Optical coherence tomography-guided vs. coronary angiography-guided percutaneous coronary intervention: a systematic review and meta-analysis

Introduction

Percutaneous coronary intervention (PCI) is one of the most effective methods of coronary revascularization, and successful stent implantation is a key factor in improving clinical outcomes for patients. Coronary angiography (CA) is considered the gold standard for diagnosing coronary artery disease and is the primary reference for PCI. However, it fails to accurately assess the anatomy of culprit lesions, and the two-dimensional (2D) lumen images presented have limited ability to reconstruct the three-dimensional (3D) structure of vessels (1). Optical coherence tomography (OCT) is an intravascular imaging technique that uses near-infrared light to produce detailed images with higher resolution and tissue structure detection than CA (2,3). The use of OCT to guide PCI involves three steps: assessment of vessel morphology, vessel sizing, and stent selection, enabling clinicians to make better decisions during lesion preparation and stent implantation (4). In addition to guiding pre-procedural preparation, it has been widely applied for immediate post-PCI evaluation and follow-up by visualizing OCT images for the presence of stent underexpansion, stent mal-apposition, and stent thrombosis (5,6).

Multiple trials have been published, sparking debate as to whether the patient outcomes of OCT-guided PCI are superior to those of CA. A substantial body of evidence from recent years indicates that minimum stent area (MSA) is not only an effective predictor of stent restenosis, but also significantly linked to patients’ future risk of adverse cardiovascular outcomes (7,8). Kim et al. revealed that in patients undergoing up-front 2-stenting for bifurcation lesions, inadequate stent expansion was significantly associated with long-term prognosis (9). Therefore, we aimed to perform a meta-analysis of published studies to evaluate the outcomes of CA- and OCT-guided PCI procedures. We present this article in accordance with the PRISMA reporting checklist (10) (available at https://qims.amegroups.com/article/view/10.21037/qims-24-1628/rc).

Methods

The protocol of this meta-analysis was registered in the PROSPERO international prospective register for systematic reviews (CRD42024524877).

Data sources and search strategy

A comprehensive search using medical subject headings and text terms “coronary angiography”, “optical coherence tomography”, “OCT”, “percutaneous coronary intervention”, and “PCI” was conducted in PubMed/Medline, Embase, and Cochrane Central up to March 2024 for all randomized controlled trials (RCTs) and observational studies, with no language restrictions. The search strategy is presented in Tables S1-S3. We also manually screened major cardiology websites, editorials, and reviews for relevant studies to maximize the data capture.

Study selection

Two investigators independently searched and selected the literature, with studies being included if they met the following criteria: (I) the study compared OCT-guided PCI with CA-guided PCI and reported at least one of the following outcomes: major adverse cardiovascular events (MACE), all-cause death, cardiovascular death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), post-intervention MSA, post-intervention minimum lumen diameter (MLD), and follow-up MLD; (II) complete data availability; (III) size of the sample per group >10. An initial screening was performed by reading titles and abstracts, then irrelevant trials were excluded by reading of full texts. Duplicate articles, conference abstracts, case reports, systematic reviews, meta-analyses, letters, and editorials were removed. If a consensus could not be reached, a senior author was consulted.

Data extraction and assessment of study quality

Study characteristics, baseline characteristics of patients, and endpoints of interest were extracted independently by two investigators. To ensure data accuracy, data comparison was performed after extraction, with a senior author resolving any disagreements. The methodological quality of RCTs was evaluated using the Cochrane risk-of-bias tool (11), while the quality of observational studies was assessed using the ROBINS-I tool (12).

Statistical analysis

Statistical analysis was performed using Review Manager (RevMan) version 5.3 (Cochrane Collaboration, London, UK) and STATA version 18 (Stata Corp, College Station, TX, USA). Risk ratio (RR) and mean deviation (MD) were presented as measures for binary and continuous variables with their corresponding 95% confidence interval (CI). Heterogeneity was quantified using the I² test, with an I² value of 0–25% designated as absent or low, an I² value of 26–50% designated as moderate, and an I² value above 50% designated as high. When heterogeneity was defined as high, a random effect model was utilized for the calculation, otherwise a fixed effect model was used. We performed subgroup analyses according to study type (RCTs vs. observational studies), follow-up time (short-term vs. long-term), stent type (drug-eluting stent/bare-metal stent vs. bioresorbable scaffold), and patient characteristics [acute coronary syndrome (ACS) vs. non-ACS]. Long-term refers to a follow-up period of at least 1 year. A trial was classified as belonging to the acute coronary syndrome (ACS) group if all patients included in the trial had ACS. Statistical significance was set at P<0.05 (two-tailed). Furthermore, sensitivity analyses were employed to assess the influence of each study’s results on the overall results. Funnel plots were used to evaluate publication bias for each outcome, and outcomes with over 10 included studies were further analyzed with Egger’s test.

