Abstract
Background
Percutaneous coronary intervention (PCI) with angiography guidance is a common procedure. Optical coherence tomography (OCT) is a non-invasive imaging method that uses light waves. This study from a single center aimed to compare 1-year outcomes in 75 patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent OCT-guided primary PCI, with 163 patients with acute STEMI who underwent PCI without OCT guidance from February 2019 to July 2021.
Material/Methods
Patients with acute STEMI were enrolled from February 2019 to July 2021. Seventy-five patients underwent OCT-guided PCI (OCT group), while 163 underwent PCI without OCT (control group). Baseline characteristics, in-hospital mortality, target lesion revascularization, post-MI heart failure, and 1-year all-cause mortality were compared between groups.
Results
The OCT group had lower diabetes mellitus and hyperlipidemia prevalence. Additionally, they experienced longer procedures (OCT: 50.45±21.75 min; control: 33.80±14.44 min; P<0.001). After PCI, the control group had lower left ventricular ejection fractions (OCT: 53.4%±10.5%; control: 47.8%±12.4%; P<0.001) and higher post-MI heart failure rates (OCT: 2.7%; control: 11.0%; P=0.030). Notably, the 1-year all-cause mortality rate was significantly lower in the OCT group (OCT: 1.3%; control: 8.0%; P=0.043).
Conclusions
During the 1-year follow-up, patients who received OCT-guided primary PCI experienced a notably lower rate of post-MI heart failure than did those who underwent primary PCI without OCT guidance. Importantly, the application of OCT in primary PCI procedures did not result in a higher incidence of distal embolism, even in cases with a significant thrombus burden.
Keywords: Myocardial Infarction, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention, Embolism, Heart Failure
Background
Acute myocardial infarction (MI) remains a leading cause of global morbidity and mortality [1]. MI disrupts the heart’s blood supply, exceeding a critical threshold and overwhelming the heart’s cellular repair mechanisms during ischemia [2]. Early effective reperfusion, achieved through thrombolytic therapy or primary percutaneous coronary intervention (PPCI), is essential to minimize ischemic damage and reduce the size of the MI [1,3]. Over the past two decades, advancements in early reperfusion therapies and pharmacotherapy have significantly improved outcomes for patients with ST-elevation myocardial infarction (STEMI) [4,5]. The timing of PPCI is critically linked to mortality risk, regardless of the time elapsed since symptom onset or the patient’s baseline mortality risk [6]. Optical coherence tomography (OCT) is a notable intracoronary diagnostic tool, providing highly detailed vascular images and superior structural detail, compared with intravascular ultrasound [7]. OCT, standing at the forefront of current intravascular imaging technology in clinical practice, excels in identifying calcified plaques and post-stent implantation, offering 3-dimensional reconstruction and real-time alignment with coronary angiographic images, thereby guiding PCI with its distinguished ability to provide high-resolution, exceptionally clear visualizations of vessel morphology [8–11]. Although OCT is gaining prominence in STEMI management during PPCI, its impact on clinical outcomes in this context is not fully established. Therefore, we aimed to compare outcomes in 75 patients from a single center with acute STEMI who underwent OCT-guided primary PCI with 163 patients with acute STEMI who underwent PCI without OCT guidance from February 2019 to July 2021.
Material and Methods
Patients and Groups
Between February 2019 and July 2021, we enrolled 75 patients with acute STEMI who underwent OCT-guided PPCI, forming the OCT group. In addition, 163 patients with acute STEMI, who did not undergo OCT-guided PPCI, were selected as the control group. The exclusion criteria included patients with a critical status, those requiring supportive devices, such as extracorporeal membrane oxygenation or intra-aortic balloon pump support, and those in need of emergent coronary artery bypass graft surgery.
Ethics Statement
This retrospective study received approval from the Institutional Review Committee of Kaohsiung Chang Gung Memorial Hospital, under approval number 201801078B0. It adhered to the ethics guidelines set forth in the 1975 Declaration of Helsinki.
