Objectives Low-molecular weight heparin (LMWH) has been approved for treatment of deep venous thrombosis and venous thromboembolism which are associated with cancer. The efficacy and safety of apixaban in management of acute deep venous thrombosis associated with active malignancy is still an unresolved issue. The aim of our study is to evaluate the efficacy and safety of apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous LMWH. Methods Of 138 randomized patients, 100 patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy were assigned to either oral apixaban therapy or subcutaneous low-molecular weight heparin (enoxaparin) through randomized clinical study in 1:1 ratio. All patients were followed up to six months. The primary end point was major bleeding, while secondary end points were recurrent deep venous thrombosis or venous thromboembolism, minor or non-fatal bleeding and mortality related to massive pulmonary embolism. Results Both groups were matched regarding their baseline demographic, clinical and laboratory characteristics. We had 84 patients with metastatic cancer (stage 4). The most prevalent type of malignancy was cancer colon (42% of cases). There was no significant difference between both groups regarding the incidence of primary and secondary end points. There were no reported mortality cases related to massive pulmonary embolism in both groups. Conclusion In this limited study, there was no difference in the major bleeding, recurrent deep venous thrombosis or minor bleeding in patients with active malignancy when treated with either apixaban or LMWH. Trial registration: ClinicalTrials.gov (NCT04462003). Registered 7 July 2020 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04462003
Introduction: Angiotensin-converting enzyme inhibitors (ACEI) combined with mineralocorticoid receptor antagonists were found to have a beneficial effect on patients with chronic kidney disease. Objective: The aim of our clinical trial was to compare the antialbuminuric effect of ramipril monotherapy, eplerenone monotherapy and eplerenone/ramipril combination therapy in patients with stage 1 hypertension and type 2 diabetes mellitus. Methods: In a single-blind, randomized clinical trial, 75 hypertensive patients (stage 1 hypertension) with type 2 diabetes mellitus and microalbuminuria were randomized in a 1: 1: 1 ratio to 1 of 3 groups: ramipril 10 mg monotherapy (25 patients), eplerenone 50 mg monotherapy (25 patients) and combination therapy of eplerenone/ramipril 50/10 mg (25 patients) through a randomized clinical trial. Blood pressure, urinary albumin/creatinine ratio (UACR), serum creatinine, estimated glomerular filtration rate (eGFR) and serum K level were measured before randomization and after 24 weeks. Results: Ramipril and eplerenone monotherapy showed a significant lowering of UACR compared with baseline levels (p ≤ 0.0001). The eplerenone/ramipril combination group showed a more significant reduction of UACR compared with the ramipril and eplerenone monotherapy groups (p = 0.0001). There was a more significant lowering of systolic blood pressure in the combination group (p < 0.0001). A nonsignificant change of serum potassium level, serum creatinine and eGFR was found among the 3 groups. Conclusion: Addition of eplerenone to ACEI shows an added antialbuminuric effect without significant change of the serum K level compared with eplerenone or ACEI.
BackgroundResults of percutaneous balloon mitral valvuloplasty (BMV) are basically dependent on suitable patient selection. Currently used two-dimensional (2D) echocardiography (2DE) scores have many limitations. Three-dimensional (3D) echocardiography (3DE)-based scores were developed for better patient selection and outcome prediction. We aimed to compare between 3D-Anwar and 2D-Wilkins scores in mitral assessment for BMV, and investigate the additive value of 3DE in prediction of immediate post-procedural outcome. Fifty patients with rheumatic mitral stenosis and candidates for BMV were included. Patients were subjected to 2D- and real-time 3D-transthoracic echocardiography (TTE) before and immediately after BMV for assessing MV area (MVA), 2D-Wilkins and 3D-Anwar score, commissural splitting, and mitral regurgitation (MR). Transesophageal echocardiography (TEE) was also undertaken immediately before and intra-procedural. Percutaneous BMV was performed by either multi-track or Inoue balloon technique.ResultsThe 2DE underestimated post-procedural MVA than 3DE (p = 0.008). Patients with post-procedural suboptimal MVA or significant MR had higher 3D-Anwar score compared to 2D-Wilkins score (p = 0.008 and p = 0.03 respectively). The 3D-Anwar score showed a negative correlation with post-procedural MVA (r = − 0.48, p = 0.001). Receiver operating characteristic (ROC) curve analysis for both scores revealed superior prediction of suboptimal results by 3D-Anwar score (p < 0.0001). The 3DE showed better post-procedural posterior-commissural splitting than 2DE (p = 0.004). Results of both multi-track and Inoue balloon were comparable except for favorable posterior-commissural splitting by multi-track balloon (p = 0.04).ConclusionThe 3DE gave valuable additive data before BMV that may predict immediate post-procedural outcome and suboptimal results.Electronic supplementary materialThe online version of this article (10.1186/s43044-019-0019-x) contains supplementary material, which is available to authorized users.
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