Validation of Intravascular Ultrasound–Defined Optimal Stent Expansion Criteria for Favorable 1-Year Clinical Outcomes

Abstract

Background: Robust evidence on optimal stent expansion using intravascular ultrasound (IVUS) is still lacking.

Objectives: The aim of this study was to validate the impact of different criteria for IVUS-defined optimal stent expansion on 1-year clinical outcomes after percutaneous coronary intervention (PCI).

Methods: Individual patient data from 3 randomized trials were aggregated for this analysis. Patients (n = 6,290) were classified into 3 groups: optimized PCI by IVUS, nonoptimized PCI by IVUS, and angiography-guided PCI. The primary endpoint was target vessel failure (TVF) at 1 year, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization.

Results: Angiography-guided PCI was performed in 3,208 patients. Optimal stent expansion was evaluated in 3,082 patients with IVUS-guided PCI. For the absolute criterion of minimal stent area (MSA) >5.5 mm2 indicating optimal stent expansion, the optimized PCI group had a lower incidence of TVF (1.45% vs 3.86% vs 5.07%) compared with the nonoptimized PCI group (adjusted HR: 0.45; 95% CI: 0.26-0.75; P = 0.002) and the angiography-guided PCI group (adjusted HR: 0.35; 95% CI: 0.22-0.54; P < 0.001). Relative criteria did not show a significantly different TVF incidence between the optimized and nonoptimized PCI groups. In particular, the absolute criterion of MSA >5.5 mm2 was associated with a significant reduction of the composite of cardiac death or target vessel myocardial infarction (0.54% in the optimized PCI group vs 1.59% in the nonoptimized PCI group; adjusted HR: 0.39; 95% CI: 0.17-0.91; P = 0.028).

Conclusions: Post-PCI stent expansion meeting an absolute criterion of MSA >5.5 mm2 was associated with the most favorable clinical outcomes. (Effect of Intravascular Ultrasound in Patients Receiving Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents: An Individual Patient Data Meta-Analysis of IVUS-XPL, ULTIMATE and IVUS-ACS Randomized Trials; CRD42024559794).