Results

Description of included trials

A total of 25 studies were included in this meta-analysis (13-37), as shown in the flowchart for screening (Figure 1). Of the included studies, 12 were RCTs. The individual sample size ranged from 29 to 2,268 patients, 15 trials were multicenter, and 22 trials intended to primarily assess mid- to long-term outcomes with median follow-up ranging from approximately 6 to 30 months. Mean age ranged from 55.46 to 71 years (weighted mean, 63.94 years), female sex ranged from 15.42% to 34.07% (mean prevalence, 23.64%), and diabetes prevalence ranged from 8% to 41.98% (mean prevalence, 26.46%). In all, 12,040 patients were enrolled, 5,612 of whom were guided by OCT, and 6,428 were guided by CA. Baseline characteristics of the included studies are shown in Table 1. The baseline variables for patients enrolled in each trial are reported in Table S4. The assessment of bias for each study is presented in Figures S1,S2.

Figure 1 Flow diagram of the systematic screening process.

All-cause death

A total of 11 studies reported all-cause death, and OCT-guided stenting significantly reduced all-cause death compared with CA-guided stenting (RR =0.62; 95% CI: 0.47–0.83; P=0.001; I²=0%) (Figure 2A). There was no significant subgroup difference in the subgroup analyses for study type (P_interaction=0.23; I²=29.1%), follow-up time (P=0.84; I²=0%), or patient characteristics (P=0.49; I²=0%) (Figure S3). Subgroup analyses of stent types were not reported due to limited data.

Figure 2 Forest plots of endpoints for included studies in OCT-guided vs. CA-guided comparison. (A) All-cause death; (B) cardiovascular death; (C) MACE; (D) restenosis. CA, coronary angiography; CI, confidence interval; MACE, major adverse cardiovascular events; OCT, optical coherence tomography.

Cardiovascular death

A total of 11 studies reported the outcome of cardiovascular death, suggesting that OCT guidance leads to a reduction in cardiovascular death compared to CA guidance (RR =0.47; 95% CI: 0.32–0.69; P<0.0001; I²=0%) (Figure 2B). Subgroup analyses for stent type were not conducted because of insufficient data. Apart from that, no subgroup differences were detected in the analyses for study type (P=0.28; I²=15.2%), follow-up duration (P=0.91; I²=0%), and patient characteristics (P=0.70; I²=0%); the results in these subgroups were similar to those in the main analysis of interest (Figure S4).

MACE

A total of 16 studies reported MACE, and OCT-guided stenting had a significantly lower incidence of MACE than contrast-guided stenting (RR =0.65; 95% CI: 0.54–0.77; P<0.00001; I²=0%) (Figure 2C). Most of the included trials defined MACE as the combined outcome of cardiovascular death, MI, and revascularization. The results of the subgroup analyses were similar to those of the main analysis. There was no subgroup difference in the analyses of patient characteristics (P=0.65; I²=0%), stent type (P=0.34; I²=0%), or follow-up time (P=0.57; I²=0%). Similar or greater benefits (P=0.04; I²=75.6%) were observed when OCT was used to guide observational studies (RR =0.54; 95% CI: 0.43–0.69; P<0.00001; I²=0%) vs. RCTs (RR =0.79; 95% CI: 0.60–1.04; P=0.09; I²=0%) (Figure S5).

Restenosis

A total of four studies reported restenosis, and there was no significant difference in restenosis between the OCT-guided PCI group and the CA-guided PCI group (RR =0.91; 95% CI: 0.73–1.13; P=0.38; I²=19%) (Figure 2D). Due to insufficient data, subgroup analyses could not be conducted for study type, patient characteristics, and stent type. No subgroup differences were observed in the result for follow-up time (P=0.07; I²=70.5%), and the result of the subgroup analysis was similar to those of the main analysis (Figure S6).

MI

A total of 16 studies reported MI; the difference between the two groups was not statistically significant (RR =0.83; 95% CI: 0.69–1.00; P=0.05; I²=0%) (Figure 3A). There was not enough data to perform subgroup analyses according to stent type. No subgroup differences were observed in the results for patient characteristics (P=0.34; I²=0%) or study type (P=0.77; I²=0%), and the subgroup results were consistent with the main analysis. In the subgroup analysis of follow-up time, the result of patients in the long-term group was consistent with the results of the main analysis (RR =0.78; 95% CI: 0.64–0.95; P=0.02; I²=0%), whereas the result in the short-term group (RR =1.33; 95% CI: 0.75–2.34; P=0.33; I²=0%) was opposite to the results of the main analysis, with no significant subgroup differences (P=0.09; I²=66.3%) (Figure S7).

