Study
Year
N (IVUS vs. angiography)
Enrolled patients
Follow-up, m
Primary endpoint
Major findings (IVUS vs. angiography)
Jakabacin et al. [3]
2010
105 vs. 105
Complex cases and high clinical risk profile
18
Composite of death, MI, TLR
No significant differences (11% vs. 12%)
Chieffo et al. [4]
2013
142 vs. 142
Complex lesions
24
Post-procedural in-lesion MLD
IVUS group had greater MLD (2.70 mm vs. 2.51 mm, p = 0.002)
Kim et al. [5]
2013
269 vs. 274
Long lesions (implanted stent ≥ 28 mm in length)
12
Composite of cardiovascular death, MI, stent thrombosis, or TVR
No significant differences by intention-to-treat analysis; but IVUS group had lower primary endpoint by per-protocol analysis (4.0% vs. 8.1%, p = 0.048)
MOZART [6]
2014
41 vs. 42
High risk of contrast-induced acute kidney injury or volume overload
–
Total volume contrast agent used during PCI
IVUS group had lower volume contrast agent (20 ml vs. 65 ml, p < 0.001)
Tan et al. [7]
2015
62 vs. 61
Unprotected LM in the elderly (aged 70 or older)
24
Composite of death, non-fatal MI, or TLR
IVUS group had lower primary endpoint (13.1% vs. 29.3%, p = 0.031)
CTO-IVUS [8]
2015
201 vs. 201
Chronic total occlusion
12
Cardiac death
No significant differences in primary endpoint; but IVUS group had lower secondary endpoint (the composite of cardiac death, MI, or TVR) (2.6% vs. 7.1%, p = 0.035)
Tian et al. [9]
2015
115 vs. 115
Chronic total occlusion
12
Late lumen loss
IVUS group had a lesser late lumen loss (0.28 mm vs. 0.46 mm, p = 0.025)
IVUS-XPL [10]
2015
700 vs. 700
Long lesions (implanted stent ≥28 mm in length)
12
Composite of cardiac death, MI, or TLR
IVUS group had lower primary endpoint (2.9% vs. 5.8%, p = 0.007)
According to the ADAPT-DES (The assessment of dual antiplatelet therapy with drug-eluting stents ) study, the most recent largest observational study with all-comers (n = 8583) [11], IVUS was utilized in 3349 patients (39%), and larger-diameter devices, longer stents, and/or higher inflation pressure were used in the IVUS-guided cases. At 1 year, propensity-adjusted multivariable analysis revealed IVUS-guidance vs. angiography-guidance was associated with a reduced definite/probable stent thrombosis (0.6% vs. 1.0%, p = 0.003), MI (2.5% vs. 3.7%, p = 0.004), and composite adjudicated major cardiac events (cardiac death, MI, or stent thrombosis) (3.1% vs. 4.7%, p = 0.002). The benefits of IVUS were especially evident in patients with acute coronary syndromes and complex lesions [11]. Further recent observational studies evaluating clinical usefulness of IVUS-guided PCI are summarized in Table 5.2 [11–17].
Table 5.2
Recent observational studies comparing clinical outcomes between IVUS-guided and angiography-guided PCI
Study | Year | N (IVUS vs. angiography) | Enrolled patients | Follow-up, m | Major findings (IVUS vs. angiography) |
|---|---|---|---|---|---|
Witzenbichler et al. [11] | 2014 | 3349 vs. 5234 | All comers | 12 | Definite/probable ST: 0.6% vs. 1.0%, p = 0.003 MI: 2.5% vs. 3.7%, p = 0.004 Composite of cardiac death, ST, MI; 3.1% vs. 4.7%, p = 0.002 |
Roy et al. [12] | 2008 | 884 vs. 884 by matching | All comers | 12 | Definite ST: 0.7% vs. 2.0%, p = 0.014 |
Park et al. [13] | 2013 | 463 vs. 463 by matching | Nearly all comers | 12 | Composite of cardiac death, MI, TLR: 4.3% vs. 2.4, p = 0.047 |
Youn et al. [14] | 2011 | 125 vs. 216 | Primary PCI cases | 36 | Composite of death, MI, TLR, TVR: 12.8% vs. 18.1%, p = NS |
Kim et al. [15] | 2011 | 487 vs. 487 by matching | Non-left main bifurcation | 36 | Death or MI: 3.8% vs. 7.8%, p = 0.03 |
Hong et al. [16] | 2014 | 201 vs. 201 by matching | Chronic total occlusion | 24 | Definite/probable ST: 0% vs. 3.0%, p = 0.014 MI: 1.0% vs. 4.0%, p = 0.058 |
de la Torre Hernandez et al. [17] | 2014 | 505 vs. 505 by matching | Left main lesions | 36 | Composite of cardiac death, MI, TLR: 11.3% vs. 16.4%, p = 0.04 Definite/probable ST: 0.6% vs. 2.2%, p = 0.04 |
Lastly, meta-analyses comparing the IVUS-guidance and angiography-guidance are presented in Table 5.3 [18–22]. Shin et al. reported the results of meta-analysis with individual patient-level data from 2345 randomized patients. IVUS-guided new-generation DES implantation vs. angiography-guided DES implantation was associated with a favorable outcome, particularly the occurrence of hard clinical endpoint (the composite of cardiac death, MI, or stent thrombosis) for complex lesions [22]. Of note, the primary endpoint of this meta-analysis did not include TLR. Therefore, different from the IVUS-XPL trial showing the benefit of IVUS due primarily to the less frequent TLR events [10], MACEs, even excluding the TLR events in this meta-analysis, were less frequent with IVUS-guidance than angiography-guidance [22].
