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Third Nordic Aortic Valve Intervention - NOTION-3
Contribution To Literature:
The NOTION-3 trial showed that PCI prior to TAVI is effective at reducing major adverse cardiac events.
Description:
The goal of the trial was to evaluate percutaneous coronary intervention (PCI) compared with conservative therapy among patients with obstructive coronary artery disease undergoing transcatheter aortic valve implantation (TAVI).
Study Design
- Randomized
- Parallel
Patients with symptomatic severe aortic stenosis with obstructive coronary artery disease in at least one vessel were randomized to PCI (n = 227) versus conservative therapy (n = 228). PCI was strongly recommended to be performed before TAVI, but could also be performed during or within 2 days after the procedure.
- Total number of enrollees: 455
- Duration of follow-up: median 2 years
- Mean patient age: 82 years
- Percentage female: 32%
- Percentage with diabetes: 26%
Inclusion criteria:
- Symptomatic severe aortic stenosis
- Obstructive coronary artery disease, defined as fractional flow reserve ≤0.80 or ≥90% stenosis in an epicardial vessel ≥2.5 mm
Exclusion criteria:
- Limited life expectancy
- Severe renal failure
- Recent acute coronary syndrome
- Left main coronary artery stenosis
Other salient features/characteristics:
- Median number of significant lesions per patient: 1
- PCI before TAVI: 74%
- PCI during TAVI: 17%
- PCI after TAVI: 9%
- Balloon-expandable valve: 40%
Principal Findings:
The primary outcome, all-cause mortality, myocardial infarction (MI), or urgent revascularization, was 26% in the PCI group vs. 36% in the conservative therapy group (p = 0.04).
Secondary outcomes:
- All-cause mortality: 23% in the PCI group vs. 27% in the conservative therapy group
- MI: 7% in the PCI group vs. 14% in the conservative therapy group
- Urgent revascularization: 2% in the PCI group vs. 11% in the conservative therapy group
- Major bleeding: 11% in the PCI group vs. 10% in the conservative therapy group
Interpretation:
Among patients with obstructive coronary artery disease and severe aortic stenosis undergoing TAVI, coronary revascularization before the valve procedure was beneficial. PCI versus conservative therapy was associated with a reduction in major adverse cardiac events. The benefit was due to a reduction in MI and urgent revascularization.
This trial was twice as large as the similar strategy ACTIVATION trial; however, that study did not meet the requirement for noninferiority at 1 year. The ongoing COMPLETE TAVR trial is also currently examining the role of PCI 1-45 days after a successful TAVI.
It is unknown why PCI prior to TAVI would be associated with a reduction in MI, although this might be due to changes in vessel-wall shear stress, which could make coronary plaque more vulnerable. It is plausible that knowledge of an un-revascularized coronary lesion could have driven some of the need for urgent revascularization in the conservative therapy group. While this trial suggests good intermediate-term results from coronary revascularization before TAVI the long-term consequences of this approach need to be considered in a self-expanding valve-enriched trial cohort (approximately 60% of subjects) and the potential issues with future coronary re-access.
References:
Lønborg J, Jabbari R, Sabbah M, et al., for the NOTION-3 Study Group. PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med 2024;Aug 31:[Epub ahead of print].
Presented by Dr. Jacob Thomsen Lønborg at the European Society of Cardiology Congress, London, UK, August 31, 2024.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and Coronary Artery Disease
Keywords: Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention, Transcatheter Aortic Valve Replacement, ESC Congress, ESC24
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