Figure 3 Forest plots of endpoints for included studies in OCT-guided vs. CA-guided comparison. (A) MI; (B) TLR; (C) TVR; (D) MSA. CA, coronary angiography; CI, confidence interval; MI, myocardial infarction; MSA, minimum stent area; OCT, optical coherence tomography; TLR, target lesion revascularization; TVR, target vessel revascularization.

TLR

A total of 15 studies reported TLR, and no significant difference in TLR was detected between OCT-guided stent implantation and CA-guided stent implantation (RR =0.86; 95% CI: 0.66–1.10; P=0.23; I²=0%) (Figure 3B). Patient characteristics (P=0.33; I²=0%), study type (P=0.17; I²=46.9%), stent type (P=0.89; I²=0%), and follow-up time (P=0.61; I²=0%) were analyzed with no subgroup differences observed (Figure S8).

TVR

A total of six studies reported TVR, and there was no significant difference observed between the OCT-guided group and the CA-guided group (RR =0.82; 95% CI: 0.63–1.07; P=0.15; I²=44%) (Figure 3C). Due to limited data, subgroup analysis based on stent type and follow-up time was not performed. In subgroup analyses comparing ACS (RR =0.60; 95% CI: 0.13–2.71; P=0.51; I²=60%) with non-ACS (RR =0.74; 95% CI: 0.37–1.45; P=0.37; I²=50%), the results were consistent with the results of the main analysis, with no significant subgroup differences (P=0.81; I²=0%). The results of the RCTs were consistent with the main analysis (RR =1.01; 95% CI: 0.73–1.40; P=0.93; I²=0%), but the results of the observational studies were opposite to the results of the main analysis (RR =0.47; 95% CI: 0.19–1.21; P=0.12; I²=62%), with no significant interaction (P=0.13; I²=55.7%) (Figure S9).

MSA

A total of six studies reported MSA, three of which were postintervention and the other three at follow-up. OCT-guided stent implantation demonstrated a statistically significant enhancement of MSA compared to CA-guided (MD =0.30; 95% CI: 0.04–0.56; P=0.03; I²=0%) (Figure 3D). Given the limited data, subgroup analyses of patient characteristics, stent type, and study type were not reported. No significant interactions were observed in the subgroup analysis of follow-up time (P=0.63; I²=0%) (Figure S10).

MLD

A total of four studies reported post-intervention MLD and there was no significant difference in post-intervention MLD in the OCT-guided group compared to the CA-guided group (MD =0.04; 95% CI: −0.02 to 0.10; P=0.19; I²=0%) (Figure 4A). Subgroup analyses for this outcome were not reported because of the limited data. Five studies reported MLD at follow-up, and OCT-guided stenting was associated with a significant enhancement of MLD at follow-up compared to CA-guided stenting (MD =0.12; 95% CI: 0.02–0.22; P=0.02; I²=72%) (Figure 4B). No subgroup differences were observed in the analysis of study type (P=0.12; I²=59.6%) (Figure S11).

Figure 4 Forest plots of endpoints for included studies in OCT-guided vs. CA-guided comparison. (A) Post-intervention MLD change; (B) MLD change at follow-up. CA, coronary angiography; CI, confidence interval; MLD, minimum lumen diameter; OCT, optical coherence tomography.

Sensitivity analysis and publication bias

Funnel plots of the endpoints are shown in Figures S12-S21. Direct observation of the individual funnel plots did not reveal any significant asymmetry. The Egger’s test for endpoints, which included more than 10 studies, did not reach the significance level (all-cause death =0.95, cardiovascular death =0.65, MACE =0.99, MI =0.40, TLR =0.45). The results of the sensitivity analysis are shown in Figures S22-S31. The sensitivity analyses demonstrated that some of the results that did not reach statistical significance exhibited alterations after the exclusion of each of the included studies (TVR =0.02, restenosis =0.03).

Discussion

This meta-analysis of 12,040 patients yielded following notable findings. First, OCT-guided PCI resulted in statistically significant reductions in cardiovascular death, all-cause death, and MACE compared with guidance by CA alone. No statistically significant differences were observed between OCT-guided and CA-guided PCI with regard to restenosis, MI, TLR, and TVR. Second, OCT-guided stenting improved MSA and MLD at follow-up to a greater extent compared with CA-guided stenting. A comparison of OCT-guided and CA-guided stenting revealed no difference in post-intervention MLD. Since patients with ACS are more likely to undergo PCI, there is often debate about including both ACS and non-ACS patients in trials. Nevertheless, the current meta-analysis demonstrated consistent outcomes in ACS and non-ACS patients, with OCT-guided PCI identified as the superior strategy for most outcomes.

