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Background Various devices and techniques have been used for plaque modification in the treatment of severe coronary artery calcification. This prospective, multicenter, randomized, open-label study aims to evaluate the safety and efficacy of cutting balloon angioplasty using a novel bioabsorbable polymer-coated everolimus-eluting coronary stent for treating various degrees of calcified coronary lesions. Methods We outline the trial design aimed at assessing whether the cutting balloon (Wolverine™) is non-inferior to the non-compliant balloon in treating patients with calcified lesions, encompassing both de novo and in-stent restenosis (ISR) lesions. We aim to enroll 250 patients who have undergone bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™) implantation. The primary endpoint is the minimal stent cross-sectional area at the calcium site as determined by intravascular ultrasonography. The secondary endpoints include major adverse cardiac events and target lesion revascularization at 12 months, alongside procedural convenience and operator-centric parameters, such as the number of balloons used, procedure time, and total contrast medium volume used. Discussion In this study, we will evaluate the efficacy and safety of Wolverine™ and non-compliant balloon in patients with calcified coronary lesions and provide a rationale for which type of balloons will optimally modify calcium lesions. In addition, we will attempt to expand the indications of the cutting balloon for treating mild-to-severe calcified coronary lesions. As the scope of insurance coverage for cutting balloons remains limited in some countries, this study may provide evidence for extending insurance coverage to the treatment of de novo calcified and ISR lesions. Trial registration ClinicalTrials.gov NCT06177808. Registered on January 1, 2024.

Elevated serum transaminase or alkaline phosphatase (ALP) has been proposed as a novel prognosticator for ST-segment elevation myocardial infarction (STEMI). We evaluated the combined prognostic impact of elevated serum transaminases and ALP on admission in STEMI patients who underwent primary percutaneous coronary intervention (PCI). A total of 1176 patients with STEMI undergoing primary PCI were retrospectively enrolled from the INTERSTELLAR registry. Hypoxic liver injury (HLI) was defined as serum transaminase > twice the upper limit of normal. The cut-off value of high ALP was set at the median level (73 IU/L). Patients were divided into four groups according to their serum transaminase and ALP levels. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, and ischemia-driven revascularization. Median follow-up duration was 25 months (interquartile range, 10-39 months). The rate of MACCE was highest in patients with HLI (+) and high ALP (25.9%), compared to those in the other groups (8.2% in HLI [-] and low ALP, 11.8% in HLI [-] and high ALP, and 15.0% in HLI [+] and low ALP). Each of HLI or high ALP was an independent predictor for MACCE (HR 1.807, 95% CI 1.191-2.741; HR 1.721, 95% CI 1.179-2.512, respectively). Combined HLI and high ALP was associated with the worst prognosis (HR 3.145, 95% CI 1.794-5.514). Combined HLI and high ALP on admission is associated with poor clinical outcomes in patients with STEMI who have undergone primary PCI.

The aim of this study is to investigate sex-related impacts on clinical outcomes after percutaneous coronary intervention (PCI). We analyzed 90,305 patients (29.0% of women) with the first episode of coronary artery disease who underwent PCI from the Korean National Health Insurance claims database between July 2013 and June 2017. Women were significantly older than men (71.5 ± 10.5 vs. 61.8 ± 11.7 years, p  < 0.001). The study population had a median follow-up of 2.2 years (interquartile range, 1.2–3.3). In the propensity-score matched angina population (15,104 pairs), the in-hospital mortality of women was not different from men (odds ratio, 0.87; 95% confidence interval: 0.71–1.08, p  = 0.202). However, the post-discharge mortality of women was significantly lower (hazard ratio, 0.74; 95% confidence interval: 0.69–0.80, p  < 0.001) than that of men. In the propensity-score matched acute myocardial infarction (AMI) population (8,775 pairs), the in-hospital mortality of women was significantly higher than that of men (odds ratio, 1.19; 95% confidence interval: 1.05–1.34, p  = 0.006). Meanwhile, there was no difference in mortality after discharge (hazard ratio, 0.98; 95% confidence interval: 0.91–1.06, p  = 0.605). The post-discharge mortality of women was not higher than men under the contemporary PCI treatment. Altered sex-related impacts on clinical outcomes might be attributed to improved medical and procedural strategies.

