AimsThe REGENERATE-DCM trial is the first phase II randomized, placebo-controlled trial aiming to assess if granulocyte colony-stimulating factor (G-CSF) administration with or without adjunctive intracoronary (IC) delivery of autologous bone marrow-derived cells (BMCs) improves global left ventricular (LV) function in patients with dilated cardiomyopathy (DCM) and significant cardiac dysfunction.Methods and resultsSixty patients with DCM and left ventricular ejection fraction (LVEF) at referral of ≤45%, New York Heart Association (NYHA) classification ≥2 and no secondary cause for the cardiomyopathy were randomized equally into four groups: peripheral placebo (saline), peripheral G-CSF, peripheral G-CSF and IC serum, and peripheral G-CSF and IC BMC. All patients, except the peripheral placebo group, received 5 days of G-CSF. In the IC groups, this was followed by bone marrow harvest and IC infusion of cells or serum on Day 6. The primary endpoint was LVEF change from baseline to 3 months, determined by advanced cardiac imaging. At 3 months, peripheral G-CSF combined with IC BMC therapy was associated with a 5.37% point increase in LVEF (38.30% ± 12.97 from 32.93% ± 16.46 P = 0.0138), which was maintained to 1 year. This was associated with a decrease in NYHA classification, reduced NT-pro BNP, and improved exercise capacity and quality of life. No significant change in LVEF was seen in the remaining treatment groups.ConclusionThis is the first randomized, placebo-controlled trial with a novel combination of G-CSF and IC cell therapy that demonstrates an improvement in cardiac function, symptoms, and biochemical parameters in patients with DCM.
The current study aimed to examine the impact of COVID-19 pandemic on patient-related delay with ST-segment elevation myocardial infarction (STEMI) at a tertiary center in the United Kingdom. The study demonstrated a significant delay in symptom-to-first medical contact and a higher cardiac troponin-I level on admission in patients with STEMI during the COVID-19 pandemic versus the pre-COVID era.
This study analyses the attitudes of patients towards the presence of medical students during consultations. It was conducted in a very culturally and ethnically diverse part of London. The study aimed to investigate the factors, particularly ethnicity, which influence patients' attitudes towards medical students. A total of 422 patients participated in the study, which was conducted in general practice and hospital outpatient waiting areas in the London Boroughs of Tower Hamlets and Hackney. In general, the results demonstrate that patients are positive towards medical student participation during consultations. In particular, older patients, patients born in the UK and patients with prior experience of medical students seem to be particularly favourable towards students. However, compared with the White-British population, the non-White-British population appears to be more negative towards medical student participation. This study highlights the need for patient education regarding the importance, for the training of future doctors, of medical student involvement in consultations.
ObjectiveTo assess the effects of different oral antithrombotic drugs that prevent saphenous vein graft failure in patients undergoing coronary artery bypass graft surgery.DesignSystematic review and network meta-analysis.Data sourcesMedline, Embase, Web of Science, CINAHL, and the Cochrane Library from inception to 25 January 2019.Eligibility criteria for selecting studies Randomised controlled trials of participants (aged ≥18) who received oral antithrombotic drugs (antiplatelets or anticoagulants) to prevent saphenous vein graft failure after coronary artery bypass graft surgery.Main outcome measuresThe primary efficacy endpoint was saphenous vein graft failure and the primary safety endpoint was major bleeding. Secondary endpoints were myocardial infarction and death.ResultsThis review identified 3266 citations, and 21 articles that related to 20 randomised controlled trials were included in the network meta-analysis. These 20 trials comprised 4803 participants and investigated nine different interventions (eight active and one placebo). Moderate certainty evidence supports the use of dual antiplatelet therapy with either aspirin plus ticagrelor (odds ratio 0.50, 95% confidence interval 0.31 to 0.79, number needed to treat 10) or aspirin plus clopidogrel (0.60, 0.42 to 0.86, 19) to reduce saphenous vein graft failure when compared with aspirin monotherapy. The study found no strong evidence of differences in major bleeding, myocardial infarction, and death among different antithrombotic therapies. The possibility of intransitivity could not be ruled out; however, between-trial heterogeneity and incoherence were low in all included analyses. Sensitivity analysis using per graft data did not change the effect estimates.ConclusionsThe results of this network meta-analysis suggest an important absolute benefit of adding ticagrelor or clopidogrel to aspirin to prevent saphenous vein graft failure after coronary artery bypass graft surgery. Dual antiplatelet therapy after surgery should be tailored to the patient by balancing the safety and efficacy profile of the drug intervention against important patient outcomes.Study registrationPROSPERO registration number CRD42017065678.