OCT-Guided PCI Procedural Steps
OCT is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional, and 3-dimensional images of the vessel microstructure during PCI (Figure 1). The OCT imaging system consists of 3 main components: the software, system, and catheter. The procedure’s steps are listed in Figure 2. In this study, the evaluation consisted of 6 steps, which included assessments of morphology, length, diameter, medial dissection, and expansion criteria. First, we performed an OCT pullback, in which an OCT catheter is inserted into the vessel and an infrared laser is used to scan the vessel wall in a spiral-like manner. The laser beam penetrates the tissue 2 to 3 mm deep, is reflected from there and returned to the OCT device via the catheter for evaluation. Second, we interpreted OCT images via the system, which can be done before PCI and is designed to help inform the treatment strategy, such as morphology, length, and diameter. Third, we detected the medial dissection, apposition, and expansion after PCI to optimize stent placement and outcome.
Figure 1.
A 58-year-old woman presented with acute anterior wall ST elevation myocardial infarction. (A) the left coronary angiogram showed the culprit lesion thrombotic occlusion at proximal left anterior descending artery (LAD), with a right anterior oblique caudal view. (B) The left coronary angiogram after thrombus suction. (C) The arrow shows the culprit site after thrombus suction, with a right anterior oblique cranial view. (D) The arrow shows the result after drug-eluting stent (DES) and optical computed tomography (OCT)-guided percutaneous coronary intervention (PCI). (E) OCT finding at the culprit site, with much thrombus and minimal luminal area (MLA) only 1.9 mm2 after thrombus suction. (F) OCT finding at the LAD reference site, with MLA 4.7 mm2. (G) OCT finding at the culprit site after DES implantation. (H) OCT finding at the LAD reference site.
Figure 2.
Stepwise explanation of the study procedures and decision-making process. The procedural guidelines for the study are delineated in a stepwise manner, encompassing several critical criteria. Morphological assessment involved identifying high calcium plaque characterized by an arc exceeding 180 degrees, thickness over 0.5 mm, and length of more than 5 mm. Landing zones for interventions were selected based on the visualization of healthy tissue and the external elastic lamina. Diameter criteria required measuring the dimensions of the vessel, stent, and balloon, with reference measurements taken distally to select stent and distal balloon sizes, and proximally for proximal balloons. Significant medial dissections, defined as those penetrating the medial layer and extending beyond 1 quadrant arc, were promptly addressed. Apposition criteria involved rectifying gross malposition, noted when the separation from the vessel wall exceeded 3 mm. Finally, expansion criteria verified stent deployment, with over 80% expansion considered acceptable and beyond 90% regarded as optimal, ensuring precision and efficacy in the intervention process.
Definitions
The definitions of MI in this study conformed to the most recent universal MI definition [12]. The Killip classes 1 to 4 were defined in 1967, when Killip and Kimball described the outcome of 250 patients with acute MI admitted to a coronary care unit, with 4 categories according to patient hemodynamic status [13]. Killip class 1 indicates without heart failure, Killip 2 indicates pulmonary rales less than half of lung field, Killip 3 indicates acute pulmonary edema, and Killip 4 indicates cardiogenic shock [14,15]. Cardiovascular mortality was defined specifically as death due to conditions including myocardial infarction, cardiac arrhythmia, and heart failure. Conversely, all-cause mortality included deaths from any cause. Target lesion revascularization was identified as any occurrence of PCI on a target lesion or coronary artery bypass graft surgery involving a target lesion.
Study Endpoints
This study was designed to evaluate a range of clinical endpoints over a 1-year follow-up period after treatment. Key among these endpoints was the incidence of MI, which signified a critical event in the cardiovascular health of the patients. Additionally, we closely monitored instances of target lesion revascularization, a significant indicator of the need for additional intervention at the site of the original cardiac event. The occurrence of heart failure was also a crucial endpoint, as it directly impacted patient quality of life and long-term health outcomes. Moreover, we assessed all-cause mortality rates within this period. This holistic approach allowed us to gain a thorough understanding of the treatment’s efficacy, encompassing both cardiac-specific and overall health outcomes in patients who underwent PPCI, with and without the guidance of OCT.