The most important finding of our meta-analysis is that patients undergoing OCT-guided PCI had significantly better clinical outcomes than those undergoing CA-guided reconstruction. At the same time, this meta-analysis was as comprehensive as possible compared to previously published meta-analyses, including studies that reported the endpoints of interest, with the aim of synthesizing data to improve the statistical power of the original results. The results of this meta-analysis are in accordance with the conclusions presented in the recent ILUMIEN IV and OCTOBER. OCTOBER demonstrated a lower incidence of MACE at 2 years with OCT-guided PCI compared to CA-guided PCI (24). ILUMIEN IV showed that OCT-guided MSA was greater than CA-guided MSA in patients undergoing PCI, but the proportion of patients with TVR at 2 years was not significantly different between the two groups (14). The benefits of OCT-guided PCI were substantial, with a 38% reduction in all-cause death and an even more pronounced 53% reduction in cardiovascular death. The OCT guidance also indicated a potential advantage with regard to outcomes that were not statistically significant. We sought to explore how OCT guidance might lower mortality and hypothesized that if a treatment significantly reduces restenosis, MI, TLR, and TVR, then it is likely to yield a reduction in mortality (38-40). Although our analysis was insufficient to demonstrate this hypothesis, we believe that further data will become available to support this view as new trials are conducted. Additionally, the reasons for the absence of significant between-group differences in certain endpoints were investigated. The results of the sensitivity analyses indicate that ILUMIEN IV may be a source of heterogeneity for these endpoints. At the same time, the large sample size of this study, which has a high weight in our analysis, will have a more pronounced influence on the final results.

Although numerous meta-analyses have investigated OCT-guided PCI, the majority have concentrated solely on clinical event endpoints while ignoring the critical role of surrogate endpoints in indicating the procedure’s efficacy (41). Since the advent of bare-metal stents, MSA has emerged as a key predictor of stent failure (42). This meta-analysis indicated a tendency towards elevated post-intervention MSA and follow-up MLD for the OCT-guided group, which is expected to reduce stent-related adverse events and thereby reinforce this viewpoint. Researchers have long sought to identify the optimal cut-off threshold as an independent predictor of clinical outcome and would like to select different cut-off thresholds depending on the type of stent. Soeda et al. demonstrated that lesions with MSA <5.0 mm² in drug-eluting stents or <5.6 mm² in bare-metal stents were independent predictors of 1-year device-directed cardiovascular events, which include cardiovascular death, target vascular-related MI, TLR, and in-stent thrombosis (7). A study utilizing data from the CLI-OPCI database demonstrated an association between a reduction in the minimal lumen area of the implanted stent and an increase in the risk of failure. Additionally, insufficient stent expansion has been shown to be linked with adverse clinical events in cases where the minimal lumen area <4.5 mm² (8). In order to optimize the OCT-guided PCI workflow, the researchers proposed an algorithm called MLD MAX (morphology, length, diameter, medial dissection, apposition, expansion), which includes the identification of plaque properties, the selection of stent lengths and diameters, the management of medial dissection, stent apposition, and expansion (43). A multicenter study conducted in the United States demonstrated that a standardized OCT workflow resulted in a change in 86% of treatment strategies (44). The utilization of OCT to optimize the procedure in two stages, to select the most appropriate stent and ensure its adequate expansion, has the potential to result in an increased MSA.

This meta-analysis has several limitations. First, in contrast to the generally accepted decision-making role of OCT in guiding stent implantation with three steps, OCT in the included studies was mainly used to check whether stents were successfully deployed and the effect of flow reconstruction. When OCT plays a decision-making role in guiding PCI, the size and number of stents implanted are affected, thereby influencing the incidence of clinical events. Although the unclear boundaries of the role of OCT in the study may affect the accuracy of comparing its strengths and weaknesses with those of CA-guided PCI, it is not possible to determine whether the strengths of OCT are due to its decision-making role. Second, unlike clinical events examined through follow-up, endpoints such as restenosis and MLD may require more sophisticated imaging techniques for precise assessment. These endpoints were examined in a smaller proportion of the studies included in our meta-analysis. Furthermore, since some studies employed OCT to assess surrogate endpoints, although the remainder employed CA, this discrepancy introduces a potential for bias. Third, the difficulty of practicing blinding during treatment may explain why a significant minority of the included studies were blinded. This lack of blinding may have resulted in a bias in the final results.

Conclusions

In this meta-analysis, the use of OCT guidance during PCI reduced cardiovascular death, all-cause death, and MACE and resulted in a higher MSA compared to CA. However, probably because of the heterogeneity and a small number of events, other outcomes, and some subgroup analyses did not show this superiority. There remains a need for higher-quality RCTs in the future to adequately evaluate the role of OCT in PCI.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://qims.amegroups.com/article/view/10.21037/qims-24-1628/rc

Funding: This work was supported by funding from the Xingliao Talent Program of Liaoning Province (No. XLYC2203095) and the Shenyang Young and Middle-Aged Science and Technology Innovation Talent Support Program (No. RC220400).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-24-1628/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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