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COREVALVE™ AND EVOLUT™ R TAVI SYSTEMSSURTAVI CLINICAL TRIAL RESULTS
INTERNATIONALCAUTION: For distribution only in markets where CoreValve Evolut R intermediate risk indication has been approved. CoreValve System is not approved for Intermediate Risk Patients.
Refer to Instructions for Use for a complete list of warnings, precautions, indications and contraindications.
A Groundbreaking Study of Intermediate Risk Symptomatic Severe Aortic Stenosis Patients
STUDY BACKGROUND AND DESIGN
The SURTAVI Clinical Trial is a prospective, multinational, randomized clinical trial evaluating the CoreValve™ and Evolut™ R systems vs. surgery in patients with symptomatic severe aortic stenosis at intermediate surgical risk. The primary objective was to show that TAVI is noninferior to SAVR.
n 1660 patients (mITT)n 87 sites in US, Canada and Europen CoreValve system and Evolut R system evaluated
PATIENT FLOW
1746 patients
randomized
TAVI ITT group:
N=879
SAVR ITT group:
N=867
TAVI mITT GROUP: N=864
SAVR mITT GROUP: N=796
TAVI implanted
group: N=863
SAVR implanted
group: N=794
ITT: intention-to-treat population consisted of all randomized subjects (n=1746)
mITT: modified intention-to-treat population consisted of all ITT subjects with an attempted implant procedure (n=1660)
CoreValve TAVI: 23, 26 and 29 mm (all sites)
US: Evolut R TAVI: 23, 26 and 29 mm
EU/CAN
CoreValve TAVI: 31 mm (all sites)
84%
16%
2012 2013 2014 2015 2016
DEC 2016
JUNE 2012
APRIL 2015
JUNE 2016
STUDY DEVICE INCLUSION TIMELINE
CoreValve TAVI (n=724)
PRIM
ARY
EN
DPO
INT
AS
SE
SS
ME
NT
Enrollment completedFirst patient enrolled
Evolut R TAVI (n=139)
Evolut™ R TAVI in US
The majority of TAVI patients were treated with the CoreValve device.
STUDY ENDPOINTS Primary Endpoint n All-cause mortality or disabling
stroke at 24 months
Secondary Endpoints Safety n All-cause mortality n All stroke n Aortic valve reintervention n Major vascular complications n Life-threatening or major bleeding n Pacemaker implantation n MACCE
Efficacy n Mean gradient n EOA n Moderate/severe AR
Quality of life n KCCQ
KEY INCLUSION CRITERIAn Severe aortic valve stenosis defined by an initial
aortic valve area of ≤1.0 cm² or aortic valve area index <0.6 cm2/m2, AND a mean gradient >40 mmHg or Vmax > 4m/sec, at rest or with dobutamine provocation in patients with a LVEF < 55%, or Doppler Velocity Index <0.25 by resting echocardiogram
n Heart team agreement that predicted 30-day surgical mortality risk is ≥3% and <15% based on STS PROM and overall clinical status including frailty, disability and comorbidity factors
n NYHA functional class II or greater
STUDY BACKGROUND AND DESIGN
n (%) or mean ± SDTAVI
(N=864)SAVR
(N=796)
Age, years 79.9 ± 6.2 79.7 ± 6.1
Body surface area, m2 1.9 ± 0.2 1.9 ± 0.2
Male sex 498 (57.6) 438 (55.0)
STS PROM, % 4.4 ± 1.5 4.5 ± 1.6
Logistic EuroScore, % 11.9 ± 7.6 11.6 ± 8.0
Diabetes mellitus 295 (34.1) 277 (34.8)
Serum Creatinine >2 mg/dl 14 (1.6) 17 (2.1)
Peripheral vascular disease 266 (30.8) 238 (29.9)
Prior stroke 57 (6.6) 57 (7.2)
Prior TIA 58 (6.7) 46 (5.8)
Prior CABG 138 (16.0) 137 (17.2)
Permanent pacemaker 84 (9.7) 72 (9.0)
BASELINE CHARACTERISTICS1
1 mITT population
KEY EXCLUSION CRITERIA (additional criteria may apply)n Any PCI or peripheral
intervention within 30 days of randomization
n Multivessel CAD with Syntax score >22
n Unsuitable anatomy including native aortic annulus <18 mm or >29 mm
n Congenital bicuspid or unicuspid valve verified by echo
SAFETY AND PERFORMANCE
The SURTAVI trial further supports the safety and performance of the Evolut R system in treating intermediate risk patients.
All-
caus
e M
orta
lity
or D
isab
ling
Stro
ke
555674796 407 241 612755864
SAVRNo. at Risk
TAVI 456 272
Months Post-Procedure
0%
5%
10%
15%
20%
25%
30%
1260 18 24
SAVR TAVI
ALL-CAUSE MORTALITY OR DISABLING STROKECoreValve and Evolut R systems demonstrated non-inferiority against an exceptional surgical cohort.
NOTE: The SURTAVI study utilized a novel Bayesian statistical methodology. A subset of the cohort had complete data at 24 months. The remaining subjects have incomplete data at various intervals in the follow-up. The data from the “completers” was used to model out the probable result for the study by simulating results for the non-completers using their status at their last known interval.
