Long-term clinical outcomes of image-guided percutaneous coronary intervention in acute myocardial infarction from the Korea Acute Myocardial Infarction Registry (2024)

Youngjoon Kwon, Conceptualization, Data curation, Formal analysis, Investigation, Visualization, Writing – original draft,¹ Namkyun Kim, Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – original draft, Writing – review & editing,^1,2,‡* Chang-Yeon Kim, Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – review & editing,^3,‡* Do-Hoon Kim, Data curation, Formal analysis,⁴ Hyewon Shin, Data curation, Formal analysis,^5,6 Min-Su Jung, Investigation, Methodology, Writing – review & editing,¹ Jong Sung Park, Investigation, Methodology, Writing – review & editing,¹ Yoon Jung Park, Validation, Writing – review & editing,^1,2 Bo Eun Park, Validation, Writing – review & editing,^1,2 Hong Nyun Kim, Writing – review & editing,^1,2 Se Yong Jang, Writing – review & editing,^1,2 Myung Hwan Bae, Supervision, Writing – review & editing,^1,2 Jang Hoon Lee, Supervision, Writing – review & editing,^1,2 Dong Heon Yang, Supervision, Writing – review & editing,^1,2 Hun Sik Park, Supervision, Writing – review & editing,^1,2 Yongkeun Cho, Supervision, Writing – review & editing,^1,2 Kwang Soo Cha, Conceptualization, Project administration, Resources, Supervision, Writing – review & editing,⁷ Seung-Ho Hur, Conceptualization, Project administration, Resources, Writing – review & editing,⁸ Jin-Yong Hwang, Conceptualization, Project administration, Resources, Writing – review & editing,⁹ Myung Ho Jeong, Funding acquisition, Project administration, Resources,¹⁰ and on behalf of the KAMIR- NIH (Korea Acute Myocardial Infarction Registry- National Institutes of Health) Investigators^¶

Study design and population

A retrospective review of all patients registered in the Korean Acute Myocardial Infarction Registry—National Institutes of Health (KAMIR-NIH), who underwent PCI with second-generation drug-eluting stents (DES) between November 2011 and December 2015, was conducted. KAMIR-NIH is a prospective, open, observational, multicenter online registry of AMI cases in the Republic of Korea. A study overview is illustrated in Fig 1. This study was approved by the Institutional Review Board of Kyungpook National University Hospital (IRB No: KNUH-2022-01-011), and all patients provided written informed consent to participate. The registry data were accessed from January 15, 2023, to February 1, 2023, for the purposes of this research. Patients presenting with cardiogenic shock as their initial manifestation were excluded from this study. Those who received primary thrombolysis before undergoing PCI were also not included. Additionally, individuals assessed solely by fractional flow reserve (FFR) and those treated with bare-metal stents or first-generation DES were excluded. The final study population (n = 9,271) was stratified into two groups based on the modality used for PCI: image- (n = 2,134) and angiography-guided (n = 7,137). The image-guided PCI population was further classified into IVUS-guided (n = 1,919) and OCT-guided PCI (n = 215).

AMI, including both ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), was diagnosed according to the standard criteria of clinical manifestations and elevated serum cardiac troponin I levels [9]. All interventional procedures were performed according to current guidelines. The diagnostic modality (IVUS/OCT) was determined by the treating cardiologists in the catheterization laboratory.

IVUS or OCT was used to analyze the characteristics of plaque and target lesions during the preinterventional phase in the image-guided PCI group [10]. Additionally, the treating physicians used IVUS or OCT to obtain information on the landing zones, stent apposition and expansion, hematoma, or coronary dissection in the peri- and post-interventional phases [2].

In accordance with the current guidelines, all patients were administered aspirin and P2Y12 inhibitors. Prior to the procedure, each patient received a loading dose of aspirin (300 mg) and either clopidogrel (300 or 600 mg), prasugrel (60 mg), or ticagrelor (180 mg), depending on the practices of the individual centers. Specifically, 2,656 patients (28%) in the clopidogrel group were administered a 300mg loading dose. Administration of unfractionated heparin during PCI followed local practice rules and protocols. Patients received guideline-directed medical therapy, based on their individual conditions, and determined by the physician, which included the administration of antiplatelet agents, renin-angiotensin-system inhibitors, beta-blockers, and statins.

