Randomized Clinical Trails regarding IVUS vs. Angiography Guided PCI
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May, 2018"Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions: Endorsed by the Chinese Society of Cardiology"summarized RCT evidence regarding IVUS vs.angiography guided PCI.

Why the Comparision between IVUS and Angiography Guided PCI

Quote from "Intravascular imaging in coronary artery disease": Coronary angiography is the traditional imaging modality for visual evaluation of coronary anatomy and guidance of percutaneous coronary interventions (PCIs). However, the derived two-dimensional lumenogram cannot depict the arterial vessel wall, and thus evaluate vessel dimensions and plaque characteristics, nor directly assess the result of stent implantation. Intracoronary imaging by means of IVUS and OCT provides valuable incremental information that can be used clinically to optimize stent implantation and minimize stent-related problems."

Figure 1. Forrest plot summarizing the effects of intravascular ultrasound-guided percutaneous coronary intervention as compared with angiography-guided percutaneous coronary intervention on cardiovascular outcomes.

Trails Comparing IVUS vs. Angiography Guided PCI & Clinical Benefit in MACE

May, 2010 HOME DES IVUS - Long-term health outcome and mortality evaluation after invasive coronary treatment using drug eluting stents with or without the IVUS guidance Randomized control trial. HOME DES IVUS

Jan, 2013 AVIO - A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial

Apr, 2013 Kim et al. - Randomized comparison of clinical outcomes between intravascular ultrasound and angiography-guided drug-eluting stent implantation for long coronary artery stenoses

Apr,2015 AIR-CTO - Angiographic and clinical comparisons of intravascular ultrasound- versus angiography-guided drug-eluting stent implantation for patients with chronic total occlusion lesions: two-year results from a randomised AIR-CTO study

May, 2015 Tan et al.  - 2nd generation DES - Intravascular ultrasound-guided unprotected left main coronary artery stenting in the elderly

Jul, 2015 CTO-IVUS - chronic total occlusions - Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation: randomized study

Nov, 2015 IVUS-XPL - lesion length >28 mm - Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial

The IVUS-XPL contribute further its trail results as IVUS-guided PCI was superior at reducing major adverse cardiac events among patients undergoing drug-eluting stent implantation for long coronary lesions at TCT 2019. Among individuals undergoing PCI for long coronary lesions (the majority with stable angina), IVUS-guided PCI was superior at reducing adverse cardiac events compared with angiography-guided PCI. This benefit was due to a reduction in target lesion revascularization with the use of IVUS, which was sustained to 5 years of follow-up. Randomized trial data supports the routine use of IVUS during PCI. Observational studies have suggested a reduction in stent thrombosis with the use of IVUS. While this study did not support a reduction in stent thrombosis, IVUS did reduce future revascularization procedures. Outcomes were similar with 6 months of DAPT compared with 12 months of DAPT.

The primary outcome for IVUS-PCI vs. angio-PCI study

- cardiac death, MI, or target lesion revascularization at 1 year occurred in 2.9% of the IVUS-guided PCI group vs. 5.8% of the angiography-guided PCI group (p = 0.007).

Secondary outcomes for IVUS-PCI vs. angio-PCI study

• Cardiac death: 0.4% with IVUS-guided PCI vs. 0.7% with angiography-guided PCI
• MI: 0% with IVUS-guided PCI vs. 0.1% with angiography-guided PCI
• Target lesion revascularization: 2.5% with IVUS-guided PCI vs. 5.0% with angiography-guided PCI (p = 0.02)
• Definite/probable stent thrombosis: 0.3% with IVUS-guided PCI vs. 0.3% with angiography-guided PCI

The primary outcome for 6-month DAPT vs. 12-month DAPT study

- cardiac death, MI, stroke, or major bleeding occurred in 2.2% of the 6-month DAPT group vs. 2.1% of the 12-month DAPT group (p = 0.85).

Secondary outcomes for 6-month DAPT vs. 12-month DAPT study

• Stent thrombosis: 0.3% with 6-month DAPT vs. 0.3% with 12-month DAPT
• Major bleeding: 0.7% with 6-month DAPT vs. 1.0% with 12-month DAPT

Five-year outcomes

Cardiac death, MI, or target lesion revascularization at 5 years occurred in 5.6% of the IVUS-guided PCI group vs. 10.7% of the angiography-guided PCI group (p = 0.001). Ischemia-driven revascularization at 5 years occurred in 4.8% of the IVUS-guided PCI group vs. 8.4% of the angiography-guided PCI group (p = 0.007).

META-ANALYSIS Comparing IVUS vs. Angiography Guided PCI & Clinical Benefit in MACE

Nov, 2015 ACS patients or complex lesions (left main, bifurcation, CTO, or long lesions) - Comparison of intravascular ultrasound guided versus angiography guided drug eluting stent implantation: a systematic review and meta-analysis

Mar, 2017 complex coronay lesionns - Intravascular ultrasound-guided vs angiography-guided drug-eluting stent implantation in complex coronary lesions: Meta-analysis of randomized trials

Dec, 2017 Clinical Outcomes Following Intravascular Imaging-Guided Versus Coronary Angiography-Guided Percutaneous Coronary Intervention With Stent Implantation: A Systematic Review and Bayesian Network Meta-Analysis of 31 Studies and 17,882 Patients

“Several points require consideration when interpreting these findings. First, the fact that most individual RCTs with DES showed a directionally favourable trend but no significant superiority of routine IVUS guidance (despite achieving larger post-intervention stent dimensions) is likely explained by the limited power of the individual studies. The inclusion of non-complex lesions, and at least in part the absence of prespecified guidance protocol represent additional limitations. Indeed, significant MACE reduction was observed in studies assessing patients with long lesions and chronic total occlusions, as well as in metaanalyses of all available RCTs.Notwithstanding these benefits, the effects of the use of intracoronary imaging in an all comers setting remains to be established.”