Statistical Analysis
Data are presented in 2 forms: for continuous variables, we report means along with standard deviations to reflect the central tendency and variability of the data. Categorical variables are expressed as counts and percentages, providing a clear representation of their distribution across different categories. To rigorously compare continuous variables, we used 2 distinct statistical tests depending on the nature of the data distribution: the independent sample t test was used for data following a normal distribution, whereas the Mann-Whitney U test was used for data not adhering to normal distribution patterns. For the analysis of categorical variables, we conducted comparisons using the chi-square test, a robust method for assessing the significance of differences between categorical groups. All statistical analyses were performed using SPSS version 22.0 (IBM Corp, Armonk, NY, USA). A P value of less than 0.05 was set as the threshold for determining statistical significance, with values below this cutoff considered statistically significant and indicative of non-random patterns in the data.
Results
Baseline Characteristics
Between the OCT and control groups, there was no significant difference in average age (OCT: 59±10.7 years; control: 60±12.2 years; P=0.208) or in the prevalence of male sex (OCT: 62.7%; control: 65.0%; P=0.331; Table 1). Both groups had a similar body mass index and systolic blood pressure at presentation. However, the control group had a higher prevalence of diabetes (OCT: 26.7%; control: 42.3%; P=0.020) and hyperlipidemia (OCT: 46.7%; control: 78.5%; P<0.001). Hemoglobin A1c levels were also notably higher in the control group (OCT: 6.5±1.4%; control: 6.9±1.8%; P=0.020). No significant differences were observed between the groups in terms of white blood cell count, creatinine levels, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, or peak troponin-I levels.
Table 1.
Comparison of baseline characteristics between groups.
| OCT | Control | P value | |
|---|---|---|---|
| Number | 75 | 163 | |
| General demographics | |||
| Age (years) | 59±10.7 | 60±12.2 | 0.208 |
| Male sex (%) | 47 (62.7) | 106 (65.0) | 0.331 |
| Body mass index (kg/m2) | 25.8±3.4 | 26.8±3.7 | 0.261 |
| SBP upon presentation (mm Hg) | 149.3±28.3 | 144.9±31.5 | 0.626 |
| Comorbidities | |||
| Hypertension (%) | 41 (54.7) | 107 (65.6) | 0.105 |
| Diabetes mellitus (%) | 20 (26.7) | 69 (42.3) | 0.020 |
| Prior stroke (%) | 2 (2.7) | 7 (4.3) | 0.541 |
| Hyperlipidemia (%) | 35 (46.7) | 128 (78.5) | <0.001 |
| ESRD (%) | 2 (2.7) | 9 (5.5) | 0.330 |
| Smoking (%) | 44 (58.7) | 94 (57.7) | 0.885 |
| Prior peptic ulcer (%) | 1 (1.3) | 6 (3.7) | 0.319 |
| Prior MI (%) | 1 (1.3) | 6 (3.7) | 0.319 |
| Laboratory examination | |||
| WBC (109/L) | 11.2±3.7 | 10.8±3.5 | 0.492 |
| Creatinine (exclude ESRD) (mg/dL) | 1.09±0.30 | 1.10±0.39 | 0.115 |
| HbA1C (%) | 6.5±1.4 | 6.9±1.8 | 0.020 |
| LDL-C (mg/dL) | 103.0±32.6 | 107.4±35.1 | 0.614 |
| HDL-C (mg/dL) | 37.9±9.5 | 39.1±10.1 | 0.216 |
| Peak Troponin-I (ng/mL) | 27.25±21.54 | 27.17±22.51 | 0.317 |
Data are expressed as mean±standard deviation or as number (percentage). OCT – optical coherence tomography; SBP – systolic blood pressure; ESRD – end stage renal disease; MI – myocardial infarction; WBC – white blood cell; HbA1C – hemoglobin A1c; LDL-C – low density lipoprotein; HDL-C – high density lipoprotein.
