Background Limited data are available on the clinical significance of residual thrombi after thrombectomy and prestenting reduced epicardial coronary flow in ST-segment elevation myocardial infarct (STEMI) patients. Materials and methods The incidence of the no-reflow phenomenon, defined as a final thrombolysis in myocardial infarction (TIMI) flow grade of up to 2 or a myocardial blush grade of up to 1, was compared in 260 STEMI patients undergoing primary percutaneous coronary intervention according to thrombotic burden. Large thrombotic burden (LTB), defined as a thrombus score of at least 3, was observed in 134 patients, among whom 66 (49.3%) underwent aspiration thrombectomy. No-reflow incidence was compared on the basis of thrombectomy treatment, thrombus residue after thrombectomy, and prestenting TIMI flow grade. Results The no-reflow phenomenon occurred most frequently in LTB patients without thrombectomy, followed by those who underwent thrombectomy and the small thrombus burden group (33.8 vs. 21.2 vs. 10.3%, respectively, P<0.001). Patients with a prestenting residual thrombus or a TIMI flow grade of up to 2 had higher no-reflow incidence than those with no visible prestenting thrombus and a TIMI flow grade of 3 (74 vs. 6.2%, P<0.001). Multiple logistic regression analysis identified a prestenting TIMI flow grade of up to 2 (odds ratio 36.422, 95% confidence interval 13.952–95.079) as an independent predictor of the no-reflow phenomenon. Conclusion Manual thrombus aspiration reduced no-reflow incidence in STEMI patients with LTB. However, even after thrombectomy, prestenting residual thrombi and decreased coronary flow were related to a higher occurrence of the no-reflow phenomenon.
Purpose: Dyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease. The risk for CVD from atherogenic dyslipidemia persists when elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels are not controlled with statin therapy. Therefore, statin/fenofibrate combination therapy is more effective in reducing CVD risk. Here, we assessed the efficacy and tolerability of pitavastatin/fenofibrate combination therapy in patients with mixed dyslipidemia and a high risk for CVD. Methods: This multicenter, randomized, double-blind, parallel-group, therapeutic-confirmatory clinical trial evaluated the efficacy and tolerability of fixed-dose combination therapy with pitavastatin/fenofibrate 2/160 mg in Korean patients with a high risk for CVD and a controlled LDL-C level (<100 mg/dL) and a TG level of 150-500 mg/dL after a run-in period with pitavastatin 2 mg alone. In the 8-week main study, 347 eligible patients were randomly assigned to receive pitavastatin 2 mg with or without fenofibrate 160 mg after a run-in period. In the extension study, patients with controlled LDLC and non-HDL-C (<130 mg/dL) levels were included after the completion of the main study. All participants in the extension study received the pitavastatin/fenofibrate combination therapy for 16 weeks for the assessment of the tolerability of long-term treatment. Findings: The difference in the mean percentage change in non-HDL-C from baseline to week 8 between the combination therapy and monotherapy groups was -12.45% (95% CI, -17.18 to -7.72), and the combination therapy was associated with a greater reduction in non-HDL-C. The changes in lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein from baseline to weeks 4 and 8 were statistically significant with combination therapy compared to monotherapy at all time points. Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively. The combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. (C) 2020 The Authors. Published by Elsevier Inc.
Introduction There 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 analysis The 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 dissemination Ethics 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 number ClinicalTrials.gov, NCT04769362.
Cardiac angiography to visualize the cardiac coronary artery for lesions causes a lot of radiation exposure dose to the interventional cardiologist. We evaluated the occupational radiation exposure to the interventional cardiologist based on changes to the angle of the X-ray tube used in cardiac angiography and calculated the conversion factor for effective dose in this study. To evaluate the occupational radiation exposure resulting from scattered radiation to interventional cardiologists, organ doses for eyeball, thyroid, and heart were calculated using Monte Carlo simulation with korean typical man(KTMAN) phantom at the left anterior oblique (LAO)30/cranial (CRAN)30, CRAN40, right anterior oblique (RAO)30/CRAN30, RAO30/caudal(CAUD)20, CAUD39, LAO40/CAUD35, and LAO40 positions in the femoral and the radial artery puncture. In this study, analysis of the different angles showed the highest radiation exposure on LAO30/CRAN30 and CRAN40 position, which were 150.65% and 135.3%, respectively, compared to AP angles. Therefore, to reduce occupational dose for interventional cardiologists, it is recommended that radiation protection, such as using radiation shield and personal protective equipment (PPE), be used at LAO30/CRAN30 and CRAN40 angulation, and the conversion factor for calculating the organ dose received by the interventional cardiologists based on patient dose can be applied for improved occupational dose management.