Slide 1: TAVI with ACURATE neo2 vs. Sapien/Evolut: A SWEDEHEART Target Trial Emulation Study
TAVI with ACURATE neo2 vs. Sapien/Evolut: A SWEDEHEART Target Trial Emulation Study Andreas Rück Karolinska University Hospital, Stockholm, Sweden andreas.ruck@ki.se SH-2140803-AA
Slide 2: Conflicts of interest
Andreas Rück, MD PhD Conflicts of interest Boston Scientific: Institutional research support, Consulting Edwards Lifesciences: Consulting Anteris: Consulting SH-2140803-AA
Slide 3: Submitted for publication
Submitted for publication SH-2140803-AA
Slide 4: ACURATE neo2: Nitinol Self-expanding TAVI
ACURATE neo2: Nitinol Self-expanding TAVI Open upper frame Supra-annular leaflets ACTIVE PVseal Accurate • Boston Scientific positioning Top-down deployment with • Investigational in US upper- and lower- crown anchoring provides first-time • Next gen ACURATE Prime now in Annulus treatment range prec
Slide 5: ACURATE IDE Trial Design and One-year Outcomes
One-year Outcomes of ACURATE neo2 vs Approved TAVR Devices in All-risk Patients with Severe AS: the ACURATE IDE Trial Houston Methodist DeBakey Heart & Vascular Center ULL es ACURATE IDE Trial Design On behalf of the ACURATE IDE Investigators Prospective, multicenter, randomized study ea a N=1500 pa
Slide 6: Post-Hoc Clinical Analysis: Valve Frame Expansion
Post-Hoc Clinical Analysis: Valve Frame Expansion ACURATE neo2 Under-expanded ACURATE neo2 Expanded Death Control Stroke 11.0% • 21% of ACURATE underexpanded 7.4% by fluoroscopy 3.7% 3.5% 3.6% 3.4% Days since Procedure Days since Procedure No. at risk No. at risk ACUR. neo2 ACUR. neo2 150 150 149 14
Slide 7: Target trial emulation
Dialysis Critical preoperative state Target trial emulation Table S1. Target trial protocol. Severe aortic insufficiency Protocol Target trial specification Target trial emulation Data sources for Mitral valve prosthesis components emulation Hypertrophic cardiomyopathy Aim To study differences in cl
Slide 8: Study flowchart
Figure S1. Flowchart of patients included in the study. Note that exclusion criteria are listed in the order that the dataset was filtered. Therefore, the initial population might have had more patients with each of the exclusion criteria listed, but they were filtered away earlier due to another ex
Slide 9: Baseline data (crude)
Baseline data (crude) Variable Overall ACURATE neo2 Control p No. 1943 644 1299 Age, years, median [IQR] 81.2 (6.1) 82.1 (5.8) 80.8 (6.2) <0.001 Female sex 49.8 % 53.9 % 47.7 % 0.012 LVEF 0.409 >50% 81.9 % 83.4 % 81.1 % 40-49% 12.2 % 10.9 % 12.9 % 30-39% 5.9 % 5.7 % 5.9 % Aortic mean pressure gradie
Slide 10: Adjusted by balancing weighting (Love plot)
Dia betes History of hypertension Histo ry of atrial fibrillation Adjusted by balancing weighting (Love plot) Histo ry of bleeding event Dia betes Histo ry of pacemaker/ICD Figure S2. Love plot showing mean Histo ry ofdifferences before and afterHisto atrial fibrillation balancing ry of PCI weightin
Slide 11: Procedural data
Procedural ACURATE Variable Overall Control p neo2 Prosthesis size, mm <0.001 data ≤23 24-26 ≥27 21.9 % 39.7 % 38.4 % 18.3 % 37.4 % 44.3 % 23.6 % 40.9 % 35.5 % Annulus diameter, mm, mean (SD) 24.1 (1.7) 24.0 (1.5) 24.1 (1.8) 0.059 Pre-dilatation 60.9 % 99.8 % 41.6 % <0.001 Pre-dilatation balloon und
Slide 12: Primary Endpoint
508 Figures and Figure legends Primary Endpoint 509 510 511 Figure 1. Weighted outcomes at one year. A: Combined outcome, B: All-cause mortality, C: Heart failure hospitalization, and D: Stroke. 100% 75% All-cause mortality, heart failure ACURATE neo2 hsopitalization and stroke Control 50% 25% HR: 0
Slide 13: Weighted outcomes at one year: components
25% HR: 0.97, 95% CI: 0.75 to 1.23 Control 12.3% hsopitalizat All-cause m ACURATE neo2 11.9% 100% 100% 0% Components 0 90 180 270 365 Time (days) 75% Number at risk 75% ACURATE neo2 644 559.5 496.1 407.8 318.2 A Control 1299 1119.7 993.2 831.8 642.2 ACURATE neo2 ACURATE neo2 Control Control 50% 50%
Slide 14: Additional endpoints
Additional endpoints Weighted cumulative incidence of acute myocardial infarction, percutaneous coronary intervention and major bleeding event at 3 and 12 months. Events / PY HR (95% CI) 3 months 12 months Acute myocardial infarction ACURATE neo2 3 / 481 0.66 (0.20-1.55) 0.3 (0.0-2.4) 0.6 (0.2-2.2)
Slide 15: Postdilatation - not dangerous
Postdilatation - not dangerous No post- Postdilatati Variable Overall dilatation on p Analysis of No 644 356 288 ACURATE Peri-procedural tamponade % 0.2 0.3 0.0 1.000 group Peri-procedural valve embolization % 0.5 0.8 0.0 0.327 Crude data Major vascular complication % 1.2 0.8 1.7 0.509 VARC2 major b
Slide 16: Comparison IDE vs SWEDEHEART (ACURATE group)
Comparison IDE vs SWEDEHEART (ACURATE group) IDE trial SWEDEHEART Age, years 78.0 82.1 Preop AS mean gradient, mmHg 44.7 47.9 Predile done (%) 99.6% 99.8% Predil balloon within 1mm of 19% 47% anular size (%) Postdil done (%) 26.1% 44.7% Postdil balloon within 1mm of 49% 74% anular size (%) Postop me
Slide 17: A SWEDEHEART target trial emulation study
A SWEDEHEART target trial emulation study Emulat ed t rial, observat ional dat a, out com es from official complet e dat abases Sam e inclusion/ exclusion crit eria, sam e prim ary out com e definit ions as ACURATE IDE t rial Adjusted analysis by balancing weighting ACURATE neo2 Evolut / Sapien3 n=6
Slide 18: Limitations
Limitations • Observational data • No imaging (frame underexpansion could not be estimated) SH-2140803-AA
Slide 19: Conclusions
Conclusions • Mortality, heart failure hospitalization and stroke was not different between ACURATE and Sapien/Evolut TAVI in Swedish observational data • Rigorous pre- and postdilatation was used • Not difficult – most often same balloon for pre/postdilatation • Post-dilatation was not associated w