Table 4.
Key Clinical Data of Intravascular Imaging-Guided PCI
| Study | Study Type | Sample Size (Imaging vs Angiography) or (OCT vs IVUS) | Study Population | Center (Country) | Followed Duration, mo | Primary and Key Secondary Endpoints |
|---|---|---|---|---|---|---|
| Intravascular imaging- vs angiography-guided PCI | Imaging vs Angiography | |||||
| RENOVATE-COMPLEX-PCI23 2023 | Random | 1,092 vs. 547 Imaging (IVUS, 74%; OCT, 26%) vs Angio |
Complex lesions | 20 (Korea) | 25 |
aTVF(CD/TV-MI/ID-TVR): 7.7% vs 12.3% (HR: 0.64; 95% CI: 0.45-0.89) CD: 1.7% vs 3.8% (HR: 0.47; 95% CI: 0.24-0.93) |
| OCT-guided vs IVUS-guided PCI | OCT vs IVUS | |||||
| OPINION24 2017 | Random | 412 vs 405 | Stable or unstable angina | 42 (Japan) | 12 |
aTVF(CD/TV-MI/ID-TVR): 5.2% vs 4.9% (HR: 1.07; 95% CI: 0.24-1.80) In-stent restenosis on 8-month angiogram: 1.6% vs 1.6% |
| MISTIC-125 2020 | Random | 54 vs 55 | Stable angina | 2 (Japan) | 12 |
aIn-stent MLA on 8-month OCT: 4.56 mm2 vs 4.13 mm2 TLF (CD/TV-MI/TLR): 7.4% vs 7.3% (HR: 1.05; 95% CI: 0.26-4.18) |
| OCTIVUS26 2023 | Random | 1,005 vs 1,003 | Stable angina or NSTE-ACS | 9 (Korea) | 12 |
aTVF(CD/TV-MI/ID-TVR): 2.5% vs 3.1% (HR: 0.80; 95% CI: 0.47-1.36) Contrast-induced nephropathy: 1.4% vs 1.5% (OR: 0.93; 95% CI: 0.45-1.91) Procedure-related complications requiring active intervention: 2.2% vs 3.7% (P = 0.003) |
| OCTIVUS (substudy)27 2023 | Random | 719 vs 756 | Complex lesions | 9 (Korea) | 24 |
aTVF(CD/TV-MI/ID-TVR): 6.5% vs 7.4% (HR: 0.87; 95% CI: 0.59-1.29) Procedure-related complications requiring active intervention: 1.7% vs 3.4% (P = 0.03) |
| RENOVATE-COMPLEX PCI (substudy)28 2023 | Random | 278 vs 800 | Complex lesions | 20 (Korea) | 25 |
aTVF(CD/TV-MI/ID-TVR): 5.8% vs 8.0% (HR: 0.72; 95% CI: 0.41-1.26) Contrast-induced nephropathy: 0.7% vs 3.0% (HR: 0.36; 95% CI: 0.09-1.54) |
| Merged KAMIR-NIH and KAMIR V55 2024 | Registry | 535 vs 4,725 | AMI | 43 (Korea) | 12 | aTLF(CD/TV-MI/ID-TLR): 2.1% vs 3.4% (HR: 0.61; 95% CI: 0.33-1.12) |
AMI = acute myocardial infarction; CCS = chronic coronary syndrome; CD = cardiac death; ID-TLR = ischemic-driven target-lesion revascularization; ID-TVR = ischemic-driven target-vessel revascularization; KAMIR-NIH = Korea Acute Myocardial Infarction-National Institutes of Health; MISTIC-1 = The Multimodality Imaging Study in Cardiology Cohort 1; MLA = minimal lumen area; NSTE-ACS = non–ST-segment elevation acute coronary syndrome; OCTIVUS = Optical Coherence Tomography versus Intravascular Ultrasound-Guided Percutaneous Coronary Intervention; OPINION = Optical Frequency Domain Imaging vs. Intravascular Ultrasound in Percutaneous Coronary Intervention; PCI = percutaneous coronary intervention; RENOVATE-COMPLEX PCI = Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes after Complex Percutaneous Coronary Intervention; ST = stent thrombosis; TLF = target-lesion failure; TLR = target-lesion revascularization; TVF = target-vessel failure; TV-MI = target-vessel myocardial infarction.
Indicates primary endpoint.