Table 1 Summary characteristics of the included RCTs
Study | Study design | Country | Total participants | Intervention | Control | MACE definition | Stent type | Primary outcome | Follow-up duration | Â |
|---|---|---|---|---|---|---|---|---|---|---|
Prospective, multi-center, single-blind, RCT | USA, Belgium, Germany, Italy, Japan, Netherlands, Spain, and UK | 450 | OCT-guided PCI and IVUS-guided PCI | Angiography-guided PCI | Composite of death, MI, stent thrombosis, or repeat revascularisation | DES | Final minimum stent area (MSA) | One year. | Â | |
Ali et al. 2023 (ILUMIEN IV)[18] | Prospective, multi-center, single-blind, RCT | Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Netherlands, New Zealand, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, UK, USA | 2487 | OCT-guided PCI | Angiography-guided PCI | NA | DES | Target-vessel failure | Two years | Â |
Antonsen et al. 2015 (OCTACS)[19] | Prospective, single-center, RCT | Denmark | 100 | OCT-guided PCI | Angiography-guided PCI | NA | DES | Assess the percentage of uncovered struts and the presence of acute malapposition | Six months. | Â |
Chamié et al. 2021 (The iSIGHT)[20] | Prospective, single-center, RCT | Brazil | 150 | OCT-guided PCI and IVUS-guided PCI | Angiography-guided PCI | Composite of cardiac death, nonfatal MI, and target lesion revascularization. | DES | The non-inferiority of postprocedure stent expansion, defined as minimum stent area (MSA) divided by the average lumen area of the distal and proximal references | Two years |  |
Chieffo et al. 2013 (AVIO)[21] | Prospective, multi-center, RCT | UK | 284 | IVUS-guided PCI | Angiography-guided PCI | Composite of any MI, cardiac death, and target vessel revascularization (TVR). | DES | Post-procedural in-lesion minimum lumen diameter (MLD) was evaluated using core laboratory quantitative coronary angiography (QCA). | Two years | Â |
Fallesen et al. 2022 (HONEST)[22] | Prospective, single-center, RCT | Denmark | 75 | OCT-guided PCI | Angiography-guided PCI | NA | BVS | Rate of in-scaffold late lumen loss (LLL) at six months | Six months. | Â |
Frey et al. 2000 (SIPS)[23] | Prospective, single-center, RCT | Germany | 269 | ICUS-Guided Group | Angio-Guided Group | Composite of all revascularization procedures (re-PTCA and CABG), myocardial infarction, and deaths | BMS | 6-month angiographic minimal lumen diameter (MLD) | Two years | Â |
Prospective, multi-center, RCT | China | 1448 | IVUS-guided PCI | Angiography-guided PCI | NA | DES | Occurrence of TVF at three years after the index procedure, which included cardiac death, target vessel MI (TVMI), and clinically driven target vessel revascularization (TVR) | Three years | Â | |
Prospective, single-center, RCT | Denmark | 108 | IVUS-guided PCI | Angiography-guided PCI | Composite of death, Q wave AMI, or revascularisation procedures. | BMS | MACE rate | 2.5 years (0.6–3.8 years, 25th and 75th centiles). |  | |
Gil et al. 2007 (DIPOL)[27] | Prospective, multi-center, RCT | Poland | 259 | IVUS-guided PCI | Angiography-guided PCI | Composite of death, myocardial infarction, and repeat coronary revascularization [RCR]) that occurred at six months. | BMS | MACE rate | Six months. | Â |
Habara et al. 2012[28] | Prospective, single-center, RCT | Japan | 70 | IVUS-guided PCI | OCT-guided PCI | NA | DES and BMS | Stent expansion was analyzed by IVUS. | NA | Â |
Holm et al. 2023 (OCTOBER)[29] | Prospective, multi-center, RCT | Denmark | 1201 | OCT-guided PCI | Angiography-guided PCI | Composite of death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. | DES | MACE rate | Two years | Â |
Prospective, multi-center, RCT | Korea | 1400 | IVUS-guided PCI | Angiography-guided PCI | Composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at one year | DES | MACE rate | Five years | Â | |
Jakabcin et al. 2010 (HOME DES IVUS)[32] | Prospective, single-center, RCT | Czech | 210 | IVUS-guided PCI | Angiography-guided PCI | Composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) | DES | NA | 18 months. | Â |
Jia et al. 2022 (EROSION III)[33] | Prospective, multi-center, RCT | China | 226 | OCT-guided PCI | Angiography-guided PCI | Composite of cardiac death, Recurrent MI, TLR, malignant arrhythmia, unstable angina-induced rehospitalization, and stroke; | BVS | Patient-level rate of stent implantation, cardiac death, recurrent MI, TLR, and unstable angina-induced rehospitalization within one month. | One year | Â |
Kala et al. 2018 (ROBUST)[34] | Prospective, multi-center, RCT | Czech | 201 | OCT-guided PCI | Angiography-guided PCI | Composite of death, myocardial infarction [MI], and target lesion revascularization [TLR] | DES | MACE rate | Nine months | Â |
Kang et al. 2023 (OCTIVUS)[35] | Prospective, multi-center, RCT | Korea | 2008 | IVUS-guided PCI | OCT-guided PCI | NA | DES | Target-vessel failure (a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) | One year | Â |
