Search Results and Study Characteristics
A total of 1641 articles were retrieved, and 653 citations were screened by checking the title or abstract. Of these, 53 full texts were reviewed, and eighteen randomized controlled trials were included in this meta-analysis finally (Fig. 1).
The baseline characteristics of the included trials were shown (Table 1). A total of 10413 patients were selected, including 4995 patients receiving intravascular imaging- guided stent implantation and 5418 patients receiving angiography-guided stent implantation. The enrolled population of ten trials was patients with complex lesions [13, 14, 16, 17, 20, 22–24, 28, 29], two trials included patients with left main coronary artery lesion [24, 28], and seven trials excluded obvious left main coronary artery lesion [15, 16, 18, 19, 21, 23, 25]. Meanwhile, the outcomes of subgroup for these patients were also reported. Two trials were related to OCT and seventeen trials were related to IVUS. The follow-up time ranged from six months to two years. In addition, sixteen trials reported the outcome of MACE and showed the difference defined of MACE.
Table 1
Baseline characteristics of the included trials.
Study
|
Publication year
|
Type
|
Country
|
Lesion type
|
Study total size
|
Randomization
|
MACE
|
Follow up (month)
|
AIR-CTO [13]
|
2015
|
RCT
|
China
|
CTO
|
115/115
|
IVUS VS Angiography
|
all-cause death, MI, TLR, ST
|
24
|
AVIO [14]
|
2013
|
RCT
|
European countries
|
Complex lesions a
|
142/142
|
IVUS VS Angiography
|
Cardiac death, MI or TVR
|
24
|
CRUISE [15]
|
2000
|
RCT
|
America
|
NR
|
270/229
|
IVUS VS Angiography
|
NR
|
9
|
CTO-IVUS [16]
|
2015
|
RCT
|
Korea, America
|
CTO
|
201/201
|
IVUS VS Angiography
|
Cardiac death, MI or TVR
|
12
|
DIPOL [17]
|
2007
|
RCT
|
Poland
|
Long lesions
|
83/80
|
IVUS VS Angiography
|
all-cause death, MI, RCR b
|
6
|
DOCTORS [18]
|
2016
|
RCT
|
France
|
Non-complex lesions
|
120/120
|
OCT VS Angiography
|
all-cause death, MI, TLR, ST
|
6
|
EXCELLENT [19]
|
2012
|
RCT
|
Korea
|
Non-unprotected left main
|
619/802
|
IVUS VS Angiography
|
all-cause death, MI, TVR, ST
|
12
|
HOME DES IVUS [20]
|
2010
|
RCT
|
Czech Republic
|
Complex lesions a
|
105/105
|
IVUS VS Angiography
|
all-cause death, MI or TLR
|
18
|
ILUMIEN III-IVUS c [21]
|
2021
|
RCT
|
America
|
Non-complex lesions
|
136/142
|
IVUS VS Angiography
|
Cardiac death, MI or TLR
|
12
|
ILUMIEN III-OCT c [21]
|
2021
|
RCT
|
America
|
Non-complex lesions
|
153/142
|
OCT VS Angiography
|
Cardiac death, MI or TLR
|
12
|
IVUS-XPL [22]
|
2015
|
RCT
|
Korea
|
Long lesions
|
700/700
|
IVUS VS Angiography
|
Cardiac death, MI or TLR
|
12
|
Kim et al [23]
|
2013
|
RCT
|
Korea
|
Long lesions
|
269/274
|
IVUS VS Angiography
|
Cardiac death, MI, TVR or ST
|
12
|
Liu et al [24]
|
2019
|
RCT
|
China
|
Unprotected left main
|
167/169
|
IVUS VS Angiography
|
Cardiac death, MI or TVR
|
12
|
OPTUCIS [25]
|
2001
|
RCT
|
European countries
|
Non-complex lesions
|
273/275
|
IVUS VS Angiography
|
all-cause death, MI, RCR b
|
12
|
RESET [26]
|
2013
|
RCT
|
Korea
|
Non-complex lesions
|
662/912
|
IVUS VS Angiography
|
Cardiac death, MI or TVR
|
12
|
SIPS [27]
|
2000
|
RCT
|
Germany
|
No CTO or emergency procedures
|
121/148
|
IVUS VS Angiography
|
all-cause death, MI, RCR b
|
24
|
Tan et al [28]
|
2015
|
RCT
|
China
|
Unprotected left main
|
61/62
|
IVUS VS Angiography
|
all-cause death, MI, TLR
|
24
|
TULIP [29]
|
2003
|
RCT
|
Holland, America
|
Long lesions
|
74/76
|
IVUS VS Angiography
|
NR
|
6
|
ULTIMATE [9]
|
2018
|
RCT
|
China
|
All comer
|
724/724
|
IVUS VS Angiography
|
Cardiac death, MI or TVR
|
12
|
Abbreviations: |
