Table 2.
Key Clinical Data of IVUS vs Angiography-Guided PCI
| Study (IVUS vs Angiography) | Sample Size (IVUS vs Angiography) | Study Population | Center (Country) | Followed Duration, mo |
Primary and Key Secondary Endpoints (IVUS vs Angiography) | Definite or Probable Stent Thrombosis (IVUS vs Angiography) |
|---|---|---|---|---|---|---|
| Multicenter randomized trial regarding IVUS- vs angiography-guided PCI | ||||||
| CTO-IVUS7 2015 | 201 vs 201 | CTO lesion | 20 (Korea) | 12 | aMACE(CD/MI/TVR): 2.6% vs 7.1% (HR: 0.35; 95% CI: 0.13-0.97) | 0.5% vs 1.0% (P = 0.11) |
| IVUS-XPL2 2015 | 700 vs 700 | Long lesion (Stent ≥ 28 mm) | 20 (Korea) | 12 |
aMACE(CD/TL-MI/ID-TLR): 2.9% vs 5.8% (HR: 0.48; 95% CI: 0.28-0.83) ID-TLR: 2.5% vs 5.0% (HR: 0.51; 95% CI: 0.28-0.91) |
0.3% vs 0.3% (HR: 1.00; 95% CI: 0.14-7.10) |
| ULTIMATE8 2018 | 722 vs 722 | All comers | 8 (China) | 12 | aTVF(CD/TV-MI/ID-TVR): 2.9% vs 5.4% (HR: 0.53; 95% CI: 0.31-0.90) | 0.1% vs 0.7% (HR: 0.20; 95% CI: 0.02-1.70) |
| IVUS-XPL (extended)9 2020 | 589 vs 594 | Long lesion (Stent ≥ 28 mm) | 20 (Korea) | 60 |
aMACE(CD/TL-MI/ID-TLR): 5.6% vs 10.7% (HR: 0.50; 95% CI: 0.34-0.75) ID-TLR: 4.8% vs 8.4% (HR: 0.54; 95% CI: 0.33-0.89) |
0.3% vs 0.3% (HR: 1.00; 95% CI: 0.14-7.10) |
| ULTIMATE (extended)10 2021 | 714 vs 709 | All comers | 8 (China) | 36 |
aTVF(CD/TV-MI/ID-TVR): 6.6% vs 10.7% (HR: 0.60; 95% CI: 0.42-0.87) ID-TLR: 3.8% vs 6.3% (HR: 0.59; 95% CI: 0.36-0.94) |
0.1% vs 1.1% (HR: 0.12; 95% CI: 0.02-0.99) |
| IVUS-ACS11 2024 | 1,753 vs 1,752 | ACS | 58 (Global) | 12 |
aTVF(CD/TV-MI/ID-TVR): 4.0% vs 7.3% (HR: 0.55; 95% CI: 0.41-0.74) TV-MI: 2.5% vs 3.8% (HR: 0.63; 95% CI: 0.43-0.92) ID-TVR: 1.4% vs 3.2% (HR: 0.44; 95% CI: 0.27-0.72) |
0.6% vs 0.9% (HR: 0.82; 95% CI: 0.35-1.90) |
| Cohort or registry data regarding IVUS- vs angiography-guided PCI | ||||||
| Choi et al12 2019 | 1,674 vs 4,331 | Complex lesions | Single center (Korea) | 64 | aCD: 10.2% vs 16.9% (HR: 0.57; 95% CI: 0.46-0.71) | 3.1% vs 4.4% (HR: 0.60; 95% CI: 0.41-0.86) |
| BCIS database13 2020 | 6,208 vs 5,056 | ULMCA | 113 (England & Wales) | 12 | aDeath: 8.9% vs 12.9% (OR: 0.66; 95% CI: 0.57-0.77) | |
| MAIN-COMPARE (subgroup)14 2021 | 756 vs 219 | ULMCA | 12 (Korea) | 143 |
aDeath: 16.4% vs 31.0% (HR: 0.73; 95% CI: 0.53-1.02) MACE (death/Q-MI/stroke): 19.2% vs 32.9% (HR 0.71; 95% CI: 0.52-0.97) |
|
| KAMIR-NIH16 2022 | 1,887 vs 7,120 | AMI | 20 (Korea) | 36 |
aTLF(CD/TV-MI/ID-TLR):4.8% vs 8.0% (HR: 0.59; 95% CI: 0.47-0.73) CD: 3.1% vs 5.5% (HR: 0.56; 95% CI: 0.42-0.73) TV-MI: 0.6% vs 1.2% (HR: 0.46; 95% CI: 0.25-0.86) |
0.4% vs 0.8% (HR: 0.42; 95% CI: 0.19-0.92) |
| ULTIMATE (subgroup)17 2019 | 180 vs 169 | CKD | 8 (China) | 12 | aTVF(CD/TV-MI/ID-TVR): 3.9% vs 10.7% (HR: 0.35; 95% CI: 0.15-0.84) | 0.0% vs 1.2% (P = 0.14) |
ACS = acute coronary syndrome; AMI = acute myocardial infarction; BCIS = British Cardiovascular Intervention Society; CD = cardiac death; CKD = chronic kidney disease; CTO = chronic total occlusion; CTO-IVUS = Chronic Total Occlusion Intervention With Drug-eluting Stents; ID-TLR = ischemic-driven target-lesion revascularization; ID-TVR = ischemic-driven target-vessel revascularization; IVUS = intravascular ultrasound; IVUS-ACS = Intravascular Ultrasound-Guided Versus Angiography-Guided Percutaneous Coronary Intervention in Acute Coronary Syndromes; IVUS-XPL, Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions; KAMIR-NIH = Korea Acute Myocardial Infarction-National Institutes of Health; MACE = major adverse cardiac event(s); MAIN-COMPARE = Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization; MI = myocardial infarction; PCI = percutaneous coronary intervention; Q-MI = Q-wave myocardial infarction; TLF = target-lesion failure; TL-MI = target-lesion myocardial infarction; TVF = target-vessel failure; TV-MI = target-vessel myocardial infarction; ULMCA = unprotected left main coronary artery; ULTIMATE = Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions.
Indicates the primary endpoint.