Deferral of PCI was non-inferior to PCI before TAVI for the 1-year composite of mortality, MI, stroke, and major bleeding (HR 0.89; 95% CI 0.62-1.28; p=0.0008 for non-inferiority).
RCT (n=466)
Open-label
1:1
Yes
Does deferral of PCI improve or maintain non-inferior outcomes for the composite of all-cause mortality, myocardial infarction, stroke, and major bleeding in patients with coronary artery disease undergoing TAVI?
In patients with coronary artery disease undergoing TAVI, an initial conservative strategy of deferring PCI is non-inferior to routine PCI before TAVI for 1-year clinical outcomes.
Effect estimate: HR 0.89 (95% CI 0.62-1.28)
Absolute Event Rate: 24% vs 26%
p-value: p=0.0008 for non-inferiority
BACKGROUND: Coronary artery disease is common in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to assess whether deferral of percutaneous coronary intervention (PCI) is non-inferior to routine PCI before TAVI in patients with coronary artery disease. METHODS: In this investigator-initiated, open-label, randomised controlled trial, done at 12 hospitals in the Netherlands, TAVI patients with coronary artery disease were randomly assigned in a 1:1 ratio to deferral of PCI or PCI before TAVI. Randomisation was done by use of a web-based system with random block sizes of 2 and 4, and stratification by presence of coronary artery disease involving proximal left anterior descending artery. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year. Non-inferiority testing was done in the intention-to-treat population against the prespecified margin of 11 percentage points. The study is registered with ClinicalTrials.gov (NCT05078619) and long-term follow-up is ongoing. FINDINGS: Between Oct 7, 2021, and Nov 19, 2024, 466 patients were enrolled: 233 were assigned to deferral of PCI and 233 to PCI before TAVI. Median age was 81 years (IQR 78-84), and 166 (36%) of 466 patients were female. The primary endpoint occurred in 56 (24%) of 233 patients in the deferral group as compared with 60 (26%) of 233 patients in the PCI group (rate difference -1·7% 95% CI -9·5 to 6·2; hazard ratio 0·89 95% CI 0·62-1·28; p=0·0008 for non-inferiority; p=0·68 for superiority). INTERPRETATION: In patients with coronary artery disease undergoing TAVI, deferral of PCI was non-inferior to PCI before TAVI for the 1-year composite of all-cause mortality, myocardial infarction, stroke, and major bleeding. These findings suggest that an initial conservative strategy can be appropriate in selected patients, although patient-tailored treatment decisions remain essential. FUNDING: ZonMw.
“For elderly TAVR patients with concomitant coronary artery disease, I think it's safe to first do TAVR and see if patients will still have complaints about chest pain or tightness. We can wait and, if they still have complaints afterward, only then do PCI.”
Delewi et al. (2026) conducted an RCT in Coronary artery disease in patients undergoing TAVI (n=466). Deferral of PCI vs. PCI before TAVI was evaluated on Composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year (HR 0.89, 95% CI 0.62-1.28, p=0.0008 for non-inferiority). Deferral of PCI was non-inferior to PCI before TAVI for the 1-year composite of mortality, MI, stroke, and major bleeding (HR 0.89; 95% CI 0.62-1.28; p=0.0008 for non-inferiority).
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