5
4.5 ± 1.6
NYHA Class III,IV
60.2
58.2
Prior CABG
15.7
17.2
Prior PCI
21.3
21.2
Cerebrovascular disease
17.5
16.3
Peripheral vascular disease
30.8
29.9
Diabetes mellitus
34.3
34.8
Chronic lung disease/COPD
35.4
33.5
Pre-existing pacemaker
10.1
9.9
Prior atrial fibrillation/flutter
28.1
26.5
Falls in past 6 months
11.8
12.7
5-Meter gait speed > 6 seconds
51.8
52.9
9
Slide11All-Cause Mortality or Disabling Stroke
All-Cause Mortality or
Disabling Stroke
TAVR
864
783
722
664
608
426
Surgery
796
696
626
573
506
338
No. at risk
Years Post Procedure
0
1
2
3
4
5
Hazard ratio, 1.02 (95% CI, 0.85 – 1.22), p = 0.85
31.3
30.8
Slide122-Year Landmark Analysis
Years Post Procedure
12.7
12.7
Log-rank p = 0.96
20.7
Log-rank p = 0.77
0
1
2
3
4
5
21.3
All-Cause Mortality or
Disabling Stroke
Slide13All-Cause Mortality
TAVR
864
783
722
664
608
426
Surgery
796
696
626
573
506
338
No. at risk
Years Post Procedure
0
1
2
3
4
5
Hazard ratio, 1.02 (95% CI, 0.85 – 1.22), p = 0.85
31.3
30.8
All-Cause Mortality
Slide14Disabling Stroke
TAVR
864
783
722
664
608
426
Surgery
796
696
626
573
506
338
No. at risk
Years Post Procedure
5.8
4.1
Disabling Stroke
Hazard ratio, 0.69 (95% CI, 0.43 – 1.10), p = 0.12
0
1
2
3
4
5
Slide1514
*Including baseline.
Clinical Outcomes
KM Rates to 2 Years
KM Rates to 5 Years
KM Rates from 2 to 5 Years
KM rates as %TAVRSurgery
p Value
TAVR
Surgery
p Value
TAVR
Surgery
p Value
Death
11.5
10.5
0.53
30.0
28.7
0.55
20.9
20.3
0.79
Cardiovascular death
7.8
17.1
0.66
17.8
17.4
0.84
10.9
11.1
0.89
Reintervention
2.5
0.5
0.002
3.5
1.9
0.02
1.0
1.3
0.60
Any stroke
6.0
8.5
0.05
11.6
13.6
0.16
6.0
5.5
0.76
MI
2.7
2.1
0.51
6.24.70.233.72.60.30Valve endocarditis0.40.80.251.01.8
0.15
0.6
1.0
0.39
Valve thrombosis
0.4
0.0
0.10
0.5
0.4
0.51
0.2
0.4
047
AV or HF hospitalization
12.8
9.5
0.06
23.9
20.8
0.13
12.7
12.5
0.89
Pacemaker*
30.9
9.8
<0.001
35.8
14.6
<0.001
7.1
5.3
0.27
Slide1615
*Including baseline.
Clinical Outcomes
KM Rates to 2 Years
KM Rates to 5 Years
KM Rates from 2 to 5 Years
KM rates as %TAVRSurgery
p Value
TAVR
Surgery
p Value
TAVR
Surgery
p Value
Death
11.5
10.5
0.53
30.0
28.7
0.55
20.9
20.3
0.79
Cardiovascular death
7.8
17.1
0.66
17.8
17.4
0.84
10.9
11.1
0.89
Reintervention
2.5
0.5
0.002
3.5
1.9
0.02
1.0
1.3
0.60
Any stroke
6.0
8.5
0.05
11.6
13.6
0.16
6.0
5.5
0.76
MI
2.7
2.1
0.51
6.24.70.233.72.60.30Valve endocarditis0.40.80.251.01.8
0.15
0.6
1.0
0.39
Valve thrombosis
0.4
0.0
0.10
0.5
0.4
0.51
0.2
0.4
047
AV or HF hospitalization
12.8
9.5
0.06
23.9
20.8
0.13
12.7
12.5
0.89
Pacemaker*
30.9
9.8
<0.001
35.8
14.6
<0.001
7.1
5.3
0.27
Slide172-Year Landmark Reinterventions
0.5
2.5
1.3
1.0
Log-rank p = 0.002
AV ReinterventionsLog-rank p = 0.60 0
1
2
3
4
5
Years Post Procedure
Slide182-Year Landmark Rehospitalizations
0
1
2
3
4
5
9.5
12.8
12.5
12.7
Log-rank p = 0.06
Log-rank p = 0.89
AV or HF Rehospitalization
Years Post Procedure
Slide19TAVR AVG
856
832
709
651
365
Surgery AVG788725
599
539
306
TAVR EOA
790
765
651
568
320
Surgery EOA
728
547
541
476
257
Time Since Procedure
Core Lab-Assessed Hemodynamics
Effective Orifice Area, cm
2
Mean Gradient, mm Hg
TAVR had significantly better hemodynamics than surgery at each follow-up (all p < 0.001)
Slide20Core Lab-Assessed Valve Regurgitation
Total Aortic Regurgitation
Proportion of Patients
Paravalvular Leak
Surgery had significantly less ≥ mild AR or PVL than TAVR at each follow-up (all p < 0.001)
Slide21Kansas City Cardiomyopathy Questionnaire
Time Since Procedure
KCCQ Overall Summary Score
Change from Baseline
TAVR
18.4 ± 22.8
20.6 ± 22.3
18.9 ± 21.1
17.2 ± 22.6
16.1 ± 24.8
15.3 ± 24.9
Surgery
5.9 ± 27.0
20.5 ± 22.2
18.6 ± 22.9
17.7 ± 22.1
16.1 ± 23.4
14.3 ± 24.2
p Value
< 0.001
0.883
0.869
0.716
0.976
0.579
Slide22New York Heart Association Class
Slide23SummaryAt 5 years following self-expanding TAVR or surgery in intermediate-risk patients;
There was no difference in the primary composite endpoint of all-cause mortality or stroke There were more reinterventions after TAVR, however after 2 years, the reintervention rates were similar After 2 years, key clinical endpoints were similar Forward-flow hemodynamics were significantly better with TAVR Paravalvular leak was significantly better with surgery Low rates of thrombosis and endocarditis
Slide24Conclusion
Longer-term outcome data from the SURTAVI randomized trial comparing early-generation TAVR to open-heart surgery are similar and encouraging for TAVR in younger, healthier patients with aortic stenosis