Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial.

BACKGROUND: Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories. METHODS: The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm2), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study. RESULTS: Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024. CONCLUSION: The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT05388357.

Differential clinical impact of chronic total occlusion revascularization based on left ventricular systolic function.

BACKGROUND: The effect of chronic total occlusion (CTO) revascularization on survival remains controversial. Furthermore, data regarding outcome differences for CTO revascularization based on left ventricular systolic function (LVSF) are limited. The differential outcomes from CTO revascularization in patients with preserved LVSF (PLVSF) versus reduced LVSF (RLVSF) were assessed. METHODS: A total of 2,173 CTO patients were divided into either a PLVSF (n = 1661, Ejection fraction ≥ 50%) or RLVSF (n = 512, < 50%) group. Clinical outcomes were compared between successful CTO revascularization (SCR) versus optimal medical therapy (OMT) within each group. The primary endpoint was a composite of all-cause death or non-fatal myocardial infarction. Inverse probability of treatment weighting for endpoint analysis and a contrast test for comparison of survival probability differences according to LVSF were used. RESULTS: Patients with RLVSF had a mean 37% ejection fraction (EF) and 19% had EF < 30%. The median follow-up duration was 1,138 days. Regardless of LVSF, the primary endpoint incidence was significantly lower in patients treated with SCR [RLVSF: 29.7% vs. 49.7%, hazard ratio (HR) = 0.46, 95% confidence interval (CI): 0.36-0.62, p < 0.0001; PLVSF 7.3% vs. 16.9%, HR = 0.68, 95% CI: 0.54-0.93, p = 0.0019], which was mainly driven by a reduction in cardiac death. The difference in survival probability was greater and became more pronounced over time in patients with RLVSF than with PLVSF (1-year, p = 0.197; 3-years, p = 0.048; 5-years, p = 0.036). CONCLUSIONS: SCR was associated with better survival benefit than OMT regardless of LVSF. The benefit was greater and became more significant over time in patients with RLVSF versus PLVSF.

Identification of plaque ruptures using a novel discriminative model comprising biomarkers in patients with acute coronary syndrome.

Soluble lectin-like oxidized low-density lipoprotein receptor-1 (sLOX-1), neutrophil gelatinase-associated lipocalin (NGAL), and matrix metalloproteinase-9 (MMP-9) are inflammatory biomarkers involved in plaque destabilization resulting in acute coronary syndrome (ACS). This study aimed to investigate the diagnostic value of a combination of biomarkers to discriminate plaque ruptures in the setting of ACS. Eighty-five ACS patients with optical coherence tomography (OCT) images of the culprit plaque were included and categorized into two groups: ACS with plaque rupture (Rupture group, n = 42) or without plaque rupture (Non-rupture group, n = 43) verified by OCT. A discriminative model of plaque rupture using several biomarkers was developed and validated. The Rupture group had higher white blood cell (WBC) counts and peak creatine kinase-myocardial band (CK-MB) levels (13.39 vs. 2.69 ng/mL, p = 0.0016). sLOX-1 (227.9 vs. 51.7 pg/mL, p < 0.0001) and MMP-9 (13.4 vs. 6.45 ng/mL, p = 0.0313) levels were significantly higher in the Rupture group, whereas NGAL showed a trend without statistical significance (59.03 vs. 53.80 ng/mL, p = 0.093). Receiver operating characteristic curves to differentiate Rupture group from Non-rupture group calculated the area under the curve for sLOX-1 (p < 0.001), MMP-9 (p = 0.0274), and NGAL (p = 0.0874) as 0.763, 0.645, and 0.609, respectively. A new combinatorial discriminative model including sLOX-1, MMP-9, WBC count, and the peak CK-MB level showed an area under the curve of 0.8431 (p < 0.001). With a cut-off point of 0.614, the sensitivity and specificity of plaque rupture were 62.2% and 97.6%, respectively. The new discriminative model using sLOX-1, MMP-9, WBC count, and peak CK-MB levels could better identify plaque rupture than each individual biomarker in ACS patients.

Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3 Valves in Transcatheter Aortic Valve Replacement in Korean Patients.

BACKGROUND AND OBJECTIVES: The Sapien 3 (S3) valve has not been compared to the Sapien XT (SXT) valve in Korea. We compared procedural and clinical outcomes between the 2 devices. METHODS: A total of 189 patients who underwent transcatheter aortic valve replacement (TAVR) with S3 (n=95) or SXT (n=94) valve was analyzed. The primary endpoint was cardiovascular mortality at 1 year. The median follow-up duration was 438 days. RESULTS: The Society of Thoracic Surgeons score was similar between the 2 groups. The device success rate (90.4% vs. 97.9%; p=0.028) was higher in the S3 than in the SXT. The S3 showed significantly fewer cases of moderate or severe paravalvular leakage (PVL) (16.7% vs. 0.0%; p=0.001) than the SXT. However, effective orifice area (EOA) (2.07±0.61 vs. 1.70±0.49 cm²; p<0.001) was smaller in the S3. Multivariable Cox regression analysis showed the S3 was associated with significantly fewer cardiovascular mortality at 1 year compared to the SXT (5.4% vs. 1.1%; hazard ratio, 0.031; 95% confidence interval, 0.001-0.951; p=0.047). Periprocedural complication rates, composite of disabling stroke or all-cause mortality, all-cause mortality, and disabling stroke at 1 year were similar between the 2 groups. CONCLUSIONS: Cardiovascular mortality was lower in the S3 group than in the SXT group over 1 year of follow-up. The reduction in PVL was attributed to the higher device success rate of TAVR with the S3 valve. However, the benefit of S3 obtained at the expense of reduced EOA should be meticulously re-evaluated in larger studies during long-term follow-up.

Efficacy and safety of endovascular treatment for femoropopliteal lesions of TASC II type C and D compared with TASC II type A and B in Korea.

Objective To compare the long-term safety and clinical efficacy of endovascular treatment for TASC-II type C/D femoropopliteal lesion compared with TASC-II type A/B femoropopliteal lesion in Korea. Methods A total of 179 limbs [TASC-II A/B femoropopliteal lesion (group I, n = 105 limbs) and TASC-II C/D (group II, n = 74 limbs)] were retrospectively analyzed from patients who underwent angioplasty with or without primary stent implantation between February 2008 and November 2012 at two medical centers in South Korea. The major adverse limb event was defined as a composite of target lesion revascularization, symptom relapse with abnormal ankle brachial index, and major amputation. Results Immediate procedural success rates were not significantly different (96.2% vs. 95.7%, p = 0.450). Although major adverse limb event, mainly driven by symptom relapse with abnormal ankle brachial index, were significantly higher in group II ( p = 0.013), the incidence of major amputation was very low and similar in both groups. Conclusion Even though there were higher incidences of overall procedural complication and major adverse limb event, the technical success rate of endovascular treatment for TASC-II C/D femoropopliteal lesion was comparable to endovascular treatment for TASC-II A/B FPL without an increase in major procedural complications or serious clinical events during follow-up.

A comparison of clinical features of coronary artery spasm with and without thyrotoxicosis.

OBJECTIVE: Several reports have suggested that thyrotoxicosis may induce severe coronary artery spasm (CAS). However, there are few data regarding the differences in clinical characteristics of CAS with and without thyrotoxicosis. The aim of our study is to compare the clinical features of CAS with and without thyrotoxicosis. METHODS: We evaluated 430 consecutive patients with CAS [patients with thyrotoxicosis (N=32, group I) and those without (N=398, group II)] at a single institute between January 2001 and June 2011. We compared clinical presentations, angiographic findings, and adverse outcomes (a composite outcome of cardiac death, myocardial infarction, or rehospitalization due to cardiac cause) of both groups. RESULTS: There was higher incidence of acute myocardial infarction at initial presentation in group I (15.6 vs. 5.8%, P=0.04). CAS with thyrotoxicosis was more diffuse (59.4 vs. 39.3%, P=0.03), more medically intractable (9.4 vs. 0%, P=0.001), and more frequently involved the left main vessel (25.0 vs.0.8%, P=0.001) than CAS without thyrotoxicosis. During the follow-up period (median 43 months), there were no significant differences between the two groups in terms of the risk of adverse outcomes (hazard ratio for CAS with thyrotoxicosis, 1.029; 95% confidence interval, 0.347-3.054). CONCLUSION: Clinical and angiographic presentations of CAS with thyrotoxicosis were more severe than CAS without thyrotoxicosis, but clinical outcomes were similar in both groups. Optimal vasodilator therapy is essential for the management of CAS with thyrotoxicosis. Thyroid function test should be mandatory for all patients with CAS.

The Brachial Ankle Pulse Wave Velocity is Associated with the Presence of Significant Coronary Artery Disease but Not the Extent.

BACKGROUND AND OBJECTIVES: Arterial stiffness is well known as an important risk factor for cardiovascular disease. At our institution, we assessed the association between arterial stiffness, as determined by brachial ankle pulse wave velocity (baPWV), and the extent of coronary artery disease (CAD), as detected by conventional coronary angiography (CAG) in patients who visited the outpatient clinic for angina without any previous history of heart disease. In addition, we evaluated if the level of baPWV could predict the revascularization as a clinical outcome. SUBJECTS AND METHODS: On a retrospective basis, we analyzed the data of 651 consecutive patients who had undergone baPWV and elective CAG for suspected CAD between June 2010 and July 2011, at a single cardiovascular center. RESULTS: The baPWV was one of the statistically meaningful predictors of significant CAD (diameter of stenosis >50%) in addition to male gender, age, the level of high density lipoprotein-cholesterol, and hemoglobin A1c in multivariate analysis. However, baPWV was not the significant predictor of revascularization. When the extent of CAD was classified into following 4 groups; no significant CAD, 1-, 2- and 3-vessel disease, there was significant difference of baPWV between the significant and non-significant CAD group, but there was no difference of baPWV among the 3 significant CAD groups, although there was a trend toward the positive correlation. CONCLUSION: Although baPWV was an independent predictor of significant CAD, it was neither associated significantly with the extent of CAD nor with the risk of revascularization. Therefore, baPWV has a limited value for portending the severity of CAD in patients with chest pain.

Takayasu's Disease in a Patient with Ulcerative Colitis.

A 35-year-old Korean man with a 10-year history of ulcerative colitis (UC) presented with pain and swelling of the right neck. The patient was diagnosed with Takayasu's arteritis (TA) and had human leukocyte antigen (HLA) B-52, which is frequently found in patients having both UC and Takayasu's disease concurrently on HLA analysis. This case is the first report of a patient with both TA and UC in Korea, to the best of our knowledge.