Three landmark trials from ACC.26 and late 2025 that redefine patient selection, imaging guidance, and outcomes in complex PCI.
Journal of the American College of Cardiology · 2026 · Khan S, Sajjad U, Fawaz S, Butt H, Simpson R, Ibrahim A, ..., Brilakis ES, Al-Lamee R, Keeble TR, Davies JR. Essex Cardiothoracic Centre / Mid and South Essex NHS.
50 patients with symptomatic single-vessel CTO and no bystander disease randomized to CTO PCI (n=25) vs. sham (n=25), Oct 2021–Oct 2025. Anti-anginal medications stopped at randomization, re-introduced patient-initiated. Primary endpoint: angina symptom score (ordinal: ORBITA-app daily burden + anti-anginal use + override events) at 6 months. CTO PCI improved angina symptom score (OR 4.38, 95% CrI 1.57–12.69, Pr[Benefit]=0.996), yielding 30.6 additional angina-free days (95% CrI 11.1–50.7). SAQ angina frequency also improved. Blinding via auditory isolation and deep conscious sedation.
The blinded RCT the field has needed since the original ORBITA (2017). The OR 4.38 is large and the Bayesian Pr[Benefit]=0.996 leaves little room for doubt about direction. Critical caveats: n=50, strict single-vessel selection, no bystander disease, anti-anginals stopped — this is a best-case scenario population. The endpoint is symptom-driven, not MACE. Do not extrapolate to post-CABG, multi-vessel, or asymptomatic CTOs. The trial validates patient selection as the defining variable in CTO PCI — right patient, right result.
Journal of the American College of Cardiology · 2026 · Gao X, Kan J, Chen Y, et al.
556 patients with complex coronary bifurcation undergoing DK crush, randomized to IVUS-guided (n=278) vs. angiography-guided (n=278) PCI at 24 centers in China. At 1 year, TVF: 6.1% vs. 14.7% (HR 0.40; 95% CI 0.23–0.71; p=0.0016). Reductions across components: target vessel MI (4.3% vs. 9.4%), spontaneous MI (1.8% vs. 6.1%), TVR (2.9% vs. 7.6%).
The largest effect size for IVUS vs. angiography in any complex PCI trial to date — TVF cut by 58%. The mechanism is well understood: IVUS catches incomplete expansion and malapposition at the carina and ostial SB after the crush, which angiography systematically misses. For any two-stent bifurcation strategy, IVUS guidance is no longer optional. This trial closes that debate.
JACC: Cardiovascular Interventions · 2025
Pre-specified imaging analysis within the ECLIPSE trial (n=2,005; orbital atherectomy vs. balloon angioplasty in severely calcified lesions). IVI used in 62.1% (OCT 819, IVUS 513 patients). IVI-guided PCI associated with significantly lower 1-year TVF vs. angiography guidance, regardless of vessel preparation method (OA or BA). Benefit consistent across subgroups.
First RCT-level evidence that imaging guidance specifically improves outcomes in severely calcified lesions — beyond the general complex PCI imaging literature. The heavier use of OCT vs. IVUS reflects calcium arc, depth, and fracture assessment advantages. Practical implication: after any calcium modification (rota, IVL, OA), imaging is mandatory before stenting. MSA targets and fracture confirmation are not optional in this lesion subset.
Commentary reflects personal clinical perspective and is not a substitute for independent clinical judgment. No industry sponsorship. No co-authorship conflict for papers in this issue.