During initial admission, baseline patient information and laboratory data were collected, and subsequent data were obtained through medical records and direct telephone interviews. The outcome of the study was target lesion failure (TLF) at 3 years after the initial intervention, defined as the composite of all cardiac deaths, target vessel myocardial infarction, and ischemia-driven target lesion revascularization. Target vessel myocardial infarction is defined as a myocardial infarction marked by myocardial necrosis occurring in the vascular area served by a previously treated target vessel. Target lesion revascularization was classified as ischemia-driven if revascularization procedures were conducted on the target lesion under specific conditions: either in the case of ≥50% angiographic diameter stenosis accompanied by ischemic symptoms or a positive functional study, or when there was ≥70% stenosis without ischemic symptoms or a positive functional study.

Statistical analysis

Continuous variables are presented as mean ± standard deviation (SD), whereas categorical variables are expressed as percentages. The comparison of parameters involved using the Student’s t-test for continuous variables and Pearson’s chi-square test for categorical variables. As the patient distribution was not uniform across study groups, propensity score (PS) matching was used to adjust for hidden confounding factors. PS was derived through logistic regression considering clinically important parameters between the two groups (age, sex, body mass index, clinical presentation, final diagnosis, hypertension, diabetes, dyslipidemia, previous myocardial infarction or cerebrovascular accident, left ventricular ejection fraction [LVEF], estimated glomerular filtration rate [eGFR], troponin I, creatine kinase-myocardial band [CK-MB], discharge medication, use of transradial approach, use of glycoprotein IIb/IIIa inhibitors, thrombus aspiration, stent diameter and length, stent type, stent number, number of vessels involved, multivessel disease, culprit vessel, and ACC/AHA lesion type). We used nearest-neighbor matching with a caliper size set at 0.2 times the SD of the logit-transformed PS.

We calculated the hazard ratios (HRs) and 95% confidence intervals (CI) from a matched stratified Cox proportional-hazards model for the main outcome in the PS-matched cohort. Cumulative clinical events at 3 years were estimated using the Kaplan–Meier survival analysis, and outcomes were compared using the log-rank test for each result. Statistical significance was set at p < 0.05. All analyses were conducted using R (version 4.3.1; R Foundation for Statistical Computing.).

Baseline characteristics

Among the 9,271 patients retrieved from the registry, 2,134 (23.0%) underwent image-guided PCI; the median follow-up period of the entire population was 1,099 days. Within the image-guided PCI group, 1,919 patients (20.6%) underwent IVUS-guided PCI, and 215 patients (2.3%) underwent the OCT-guided PCI. The angiography-guided PCI group had a higher average patient age (63.29 ± 12.39 years vs 62.23 ± 12.10 years; p < 0.001) and a higher prevalence of previous hypertension (n = 3,598 [50.4%] vs n = 963 [45.1%]; p < 0.001) and cerebrovascular accidents (n = 434 [6.1%] vs n = 104 [4.9%]; p = 0.041) than the image-guided PCI group. Moreover, the angiography-guided PCI group exhibited significantly lower levels of LVEF on admission (52.12% ± 10.44% vs 53.14% ± 9.82%; p < 0.001).

However, the troponin I levels at admission were significantly higher in the angiography-guided PCI group than in the image-guided PCI group (47.02 ± 96.11 ng/mL vs 32.93 ± 118.25 ng/mL; p < 0.001). Furthermore, the frequency of RAS inhibitor usage was considerably higher in the angiography-guided PCI group (n = 5,981 [83.8%] vs n = 1,713 [80.3%]; p = 0.001), as was the use of beta-blockers (n = 6,259 [87.7%] vs 1,799 [84.3%]; p < 0.001).

