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. 2024 Aug 20;4(9):639–656. doi: 10.1016/j.jacasi.2024.07.003

Table 6.

Key Clinical Data of Intravascular Imaging–Guided Stent Optimization

Study Imaging Modality
Study Type		 Study Population Optimization Criteria % Patients Meeting the Optimization Criteria of the Total Image-Guided Patients Followed Duration, mo Key Endpoint (Optimal PCI vs Suboptimal PCI)
IVUS-XPL2 2015 IVUS
Random		 Long lesion (Stent ≥28 mm) MSA ≥100% of the distal RLA 54% (363/700 patients) 12 MACE(CD/TL-MI/ID-TLR): 1.5% vs 4.6% (HR: 0.31; 95% CI: 0.11-0.86)
60 MACE(CD/TL-MI/ID-TLR): 4.0% vs 7.4% (HR: 0.48; 95% CI: 0.28-0.83)
ULTIMATE8 2018 IVUS
Random		 All comers
  • 1)

    MSA >5.0 mm2 or ≥90% of the distal RLA

  • 2)

    Plaque burden <50% at both reference segments

  • 3)

    Edge dissection involving only intima with a length ≤3.0 mm

 53% (384/724 patients) 12 TVF(CD/TV-MI/ID-TVR): 1.6% vs 4.4% (HR: 0.35; 95% CI: 0.14-0.90)
36 TVF(CD/TV-MI/ID-TVR): 4.2% vs 9.2% (HR: 0.44; 95% CI: 0.24-0.81)
Merged data of IVUS-XPL and ULTIMATE32 2022 IVUS
Pooled analysis		 Long lesion (Stent ≥28 mm) Optimization criteria according to each trial’s definition 52% (654/1,267 patients) 36 CD: 0.5% vs 1.5% (HR: 0.31; 95% CI: 0.08-1.15)
MACE(CD/MI/ST): 0.5% vs 2.2% (HR: 0.22; 0.06-0.75)
Merged data of 4 randomized trials61 2020 IVUS
Pooled analysis		 Long lesion (Stent ≥26 mm) or CTO MSA ≥4.5 mm2 or MSA ≥80% of mead RLA 41% (578/1,396) 12 MACE(CD/MI/ST/TVR): 1.9% vs 4.8% (HR: 0.34; 95% CI: 0.17-0.70)
CLI-OPCI II56 2015 OCT
Registry		 All comers
  • 1)

    MSA ≥4.5 mm2

  • 2)

    MSA ≥70% of the mean RLA

  • 3)

    RLA ≥4.5 mm2

  • 4)

    Malapposition ≤200 μm

  • 5)

    Edge dissection with flap width <200 μm

  • 6)

    Intrastent tissue protrusion <500 μm in thickness

 69% (679/984 lesions) 10.4 MACE(Death/MI/TLR): 7.1% vs 25.2% (HR: 0.23; 95% CI: 0.15-0.34)
IVUS-ACS11 2024 IVUS
Random		 ACS
  • 1)
    non-LM lesions
    • •
      MSA >5.0 mm2 or ≥90% of the distal RLA
    • •
      Plaque burden <55% at both reference segments
    • •
      Edge dissection involving only intima with a length ≤3.0 mm
  • 2)

    LM segment: MSA >10 mm2

  • 3)

    Ostial or proximal LAD: MSA >7 mm2

  • 4)

    Ostial or proximal LAD: MSA >6 mm2

 79.9% (1,392/1,743 patients) 12 TVF(CD/TV-MI/ID-TVR): 3.2% vs 7.1% (P < 0.001)

LAD = left anterior descending artery; LM = left main; MSA = minimal stent area; RLA = reference lumen area; other abbreviations as in Table 1, Table 2, Table 3, Table 4, Table 5.