Table 2 Summary of clinical trials investigating the benefits of intravascular imaging-guided PCI in ACS patients
Trial | Year | Study Design | Study Population | Comparison | IVI criteria for optimal PCI | Follow-up | Primary endpoint and results |
|---|---|---|---|---|---|---|---|
OCTACS108 | 2015 | RCT | NSTEMI | OCT (n = 40) vs. Angio (n = 45) | • Relative stent expansion of >90% (MSA divided by distal/proximal reference lumen area) • No malapposition with ≥3 struts per cross-sectional area with axial distance >140 μm • No stent edge dissection (causing a MLA < 4 mm2) • Residual stenosis (causing a MLA < 4 mm2) | 6-month OCT follow-up | • Strut coverage (1) Percentage of uncovered struts: 4.3% vs. 9.0%, p < 0.01 (2) Percentage of completely covered stents: 17.5% vs. 2.2%, p = 0.02 |
DOCTORS109 | 2016 | RCT | NSTE-ACS | OCT (n = 120) vs. Angio (n = 120) | • Relative stent expansion of >90% (MSA divided by distal/proximal reference lumen area) • No stent edge dissection | NA | • Post-PCI FFR: 0.94 ± 0.04 versus 0.92 ± 0.05, P = 0.005 |
Kala et al.110 | 2018 | RCT | STEMI | OCT (n = 105) vs. Angio (n = 96) | • Relative stent expansion of >80% (MSA divided by average reference lumen area) or >90% (MSA divided by distal reference lumen area) • No significant malapposition • No stent edge dissection | 9-month OCT and clinical follow-up | • OCT-detected in-stent area stenosis: 6% vs. 18%, p = 0.0002 • MACE: 3% vs. 2%, p = 0.87 |
COREA-AMI112 | 2021 | Retro | ACS | IVUS (n = 2,032) vs. Angio (n = 7,814) | No dedicated criteria for IVUS-guided PCI | 4-year follow-up | • MACE: 15.3% vs. 19.0%, p < 0.001 |
KAMIR-NIH113 | 2022 | Retro | ACS | IVUS (n = 1,887) vs. Angio (n = 7,120) | No dedicated criteria for IVUS-guided PCI | 3-year follow-up | • Target lesion failure: 4.8% vs. 8.0%, p < 0.001 |
KAMIR-NIH114 | 2023 | Retro | ACS | IVUS (n = 879) vs. Angio (n = 3,191) | No dedicated criteria for IVUS-guided PCI | 3-year follow-up | • Target lesion failure: 6.7% vs. 12.0%, p < 0.001 |
IVUS-ACS7 | 2024 | RCT | ACS | IVUS (n = 105) vs. Angio (n = 96) | For non-left main coronary arteries: • MSA > 5.0 mm2 or relative stent expansion of >80% (MSA divided by distal reference lumen area) • Residual PB < 55% within 5 mm proximal or distal to the stent edge • The absence of dissection over 3 mm in length For left main coronary arteries: • MSA > 10 mm² for the left main segment, > 7 mm² for the ostial or proximal LAD, and > 6 mm² for the ostial or proximal LCx | 1-year clinical follow-up | • Target vessel failure: 4.0% vs. 7.3%, p = 0.0001 |
KAMIR-NIH and KAMIR-V115 | 2024 | Retro | ACS | OCT (n = 535) vs. IVUS (n = 4,725) | No dedicated criteria for imaging-guided PCI | 1-year follow-up | • Target lesion failure: 2.1% vs. 3.4%, p = 0.11 |
OPINION ACS111 | 2024 | RCT | ACS | OCT (n = 70) vs. IVUS (n = 69) | • Relative stent expansion of >80% (MSA divided by the mean reference lumen area) • Incomplete stent apposition | 8-month OCT follow-up | •In-stent MLA: 4.91 (4.53-5.30) mm2 vs. 4.76 (4.35-5.17) mm2, p for non-inferiority <0.001 |