Regarding procedural characteristics, the transradial approach was more commonly preferred in the image-guided PCI group (n = 920 [43.1%] versus n = 2,683 [37.6%]; p < 0.001). Moreover, this group frequently used stents with larger diameters (≥3 mm), longer lengths (≥35 mm), and employed multiple stent implantations (≥2 stents). In terms of lesion characteristics, the image-guided PCI group showed higher instances of multivessel disease (n = 1,174 [55.0%] vs n = 3,501 [49.1%]; p < 0.001) and complex left main vessel disease (n = 175 [8.2%] vs n = 183 [2.6%]; p < 0.001).

The PS matching results indicated adequacy based on standardized mean differences (SMD) in all clinical variables. Patient characteristics, such as age, sex, comorbidities, and lesion and procedure characteristics, were statistically similar between the two groups in this matched cohort (Table 1).

Within the image-guided PCI group, the IVUS- and OCT-guided subgroups were statistically similar in mean age, sex, body mass index, clinical manifestation, incidence of diabetes, dyslipidemia, previous myocardial infarctions, and cardiac enzyme levels. The exceptions were a previous history of cerebrovascular accidents (n = 100 [5.2%] vs n = 4 [1.9%]; p = 0.046) and the use of P2Y12 inhibitors and beta-blockers (n = 1,597 [83.2%] vs n = 202 [94.0%]; p < 0.001). Furthermore, the initial eGFR was high in the OCT-guided PCI group (94.51 ± 26.29 mL/min/1.73 m² vs 84.92 ± 37.75 mL/min/1.73 m²; p < 0.001).

Given the substantial disparity in patient numbers, PS matching at a ratio of 2 was also performed within the image-guided PCI group, resulting in no significant differences between the matched groups according to SMD (Table 2).

Clinical outcomes

The main study outcomes are summarized in Fig 2 and Table 3. In the overall population, the incidence of TLF was significantly lower in the image-guided PCI group than in the angiography-guided PCI (n = 485 [6.8%] vs n = 113 [5.3%], p = 0.015), primarily owing to a reduction in cardiac deaths (n = 283 [4.0%] vs n = 58 [2.7%], p = 0.009) and target vessel myocardial infarctions (n = 103 [1.4%] vs n = 18 [0.8%], p = 0.042). Following PS matching, the incidence of TLF remained statistically lower in the image-guided PCI group than in the angiography-guided PCI (n = 143 [6.8%] vs n = 110 [5.3%], p = 0.038), mainly driven by a decrease in cardiac deaths (n = 85 [4.1%] vs n = 57 [2.7%], p = 0.021). According to the stratified Cox proportional hazard model in the matched cohort, image-guided PCI was associated with a significant reduction in TLF (HR: 0.76, 95% CI: 0.59–0.98; p = 0.035) and cardiac death (HR: 0.67, 95% CI: 0.48–0.92; p = 0.016) (Table 4).

The survival analysis, depicted using Kaplan–Meier curves, is presented in Fig 3. In the unmatched population, the 3-year cumulative incidences of TLF, cardiac death, and target vessel myocardial infarction were statistically lower in the image-guided PCI group than in the angiography-guided PCI (6.8% vs 5.3%, log-rank p = 0.016; 4.0% vs 2.7%, log-rank p = 0.008; 1.4% vs 0.8%, log-rank p = 0.033). The cumulative incidences of TLF and cardiac deaths remained significantly low in the image-guided PCI group (6.8% vs 5.3%, log-rank p = 0.036; 4.1% vs 2.7%, log-rank p = 0.018) following PS matching, except target vessel myocardial infarction (1.4% vs 0.9%, log-rank p = 0.083).

In the subgroup analysis, clinical outcomes were compared between the IVUS- and OCT-guided PCI groups (Fig 4 and Table 5). All outcomes, including TLF, cardiac death, treated vessel myocardial infarction, and ischemia-driven target vessel revascularization, were statistically similar between the OCT- and IVUS-guided PCI groups in the unmatched and PS-matched cohorts. Furthermore, in the survival analysis, clinical outcomes between the IVUS- and OCT-guided PCI groups were similar, both before and after PS matching, as illustrated in Fig 5.

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