NOTION-3
Trial question
What is the role of PCI in patients with coronary artery disease undergoing TAVI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 455
455 patients (148 female, 307 male).
Inclusion criteria: patients with coronary artery disease undergoing TAVI.
Key exclusion criteria: life expectancy < 1 year; severe renal failure; acute coronary syndrome within 14 days; left main coronary artery stenosis.
Interventions
N=227 PCI (PCI completed before TAVI as a staged procedure).
N=228 conservative treatment (receipt of medical treatment with no PCI of any lesions).
Primary outcome
Major adverse cardiac event at 2 years
26%
36%
36.0 %
27.0 %
18.0 %
9.0 %
0.0 %
Percutaneous coronary
intervention
Conservative
treatment
Significant
decrease ▼
NNT = 10
Significant decrease in major adverse cardiac event at 2 years (26% vs. 36%; HR 0.71, 95% CI 0.51 to 0.99).
Secondary outcomes
No significant difference in death from any cause (23% vs. 27%; HR 0.85, 95% CI 0.59 to 1.23).
Significant decrease in MI (7% vs. 14%; HR 0.54, 95% CI 0.3 to 0.97).
Significant decrease in urgent revascularization (2% vs. 11%; HR 0.2, 95% CI 0.08 to 0.51).
Safety outcomes
No significant difference in stent thrombosis.
Significant differences in acute kidney failure (5% vs. 11%), any bleeding event (28% vs. 20%).
Conclusion
In patients with coronary artery disease undergoing TAVI, PCI was superior to conservative treatment with respect to major adverse cardiac event at 2 years.
Reference
Jacob Lønborg, Reza Jabbari, Muhammad Sabbah et al. PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2024 Dec 12;391(23):2189-2200.
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