IntroductionThere is a lack of evidence to support the effectiveness of prolonged β-blocker therapy after stabilisation of patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular systolic dysfunction.Methods and analysisThe SMart Angioplasty Research Team: DEcision on Medical Therapy in Patients with Coronary Artery DIsease or Structural Heart Disease Undergoing InterventiON (SMART-DECISION) trial is a multicentre, prospective, open-label, randomised, non-inferiority trial designed to determine whether discontinuing β-blocker therapy after ≥1 year of maintenance in stabilised patients after AMI is non-inferior to continuing it. Patients eligible for participation are those without HF or left ventricular systolic dysfunction (ejection fraction >40%) who have been continuing β-blocker therapy for ≥1 year after AMI. A total of 2540 patients will be randomised 1:1 to continuation of β-blocker therapy or not. Randomisation will be stratified according to the type of AMI (ie, ST-segment-elevation MI or non-ST-segment-elevation MI), type of β-blocker (carvedilol, bisoprolol, nebivolol or other) and participating centre. The primary study endpoint is a composite of all-cause death, MI and hospitalisation for HF over a median follow-up period of 3.5 years (minimum, 2.5 years; maximum, 4.5 years). Adverse effects related to β-blocker therapy, the occurrence of atrial fibrillation, medical costs and Patient-reported Outcomes Measurement Information system-29 questionnaire responses will also be collected as secondary endpoints.Ethics and disseminationEthics approval for this study was granted by the Institutional Review Board of Samsung Medical Center (no. 2020-10-176). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.Trial registration numberClinicalTrials.gov, NCT04769362.

Despite an obvious improvement in the treatment of coronary artery disease (CAD) and survival rate of patients with CAD during recent decades, diabetes mellitus (DM) is still considered a risk factor of adverse clinical outcomes in these patients. Therefore, we sought to evaluate the clinical implications of DM in patients with CAD who underwent contemporary percutaneous coronary intervention (PCI). Based on the National Health Insurance claims data in South Korea, patients aged 18 years or older who had undergone PCI for the diagnosis of CAD between 2011 and 2015 were analyzed. Patients were classified into the DM (n = 26,872) and non-DM (n = 54,243) groups. The primary endpoint was all-cause mortality, and it was compared between the two groups via a propensity score matching analysis. The study population was categorized as patients with angina (n = 49,228) or acute myocardial infarction (AMI, n = 31,887). The study population had a median follow-up of 2.1 years (interquartile range, 1.1-3.2). After the propensity score matching analysis, 8,157 and 4,266 pairs of patients with angina and AMI were identified, respectively. In the matched angina group, the incidence of all-cause death was significantly higher in patients with DM (adjusted hazard ratio [aHR]: 1.30; 95% confidence interval [CI]: 1.16-1.47; p<0.001) than in those without DM. Moreover, in the matched AMI group, the incidence of all-cause death was significantly higher in patients with DM (aHR: 1.35; 95% CI: 1.19-1.53; p<0.001) than in those without DM. In patients undergoing contemporary PCI in Korea, the presence of DM was associated with poorer clinical outcomes.

Patient selection for and predicting clinical outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) remain challenging. We hypothesized that both J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores will predict not only angiographic success but also long-term clinical outcomes of the patients who underwent PCI of CTO. Of 325 CTO PCIs performed at 2 Emory University hospitals from January 2012 to August 2015, 249 patients with complete baseline clinical, angiographic and follow-up data, were included in this analysis. Major adverse cardiovascular events (MACEs) consisted of a composite of death, myocardial infarction, and target vessel revascularization. Mean age was 63 ± 11 years old and mean follow-up was 19.8 ± 13.1 months. Angiographic success rates increased from 74.5% in 2012 to 85.7% in 2015. Greater J-CTO and PROGRESS CTO scores were not only associated with lower likelihood of angiographic success but also higher rates of long-term MACE. Compared with the scores of 0 to 2, J-CTO and PROGRESS CTO scores of ≥3 were associated with higher MACE. Multivariable analysis demonstrated that PROGRESS CTO scores of ≥3, male sex, and peripheral vascular disease were independent predictors of MACE. In conclusion, J-CTO and PROGRESS CTO scores are useful in predicting procedural success. In addition, the PROGRESS CTO score, and to a lesser degree J-CTO score, have predictive value for long-term outcomes in patients who underwent CTO PCI.