AimsThe effect of combined cytokine and cell therapy in ischaemic cardiomyopathy is unknown. Meta‐analyses suggest improved cardiac function with cell therapy. The optimal cell delivery route remains unclear. We investigated whether granulocyte colony‐stimulating factor (G‐CSF) alone or in combination with intracoronary (i.c.) or intramyocardial (i.m.) injection of autologous bone marrow‐derived cells (BMCs) improves cardiac function.Methods and resultsNinety patients with symptomatic ischaemic cardiomyopathy and no further treatment options were enrolled in the randomized, placebo‐controlled, single‐centre REGENERATE‐IHD study. Randomization was to one of three arms: peripheral, i.c., or i.m. In each arm, patients were randomized to active treatment or placebo. All patients, apart from the peripheral placebo group (saline only) received G‐CSF for 5 days. The i.c. and i.m. arms received either BMCs or serum (placebo). The primary endpoint was change in LVEF at 1 year assessed by cardiac magnetic resonance imaging/computed tomography. The i.m. BMC group showed a significant improvement in LVEF of 4.99% (95% confidence interval 0.33–9.6%; P = 0.038) at 1 year. This group also showed a reduction in NYHA class at 1 year and NT‐proBNP at 6 months. No other group showed a significant change in LVEF. This finding is supported by post‐hoc between‐group comparisons.ConclusionWe have shown that G‐CSF combined with autologous i.m. BMCs has a beneficial effect on cardiac function and symptoms. However, this result should be considered preliminary in support of a clinical benefit of i.m. stem cell infusion in ‘no option’ patients and needs further exploration in a larger study.
ST segment elevation myocardial infarction remains a significant contributor to morbidity and mortality worldwide, despite a declining incidence and better survival rates. It usually results from thrombotic occlusion of a coronary artery at the site of a ruptured or eroded plaque. Diagnosis is based on characteristic symptoms and electrocardiogram changes, and confirmed subsequently by raised cardiac enzymes. Prognosis is dependent on the size of the infarct, presence of collaterals and speed with which the occluded artery is reopened. Mechanical reperfusion by primary percutaneous coronary intervention is superior to fibrinolytic therapy if delivered by an experienced team in a timely fashion. Post-reperfusion care includes monitoring for complications, evaluation of left ventricular function, secondary preventive therapy and cardiac rehabilitation.
Aims: Despite the widespread use of the radial approach in coronary interventions, left ventricular endomyocardial biopsy (LV-EMB) is most frequently performed via the femoral artery. We sought to assess the feasibility and safety of radial compared to femoral access in a large cohort of patients undergoing LV-EMB.Methods and results: Data from 264 patients who underwent LV-EMB in Germany, Portugal, Japan and Canada were collected. Clinical, procedural, safety and feasibility data were evaluated and compared between the two groups. LV-EMB was successfully performed by the radial approach in 129 (99%) of 130 and in 134 (100%) patients by the femoral access. Patients in the radial group were older (mean age 55.7 versus 44.3 years) and were more likely to have moderate-severe mitral regurgitation (27.7% versus TF 0%). Sheathless guides were used in 108 (83.1%) of the radial and 2 (1.5%) of the femoral patients, so the mean guiding catheter size (radial 7.0±1.0 Fr versus femoral 8.0±0.0 Fr) was significantly smaller in the radial group (p<0.001). Mild or moderate radial artery spasm occurred in 13 (10.0%) patients but only one (0.8%) patient required conversion to femoral access due to severe spasm. No access site-related complications were reported in the radial group, while 11 (8.2%) patients in the femoral group had access-site haematomas (p=0.001). There were no major complications (mitral valve injury, pericardial tamponade requiring intervention, cerebrovascular accidents, persistent high-degree atrioventricular block, major bleeding or death) in either group. Conclusions:The radial approach for LV-EMB appears to be safe and associated with a high success rate while possibly leading to fewer access-site bleeding complications compared to the femoral access. The results of this international multicentre study support the radial approach for LV-EMB and further inspire the expansion of "radial first" in the field of interventional cardiology.
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