Updates From NOTION: The First All-Comer TAVR Trial

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Presentation transcript:

Updates From NOTION: The First All-Comer TAVR Trial Lars Sondergaard, MD, DMSc Professor of Cardiology Rigshospitalet Copenhagen, Denmark

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting Fees/Honoraria BSci, SJM, Symetis BSci, Medtronic, SJM, Symetis

Nordic Aortic Valve Intervention Trial The NOTION Trial Objective: Compare TAVR vs. SAVR in patients >70 years eligible for surgery (all-comers population) Primary outcome: Composite rate of death from any cause, stroke or myocardial infarction at 1 year (VARC II-defined) Secondary outcomes: Safety and efficacy (NYHA), echocardiographic outcomes (VARC II-defined) Design: Prospective, multicenter, non-blinded, randomized trial Enrollment period: December 2009 - April 2013

Enrollment Criteria Main inclusion criteria Main exclusion criteria Severe AS Age ≥70 years Life expectancy ≥ 1 year Suitable for TAVR & SAVR Main exclusion criteria Severe CAD Severe other valve disease Prior heart surgery Need for acute treatment Recent stroke or MI Severe lung disease Severe renal failure

Device and Access Routes Self-expanding Bioprosthesis (annulus diameter 18-29 mm ) Subclavian Transfemoral 18Fr delivery system 5 5 5

Baseline Characteristics Characteristic, % or mean ± SD TAVR n=145 SAVR n=135 p-value Age (yrs) 79.2 ± 4.9 79.0 ± 4.7 0.71 Male 53.8 52.6 0.84 STS Score 2.9 ± 1.6 3.1 ± 1.7 0.30 STS Score < 4% 83.4 80.0 0.46 Logistic EuroSCORE I 8.4 ± 4.0 8.9 ± 5.5 0.38 NYHA class III or IV 48.6 45.5 0.61

Trial Compliance ITT TAVR N=145 ITT SAVR N=135 Baseline 100% (145/145) (135/135) 1 Month Follow-Up 96.4% (135/140) 92.1% (116/126) 3 Months Follow-Up 96.4% (135/140) 93.6% (117/125) 1 Year Follow-Up 98.5% (134/136) 96.0% (119/124) 2 Year Follow-Up 94.6% (123/130) 95.8% (113/118)

Primary Outcome* TAVR 13.1% vs. SAVR 16.3% Composite rate of death from any cause, stroke or myocardial infarction 1 year after the procedure TAVR 13.1% vs. SAVR 16.3% Absolute difference -3.2%; p=0.43 (for superiority) *Intention-to-treat population

All-cause mortality, stroke or MI Sondergaard et al. Circ carciovasc Interv 2016

All-cause mortality, Stroke or MI Patients with STS <4% Sondergaard et al. Circ carciovasc Interv 2016

Functional Class Baseline 3 months 1 year 2 years Sondergaard et al. Circ carciovasc Interv 2016

Valve Performance Δ EOA Δ Mean gradient Sondergaard et al. Circ carciovasc Interv 2016

Aortic Valve Regurgitation 3 months 1 year 2 years Sondergaard et al. Circ carciovasc Interv 2016

All-cause mortality in TAVR patients according to PVL rate Sondergaard et al. Circ carciovasc Interv 2016

Conclusions (I) The NOTION trial was the first all-comers trial to randomize lower-risk patients to TAVR or SAVR TAVR was safe and effective, and comparable to SAVR regarding the composite rate of death from any cause, stroke or myocardial infarction after 2 years

Conclusions (II) TAVR resulted in larger EOA and lower gradients, but higher rate of moderate PVL than SAVR These two year data support the safety and effectiveness of TAVR in lower risk patients Longer term data on durability and more randomized clinical trials in lower risk patients are necessary

All-cause mortality benefits for TAVI All-cause Mortality at 2 years 4 randomized trials (N =3,806) Trial TAVR SAVR HR (95% CI) PARTNER 1A 116/348 114/351 0.90 (0.71-1.15) US CoreValve 85/391 99/359 0.79 (0.61-1.01) NOTION 11/145 14/135 0.72 (0.33-1.59) PARTNER 2A 166/1011 170/1021 0.92 (0.74-1.13) Overall 0.87 (0.76-0.99), P=0.038 Siontis et al. EHJ 2016, in press

RCT in TAVI Extreme High Intermediate Low STS score (%)

RCT in TAVI – same age! Extreme High Intermediate Low 100 80 60 STS score (%) Age (years) 40 20

Use of surgical bioprosthetic aortic valves Eastern Denmark 68 years 61 years De Backer et al. JACC Cardiovasc Interv 2016

NOTION I – Mortality at 2 Years

NOTION II Study design Inclusion criteria Primary end-point Design Severe symptomatic aortic stenosis Age ≤75 years & STS score ≤4% Anticipated usage of aortic bioprosthesis Primary end-point Composite rate of all-cause mortality, stroke & MI at 1 year Design RCT, 1:1, TF TAVI vs. SAVR, superior, N=992 Bicuspid valves & revascularization (CABG or PCI) allowed Any aortic bioprosthesis allowed