Procedural Characteristics Between Groups
The location of the infarction was similar in both groups, with most patients experiencing anterior wall STEMI (OCT: 57.3% vs control: 54.0%; P=0.872), as shown in Table 2. The severity of the condition, measured by Killip class, was also comparable, with most patients classified as Killip class 1 or 2 (OCT: 89.3% vs control: 91.4%; P=0.236). However, a notably higher percentage of patients in the control group were transferred from other hospitals (OCT: 26.7% vs control: 48.5%; P=0.002). While reperfusion times were similar between the groups, the procedure time was significantly longer in the OCT group (OCT: 50.45±21.75 min vs control: 33.80±14.44 min; P<0.001). The use of thrombectomy was similar in both groups (OCT: 74.7% vs control: 65.6%; P=0.164), but the OCT group had a higher usage of glycoprotein 2b/3a inhibitors than did the control group (OCT: 46.7% vs control: 27.6%; P=0.004). Furthermore, there were no significant differences in the incidence of slow flow and/or no reflow between the groups (OCT: 4.0% vs control: 5.5%; P=0.325).
Table 2.
Comparison of procedural characteristics between groups.
| OCT | Control | P value | |
|---|---|---|---|
| Number | 75 | 163 | |
| MI territory (%) | 0.872 | ||
| Anterior wall (%) | 43 (57.3) | 87 (54.0) | |
| Inferior wall (%) | 31 (41.3) | 70 (43.5) | |
| Lateral and posterior wall (%) | 1 (1.3) | 4 (2.5) | |
| Killip class | 0.236 | ||
| 1 and 2 (%) | 67 (89.3) | 149 (91.4) | |
| 3 and 4 (%) | 8 (10.7) | 14 (8.6) | |
| Transfer from other hospital (%) | 20 (26.7) | 79 (48.5) | 0.002 |
| Reperfusion time (min) | 13.27±6.27 | 14.70±6.92 | 0.129 |
| Procedure time (min) | 50.45±21.75 | 33.80±14.44 | <0.001 |
| Thrombectomy and/or Glycoprotein 2b/3a use | |||
| Thrombectomy (%) | 56 (74.7) | 107 (65.6) | 0.164 |
| Glycoprotein 2b/3a use (%) | 35 (46.7) | 45 (27.6) | 0.004 |
| Slow flow and/or no reflow (%) | 3 (4.0) | 9 (5.5) | 0.325 |
Data are expressed as mean±standard deviation or as number (percentage). OCT – optical coherence tomography; MI – myocardial infarction.
Findings of OCT Imaging
The OCT findings are summarized in Table 3. In the OCT group, thrombus was present in 18.7% (14 out of 75) of patients, with 10.7% (8 out of 75) exhibiting white thrombus, and 8.0% (6 out of 75) showing red thrombus. Plaque rupture and erosion were observed in 32.0% (24 out of 75) of patients. A calcified nodule was noted in 2.7% (2 out of 75), and an intact fibrous cap (small protruding thrombus) was identified in 6.7% (5 out of 75) of cases.
Table 3.
The findings of optical coherence tomography.
| Optical coherence tomography findings | Number (%) |
|---|---|
| Thrombus | 14 (18.7%) |
| White thrombus | 8 (10.7%) |
| Red thrombus | 6 (8.0%) |
| The condition of plaque | 24 (32.0%) |
| Plaque rupture | 23 (30.7%) |
| Plaque erosion | 1 (1.3%) |
| Calcified nodule | 2 (2.7%) |
| Intact fibrous cap (small protruding thrombus) | 5 (6.7%) |
Data are expressed as number (percentage).