Table 5.3
Recent meta-analyses comparing clinical outcomes between IVUS-guided and angiography-guided PCI
Study | Year | N (analyzed studies) | N (IVUS vs. angiography) | Data analysis | Major findings (IVUS vs. angiography) |
|---|---|---|---|---|---|
Jang et al. [18] | 2014 | 3 RCTs and 12 observational studies with DES implantation | 11,793 vs. 13,056 | Study-level meta-analysis | IVUS had lower MACE (OR = 0.79, p = 0.001), all-cause mortality (OR = 0.64, p < 0.001), MI (OR = 0.57, p < 0.001), TVR (OR = 0.81, p = 0.01), and ST (OR = 0.59, p = 0.002) |
Ahn et al. [19] | 2014 | 3 RCTs and 14 observational studies with DES implantation | 12,499 vs. 14,004 | Study-level meta-analysis | IVUS had lower TLR (OR = 0.81, p = 0.046), death (OR = 0.61, p < 0.001), MI (OR = 0.57, p < 0.001), and ST (OR = 0.59, p < 0.001) |
Elgendy et al. [20] | 2016 | 7 RCTs with DES implantation | 1593 vs. 1599 | Study-level meta-analysis | IVUS group had lower MACE at a mean of 15 months (6.5% vs. 10.3%, p < 0.0001), mainly because of reduction in the risk of TLR (4.1% vs. 6.6%, p = 0.003) |
Steinvil et al. [21] | 2016 | 7 RCTs and 18 observational studies with DES implantation | 14,659 vs. 16,624 | Study-level meta-analysis | IVUS group had lower MACE (OR = 0.76, p < 0.001), death (OR = 0.62, p < 0.001), MI (OR = 0.67, p < 0.001), ST (OR = 0.58, p < 0.001), TLR (OR = 0.77, P = 0.005), and TVR (OR = 0.85 p < 0.001) |
Shin et al. [22] | 2016 | 3 RCTs with new-generation DES implantation | 1170 vs. 1175 | Individual patient-level meta-analysis | IVUS group had a lower occurrence of hard clinical outcome (composite of cardiac death, MI, or ST) at 1 year (0.4% vs. 1.2%, p = 0.04) |
5.2 Left Main Lesion
Procedural complication or failure of left main lesion of PCI is critical. Thus, IVUS-guidance PCI for left main lesion is currently recommended as a class IIa or class IIb recommendation [1, 2]. In addition to the stent optimization, particularly for left main lesions, functionally significant lesion can be relatively accurately predicted by IVUS examination for intermediate lesions because of the limited variability of left main coronary artery length, diameter, and the amount of supplied myocardium. Minimal lumen area (MLA) less than 4.5 mm2 predicted the fractional flow reserve (FFR) less than 0.80 with sensitivity of 77% and specificity of 82% [23]. Other studies also reported the optimal cut-off value of MLA by IVUS for predicting functionally significant left main lesions (FFR less than 0.75) were 5.9 mm2 and 4.8 mm2, respectively [24, 25]. IVUS is also essential for the optimization to reduce the restenosis. A previous study showed that the cut-off values of post-stenting MLA that best predicted in-stent restenosis were 5.0 mm2 in ostial left circumflex, 6.3 mm2 in ostial left anterior descending, 7.2 mm2 in polygon of confluence, and 8.2 mm2 in left main [26].
Recently, a randomized trial for unprotected left main lesions revealed that IVUS-guided group had a lower composite of death, non-fatal MI, or TLR (13.1% vs. 29.3%, p = 0.031), although small number of patients were studied in this study [7]. Also, a recent pooled analysis from 4 Spanish registries demonstrated that IVUS-guided DES implantation for unprotected left main showed a lower 3-year composite rate of cardiac death, MI, and TLR compared with the angiography-guided DES implantation (11.3% vs 16.4%, p = 0.04), and a more prominent in the subgroup with distal left main lesions (10.0% vs 19.3%, p = 0.03) [17].
5.3 Bifurcation Lesion
There were no randomized studies performed particularly for the bifurcation lesions . According to the observational studies, Kim et al. demonstrated that the 3-year cumulative incidence of death or MI was significantly lower in the IVUS-guided PCI group than the angiography-guided PCI group (3.8% vs 7.8%, p = 0.03) [15]. Another observational study with bifurcation lesions, the rate of TLR was significantly lower in the IVUS-guided PCI group (6% vs 21%, p = 0.001) [27]. In the first study, two-stent technique and final kissing balloon were more frequently used in the IVUS-guidance group [15], whereas in the second study, the number of implanted stents was significantly lower in the IVUS-guidance group [27]. In this regard, although further studies are needed to determine the optimal stent strategies including the stent number particularly for bifurcation lesions, the role of IVUS for the decision of stent strategies may be important to improve clinical outcomes for the complex bifurcation lesions. A previous study evaluated the IVUS parameters predicting the IVUS ≥4 mm2 at 9-month follow-up IVUS for both main vessel and side branch after bifurcation T-stenting with first-generation DES [28]. Inadequate post-procedural minimal stent area (MSA) with increased neointimal hyperplasia may cause the side branch ostium to be the most frequent restenotic site after bifurcation PCI and the optimal cut-off value of post-procedural MSA was 4.83 mm2 [28].
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
