CCTA-Guided PCI Matches IVUS in Trial

Two coronary trials report outcomes comparable to established approaches for guiding stents and treating lesions in heart disease patients.

Updated on Nov. 2, 2026 in Heart Disease

Stainless-steel catheterization lab imaging equipment and a coiled guidewire on a sterile blue drape under cool clinical light.
Two coronary trials report that CCTA-guided stent placement matched IVUS-guided PCI at 12 months, while a sirolimus-coated balloon was noninferior to everolimus drug-eluting stents. AI Illustration. Upload story photo >

The P4 trial found that CCTA-guided percutaneous coronary intervention was noninferior to IVUS-guided PCI for target-vessel failure at 12 months. A separate TRANSFORM II trial found a sirolimus-coated balloon noninferior to everolimus drug-eluting stents in native coronary arteries.

Why it matters

The findings suggest that less invasive imaging guidance may achieve outcomes similar to intravascular ultrasound, and that drug-coated balloons may offer an alternative to stents for certain patients. Results were published and presented at TCT 2026.

Both trials were randomized controlled studies, with the P4 trial reporting 4.1% versus 4.6% target-vessel failure at 12 months across 1,105 patients and TRANSFORM II reporting 2.1% versus 2.4% target-lesion failure among 1,842 patients. The extraction does not address outcomes beyond one year.

The details

The P4 trial randomized 1,105 patients, with a median age of 65 years and nearly 22% women, to CCTA-guided or IVUS-guided PCI. TRANSFORM II enrolled 1,842 patients from 53 sites across Europe, Southeast Asia and Brazil between December 2021 and June 2025, comparing sirolimus-coated balloons with everolimus drug-eluting stents after successful lesion preparation.

Timeline

  1. TRANSFORM II enrollment ran from December 2021 to June 2025.

  2. P4 primary endpoint was assessed at 12 months.

  3. Results were published and presented at TCT 2026 on November 1, 2026.

Health Landscape

These trials add comparative evidence on how coronary interventions are guided and which device strategies achieve similar outcomes. The results inform ongoing choices between imaging-guided approaches and alternatives to drug-eluting stents.

Patients undergoing coronary stenting may encounter different imaging guidance or device options depending on center practice. The trials suggest that discussions with cardiologists about imaging and device choice can consider these comparable outcome data.

The takeaway

Patients and clinicians may consider that CCTA guidance and sirolimus-coated balloons produced outcomes comparable to established methods in these trials. Decisions should account for individual anatomy and specialist advice.

Further reading

Explore more coverage in Heart Disease.