Slide 1: ACURATE neo2 v SAPIEN 3 Ultra Head-to-Head Comparison
ACURATE neo2TM v SAPIEN 3 UltraTM Head-to-Head Comparison © 2022 Boston Scientific Corporation or its affiliates. SH-1169701-AC
Slide 2: Device Overview ACURATE neo2 & SAPIEN 3 Ultra
Device Overview ACURATE neo2 & SAPIEN 3 Ultra ACURATE neo2 Aortic Valve System SAPIEN 3 Ultra Transcatheter Heart Porcine Pericardium, Supra Annular Leaflets Valve Bovine Pericardium, Intra-annular Leaflets Self-Expanding (Top-down) Nitinol frame Balloon-Expanding Cobalt-Chromium Frame CE marked 202
Slide 3: Study Design
Study Design 1st head-to-head comparison of ACURATE neo2 & SAPIEN 3 Ul Objective: To compare VARC-3 device and technical success (Primary Endpoint) and 30-day VARC-3 clinical endpoints (Secondary Endpoint) of ACURATE neo2 to SAPIEN 3 Ultra Head-to-Head Transfemoral TAVR n = 1356 Patients | 4 German
Slide 4: Baseline Characteristics
Baseline Characteristics ACURATE neo2 & SAPIEN 3 Ultra Matched population ACURATE neo2 SAPIEN 3 Ultra p-value n=472 n=472 Age, years 82.0 [78.7 – 85.0] 81.6 [77.6 – 85.1] 0.584 Female gender 239 (50.6) 246 (52.1) 0.696 Logistic EuroScore, % 13.8 [7.9 – 23.0] 12.5 [7.9 - 21.9] 0.184 NYHA III/IV 305 (
Slide 5: Essential Outcomes
Essential Outcomes ACURATE neo2 & SAPIEN 3 Ultra ACURATE neo2 SAPIEN 3 Ultra p-value n=472 n=472 Pre-dilatation, n (%) 434 (91.9) 148 (31.4) <0.001 Post-dilatation, n (%) 211 (44.7) 69 (14.6) <0.001 Procedural time, min 45.0 [36.0 – 59.0] 46.0 [35.0 – 57.0] 0.472 Fluoroscopy time, min 9.8 [7.3 - 13.
Slide 6: Essential Matched Cohort Outcomes
Essential Matched Cohort Outcomes ACURATE neo2 & SAPIEN 3 Ultra Similar and low Rates of Lower Mean Lower Severe PPVL = 0.686 Gradients Before TAVR After TAVR Prothesis-Patient 43+9 vs 43+8 mmHg 9+4 vs 13+4 mmHg Mismatch P < 0.001 0.6% 1.1% 20.0% P = 0.940 32.8% ACURATE neo2 2.9% 2.9% Severe PPM 78.
Slide 7: Conclusions
Conclusions ACURATE neo2 & SAPIEN 3 Ultra • First direct head-to-head propensity score matched comparison of the 2nd generation ACURATE neo2 and 4th generation SAPIEN 3 Ultra valves Data from this study demonstrated: – Low and similar rates of Moderate/Severe PVL (0.6% vs 1.1%; p=0.723)* and Permane
Slide 8: Study Limitations
Study Limitations ACURATE neo2 & SAPIEN 3 Ultra This is a non-randomized study, which incorporates 1:1 propensity matching (PSM), which does not fully exclude selection biases. Site-reported data are reported. No independent Core-Laboratory or Clinical Event Committee adjudication have been used
Slide 9: Backup: Entire Population Baseline Characteristics and Essential Outcomes
Backup: Entire Population Baseline Characteristics and Essential Outcomes
Slide 10: Baseline Characteristics
Baseline Characteristics ACURATE neo2 & SAPIEN 3 Ultra Entire population Matched population ACURATE neo2 SAPIEN 3 Ultra ACURATE neo2 SAPIEN 3 Ultra p-value p-value n=608 n=748 n=472 n=472 Age, years 82.0 [78.7 – 85.0] 81.4 [77.1 – 85.0] 0.032 82.0 [78.7 – 85.0] 81.6 [77.6 – 85.1] 0.584 Female gender
Slide 11: Essential Outcomes
Essential Outcomes ACURATE neo2 & SAPIEN 3 Ultra ACURATE neo2 SAPIEN 3 Ultra ACURATE neo2 SAPIEN 3 Ultra p-value p-value n=608 n=748 n=472 n=472 Pre-dilatation, n (%) 534 (87.8) 268 (35.8) <0.001 434 (91.9) 148 (31.4) <0.001 Post-dilatation, n (%) 250 (41.4) 111 (14.8) <0.001 211 (44.7) 69 (14.6) <0