The numerical comparisons made throughout the study and this data summary are the posterior median rates modeled by the Bayesian analysis. The Kaplan-Meier curves are also included, and patients are censored from the analysis at the last point of the follow-up as is the convention with Kaplan-Meier analyses.
Bayesian Analysis: 24-month all-cause mortality or disabling stroke
TAVI SAVR
12.6% 14.0%
1.2% 30-DAY DISABLING STROKE RATE FOR
TAVI ARM
Dis
ablin
g St
roke
0%
2%
4%
6%
8%
10%
1260 18 24
555674796 407 241 612755864
SAVRNo. at Risk
TAVI 456 272
SAVR TAVI
Months Post-Procedure
LOW RATES OF DISABLING STROKE
STRONG SAFETY AND PERFORMANCE
Bayesian Analysis: 24-Month Disabling Stroke
TAVI SAVR 95% Cl for Difference
2.6% 4.5% -4.0, 0.1
Data modeled by the Bayesian analysis
*Post-Procedure/Discharge
3.45.6
12.5
41.1
0.73.5
6.0
1.1
25.9
6.63.8
1.1
43.4
12.9
4.41.7
30-D
ay S
afet
y O
utco
mes
(%)
0%
10%
20%
30%
40%
50%
TransfusionUse
All-stroke
AtrialFibrillation
Moderate/SevereAortic
Regurgitation*
AcuteKidneyInjury
MajorVascular
Complications
CardiogenicShock
PermanentPacemaker
Implant
TAVI SAVR
SIGNIFICANTLY BETTER FOR TAVI
SIGNIFICANTLY BETTER FOR SAVREXCELLENT EARLY
OUTCOMESAt 30 days, TAVI was superior to SAVR in several key areas, including all-stroke, atrial fibrillation and acute kidney injury.
5.75
9.75Le
ngth
of H
ospi
tal S
tay
(Day
s)
0
5
10
15
20
SAVRTAVI
FASTER RECOVERY WITH TAVI
SHORTER HOSPITAL STAYSTAVI associated with significantly earlier hospital discharge than SAVR.
SAVR TAVI
40
60
80
100
Baseline 30 Days 6 Months 12 Months
Change From TAVI 18.4 ± 22.8 21.8 ± 22.3 20.9 ± 22.2Baseline SAVR 5.9 ± 27.0 21.3 ± 22.3 20.6 ± 22.2 95% Cl for difference (10.0, 15.1) (-1.9, 2.8) (-2.2, 2.9)
KCC
Q S
core
FASTER FUNCTIONAL RECOVERYHigher quality of life scores at 30 days in the TAVI group.
*Core lab adjudicated
TAVI had significantly better valve performance over SAVR at all follow-up visits
SIGNIFICANTLY BETTER HEMODYNAMICS* The supra-annular design of the Core-Valve and Evolut R valves provides excellent hemo-dynamic perform-ance with large, stable EOA and low single digit gradients.
SAVR TAVI
Effec
tive
Ori
fice
Are
a, c
m2
0.0
0.5
1.0
1.5
2.0
2.5
Baseline Discharge 6 Months 1 Year 2 Years0.0
Mean G
radient, mm
Hg
10.0
20.0
30.0
40.0
50.0
60.0
47.8
12.4 11.1 11.7 11.8
1.82
0.77
1.79 1.76 1.68
47.2
0.78
2.13 2.15 2.15 2.19
8.9 8.3 8.3 7.8
UNSURPASSED HEMODYNAMICS
STUDY SUMMARY
SURTAVI met its primary endpoint demonstrating that TAVI with CoreValve and Evolut R systems is non-inferior to SAVR for all-cause mortality or disabling stroke at 24 months
The SAVR arm performed exceptionally well, with an extremely low observed to expected surgical mortality ratio at 30 days
At 30 days, TAVI was associated with significantly lower rate of all-stroke vs. SAVR
At 30 days, TAVI had lower rates of acute kidney injury and atrial fibrillation, while SAVR had lower rates of major vascular complications and new permanent pacemaker
TAVI resulted in significantly lower mean gradients and greater aortic valve areas than SAVR at all post-implant time points
Functional recovery times were faster and hospital stays were shorter for patients treated with TAVI
1
2
3
5
4
6
THE CHOICE FOR INTERMEDIATE RISK PATIENTS
Designed for durability, the Evolut R system addresses anatomic and procedural challenges in patients with symptomatic severe aortic stenosis.
7.8mmHg SINGLE DIGIT GRADIENTS
2.2cm2 LARGE EOA
Commissure height and deep leaflet cuts minimize leaflet stress
Self-expanding nitinol frame conforms to varying annular anatomy
Unsurpassed hemodynamics at 24 months:
Supra-annular valve design provides optimal leaflet mounting and coaptation
INTERNATIONALCAUTION: For distribution only in markets where Evolut R intermediate risk indication has been approved. CoreValve System is not approved for Intermediate Risk Patients.
Refer to Instructions for Use for a complete list of warnings, precautions, indications and contraindications.
©2017 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company.
710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Toll-free: (800) 328-2518
LifeLine CardioVascular Technical Support Tel: (877) 526-7890 Tel: (763) 526-7890 Fax: (763) 526-7888 rs.cstechsupport@medtronic.com
medtronic.comUC201710224a EE 03/2017
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