Why the study?
Is a CCTA-guided PCI strategy noninferior to an IVUS-guided PCI strategy with respect to target-vessel failure at 12 months in patients with significant coronary artery stenosis undergoing revascularization?
RCT (n=1,105)
Open-label with blinded end-point adjudication
1:1 ratio
Yes
Is a CCTA-guided PCI strategy noninferior to an IVUS-guided PCI strategy with respect to target-vessel failure at 12 months in patients with significant coronary artery stenosis undergoing revascularization?
Pre-procedural CCTA-guided PCI is noninferior to invasive IVUS-guided PCI for 12-month target-vessel failure, supporting non-invasive CT planning as a viable alternative to intravascular imaging guidance.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“PCI decisions are often made during the procedure. We diagnose, interpret, think, decide, and treat—and react—in real time”
“Right now, there are a lot of interventionalists who don’t know how to read CTs and don’t know how to understand them,”
Supports CCTA as a noninvasive alternative to IVUS for PCI guidance; extends randomized evidence for CT-based revascularization planning.
Background Intravascular ultrasound (IVUS)–guided percutaneous coronary intervention (PCI) improves clinical outcomes. Coronary computed tomographic angiography (CCTA) provides anatomical and physiological information before cardiac catheterization that may enable PCI planning. Data regarding the use of CCTA-guided PCI as compared with IVUS-guided PCI with respect to clinical outcomes are lacking. Methods In this investigator-initiated, international, open-label, randomized, noninferiority trial with blinded end-point adjudication, we randomly assigned patients with a clinical indication for revascularization, at least one epicardial lesion with a diameter stenosis of more than 70%, and a fractional flow reserve derived from CCTA of 0.80 or less in a 1:1 ratio to a CCTA-guided or IVUS-guided PCI strategy. The primary end point was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization, at 12 months. The noninferiority margin for the absolute risk difference was 4.5 percentage points, with a prespecified hierarchical testing strategy for superiority. Results A total of 1105 patients underwent randomization: 556 to the CCTA-guided PCI group and 549 to the IVUS-guided PCI group. The median age of the patients was 65 years, and 21.7% were women. At 12 months, target-vessel failure had occurred in 23 patients (4.1%) in the CCTA-guided PCI group and in 25 patients (4.6%) in the IVUS-guided PCI group (risk difference, −0.42 percentage points; 95% confidence interval, −2.82 to 1.99; P<0.001 for noninferiority; P=0.73 for superiority). A total of 6 patients in the CCTA-guided PCI group and 9 patients in the IVUS-guided PCI group had clinical procedural complications. Conclusions A CCTA-guided PCI strategy was noninferior to IVUS-guided PCI with respect to target-vessel failure at 12 months.
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Collet et al. (2026) conducted an RCT in Coronary artery disease with clinical indication for revascularization (n=1,105). Coronary computed tomographic angiography (CCTA)-guided percutaneous coronary intervention (PCI) vs. Intravascular ultrasound (IVUS)-guided PCI was evaluated on Target-vessel failure (composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 12 months (Risk difference -0.42 percentage points, 95% CI -2.82 to 1.99, p=<0.001 for noninferiority; 0.73 for superiority).
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