The impact of pre-existing depression on mortality in individuals with established coronary artery disease (CAD) remains unclear. We evaluate the clinical implications of pre-existing depression in patients who underwent percutaneous coronary intervention (PCI). Based on National Health Insurance claims data in Korea, patients without a known history of CAD who underwent PCI between 2013 and 2017 were enrolled. The study population was divided into patients with angina (n = 50,256) or acute myocardial infarction (AMI; n = 40,049). The primary endpoint, defined as all-cause death, was compared between the non-depression and depression groups using propensity score matching analysis. After propensity score matching, there were 4262 and 2346 matched pairs of patients with angina and AMI, respectively. During the follow-up period, there was no significant difference in the incidence of all-cause death in the angina (hazard ratio [HR] of depression, 1.013; 95% confidence interval [CI] 0.893–1.151) and AMI (HR, 0.991; 95% CI 0.865–1.136) groups. However, angina patients less than 65 years of age with depression had higher all-cause mortality (HR, 1.769; 95% CI 1.240–2.525). In Korean patients undergoing PCI, pre-existing depression is not associated with poorer clinical outcomes. However, in younger patients with angina, depression is associated with higher all-cause mortality.

The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk. This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed. The percentage change of LDL-C ranged from –45% to –56% (mean, –51%) in the monotherapy groups and from –58% to –63% (mean, –60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P < 0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups. Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

Serum alkaline phosphatase (ALP) has been shown to be a prognostic factor in several subgroups of patients due to its promotion of vascular calcification. However, the prognostic impact of serum ALP level in ST-segment elevation myocardial infarction (STEMI) patients with a relatively low calcification burden has not been determined. We aimed to investigate the association of ALP level measured at time of presentation on clinical outcomes in patients with STEMI requiring primary percutaneous coronary intervention (PCI). A total of 1178 patients with STEMI undergoing primary PCI between 2007 and 2014 were retrospectively enrolled from the INTERSTELLAR registry and classified into tertiles by ALP level (<64, 65-82, or >83 IU/L). The primary study outcome was a major adverse cardiac or cerebrovascular event (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, and ischemia-driven revascularization. Median follow-up duration was 25 months (interquartile range, 10-39 months). The incidence of MACCE significantly increased as ALP level increased, that is, for the <64, 65-82, and >83 IU/L tertiles incidences were 8.7%, 11.7%, and 15.7%, respectively; p for trend = 0.003). After adjustment for potential confounders, the adjusted hazard ratios for MACCE in the middle and highest tertiles were 1.69 (95% CI 1.01-2.81) and 2.46 (95% CI 1.48-4.09), respectively, as compared with the lowest ALP tertile. Elevated ALP level at presentation, but within the higher limit of normal, was found to be independently associated with higher risk of MACCE after primary PCI in patients with STEMI.

Besides contrast-induced acute kidney injury(CI-AKI), adscititious vital organ damage such as hypoxic liver injury(HLI) may affect the survival in patients with ST-elevation myocardial infarction (STEMI). We sought to evaluate the prognostic impact of CI-AKI and HLI in STEMI patients who underwent primary percutaneous coronary intervention (PCI). A total of 668 consecutive patients (77.2% male, mean age 61.3±13.3 years) from the INTERSTELLAR STEMI registry who underwent primary PCI were analyzed. CI-AKI was defined as an increase of ≥0.5 mg/dL in serum creatinine level or 25% relative increase, within 48h after the index procedure. HLI was defined as ≥2-fold increase in serum aspartate transaminase above the upper normal limit on admission. Patients were divided into four groups according to their CI-AKI and HLI states. Major adverse cardiovascular and cerebrovascular events (MACCE) defined as a composite of all-cause mortality, non-fatal MI, non-fatal stroke, ischemia-driven target lesion revascularization and target vessel revascularization were recorded. Over a mean follow-up period of 2.2±1.6 years, 94 MACCEs occurred with an event rate of 14.1%. The rates of MACCE and all-cause mortality were 9.7% and 5.2%, respectively, in the no organ damage group; 21.3% and 21.3% in CI-AKI group; 18.5% and 14.6% in HLI group; and 57.7% and 50.0% in combined CI-AKI and HLI group. Survival probability plots of composite MACCE and all-cause mortality revealed that the combined CI-AKI and HLI group was associated with the worst prognosis (p<0.0001 for both). Combined CI-AKI after index procedure and HLI on admission is associated with poor clinical outcomes in patients with STEMI who underwent primary PCI. (INTERSTELLAR ClinicalTrials.gov number, NCT02800421.).