- Design
- International, open-label, randomised noninferiority trial with blinded adjudication
- Population
- 1,105 patients needing revascularisation, lesion over 70%, CT-FFR 0.80 or less
- Primary outcome
- Target-vessel failure at 12 months
- Effect
- 4.1% vs 4.6%; difference −0.42 points (95% CI −2.82 to 1.99); P<0.001 noninferiority
An international NEJM trial randomised 1,105 patients with a clinical indication for revascularisation, a lesion over 70% and a CT-derived fractional flow reserve of 0.80 or less, to PCI planned on coronary CT angiography or guided by intravascular ultrasound.
At 12 months, target-vessel failure — cardiac death, target-vessel MI or ischaemia-driven revascularisation — occurred in 4.1% with CT guidance and 4.6% with IVUS (risk difference −0.42 points, 95% CI −2.82 to 1.99). That met noninferiority; CT planning was not superior.
Intravascular imaging already improves PCI outcomes but adds time, cost and catheter work. If CT done before the catheter lab can plan stent length, diameter and landing zones, a patient who already has a diagnostic CT may not need IVUS for a straightforward lesion. In Indian centres where IVUS catheters add materially to cost, that matters.
The trial is one, industry funded and open label, with a wide margin. Adopt it where CT quality and expertise are good, and keep intravascular imaging for complex anatomy.
- Consider using a good-quality pre-procedure CT angiogram to plan stent size and length
- The trial included only lesions with CT-derived FFR of 0.80 or less
- Keep intravascular imaging for left main, bifurcation and heavily calcified lesions until more data exist
- Discuss in the heart team whether your CT protocols are good enough to plan from
Why it matters
It turns the diagnostic CT into a procedural plan, which could save time and catheter costs.
Don't overread it
Noninferior within a wide 4.5-point margin in one industry-funded, open-label trial is not proof CT can replace IVUS in complex disease.
The statistics, in plain English
The 95% confidence interval for the difference, −2.82 to 1.99 points, shows CT guidance could be up to about 2 points worse or 3 points better; that range fell inside the prespecified 4.5-point margin, so noninferiority was met.
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