Kim et al. 2013 (RESET)[36] | Prospective, multi-center, RCT | Korea | 543 | IVUS-guided PCI | Angiography-guided PCI | Composite of cardiovascular death, myocardial infarction, target vessel revascularization, or stent thrombosis at one year following intervention | DES | MACE rate | One year | Â |
Kim et al. 2015 (CTO-IVUS)[37] | Prospective, multi-center, RCT | Korea | 402 | IVUS-guided PCI | Angiography-guided PCI | Composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up | DES | Cardiac death. | One year | Â |
Kim et al. 2015[38] | Prospective, single-center, RCT | Korea | 101 | OCT-guided PCI | Angiography-guided PCI | Composite of cardiac death, nonfatal myocardial infarction, or patients requiring target lesion revascularization. | DES | the percentage of uncovered struts in the 6-month follow-up OCT assessments. | One year | Â |
Kubo et al. 2017 (OPINION)[39] | Prospective, multi-center, RCT | Japan | 817 | IVUS-guided PCI | OCT-guided PCI | Composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization | DES | Target vessel failure | One year | Â |
Lee et al. 2020[40] | Prospective, multi-center, RCT | Korea | 176 | OCT-guided PCI | Angiography-guided PCI | NA | DES | minimal scaffold area < 5 mm2, residual area stenosis > 20%, percent ISA struts > 5%, major edge dissection, or scaffold disruption. | NA |  |
Lee et al. 2023 (RENOVATE-COMPLEX-PCI)[41] | Prospective, multi-center, RCT | Korea | 1639 | IVUS-guided PCI | Angiography-guided PCI | NA | DES | Target vessel failure | Two years. | Â |
Liu et al. 2018[42] | Prospective, single-center, RCT | China | 336 | IVUS-guided PCI | Angiography-guided PCI | Composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). | DES | MACE rate | One year | Â |
Prospective, single-center, RCT | Brazil | 83 | IVUS-guided PCI | Angiography-guided PCI | NA | DES | the total volume contrast, Cardiovascular events agent used during PCI. | One year | Â | |
Meneveau et al. 2016 (DOCTORS)[45] | Prospective, multi-center, RCT | France | 240 | OCT-guided PCI | Angiography-guided PCI | NA | BMS/DES | Fractional flow reserve (FFR) | Six months | Â |
Mudra et al. 2001 (OPTICUS)[46] | Prospective, multi-center, RCT | Germany, Spain, Sweden, Italy, Greece, France, Netherlands, United Kingdom, Belgium, and Israel | 550 | ICUS-guided PCI | Angiography-guided PCI | Composite of death, myocardial infarction, coronary bypass surgery, and repeat percutaneous intervention | BMS | The incidence of angiographic restenosis (0.50% lumen diameter reduction), minimal lumen diameter, and percent diameter stenosis after 6 months. | One year | Â |
Muramatsu et al. 2020 (MISTIC-1)[47] | Prospective, multi-center, RCT | Japan | 109 | IVUS-guided PCI | OCT-guided PCI | Composite of cardiovascular mortality, target-vessel myocardial infarction, or clinically driven target-lesion revascularization. | DES | in-segment minimum lumen area assessed using OFDI at eight months and MACE rate | Three years | Â |
Oemrawsingh et al. 2003 (TULIP)[48] | Prospective, single-center, RCT | Netherlands | 150 | IVUS-guided PCI | Angiography-guided PCI | NA | BMS | 6-month minimal lumen diameter (MLD) and the combined end point of death, myocardial infarction, and target-lesion revascularization (TLR). | Six months | Â |
Russo et al. 2009 (AVID)[49] | Prospective, multi-center, RCT | USA | 800 | IVUS-guided PCI | Angiography-guided PCI | NA | BMS | target lesion revascularization at 12 months | One year | Â |
Schiele et al. 1998 (The RESIST)[50] | Prospective, multi-center, single-blind, RCT | France | 155 | IVUS-guided PCI | Angiography-guided PCI | NA | BMS | the 6-month restenosis rate, defined as 0.50% narrowing at the stent site or 5Â mm proximal or distal to the stent, as assessed by QCA | Six months. | Â |
Schneider et al. 2021 (OPTICO‑integration II)[51] | Prospective, single-center, RCT | Germany | 56 | OCT-guided PCI | Angiography-guided PCI | NA | NA | composite imaging endpoint, including major edge dissections and/or LGM as assessed by post-procedural OCT | NA |  |
Tan et al. 2015[52] | Prospective, single-center, RCT | China | 123 | IVUS-guided PCI | Angiography-guided PCI | Composite of death, non-fatal myocardial infarction, and target lesion revascularization (TLR). | DES | MACE rate | Two years | Â |
Tian et al. 2015 (AIR-CTO)[53] | Prospective, multi-center, RCT | China | 230 | IVUS-guided PCI | Angiography-guided PCI | NA | DES | late lumen loss (LLL) at 12 months | Two years | Â |
Ueki et al. 2020 (OPTICO BVS)[54] | Prospective, multi-center, RCT | Switzerland | 38 | OCT-guided PCI | Angiography-guided PCI | NA | BVS | in-scaffold minimal lumen area (MLA) at 6-month | One year | Â |
Wang et al. 2015[55] | Prospective, single-center, RCT | China | 80 | IVUS-guided PCI | Angiography-guided PCI | Composite of refractory myocardial ischemia, second target vessel reconstruction, new AMI, and cardiac death. | NA | MACE rate | One year | Â |