Post-MI Echocardiographic Parameters and 1-Year Clinical Follow-Up Clinical Outcomes
Table 4 shows the 1-year clinical follow-up results and echocardiography parameters. After PPCI, the control group exhibited a significantly lower left ventricular ejection fraction than the OCT group (OCT: 53.4±10.5% vs control: 47.8±12.4%; P<0.001). The prevalence of reduced and mildly reduced ejection fraction was comparable between the groups. Similarly, the incidence of mitral regurgitation grade exceeding 2 was not significantly different (OCT: 2.7% vs control: 7.2%; P=0.168). There were no significant differences in the rates of in-hospital mortality and 1-year target lesion revascularization. However, the OCT group demonstrated a lower incidence of post-myocardial infarction heart failure (OCT: 2.7% vs control: 11.0%; P=0.030). Importantly, the 1-year mortality rate was significantly lower in the OCT group than in the control group (OCT: 1.3% vs control: 8.0%; P=0.043).
Table 4.
Post-myocardial infarction echocardiographic parameters and 1-year follow-up clinical outcomes.
| OCT | Control | P value | |
|---|---|---|---|
| Number | 75 | 163 | |
| Follow up echocardiographic parameters | |||
| LVEF (%) | 53.4±10.5 | 47.8±12.4 | <0.001 |
| <40% (%) | 7 (9.3) | 22 (10.4) | 0.741 |
| 40–50% (%) | 22 (29.3) | 63 (38.7) | 0.161 |
| MR grade >2 (%) | 2 (2.7) | 10 (7.2) | 0.168 |
| Follow-up outcomes | |||
| In-hospital mortality (%) | 1 (1.3) | 8 (4.9) | 0.179 |
| Target lesion revascularization (%) | 3 (4.0) | 9 (5.5) | 0.624 |
| Post-MI heart failure (%) | 2 (2.7) | 18 (11.0) | 0.030 |
| All-cause mortality (%) | 1 (1.3) | 13 (8.0) | 0.043 |
Data are expressed as mean±standard deviation or as number (percentage). MI – myocardial infarction; OCT – optical coherence tomography; LVEF – left ventricular ejection fraction; MR – mitral regurgitation.
Discussion
In our study, the occurrence of no-reflow and/or slow flow phenomena showed no significant difference between patients receiving OCT-guided and angiographic-guided PCI (OCT: 4.0% vs control: 5.5%; P=0.325). This finding challenges the prevailing concerns regarding the use of OCT-guided PCI in complex STEMI cases, suggesting that these concerns may not necessarily lead to increased procedural risks as previously speculated. This insight is crucial, endorsing the wider and more confident application of OCT in acute scenarios. Additionally, we observed a lower incidence of post-MI heart failure and all-cause mortality in patients who underwent OCT-guided PCI for acute STEMI, a finding that has not been distinctly addressed in earlier clinical trials.
OCT offers unprecedented insights into the intricate details of vessel walls and plaques, far surpassing what was previously achievable [16,17]. However, the application of OCT-guided PCI in patients with STEMI, particularly in high-thrombus situations, has not been extensively explored in comparative studies with angiographic-guided PCI. While some observational studies have suggested the potential benefits of OCT-guided PCI in STEMI, a definitive conclusion is yet to be drawn, due to the scarcity of data from randomized controlled trials [18–20]. These trials are essential to fully understand and validate the advantages of OCT in these critical scenarios. The body of existing evidence has thoroughly characterized the primary plaque features in STEMI cases, such as plaque rupture, plaque erosion, and calcified nodules [21]. These findings are instrumental in understanding the pathophysiology of STEMI and in guiding targeted interventions. In our study, we observed a notable lower incidence of post-MI heart failure and all-cause mortality in patients who underwent OCT-guided PCI for acute STEMI. This suggests a potential advantage of using OCT in guiding PCI, offering a more informed and precise approach to treatment that could translate into improved clinical outcomes, which was also found in the ILUMIEN IV trial recently [22].