"Notably, the pooled benefit emerged despite the fact that predefined stent optimization targets were not reached in many of the enrolled patients (Figure 2). It should also be noted that, although pre-specified expansion targets in imaging-guided PCI are not always achievable, it is reasonable to assume that these targets do guide operators in attempting to achieve the goals and potentially result in increasing minimum stent area (MSA). Whether a higher rate of acute procedural optimization or alternative optimization targets might result in an incremental improvement in clinical outcomes is unclear. Another unknown factor is the potential effect of a systematic implementation of quantitative coronary analysis to assist angiographyguided PCI as compared to visual estimation alone."

Apr, 2019 Chio et al. - Complex PCI - "Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures" determined IVUS) guidance compared with angiographic guidance reduces long-term (64 months of median follow-up) risk of cardiac death in patients undergoing complex PCI.

New added Evidence of RCT Comparing IVUS vs. Angiography Guided PCI & Clinical Benefit in TVF

Sep, 2018 ULTIMATE Trial - all-comer patients - Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers: The ULTIMATE trial

Main outcome of ULTIMATE Trial

1) 1 year TVF in IVUS guided PCI group vs. angiography guided PCI group: HR=0.530, 95% confidence interval [CI] 0.312-0.901; p=0.019

2) 1 year TVF in IVUS guided PCI group, IVUS with successful procedures vs. patients who failed to achieve all optimal criteria: HR= 0.349; 95% confidence interval [CI] : 0.135-0.898; p=0.029

The IVUS-defined criteria for the optimal stent deployment included

criterion 1) the MLA in stented segment > 5.0 mm² , or 90% of the MLA at the distal reference segments;

criterion 2) plaque burden at the 5 mm proximal or distal to the stent edge less than 50%；

criterion 3) no edge dissection involving media with length longer than 3mm.

New added Evidence of Subgroup Analysis Comparing IVUS vs. Angiography Guided PCI

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Patients With Chronic Kidney Disease

Under the background that patients with chronic kidney disease (CKD) present more frequently with complex and extensive lesions, and intravascular ultrasound (IVUS)–guided drug-eluting stent (DES) implantation is associated with improved clinical outcomes in complex lesions. However, it still remains controversial that routine IVUS guidance could be beneficial to CKD patients. Subgroup analysis of ULTIMATE trail demonstrated that CKD patients undergoing DES implantation had a higher risk of TVF during 12 months of follow-up. More importantly, the risk of TVF in CKD patients could be significantly decreased through IVUS guidance compared with angiography guidance.

Estimated glomerular filtration rate (eGFR) was available in 1,443 patients, with mean eGFR 81.41 ± 28.92 ml/min/1.73 m², of whom 723 were in the IVUS guidance group and 720 in the angiography guidance group. Finally, CKD was present in 349 (24.2%) patients. At 12 months, the target vessel failure (TVF) in the CKD group was 7.2%, significantly higher than 3.2% in the no CKD group (hazard ratio [HR]: 2.30; 95% CI: 1.38 to 3.84; p = 0.001), mainly driven by increased risk of cardiac death (2.9% vs. 0.5%; p < 0.001) in CKD patients. Moreover, there were 25 TVFs in CKD patients, with 7 (3.9%) in the IVUS group and 18 (10.7%) in the angiography group (HR: 0.35; 95% CI: 0.15 to 0.84; p = 0.01) (Figure), while 35 TVFs occurred in patients without CKD, with 14 (2.6%) in the IVUS group and 21 (3.8%) in the angiography group (HR: 0.67; 95% CI: 0.34 to 1.32; p = 0.25; p for interaction = 0.24). The reduced risk of TVF in the IVUS group for CKD patients was mainly driven by the lower risk of TVMI (0.6% vs. 3.6%; borderline p = 0.05) and TVR (1.1% vs. 4.7; p = 0.04).

March 2020, a substudy of the NOBLE Trail compared 5-year composite outcome of patients underwent PCI with post-PCI IVUS assessment and those without, the results showed that:

1) MACCE of patients with post-PCI IVUS was 18.9% vs. 25.0% without (p=0.45, after adjustment)

2) although repeat revascularization was not statisticallly influenced by post-PCI IVUS assessment (10.6% vs. 16.5%, p=0.11), however LMS TLR do (5.1% vs. 11.6%, p=0.01)

3) although no significant difference in MACCE, death, myocardial infarction or stent thrombosis were found regarding stent expansion and LMS MSA, however LMS MSA do influence repeat revascularization (upper tertile LM MSA ≥13.4mm² vs. lower tertile LM MSA≤10.8mm², 17.6% vs.  5.2%, p=0.02) and LMS TLR (upper tertile LM MSA ≥13.4mm² vs. lower tertile LM MSA≤10.8mm², 12.2% vs. 0%, p=0.002).

The study made the conclusion that post-PCI IVUS assessment and adequate stent expansion are not associated with reduced MACCE, however there is an association with reduced LMS TLR. Use of intra-coronary imaging to prevent stent under-expansion in LMS PCI is likely to improve outcomes.

Operation techniques used in this study: