Early Left Ventricular Unloading or Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: The EARLY-UNLOAD Randomized Clinical Trial.

BACKGROUND: Although venoarterial extracorporeal membrane oxygenation (VA-ECMO) is beneficial for the treatment of profound cardiogenic shock, peripheral VA-ECMO cannulation can increase left ventricular afterload, thus compromising myocardial recovery. We investigated whether early routine left ventricular unloading can reduce 30-day mortality compared with the conventional approach in patients with cardiogenic shock undergoing VA-ECMO. METHODS: This randomized clinical trial involved 116 patients with cardiogenic shock undergoing VA-ECMO from March 2021 to September 2022 at Chonnam National University Hospital, Gwangju, South Korea. The patients were randomly assigned to undergo either early routine left ventricular unloading with transseptal left atrial cannulation within 12 hours after randomization (n=58) or the conventional approach, which permitted rescue transseptal left atrial cannulation in case of an increased left ventricular afterload (n=58). The primary outcome was all-cause mortality within 30 days. RESULTS: All 116 randomized patients (mean age, 67.6±13.5 years; 34 [29.3%] women) completed the trial. At 30 days, all-cause death had occurred in 27 (46.6%) patients in the early group and 26 (44.8%) patients in the conventional group (hazard ratio, 1.02 [95% CI, 0.59-1.74]; P=0.942). Crossover to rescue transseptal left atrial cannulation occurred in 29 patients (50%) in the conventional group according to a clear indication. Time to rescue transseptal cannulation in the conventional group was a median of 21.8 (interquartile range, 12.4-52.2) hours after randomization. There were no significant differences in other secondary outcomes between the 2 groups except for a shorter time to disappearance of pulmonary congestion in the early group (median, 3 [interquartile range, 2-6] versus 5 [interquartile range, 3-7] days; P=0.027). CONCLUSIONS: Among patients with cardiogenic shock undergoing VA-ECMO, early routine left ventricular unloading with transseptal left atrial cannulation did not reduce 30-day mortality compared with the conventional strategy, which permitted rescue transseptal left atrial cannulation. These findings should be cautiously interpreted until the results of multicenter trials using other unloading modalities become available. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04775472.

Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial.

BACKGROUND: Current guidelines recommend complete revascularization (CR) in hemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD). With regard to the timing of percutaneous coronary intervention (PCI) for non-infarct-related artery (non-IRA), recent randomized clinical trials have revealed that immediate CR was non-inferior to staged CR. However, the optimal timing of CR remains uncertain. The OPTION-STEMI trial compared immediate CR and in-hospital staged CR guided by fractional flow reserve (FFR) for intermediate stenosis of the non-IRA. METHODS: The OPTION-STEMI is a multicenter, investigator-initiated, prospective, open-label, non-inferiority randomized clinical trial. The study included patients with at least 1 non-IRA lesion with ≥50% stenosis by visual estimation. Patients fulfilling the inclusion criteria were randomized into 2 groups at a 1:1 ratio: immediate CR (i.e., PCI for the non-IRA performed during primary angioplasty) or in-hospital staged CR. In the in-hospital staged CR group, PCI for non-IRA lesions was performed on another day during the index hospitalization. Non-IRA lesions with 50%-69% stenosis by visual estimation were evaluated by FFR, whereas those with ≥70% stenosis was revascularized without FFR. The primary endpoint was the composite of all-cause death, non-fatal myocardial infarction, and all unplanned revascularization at 1 year after randomization. Enrolment began in December 2019 and was completed in January 2024. The follow-up for the primary endpoint will be completed in January 2025, and primary results will be available in the middle of 2025. CONCLUSIONS: The OPTION-STEMI is a multicenter, non-inferiority, randomized trial that evaluated the timing of in-hospital CR with the aid of FFR in patients with STEMI and MVD. TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT04626882; and URL: https://cris.nih.go.kr. Unique identifier: KCT0004457.

Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model.

BACKGROUND: Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION®) in comparison with a commercial durable polymer everolimus-eluting stent (XIENCE Alpine®) in a porcine coronary restenosis model. METHODS: Twenty-eight coronary arteries from 14 mini-pigs were randomly allocated to TIGEREVOLUTION® stent and XIENCE Alpine® stent groups. The stents were implanted in the coronary artery at a 1.1-1.2:1 stent-to-artery ratio. Eleven stented coronary arteries in each group were finally analyzed using coronary angiography, optical coherence tomography, and histopathologic evaluation 6 months after stenting. RESULTS: Quantitative coronary analysis showed no significant differences in the pre-procedural, post-procedural, and 6-month lumen diameters between the groups. In the volumetric analysis of optical coherence tomography at 6 months, no significant differences were observed in stent volume, lumen volume, and percent area stenosis between the groups. There were no significant differences in injury score, inflammation score, or fibrin score between the groups, although the fibrin score was zero in the TIGEREVOLUTION® stent group (0 vs. 0.07 ± 0.11, P = 0.180). CONCLUSION: Preclinical evaluation, including optical coherence tomographic findings 6 months after stenting, demonstrated that the TIGEREVOLUTION® stent exhibited efficacy and safety comparable with the XIENCE Alpine® stent, supporting the need for further clinical studies on the TIGEREVOLUTION® stent.

Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation.

AIMS: We aim to determine the optimal dose of dabigatran in Korean patients with atrial fibrillation (AF). METHODS AND RESULTS: We analysed 1834 patients with non-valvular AF, classified into a warfarin group (n = 990), dabigatran 150 mg group (D150, n = 294), and 110 mg group (D110, n = 550). The D110 group was further classified into patients concordant (co-D110, n = 367) and patients discordant (di-D110, n = 183) with guidelines to dose reduction. Propensity-matched 1-year clinical outcomes were then compared. Efficacy outcomes were defined as thromboembolism composed of new-onset stroke or systemic embolism. Safety outcomes were major bleeding. Both D150 and D110 had comparable efficacies as warfarin. However, only D110 significantly lowered the risk of major bleeding [hazard ratio (HR) 0.19, 95% confidence interval (CI) 0.07-0.55, P = 0.002]. In a subgroup analysis according to guideline-concordant indications for dose reduction, both co-D110 and di-D110 displayed a comparable efficacy as warfarin. Both co-D110 (HR 0.22, 95% CI 0.06-0.76, P = 0.017) and di-D110 (HR 0.11, 95% CI 0.02-0.81, P = 0.030) significantly lowered incidences of major bleeding. There were no differences in the efficacy and safety between di-D110 and D150, and net clinical outcomes were similar. CONCLUSION: Although D150 and D110 had a comparable efficacy, only D110 lowered the risk of major bleeding in Korean AF patients compared with warfarin. Even the guideline-discordant use of dabigatran 110 mg demonstrated a similar efficacy and safety compared with D150. However, further prospective randomized trials are needed in order to comprehensively evaluate whether D150 or D110 is the optimal dosage in Asian patients with AF.

Efficacy and Safety Evaluation of Tacrolimus-Eluting Stent in a Porcine Coronary Artery Model.

BACKGROUND: A drug-eluting stent (DES) is a highly beneficial medical device used to widen or unblock narrowed blood vessels. However, the drugs released by the implantation of DES may hinder the re-endothelialization process, increasing the risk of late thrombosis. We have developed a tacrolimus-eluting stent (TES) that as acts as a potent antiproliferative and immunosuppressive agent, enhancing endothelial regeneration. In addition, we assessed the safety and efficacy of TES through both in vitro and in vivo tests. METHODS: Tacrolimus and Poly(lactic-co-glycolic acid) (PLGA) were applied to the metal stent using electrospinning equipment. The surface morphology of the stent was examined before and after coating using a scanning electron microscope (SEM) and energy dispersive X-rays (EDX). The drug release test was conducted through high-performance liquid chromatography (HPLC). Cell proliferation and migration assays were performed using smooth muscle cells (SMC). The stent was then inserted into the porcine coronary artery and monitored for a duration of 4 weeks. RESULTS: SEM analysis confirmed that the coating surface was uniform. Furthermore, EDX analysis showed that the surface was coated with both polymer and drug components. The HPCL analysis of TCL at a wavelength of 215 nm revealed that the drug was continuously released over a period of 4 weeks. Smooth muscle cell migration was significantly decreased in the tacrolimus group (54.1% ± 11.90%) compared to the non-treated group (90.1% ± 4.86%). In animal experiments, the stenosis rate was significantly reduced in the TES group (29.6% ± 7.93%) compared to the bare metal stent group (41.3% ± 10.18%). Additionally, the fibrin score was found to be lower in the TES group compared to the group treated with a sirolimus-eluting stent (SES). CONCLUSION: Similar to SES, TES reduces neointimal proliferation in a porcine coronary artery model, specifically decreasing the fibrins score. Therefore, tacrolimus could be considered a promising drug for reducing restenosis and thrombosis.

Preliminary Investigation on Efficacy and Safety of Substance P-Coated Stent for Promoting Re-Endothelialization: A Porcine Coronary Artery Restenosis Model.

BACKGROUND: Current polymer-based drug-eluting stents (DESs) have fundamental issues about inflammation and delayed re-endothelializaton of the vessel wall. Substance-P (SP), which plays an important role in inflammation and endothelial cells, has not yet been applied to coronary stents. Therefore, this study compares poly lactic-co-glycolic acid (PLGA)-based everolimus-eluting stents (PLGA-EESs) versus 2-methacryloyloxyethyl phosphorylcholine (MPC)-based SP-eluting stents (MPC-SPs) in in-vitro and in-vivo models. METHODS: The morphology of the stent surface and peptide/drug release kinetics from stents were evaluated. The in-vitro proliferative effect of SP released from MPC-SP is evaluated using human umbilical vein endothelial cell. Finally, the safety and efficacy of the stent are evaluated after inserting it into a pig's coronary artery. RESULTS: Similar to PLGA-EES, MPC-SP had a uniform surface morphology with very thin coating layer thickness (2.074 µm). MPC-SP showed sustained drug release of SP for over 2 weeks. Endothelial cell proliferation was significantly increased in groups treated with SP (n = 3) compared with the control (n = 3) and those with everolimus (n = 3) (SP: 118.9 ± 7.61% vs. everolimus: 64.3 ± 12.37% vs. the control: 100 ± 6.64%, p < 0.05). In the animal study, the percent stenosis was higher in MPC-SP group (n = 7) compared to PLGA-EES group (n = 7) (MPC-SP: 28.6 ± 10.7% vs. PLGA-EES: 16.7 ± 6.3%, p < 0.05). MPC-SP group showed, however, lower inflammation (MPC-SP: 0.3 ± 0.26 vs. PLGA-EES: 1.2 ± 0.48, p < 0.05) and fibrin deposition (MPC-SP: 1.0 ± 0.73 vs. PLGA-EES: 1.5 ± 0.59, p < 0.05) around the stent strut. MPC-SP showed more increased expression of cluster of differentiation 31, suggesting enhanced re-endothelialization. CONCLUSION: Compared to PLGA-EES, MPC-SP demonstrated more decreased inflammation of the vascular wall and enhanced re-endothelialization and stent coverage. Hence, MPC-SP has the potential therapeutic benefits for the treatment of coronary artery disease by solving limitations of currently available DESs.

Clinical Outcome after Everolimus-Eluting Stent Implantation for Small Vessel Coronary Artery Disease: XIENCE Asia Small Vessel Study.

There are limited data on outcomes after implantation of everolimus-eluting stents (EES) in East Asian patients with small vessel coronary lesions. A total of 1,600 patients treated with XIENCE EES (Abbott Vascular, CA, USA) were divided into the small vessel group treated with one ≤2.5 mm stent (n=119) and the non-small vessel group treated with one ≥2.75 mm stent (n=933). The primary end point was a patient-oriented composite outcome (POCO), a composite of all-cause death, myocardial infarction (MI), and any repeat revascularization at 12 months. The key secondary end point was a device-oriented composite outcome (DOCO), a composite of cardiovascular death, target-vessel MI, and target lesion revascularization at 12 months. The small vessel group was more often female, hypertensive, less likely to present with ST-elevation MI, and more often treated for the left circumflex artery, whereas the non-small vessel group more often had type B2/C lesions, underwent intravascular ultrasound, and received unfractionated heparin. In the propensity matched cohort, the mean stent diameter was 2.5±0.0 mm and 3.1±0.4 mm in the small and non-small vessel groups, respectively. Propensity-adjusted POCO at 12 months was 6.0% in the small vessel group and 4.3% in the non-small vessel group (p=0.558). There was no significant difference in DOCO at 12 months (small vessel group: 4.3% and non-small vessel group: 1.7%, p=0.270). Outcomes of XIENCE EES for small vessel disease were comparable to those for non-small vessel disease at 12-month clinical follow-up in real-world Korean patients.

Optimal timing of percutaneous coronary intervention for non-ST elevated myocardial infarction with congestive heart failure.

OBJECTIVES: This study investigated the optimal timing for percutaneous coronary intervention (PCI) in patients with NSTEMI complicated by heart failure (HF). METHODS: In total, 762 patients with NSTEMI and HF in a multicenter, prospective registry in South Korea were classified according to the Killip classification (Killip class 2, n = 414 and Killip class 3, n = 348) and underwent early (within 24 h) and delayed (after 24 h) PCI. The primary outcome was all-cause mortality which was further analyzed with landmark analysis with two months as a cut-off. Secondary outcomes were cardiovascular death, in-hospital cardiogenic shock (CS), readmission due to HF, and acute myocardial infarction during follow-up. RESULTS: Delayed PCI was associated with lower rates of 2-month mortality (6.1 % vs. 15.8 %, p = 0.007) and in-hospital CS (4.3 % vs. 14.1 %, p = 0.003), along with lower risks of 2-month mortality (hazard ratio [HR] = 0.38, 95 % confidence interval [CI] = 0.18-0.83, p = 0.014), in-hospital CS (HR = 0.29, 95 % CI = 0.12-0.71, p = 0.006) in multivariate Cox models of Killip class 3 patients. There was no statistical difference of incidence and risk of all predefined outcomes according to varying timing of PCI in Killip 2 patients. CONCLUSIONS: Based on these results, the timing of PCI in patients with NSTEMI complicated by HF should be determined based on HF severity. Delayed PCI should be considered in patients with NSTEMI and more severe HF.

Comparison of long-term clinical outcomes among zotarolimus-, everolimus-, and biolimus-eluting stents in acute myocardial infarction patients with renal impairment.

BACKGROUND: It is important to determine the best drug-eluting stent (DES) for acute myocardial infarction (AMI) in patients with renal impairment. In this studythe outcomes of everolimus-eluting stents (EESs), zotarolimus-eluting stents (ZESs) and biolimus-eluting stents (BESs) were evaluated. METHODS: From the Korea Acute Myocardial Infarction-National Institutes of Health registry, a total of 1,470 AMI patients with renal impairment undergoing percutaneous coronary intervention (PCI) were enrolled (816 with EES, 345 with ZES, and 309 with BES). Renal impairment was defined as creatinine clearance < 60 mL/min/1.73 m² estimated by the Cockcroft-Gault method. Major adverse cardiac and cerebrovascular events were determined as the composite of all-cause death, non-fatal myocardial infarction (MI), cerebrovascular accident, any revascularization, rehospitalization and stent thrombosis. All clinical outcomes were analyzed. RESULTS: The baseline characteristics of the patients revealed no significant difference between the three groups, except for Killip classification > 2, beta-blockers, lesion type, vascular approach, staged PCI, left main coronary artery (LMCA) complex lesions, LMCA PCI, and the number and length of implanted stents. In the Kaplan-Meier analysis, similar clinical outcomes were derived from the unadjusted data between the three DES groups. However, after the inverse probability of treatment weighting, a statistically significant difference was found in non-fatal MI, which implied a higher incidence of non-fatal MI in the ZES group than in the other two DES groups. CONCLUSIONS: In AMI patients with renal impairment, there was no significant difference between the three stent groups in terms of long-term clinical outcomes, except for non-fatal MI.

Case report: A fatal case of myocardial infarction due to myocardial bridge and concomitant vasospasm: the role of stress gated SPECT.

Introduction: Although most cases of myocardial bridge (MB) are clinically benign, sometimes it can be one of potential threats of myocardial infarction (MI) and life-threatening arrhythmia. In the present study, we present a case of ST-segment elevation MI caused by MB and concomitant vasospasm. Case Presentation: A 52-year-old woman was brought to our tertiary hospital due to resuscitated cardiac arrest. Because the 12-lead electrocardiogram indicated ST-segment elevation MI, coronary angiogram was promptly commenced, which showed near-total occlusion at the middle portion of left anterior descending coronary artery (LAD). After intracoronary nitroglycerin administration, this occlusion was dramatically relieved, however, systolic compression at this site remained, indicative of myocardial bridge (MB). Intravascular ultrasound also showed eccentric compression with a "half-moon" sign, which is consistent with MB. Coronary computed tomography also showed a bridged coronary segment surrounded by myocardium at the middle portion of LAD. To assess the severity and extent of myocardial damages and ischemia, myocardial single photon emission computed tomography (SPECT) was additionally conducted, showing a moderate fixed perfusion defect around the cardiac apex, suggesting MI. After receiving optimal medical therapy, the patient's clinical symptoms and signs were improved then the patient was discharged from the hospital successfully and uneventfully. Conclusion: We demonstrated a case of MB-induced ST-segment elevation MI which was confirmed with its perfusion defects via myocardial perfusion SPECT. There have been proposed a number of diagnostic modalities to examine its anatomic and physiologic significance. Among them, myocardial perfusion SPECT can be available as one of useful modalities to evaluate the severity and extent of myocardial ischemia in patients with MB.

Different outcomes between iso-osmolar and low-osmolar contrast media in acute myocardial infarction with renal impairment.

BACKGROUND: The selection of appropriate contrast media (CM) remains an important issue in terms of renal preservation in patients with acute myocardial infarction (AMI) and renal impairment scheduled for percutaneous coronary intervention (PCI). We compared the clinical outcomes of patients with AMI and renal impairment, depending on the CM type (iso-osmolar CM [IOCM] vs. low-osmolar CM [LOCM]) that was used during PCI. METHODS: From the Convergent Registry of Catholic and Chonnam University for Acute Myocardial Infarction, 3174 post-PCI patients with AMI and renal impairment were subdivided into two groups (IOCM [n = 2101] and LOCM [n = 1073]). RESULTS: Regarding in-hospital clinical outcomes, the IOCM group had a higher peak creatinine (Cr) level and lower "Cr differential" than the LOCM group. A higher proportion of dialysis was noted in the IOCM group. In 30-day clinical outcomes, the IOCM group showed higher incidence of new-onset heart failure (HF) but lower incidence of revascularization than the LOCM group. The differences in in-hospital and 30-day clinical outcomes were attenuated after inverse probability of treatment weighting, except for new-onset HF. All other variables in 30-day clinical outcomes, including all-cause death, non-fatal myocardial infarction, cerebrovascular accidents, stent thrombosis, and any dialysis events, were similar between the two groups. CONCLUSIONS: IOCM use did not prevent future incidence of dialysis compared to LOCM use in AMI patients with renal impairment.

A novel polymer-free everolimus-eluting stent with a nitrogen-doped titanium dioxide film inhibits restenosis and thrombosis in a swine coronary model.

BACKGROUND: Short-term outcomes regarding the safety and efficacy of a polymer-free everolimus-eluting stent (EES) with a nitrogen-doped titanium dioxide (N-TiO2) film in a swine coronary model have been reported. However, the long-term results of the use of this type of stent have not yet been evaluated or compared to those of other polymer-free coronary stents. Therefore, this study aimed to determine the mid- to long-term safety and efficacy of a polymer-free EES with an N-TiO2 film in a swine coronary model. METHODS: Polymer-free EES with N-TiO2 films (n = 30) and polymer-free sirolimus-eluting stents (SES; n = 30) were implanted in 30 pigs. Quantitative coronary analysis and optical coherence tomography were conducted immediately and at 1 (quantitative coronary analysis only), 3, and 6 months after stenting. Histopathologic examinations were performed at 1, 3, and 6 months after stenting. RESULTS: The polymer-free EES group had a lower percentage of neointimal growth than the polymer-free SES group at 3 months (22.5% ± 11.4% vs. 32.1% ± 12.3%; p < 0.001). The polymer-free EES group had a lower fibrin score than the polymer-free SES group at 1 month (1.9 ± 0.45 vs. 2.5 ± 0.54; p = 0.001). The re-endothelialization rates were similar between groups. The polymer-free EES group had a lower percentage of the area of stenosis than the polymer-free SES group throughout the follow-up period. CONCLUSIONS: The novel polymer-free EES with an N-TiO2 film has superior safety and efficacy than the polymer-free SES at the 6-month follow-up in a swine model.

Long-term clinical outcomes in patients with acute myocardial infarction complicated by cardiogenic shock according to the application and initiation time of extracorporeal membrane oxygenation in South Korea.

BACKGROUND: Limited data are available regarding the proper application time and long-term outcomes of extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock. This cohort study appraised the clinical outcomes according to ECMO application without or before cardiopulmonary resuscitation (CPR) in patients with acute myocardial infarction (AMI) combined with cardiogenic shock. METHODS: Between 2011 and 2015, a total of 13,104 patients with AMI were enrolled in a nationwide AMI registry. Eligible patients with cardiogenic shock, who underwent percutaneous coronary intervention, with a 3-year clinical follow-up, were analyzed. The 949 included patients were divided into two groups: no ECMO (n = 845) and ECMO application (n = 104). The ECMO group was further divided into ECMO without or before CPR (n = 11) and ECMO after CPR (n = 93). RESULTS: Significant differences were noted in major adverse cardiac events (MACEs) between the no ECMO and ECMO application groups during the 3-year follow-up (41.5% vs. 80.8%; p < 0.001). However, the ECMO without or before CPR group showed similar outcomes to the no ECMO group in 3-year MACEs (63.6% vs. 41.5%; p = 0.055). MACEs during 3 years of follow-up were significantly lower in the ECMO without or before CPR group than in the ECMO after CPR group (63.6% vs. 82.8%; p = 0.005). CONCLUSIONS: A significantly lower risk of major cardiac events in ECMO without or before CPR suggests that early application of ECMO can be a reasonable strategy to improve outcomes in patients with AMI complicated by cardiogenic shock.

Impact of sex difference on clinical outcomes in acute myocardial infarction patients with single-vessel and multi-vessel disease: based on Korea Acute Myocardial Infarction Registry-National Institute of Health.

Background: Several studies have compared clinical outcomes according to sex in patients with acute myocardial infarction (AMI). However, studies evaluating sex differences in clinical outcomes of single-vessel disease (SVD) and multi-vessel disease (MVD) in Korean patients with AMI are lacking. Therefore, this study aimed to analyze sex differences in the clinical characteristics of patients with AMI with SVD and MVD and to evaluate the impact of sex differences on the clinical outcomes in patients with AMI with SVD and MVD. Methods: A total of 11,002 AMI patients from November 2011 to June 2015 in the Korea AMI Registry, National Institute of Health, were enrolled. The current study was retrospective observational study. Patients were divided into SVD (n=5,644) and MVD (n=5,358) groups, and clinical impact of sex difference were analyzed by propensity score matching analysis and Cox proportional hazard regression model. Results: Women were older and had poor baseline clinical characteristics than men. Propensity score-matched analysis of men and women with SVD and MVD revealed that the adjusted 3-year risk of major adverse cardiac event (MACE) (15.0% vs. 9.4%; hazard ratio, 1.86; 95% confidence interval, 1.10-3.13; P=0.020) was higher in women with SVD aged <65 years. However, the incidence and risk of MACE were similar for men and women with MVD, and those with SVD aged ≥65 years. Conclusions: In the present study of Korean patients with AMI, women were older and exhibited a higher prevalence of comorbidities than men. Women with SVD aged <65 years had a significantly higher risk of MACE.

Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model.

BACKGROUND: Biodegradable poly (l-lactic acid) (PLLA), a bio safe polymer with a large elastic modulus, is widely used in biodegradable medical devices. However, because of its poor mechanical properties, a PLLA strut must be made twice as thick as a metal strut for adequate blood vessel support. Therefore, the mechanical properties of a drug-eluting metal-based stents (MBS) and a bioresorbable vascular scaffolds (BVS) were evaluated and their safety and efficacy were examined via a long-term rabbit iliac artery model. METHODS: The surface morphologies of the MBSs and BVSs were investigated via optical and scanning electron microscopy. An everolimus-eluting (EE) BVS or an EE-MBS was implanted into rabbit iliac arteries at a 1.1:1 stent-to-artery ratio. Twelve months afterward, stented iliac arteries from each group were analyzed via X-ray angiography, optical coherence tomography (OCT), and histopathologic evaluation. RESULTS: Surface morphology analysis of the EE coating on the MBS confirmed that it was uniform and very thin (4.7 µm). Comparison of the mechanical properties of the EE-MBS and EE-BVS showed that the latter outperformed the former in all aspects (radial force (2.75 vs. 0.162 N/mm), foreshortening (0.24% vs. 1.9%), flexibility (0.52 vs. 0.19 N), and recoil (3.2% vs. 6.3%). At all time points, the percent area restenosis was increased in the EE-BVS group compared to the EE-MBS group. The OCT and histopathological analyses indicate no significant changes in strut thickness. CONCLUSION: BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted.

Culprit lesion plaque characteristics and angiopoietin like 4 in acute coronary syndrome: A virtual histology-intravascular ultrasound analysis.

BACKGROUND: Thin-cap fibroatheroma is a rupture-prone vulnerable plaque that leads to acute coronary syndrome (ACS). However, its underlying mechanisms are not fully understood. Several studies have investigated the clinical association between angiopoietin-like protein 4 (ANGPTL4) and coronary artery disease. Therefore, this study aimed to investigate the correlation of plasma ANGPTL4 in culprit lesion of ACS patients using intravascular ultrasound (IVUS) and virtual-histology IVUS (VH-IVUS). METHODS: Fifty patients newly diagnosed with ACS between March to September 2021 were selected. Blood samples for baseline laboratory tests, including ANGPTL4, were collected before percutaneous coronary intervention (PCI), and all pre- and post-PCI IVUS examinations were performed of the culprit lesions. RESULTS: Linear regression analysis between plasma ANGPTL4 and grayscale IVUS/VH-IVUS parameters revealed that plasma ANGPTL4 was strongly correlated with the necrotic core (NC) of the minimal lumen site (r = -0.666, p = 0.003) and largest NC site (r = -0.687, p < 0.001), and patients with lower plasma ANGPTL4 levels showed a significantly higher proportion of TFCA. CONCLUSION: The present study further demonstrated the protective role of ANGPTL4 in the spectrum of atherosclerotic development in patients with ACS by culprit lesion morphology analysis using IVUS and VH-IVUS.

Early left ventricular unloading after extracorporeal membrane oxygenation: rationale and design of EARLY-UNLOAD trial.

AIMS: The clinical benefits of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for profound cardiogenic shock are well known. However, peripheral VA-ECMO increases the left ventricular afterload, thus compromising myocardial recovery. Recent studies have revealed the benefit of left ventricular unloading using various methods applied at different times. The EARLY-UNLOAD trial compares the clinical outcomes of early left ventricular unloading and conventional approach after VA-ECMO. METHODS AND RESULTS: The EARLY-UNLOAD trial is a single-centre, open-label, randomized trial that recruited 116 patients with cardiogenic shock undergoing VA-ECMO. Patients meeting the inclusion criteria were randomized in a 1:1 ratio to two groups: routine left ventricular unloading via intracardiac echocardiography-guided transseptal left atrial cannulation within 12 h of VA-ECMO initiation or conventional approach that indicates rescue left ventricular unloading if clinical signs of an increased left ventricular afterload are present. The primary endpoint is the cumulative incidence of all-cause death within 30 days, and patients will be followed-up for 12 months. A key secondary endpoint is a composite measure of all-cause death and rescue transseptal left atrial cannulation in the conventional group (suggestive of VA-ECMO treatment failure) within 30 days. The enrolment of patients was finished in September 2022. CONCLUSIONS: The EARLY-UNLOAD trial is the first randomized controlled trial to compare early left ventricular unloading and conventional approach after VA-ECMO using the same unloading modality. The results could impact clinical practice to overcome the haemodynamic issues associated with VA-ECMO.

Long-term outcomes in ST-elevation myocardial infarction patients treated according to hospital visit time.

BACKGROUND/AIMS: Rapid percutaneous coronary intervention (PCI) is the cornerstone of treatment for ST-elevation myocardial infarction (STEMI). However, there have been conflicting results regarding the differences in clinical outcomes between on-hours and off-hours presentation in STEMI patients. We aimed to examine the difference in long-term outcomes between off-hours and on-hours PCI in patients with STEMI. METHODS: The characteristics and clinical outcomes of 5,364 STEMI patients between November 2011 and June 2015 from the Korea Acute Myocardial Infarction Registry-National Institutes of Health (KAMIR-NIH) registry were analyzed. Patients were divided into two groups: the off-hours group (weekdays from 6:01 PM to 7:59 AM, weekends, and legal holidays) and the on-hours group (weekdays from 8:00 AM to 6:00 PM). Major adverse cardiac and cerebrovascular events (MACCEs) were defined as a composite of allcause mortality, non-fatal myocardial infarction, any revascularization, cerebrovascular accident, and stent thrombosis. The primary endpoint was the occurrence of MACCEs, and all other clinical outcomes were analyzed. RESULTS: A total of 3,119 patients (58.1%) underwent primary PCI due to STEMI during off-hours and 2,245 patients (41.9%) during on-hours. At 36 months, the clinical outcomes of the off-hours group were similar to those of the on-hours group in both the unadjusted and propensity score weighting-adjusted analyses. CONCLUSION: Our analysis revealed that the long-term outcomes in STEMI patients admitted to hospitals during off-hours were similar to outcomes of those admitted during on-hours.

Successful implantation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film with good patency on follow-up angiography: A case report.

RATIONALE: Despite technological advances in interventional cardiology during the last decades, many concerns remain regarding the narrowing and occlusion of the in-stent area. Particularly, polymer materials pose several problems, including chronic arterial inflammation, impaired arterial healing, and stent thrombosis. To avoid these complications, we invented the TIGEREVOLUTION stent with a cobalt-chromium alloy-based stent platform deposited with N-TiO2 film, which has demonstrated good biocompatibility. As this stent is not coated with polymer, it is expected to have decreased risk of stent thrombosis. PATIENT CONCERNS: A 62-year-old Korean man visited our department because of angina. We commenced coronary angiography (CAG). DIAGNOSIS: CAG revealed critical stenosis in the mid-portion of the right coronary artery, with a minimum lumen area of 1.08mm2 on optical coherence tomography (OCT). INTERVENTION: Percutaneous coronary intervention was performed with implantation of a novel 3.5 × 26-mm polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film (TIGEREVOLUTION® stent). Post-percutaneous coronary intervention OCT showed good stent expansion and apposition, and the patient was discharged successfully and uneventfully. OUTCOMES: Eight months later, follow-up coronary angiography demonstrated good stent patency with no definitive evidence of in-stent restenosis, with thin stent strut coverage demonstrated on OCT. LESSONS: We report the first case of TIGEREVOLUTION stent implantation with follow-up OCT at 8 months.

Comparison of outcomes after transcatheter aortic valve replacement between elderly (65-79 years) and super-elderly (≥80 years) patients.

Transcatheter aortic valve replacement (TAVR) is an effective treatment option for patients with severe symptomatic aortic stenosis. Nonetheless, there is a paucity of data regarding the differences in the clinical outcomes of TAVR procedures between elderly and super-elderly patients. This study aimed to compare the clinical characteristics and outcomes of patients aged 65 to 79 years and ≥80 years who underwent TAVR for aortic stenosis. The clinical characteristics and outcomes of 134 patients with aortic stenosis who underwent TAVR were analyzed. Patients were categorized into 2 groups: an elderly group (EG; 65-79 years) and a super-elderly group (SEG) (≥80 years). The in-hospital and follow-up clinical outcomes were compared between the 2 groups. The EG tended to be more overweight, obese, and diabetic than the SEG, whereas the SEG had a higher surgical risk but lower creatinine clearance, hematocrit level, and effective orifice area than the EG. However, no difference was found in in-hospital clinical outcomes between the 2 groups, except for atrial fibrillation. In the propensity score matching and inverse probability of treatment weighting-adjusted analyses, these results were similar. All follow-up clinical outcomes were similar, except for rehospitalization, which was statistically attenuated after propensity score matching and inverse probability of treatment weighting-adjusted analyses. TAVR was associated with similar safety outcomes in the EG (65-79 years) and the SEG (≥80 years). Advanced age is not negatively associated with clinical outcomes after the TAVR procedure.