Interventional cardiologists often face challenges in using OCT-guided PCI, especially in specific clinical scenarios, including ostial lesions, acute STEMI lesions, and chronic total occlusion lesions, and among patients with chronic kidney disease. A clear image on OCT requires a robust injection of contrast medium to effectively remove red blood cells from the coronary arteries. This process not only poses procedural challenges but also carries the risk of adversely affecting renal function, especially in patients with chronic kidney disease, in whom kidney health is already compromised. In STEMI cases with a high thrombus burden, additional apprehensions arise. There is a worry that OCT guidance might increase the risk of no reflow and/or slow flow phenomena following PCI, potentially complicating the procedure, and impacting patient outcomes. Such concerns have made some interventional cardiologists hesitant to use OCT in these high-risk scenarios. However, it is crucial to balance these concerns with the benefits of OCT’s superior imaging capabilities, which can significantly enhance the precision of PCI by providing detailed visualization of the coronary artery structure and lesion characteristics. In our study, we specifically addressed these concerns by comparing the incidence of no reflow and/or slow flow after PCI in patients who underwent OCT-guided vs angiographic-guided PCI. Our findings revealed that there were no significant differences between the 2 groups in terms of these complications. This suggests that while the concerns about OCT-guided PCI in complex STEMI cases are valid, they may not translate into increased procedural risks as previously thought. This finding is important, as it supports the broader and more confident use of OCT in a variety of clinical contexts, potentially improving patient outcomes through more precise and informed interventions.
Current guidelines for myocardial revascularization assign a class 3 recommendation to routine aspiration thrombectomy, indicating that it should not be performed as a standard practice. The decision to use thrombectomy and glycoprotein 2b/3a inhibitors during PCI is largely left to the discretion of the operating cardiologist, as routine use is not recommended according to guidelines [22,23]. However, there is some evidence suggesting that the use of glycoprotein 2b/3a inhibitors can reduce post-MI angina, a critical aspect in improving patient recovery and quality of life after MI [24,25]. In our study, a notable trend was observed where OCT-guided PCI resulted in a higher utilization of glycoprotein 2b/3a inhibitors. This could be attributed to the enhanced visualization of plaque morphology that OCT provides during the procedure, allowing for more informed decision-making regarding the use of these inhibitors. Our study is unique as it is the only prospective trial to date that demonstrates superior 1-year clinical outcomes with OCT-guided PCI in acute STEMI cases. The findings of our study suggest that the use of OCT guidance in acute STEMI PCI, in contrast to exclusive reliance on angiographic guidance, can be instrumental in reducing the incidence of post-MI heart failure and mortality. By providing a clearer picture of the coronary anatomy and lesion characteristics, OCT enables a more targeted and effective intervention, potentially setting a new standard in the treatment approach for patients with acute STEMI.
Limitations
First, it is crucial to acknowledge that this study was conducted as a retrospective cohort study and did not incorporate randomization to reduce potential bias. The potential confounders influenced the study’s results and conclusions. Second, the study was limited by a relatively small number of enrolled patients and the exclusion of individuals requiring extracorporeal membrane oxygenation or intra-aortic balloon pump support. Third, our analysis could not establish a correlation between OCT findings and clinical outcomes, due to the limited number of clinical events observed in the OCT group. Fourth, it may be beneficial to include a group undergoing intravascular ultrasound-guided PCI to compare results. This could help in highlighting the differences and potential advantages of OCT-guidance PCI. Despite these limitations, our study, which was prospective and observational in nature, still provides valuable insights. Notably, OCT-guided PCI did not increase the incidence of distal embolism, especially in STEMI cases characterized by a high thrombus burden.
Conclusions
During the 1-year follow-up, patients who received OCT-guided PPCI experienced a notably lower rate of post-MI heart failure than did those who underwent PPCI without OCT guidance. Importantly, the application of OCT in PPCI procedures did not result in a higher incidence of distal embolism, even in cases with a significant thrombus burden.
Footnotes
Conflict of interest: None declared
Declaration of Figures’ Authenticity: All figures submitted have been created by the authors who confirm that the images are original with no duplication and have not been previously published in whole or in part.
Financial support: This study was supported by the research program of Kaohsiung Chang Gung Memorial Hospital (grant CMRPG8H1471)
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