Boston Scientific Corporation · NYSE:BSX
Boston Scientific — TCT 2022
16 slides from Boston Scientific's conference presentation, Dec 3, 2022
Slide 1: Three-Year Outcomes of the Randomized SCOPE I Trial
Three-Year Outcomes of the Randomized SCOPE I Trial Comparing the ACURATE Neo vs the SAPIEN 3 Transcatheter Heart Valve System in Patients With Symptomatic Severe Aortic Stenosis Presented by Jonas Lanz at TCT 2022 SH-1415703-AA
Slide 2: SCOPE I THV Device Overview
SCOPE I THV Device Overview 1st Generation* ACURATE neoTM 3rd Generation SAPIEN 3 THV Supra Annular Leaflets, Porcine Pericardium Intra-annular Leaflets, Bovine Pericardium Self-Expanding (Top-down) Nitinol frame Balloon-Expanding Cobalt-Chromium Frame *The 2nd Generation ACURATE neo2 was not studie
Slide 3: Study Design
Study Design Patients with severe aortic stenosis requiring intervention Screening Log TF TAVI Randomized controlled trial (739 patients) ACURATE neo SAPIEN 3 Primary endpoint: Combined early safety & clinical efficacy at 30 days (VARC-2) Clinical and echocardiographic follow-up: at 30-days, 1 year
Slide 4: Baseline characteristics
Baseline characteristics Age Female sex STS-PROM 100 100% 20 18 95 80% 16 90 14 85 60% 12 83 83 Score % 10 Years 80 40% 8 75 6 58.6% 55% 70 20% 4 3.7 3.4 65 2 60 0 0% ACURATE neo SAPIEN 3 ACURATE neo SAPIEN 3 ACURATE neo SAPIEN 3 N=372 N=367 N=372 N=367 N=372 N=367 The ACURATE neo and neo2™ Valve Sy
Slide 5: SCOPE I: Primary Endpoint At 30-Days
SCOPE I: Primary Endpoint At 30-Days Primary Secondary Key Components of the Primary Endpoint Analysis Analysis ACURATE neo (N=367) SAPIEN 3 (N=364) P=0.42 P=0.02 ACURATE neo failed to 30 12 meet pre-specified P=0.01 P=0.03 24 24 criteria for non-inferiority 10 compared to S3 regarding 20 the primar
Slide 6: SCOPE I Study
SCOPE I Study Objective: To evaluate whether early differences in device performance between the 1st generation ACURATE neo and 3rd generation SAPIEN 3 translate into differences in patient clinical outcomes 3 years after TAVR Randomized parallel-group assessor-blinded trial n = 739 Patients | 20 Eu
Slide 7: Patient Flow Chart
Patient Flow Chart 739 patients with severe, symptomatic aortic stenosis selected for TF TAVI by the Heart Team Randomization 372 allocated to ACURATE neo 367 allocated to SAPIEN 3 369 TF TAVI initiated 363 TF TAVI initiated 363 received ACURATE neo 362 received SAPIEN 3 11 multiple valve implantati
Slide 8: SCOPE I 3-years– Kaplan Meier Cumulative Event Curves
SCOPE I 3-years– Kaplan Meier Cumulative Event Curves 30-day differences in device performance between neo and S3 did not translate into differences in clinical outcomes at 3 years All-cause death All-cause death, or stroke or heart failure re- 24.5% hospitalization 37.1% 37.1% 23.7% 34.1% 34.1% T
Slide 9: Clinical Outcomes at 3 years
Clinical Outcomes at 3 years ACURATE neo SAPIEN 3 Hazard ratio/Sub-hazard ratio (95% CI) no. of events/total no. (%) All-cause death 84/346 (24.3%) 85/340 (25.0%) 0.98 (0.73 to 1.33) Cardiovascular death 58/346 (16.8%) 57/340 (16.8%) 1.01 (0.70 to 1.45) Non-cardiovascular death 26/346 (7.5%) 28/340
Slide 10: Functional Outcomes - NYHA Class
Functional Outcomes - NYHA Class Pre-TAVI 1 year 3 years p=0.67 p=0.66 p=0.97 100% 0.7% 0.3% 0.4% 0.4% 5.4% 5.2% 11.5% 14.2% 14.8% 90% 16.0% NYHA class IV 80% NYHA class III 70% NYHA class II 43.9% 44.7% NYHA class I 60% 67.8% 71.8% 51.2% 51.6% 50% 40% 30% 43.9% 20% 40.9% 33.6% 32.0% 25,9% 22.0% 10%
Slide 11: Echocardiography - Mean Gradient & EOA
Echocardiography - Mean Gradient & EOA 50 1,95 ± 0.6 2,00 p = 0.011 1.74 ± 0.5 Aortic valve mean gradient (mmHg) 1.78 ± 0.5 41.5 ± 15.2 42.6 ± 16.6 1,69 ± 0.5 Effective orifice area (cm2) 40 1.56 ± 0.4 1.57 ± 0.4 1,60 30 1,20 20 0,80 0.73 ± 0.2 0.72 ± 0.2 p < 0.001 10 11.2 ± 4.2 12.5 ± 5.1 12.1 ± 4.
Slide 12: Non-Structural Bioprosthetic Valve Dysfunction
Non-Structural Bioprosthetic Valve Dysfunction Prosthetic Aortic Valve Regurgitation Prosthesis-patient mismatch (at 30 days) (at 30 days) p < 0.001 p < 0.001 0.6% 0.3% 100% 2.5% 100% 9.0% 6.6% severe 20.3% severe moderate 20.2% 80% 31.0% 80% moderate mild none insignificant 51.5% 31.3% 60% 60% 40%
Slide 13: Acquired Bioprosthetic Valve Dysfunction
Acquired Bioprosthetic Valve Dysfunction Structural valve deterioration Endocarditis (with at least moderate HVD)* Sub-hazard ratio: Sub-hazard ratio: 0.19 (95% CI: 0.02 to 1.76) 0.71 (95% CI: 0.22 to 2.27) 5% 5% 4% 4% 3% 3% 2% 2% 2.9% 1% 1% 2.1% 1.4% 0.4% 0% 0% ACURATE neo SAPIEN 3 ACURATE neo SAPI
Slide 14: Bioprosthetic Valve Dysfunction and Failure
Bioprosthetic Valve Dysfunction and Failure Valve thrombosis Aortic valve re-intervention Valve-related death* Sub-hazard ratio: 0.16 (95% CI: 0.02 to 1.35) Sub-hazard ratio: Sub-hazard ratio: 1.32 (95% CI: 0.30 to 5.85) 1.52 (95% CI: 0.25 to 9.28) 5% 5% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 1% 1% 1% 1.8% 1
Slide 15: Limitations
Limitations • Study not powered for clinical endpoints at 3 years • Findings may not apply to low-risk populations with higher life- expectancy • Echocardiographic data at 3 years not core lab adjudicated and structural valve deterioration based on evolution of mean gradients only, without morpholog
Slide 16: Conclusion
Conclusion • 30-day differences in device performance between neo and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure (BVF) at 3 years. • There is no evidence of compromised valve durability in neo in comparison to S3 over the course of the 3 yea