RIvaroxaban in mitral stenosis (RISE MS): A pilot randomized clinical trial.

BACKGROUND: Patients with moderate-to-severe mitral stenosis (MS) have bee excluded from all major randomized controlled trials (RCTs) comparing non-vitamin K antagonist oral anticoagulants (NOACs) with warfarin in patients with atrial fibrillation (AF). METHODS AND RESULTS: In this pilot RCT, 40 patients were randomized to rivaroxaban 20 mg daily or warfarin. No patients experienced symptomatic ischemic strokes and systemic embolic events (the primary composite study outcome) during a 12-month follow-up. No major bleeding was reported. During the follow-up, 18.2% of patients in both groups showed echocardiographic signs of increased thrombogenicity in the left atrial appendage. The rate of silent cerebral ischemia was 13.3% in the rivaroxaban group and 17.6% in the warfarin group at brain magnetic resonance imaging. CONCLUSION: Our results suggest acceptable efficacy and safety for rivaroxaban in patients with AF and moderate-to-severe MS and are encouraging for larger RCTs in this so far neglected setting (NCT03926156).

Diagnostic accuracy of two-dimensional coronary angiographic-derived fractional flow reserve-Preliminary results.

AIM: Noninvasive fractional flow reserve (NiFFR) is an emerging method for evaluating the functional significance of a coronary lesion during diagnostic coronary angiography (CAG). The method relies on the computational flow dynamics and the three-dimensional (3D) reconstruction of the vessel extracted from CAG. In the present study, we sought to evaluate the diagnostic performance and applicability of 2D-based NiFFR. METHODS: In this prospective observational study, we evaluated 2D-based NiFFR in 279 candidates for invasive CAG and invasive fractional flow reserve (FFR). NiFFR was calculated via two methods: variable NiFFR, in which the contrast transport time was extracted from the angiographic view, and fixed NiFFR, in which a prespecified frame count was applied. RESULTS: The final analysis was performed on 245 patients (250 lesions). Variable NiFFR had an area under the receiver operating characteristic curve of 81.5%, an accuracy of 80.0%, a sensitivity of 82.2%, a specificity of 82.2%, a negative predictive value of 91.4%, and a positive predictive value of 63.6%. The mean difference between FFR and NiFFR was -0.0244 ±.0616 (p ≤.0001). A pressure wire-free hybrid strategy was possible in 68.8% of our population with variable NiFFR. CONCLUSIONS: Our 2D-based NiFFR yielded results comparable to those derived from 3D-based software. Our findings should; however, be confirmed in larger trials.

Rivaroxaban in patients undergoing surgical mitral valve repair.

In patients undergoing mitral valve repair (MVre), a 3-month course of anticoagulation is currently recommended. The role of the non-vitamin K antagonist oral anticoagulants has here been scarcely studied. In the present mixed cohort study, the safety and efficacy of rivaroxaban (prospective analysis) were compared with those of warfarin (retrospective analysis) in patients undergoing MVre. Anticoagulation therapy was continued for at least 3 months, and the patients were followed for 1 year following surgery. The present study recruited 736 patients undergoing MVre with or without concomitant coronary artery bypass or surgical repair on the other valves. Concomitant valvular replacement and severe chronic kidney diseases were the most important exclusion criteria. The final analysis was conducted on 153 patients treated with rivaroxaban and 144 patients treated with warfarin. Dissimilarities in baseline characteristics necessitated propensity score matching, in which 104 patients in each group were compared. No major bleeding or cerebrovascular accident occurred during the 1-year follow-up. Clinically relevant non-major bleeding was reported in 2 patients in the rivaroxaban group and 4 patients in the warfarin group, a difference non-statistically significant before and after propensity score matching (P = 0.371 and P = 0.407, respectively). The type of anticoagulation did not predict the 1-year outcome (HR 2.165, 95% CI 0.376 to 12.460; P = 0.387). In this mixed cohort study, rivaroxaban was both safe and efficient in patients with MVre. Such preliminary results should prompt larger randomized controlled trials.

Carvedilol Administration Can Prevent Doxorubicin-Induced Cardiotoxicity: A Double-Blind Randomized Trial.

OBJECTIVE: The aim of this study is to evaluate the preventive effects of carvedilol on doxorubicin-induced cardiotoxicity. METHODS: In this trial, 70 female patients with breast cancer who were candidates to receive doxorubicin were enrolled, from which 30 were selected randomly to receive carvedilol 6.25 mg daily during chemotherapy, with the rest receiving placebo as the control group. Both groups were evaluated 1 week before and 1 week after chemotherapy by measuring the left ventricular ejection fraction and strain/strain rate. RESULTS: Data analysis showed that the case group presented no significant reduction in strain and strain-rate parameters after intervention, while there was a significant reduction in these parameters in the control group (all p values <0.001). Also, the mean differences of strain parameters in the case group were significantly less than in the control group in all evaluated heart walls (basal septal strain, p = 0.005, basal lateral strain, p = 0.001, basal inferior strain, p < 0.001, and basal anterior strain, p < 0.001); the same was true for the strain-rate parameters (the p values for basal septal, basal lateral, basal inferior and basal anterior strain rate were 0.037, 0.037, 0.002 and <0.001, respectively). CONCLUSION: This study shows that carvedilol can prevent doxorubicin-induced cardiotoxicity. Whether this prophylaxis should be considered as the preferred method needs further investigation.