RCT, randomized controlled trial; CTO, chronic total occlusion; IVUS, intravascular ultrasound; OCT, optical coherence tomography; Angio, angiography; MI, myocardial infarction; TLR, target lesion revascularization; ST, stent thrombosis; TVR, target vessel revascularization; RCR, repeat coronary revascularization; NR, not reported. |
a. Based on the trials included, complex lesions were defined as one of the following: lesion type B2 and C according to the American Heart Association; chronic total occlusions (CTO); bifurcation lesions; proximal left anterior descending artery; long lesions (༞20 mm); small vessels (reference vessel diameter ≤ 2.5mm); left main coronary artery lesions and patients requiring 4 or more stents; insulin dependent diabetes mellitus and acute coronary syndrome. |
b. Based on the trials included, RCR was defined as target lesion revascularization, target vessel revascularization or any coronary revascularization. |
c. ILUMIEN III-IVUS and ILUMIEN III-OCT come from the ILUMIEN III trial. |
The baseline clinical characteristics of the included patients were shown (Table 2). In all trials included, the average age of patients was approximately 63 years old in the intervascular imaging-guided coronary stenting group and about 73.5% of patients were male. In addition, 29.5% of patients had diabetes, 59.7% of patients suffered from dyslipidemia, 62.7% of patients accompanied hypertension, and 35.1% of patients had a history of current smoking. The period of follow-up ranged from 6 to 24 months. Meanwhile, the average age of patients was approximately 64 years old in the angiography-guided coronary stent implantation, of which 72.4% of patients were male. Furthermore, 28.2% of patients had diabetes, 60.1% of patients merged dyslipidemia, 62.6% of patients amalgamated hypertension, and 36.1% of patients suffered from a history of current smoking approximately. Angiography and procedural characteristics are shown (Table 3).
Assessment of quality and Publication Bias
The risk of bias assessment showed that there were no obvious bias of selection, detection, attrition, reporting, and others, meanwhile, the performance bias was unclear (Figure S1). The funnel plot showed that the distribution was symmetrical for all outcomes (Figure S2). However, the P-value of MI outcome by Egger’s test was 0.00 (P < 0.05) (Figure S3), which implied publication bias. No signs of publication bias was found by trim method (no new trials added) (Figure S2). In addition, the P-value of TLR, TVR, cardiac death, ST, MACE, and all-cause death were more than 0.05 by Egger’s and Bgge’s test, which meaned that there were no publication bias (Figure S3). The quality of GRADE evidence was moderate for the TLR, TVR, cardiac death, ST, MACE, and all-cause death, while the quality of evidence was low for MI outcome (Table S2).
Trial Sequential Analysis
Trial sequential analysis (TSA) were performed for each outcome (Figure S4). The cumulative Z curve of TLR, TVR, and MACE exceeded the traditional boundary and the TSA boundary, which meaned the results were reliable. However, the cumulative Z curve of cardiac death, ST, and MI exceeded the traditional boundary and did not reach the TSA boundary and expected sample size, which may be a false positive caused by a small number of studies and small sample size. In addition, the cumulative Z curve of all-cause death did not cross the traditional boundary or the TSA boundary, and the sample size did not reach the expected amount of information, indicating that there was no statistical significance between the two groups, and more trials may be needed to prove this.
The Primary Outcome
The risk of TLR was reported in fifteen trials (3.3% vs 5.4%, RR 0.62, 0.49–0.77, P༜0.0001, I2 = 0%, Pheterogeneity = 0.85), which showed that it is favor of intravascular imaging-guided coronary stent implantation (Fig. 2).
