ACURATE neo Aortic Valve System – Clinical Data

PROGRESS PVL Registry

The PRospective Observation of aortic reGuRgitation aftEr TAVI and progreSS over time (PROGRESS) PVL registry Kim, WK, Presented PCR e-Course June 25-27, 2020

Study Design

Endpoints Selection

Study Outcomes

PROGRESS PVL is an open-label, single arm study of 500 patients enrolled at 22 centers in Germany, Canada, the United Kingdom, and Italy between January 2017 and July 2018. The patient population can be assessed as representative for real-world practice, high age, with intermediate surgical risk (STS score 6.0%). No specific inclusion or exclusion criteria were mandated by protocol.

The primary endpoint (per protocol analysis) includes the rate of total aortic regurgitation over time, as determined by an independent echocardiography core laboratory. Key secondary endpoints (intention to treat analysis) include core-lab adjudicated mortality and stroke, VARC-2 early safety composite at 30 days, and hemodynamic function, as well as NYHA functional improvement.

Low overall VARC-2 complication rates, PVL improvement over time, and excellent hemodynamic performance

VARC-2 Clinical Outcomes

VARC-2 30-dayearly safetycomposite

All-CauseMortality

All Stroke Major vascularcomplications

Life-threatening or disabling

bleeding

Acute kidney injury

(Stage 2 or 3)

Repeat procedure for valve-related

dysfunction

Coronary obstruction

requiring intervention

9.2

2.2 2.63.6

1.4 0.8 1.20

11.3

3.6 4 3.4

11.7

00

20

15

10

5

30-Days 1-Year

% o

f Pat

ient

s

ACURATE neo Aortic Valve System – Clinical Data

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CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority product registrations. Information not for use or distribution in France.

Conclusion

Reconfirming the positive clinical and procedural outcomes seen with ACURATE neo in other studies and registries

One-year results from the PROGRESS PVL registry support the sustained safety and performance of TAVI with the ACURATE neo Aortic Valve System in patients with severe aortic stenosis.

Core laboratory adjudicated paravalvular leakage (PVL) rates were low (4.3% ≥moderate at discharge, 2.9% at 1-year) and showed a significant overall improvement between discharge and 1-year in a paired analysis (P<0.001).

These positive outcomes of the PROGRESS PVL registry, compared to outcomes seen in SCOPE I, may be attributable to the implanters’ experience using ACURATE neo and, most importantly, tailoring of device therapy to the individual patient characteristics.

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SH-827502-AA DINSH0265EA

PVL, ITT Population(core-lab adjudicated)

PVL, Paired Analysis(N = 209, core-lab adjudicated)

% o

f Eva

luab

le

Echo

card

iogr

ams

Discharge 12 Months

SevereModerateMildNone/Trace

Discharge(N = 373)

30 Days(N = 281)

12 Months(N = 230)

51.2

44.2

4.30.3

44.8

50.2

5.0

68.3

29.1

2.6

(P < 0.001)

53.6

42.1

4.3

67.9

29.2

2.9

Hemodynamic Performance(mmHg/cm2, core-lab adjudicated)

Mea

n tr

ansv

alvu

lar g

radi

ent (

mm

Hg)

Effective orifice area (cm2)

Baseline Discharge 30 Days 12 Months0 0

40 2

50 2.5

30 1.5

20 1

10 0.5

40.7(n = 325)

Mean transvalvular gradient Effective orifice area

7.9(n = 359)

6.7(n = 273)

6.9(n = 223)

1.85(n = 285)

1.94(n = 234)

2.05(n = 198)

0.79(n = 267)