Table 5.
Clinical Data of Intravascular Guidance by Lesion and Patients Subsets
| Study | Study Type | Study Population | Followed Duration, mo |
Primary Endpoint (Imaging vs Angiography) |
|---|---|---|---|---|
| Unprotected left main coronary artery disease | ||||
| NOBLE29 2020 | RCT subgroup | Post-PCI IVUS (n = 435) vs No post-PCI IVUS (n = 164) | 12 | TLR: 5.1% vs 11.6% (HR: 0.44; 95% CI: 0.24-0.82) |
| BCIS database13 2020 | Registry | Imaging (n = 5056) vs Angiography (n = 6208) | 12 | Death: 8.9% vs 12.9% (OR: 0.66; 95% CI: 0.57-0.77) |
| MAIN-COMPARE (subgroup)14 2021 | Registry | IVUS (n = 756) vs Angiography (n = 219) | 143 | MACE(Death/Q-MI/stroke): 22.2 vs 30.3% (HR: 0.71; 95% CI: 0.52-0.97) |
| RENOVATE-COMPLEX-PCI (substudy)30 2023 | RCT | Imaging (n = 138) vs angiography (n = 54) | 25 | TVF(CD/TV-MI/ID-TVR): 6.8% vs 25.1% (HR: 0.31; 95% CI: 0.13-0.76) |
| LEMON31 2021 | Pilot Study |
OCT-guided LM PCI (n = 70) | — | Procedural success: 86%a |
| Diffuse long lesions | ||||
| IVUS-XPL2 2015 | RCT | IVUS (n = 700) vs Angiography (n = 700) | 12 | MACE(CD/TL-MI/ID-TLR): 2.9% vs 5.8% (HR: 0.48; 95% CI: 0.28-0.83) |
| Merged IVUS-XPL and ULTIMATE32 2022 | Pooled analysis | IVUS (n = 1289) vs Angiography (n = 1,288) | 36 | CD: 1.0% vs 2.2% (HR: 0.43; 95% CI: 0.22-0.84) |
| RENOVATE-COMPLEX-PCI23 2023 | RCT subgroup | Imaging (n = 617) vs Angiography (n = 281) | 25 | TVF(CD/TV-MI/ID-TVR): 6.5% vs 11.9% (HR: 0.52; 95% CI: 0.32-0.83) |
| ILUMIEN IV22 2023 | RCT subgroup | OCT (n = 853) vs Angiography (n = 824) | 24 | TVF(CD/TV-MI/ID-TVR): 6.4% vs 7.9% (HR: 0.81; 95% CI: 0.56-1.16) |
| Chronic total occlusion lesions | ||||
| CTO-IVUS7 2015 | RCT | IVUS (n = 201) vs Angiography (n = 201) | 12 | MACE(CD/MI/TVR): 2.6% vs 7.1% (HR: 0.35; 95% CI: 0.13-0.97) |
| Calcified lesions | ||||
| IVUS-derived calcium score35 2021 | In superficial calcium >270°, 1) ≥5mm length; 2) 360° of calcium; 3) calcified nodule; 4) vessel size <3.5 mm | Cutoff value of stent expansion <70%: calcium score ≥2 | ||
| OCT-based calcium score39 2018 | 1) >180° of calcium (2 point); 2) >0.5 mm of calcium thickness (1 point); ≥5mm length (1 point) | Stent expansion at target-lesion calcium: 96% (score 0-3) vs 78% (score 4) (P < 0.01) | ||
| Bifurcation lesions | ||||
| COBIS40 2011 | Registry | IVUS (n = 487) vs Angiography (n = 487) | 36 | MACE(Death/MI): 3.8% vs 7.8% (HR: 0.44; 95% CI: 0.12-0.96) |
| Kim et al.41 2010 | Registry | IVUS (n = 473) vs Angiography (n = 285) | 48 | Death: 0.4% vs 3.6% (HR: 0.17; 95% CI: 0.04-0.81) |
| OCTOBER3 2023 | RCT | OCT (n = 600) vs Angiography (n = 601) | 24 | MACE(CD/TL-MI/ID-TLR): 10.1% vs 14.1% (HR: 0.70; 95% CI: 0.50-0.98) |
| In-stent restenosis lesions | ||||
| iOPEN-ISR45 2021 | Registry | IVUS (n = 1,003) vs Angiography (n = 519) | 12 | MACE(Death/Q-MI/TVR): 18.0% vs 24.5% (HR: 0.77; 95% CI: 0.60-0.98) |
| RESTENT-ISR46 2016 | RCT | EES (n = 158) vs ZES (n = 146) | 36 | Neointimal volume on 9-month IVUS: 0.51 vs 0.56 mm3/1 mm (EES vs ZES) (P = 0.47) MACE(Death/MI/TLR/ST): 15.8% vs 22.6% (EES vs ZES) (P = 0.276) |
| Acute myocardial infarction | ||||
| KAMIR-NIH16 2022 | Registry | IVUS (n = 1,887) vs Angiography (n = 7,120) | 36 | TLF(CD/TV-MI/ID-TLR): 4.8% vs 8.0% (HR: 0.59; 95% CI: 0.47-0.73) |
COBIS = Coronary Bifurcation Stenting; iOPEN-ISR = intravascular ultrasound on Outcomes following PErcutaneous coronary interventioN for In-stent Restenosis; LEMON = Left Main OCT-Guided Interventions; NOBLE = Nordic-Baltic-British Left Main Revascularization; QCA = quantitative coronary angiography; RESTENT-ISR = Prospective, Single-blinded, Randomized Comparison of the Clinical and Angiographic Results With Intravascular Analysis of Everolimus-Eluting Versus Zotarolimus-Eluting Stents for In-Stent Restenosis Lesions: Volumetric Analysis With Intravascular Ultrasound: Phase IV Multicenter Trial; ZES = zotarolimus-eluting stent(s); other abbreviations as in Table 1, Table 2, Table 3, Table 4.
Procedural success defined as TIMI flow grade 3 in all vessels + residual stenosis <50% by QCA + adequate stent expansion (MSA ≥80% of reference minimal luminal area in both proximal and distal stent sections, respectively).