The Secondary Outcomes
Of all trials, eleven trials reported the event of TVR. The results showed that compared with angiography-guided coronary stent implantation, coronary stent implantation guided by intravascular imaging can significantly reduce the risk of TVR (3.4% vs 4.9%, RR 0.65, 0.52–0.81, P = 0.0001, I2 = 0%, Pheterogeneity = 0.50) (Fig. 3a). Meanwhile, the cardiac death outcome was established in ten trials, the results demonstrated that the risk of cardiac death was significantly lower in the coronary stent implantation guided by intravascular imaging than that in the angiography-guided coronary stent implantation (0.8% vs 1.3%, RR 0.59; 0.39–0.91; P = 0.02) without significant heterogeneity (I2 = 0%; Pheterogeneity = 0.97) (Fig. 3b).
The ST outcome was also reported in eleven trial, and which indicated that intravascular imaging-guided coronary stenting was associated with a reduced risk of ST (0.5% vs 0.9%, RR 0.54, 0.30–0.97; P = 0.04) without heterogeneity across the trials (I2 = 0%; Pheterogeneity = 0.94) (Fig. 3c). In addition, MACE was selected as the outcome for fifteen trials. The results indicated that intravascular imaging-guided coronary stenting significantly reduced the risk of MACE compared with angiography guidance (7.6% vs 9.0%, RR 0.81, 0.71–0.93; P = 0.003, I2 = 36%; Pheterogeneity = 0.07) (Fig. 3d).
However, all included trails analyzed the incidence of MI, and fourteen trials reported the data regarding all-cause death. There was no significant difference in incidence of MI (RR 0.78, 0.61-1.00, P = 0.05, I2 = 0%, Pheterogeneity = 0.17), and all-cause death (RR 0.85, 0.58–1.27, P = 0.44, I2 = 0%, Pheterogeneity = 0.69) between the two groups (Fig. 3e-f).
Subgroup Analysis
The subgroup analysis was performed according to the lesion type with MACE as the outcome, to explore the possible causes of the heterogeneity, which suggested that there was significant heterogeneity (Pheterogeneity = 0.07, I2 = 36%) (Fig. 4). Meanwhile, the results showed that intravascular imaging guidance can reduce the risk of MACE in patients with complex lesions (RR 0.61, 0.50–0.75, P < 0.00001, I2 = 0%, Pheterogeneity = 0.66). However, in patients with non-complex lesions, there was no statistical difference between intravascular imaging-guided and angiography-guided groups (RR 1.08, 0.89–1.31, P = 0.45, I2 = 0%, Pheterogeneity = 0.67). In addition, there was significant difference in the interaction analysis between the two subgroups (Pinteraction <0.0001, I2 = 93.8%), while no heterogeneity was found within the two subgroups (Pheterogeneity = 0.66, I2 = 0% and Pheterogeneity = 0.67, I2 = 0%). Therefore, subgroup analyzes of other outcomes were performed according to the lesion types and intravascular imaging type, and presence or absence of left main coronary artery to explored the impact of these factors on each outcome. The results also showed that intravascular imaging guidance can reduce the risk of TVR in patients with complex lesions (RR 0.53, 0.39–0.72, P < 0.0001, I2 = 0%, Pheterogeneity = 0.98). However, there was no significant difference between the two groups in patients with non-complex lesions (RR 0.83, 0.59–1.15, P = 0.17, I2 = 40%, Pheterogeneity = 0.17), and the differences of interaction analysis between the two groups was statistically significant (I2 = 72.3%, P interaction = 0.06). In addition, there were no significant differences in the risk of TLR, MI, cardiac death, ST, and all-cause death in the subgroup analyzes of lesion types (Figure S5). Furthermore, compared with angiography guidance, intravascular imaging guidance can reduce the risk of MACE in patients with left main coronary artery lesion (RR 0.56, 0.37–0.85, P = 0.006, I2 = 0%, Pheterogeneity = 0.62) and non-left main coronary artery lesion (RR 0.85, 0.74–0.99, P = 0.03, I2 = 34%, Pheterogeneity = 0.11), and heterogeneity was observed between the two groups (I2 = 71.8%, P interaction = 0.06). However, there is no significant difference in the risk of TLR, cardiac death, and ST between the two groups (Figure S6). In addition, there were also no statistical significance in the risk of MI, all- cause death, ST, and MACE between intravascular imaging type subgroups (Figure S7).