Dataset Information

Rationale and design of a randomized trial of the dapagliflozin evaluation on atrial fibrillation patients followed Cox-Maze IV: the DETAIL-CMIV study.

ABSTRACT:

Background and aims

Dapagliflozin has been widely used for the treatment of type 2 diabetes mellitus (T2DM) and heart failure (HF). However, data concerning the association between dapagliflozin and the recurrence of atrial fibrillation (AF), especially in patients following Cox Maze IV (CMIV), are rare. We aim to explore the effect of dapagliflozin on the recurrence of AF after CMIV with and without T2DM or HF.

Methods

The study of dapagliflozin evaluation in atrial fibrillation patients followed by Cox-Maze IV (DETAIL-CMIV) is a prospective, double-blind, randomized, placebo-controlled trial. A total of 240 AF patients who have received the CMIV procedure will be randomized into the dapagliflozin group (10 mg/day, n=120) and the placebo group (10 mg/day, n=120) and treated for 3 months. The primary endpoint is any documented atrial tachyarrhythmia (AF, atrial flutter or atrial tachycardia [AF/AT]) lasting 30 s following a blanking period of 3 months after CMIV.

Conclusion

DETAIL-CMIV will determine whether the SGLT2 inhibitor dapagliflozin, added to guideline-recommended postoperative AF therapies, safely reduces the recurrence rate of AF in patients with and without T2DM or HF.

Clinical trial registration

NCT05816733.

SUBMITTER: Peng Z

PROVIDER: S-EPMC10655060 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Publications

Rationale and design of a randomized trial of the dapagliflozin evaluation on atrial fibrillation patients followed Cox-Maze IV: the DETAIL-CMIV study.

Peng Zhan Z Osmanaj Florian F Yang Yunxiao Y Hua Kun K Yang Xiubin X

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20231101 11

<h4>Aims</h4>Dapagliflozin has been widely used for the treatment of type 2 diabetes mellitus (T2DM) and heart failure (HF). However, data concerning the association between dapagliflozin and the recurrence of atrial fibrillation (AF), especially in patients following Cox-Maze IV (CMIV), are rare. We aim to explore the effect of dapagliflozin on the recurrence of AF after CMIV with and without T2DM or HF.<h4>Methods and results</h4>The study of dapagliflozin evaluation in AF patients followed by ...[more]

PMID: 37939825

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Project description:Objective: Atrial fibrillation is the most prevalent persistent arrhythmia in patients with hypertrophic obstructive cardiomyopathy. Comparative analyses of the safety and effectiveness of septal myectomy with and without surgical ablation are limited. This study aimed to compare the outcomes of septal myectomy with and without the Cox-maze IV procedure in patients with hypertrophic obstructive cardiomyopathy and atrial fibrillation. Methods: Ninety-four patients with hypertrophic obstructive cardiomyopathy and atrial fibrillation who underwent septal myectomy were analyzed, we divided it into concomitant Cox maze surgery (Cox-maze group) and no concomitant Cox maze operation (no Cox-maze group). Freedom from atrial fibrillation recurrence and all-cause mortality after surgery were assessed. Results: Freedom from all-cause mortality after septal myectomy at 1, 3, and 5 years was 98.5 ± 1.5% each in the Cox-maze group and 90.8 ± 6.3%, 85.1 ± 8.1%, and 85.1 ± 8.1%, respectively, in the no Cox-maze group. Patients in the no Cox-maze group had lower survival, freedom from atrial fibrillation recurrence off antiarrhythmic drugs, and arrhythmia control rate (including patients with successful antiarrhythmic drug conversion) than those in the Cox-maze group (P = 0.046, P = 0.040, and P = 0.012, respectively). Patients who underwent the Cox-maze IV procedure had lower atrial fibrillation recurrence rate than those who did not (hazard ratio, 0.141; 95% confidence interval, 0.042-0.479; P = 0.002). Post-operative increases in left atrial diameters (hazard ratio, 1.099; 95% confidence interval, 1.024-1.179; P = 0.009) were associated with atrial fibrillation recurrence. Conclusions: The Cox-maze IV procedure combined with septal myectomy improved mid-term survival and reduced mid-term atrial fibrillation recurrence in patients with hypertrophic obstructive cardiomyopathy and atrial fibrillation. The concomitant Cox-maze IV procedure was associated with a lower atrial fibrillation recurrence in patients with surgical hypertrophic obstructive cardiomyopathy and atrial fibrillation.

Project description:ObjectivesTo evaluate the efficacy of the Cox-Maze IV procedure (CMP-IV) in combination with valve surgery in patients with both atrial fibrillation (AF) and valvular disease and use machine learning algorithms to identify potential risk factors of AF recurrence.MethodsA total of 1,026 patients with AF and valvular disease from two hospitals were included in the study. 555 patients received the CMP-IV procedure in addition to valve surgery and left atrial appendage ligation (CMP-IV group), while 471 patients only received valve surgery and left atrial appendage ligation (Non-CMP-IV group). Kaplan-Meier analysis was used to calculate the sinus rhythm maintenance rate. 58 variables were selected as variables for each group and 10 machine learning models were developed respectively. The performance of the models was evaluated using five-fold cross-validation and metrics including F1 score, accuracy, precision, and recall. The four best-performing models for each group were selected for further analysis, including feature importance evaluation and SHAP analysis.ResultsThe 5-year sinus rhythm maintenance rate in the CMP-IV group was 82.13% (95% CI: 78.51%, 85.93%), while in the Non-CMP-IV group, it was 13.40% (95% CI: 10.44%, 17.20%). The eXtreme Gradient Boosting (XGBoost), LightGBM, Category Boosting (CatBoost) and Random Fores (RF) models performed the best in the CMP-IV group, with area under the curve (AUC) values of 0.768 (95% CI: 0.742, 0.786), 0.766 (95% CI: 0.744, 0.792), 0.762 (95% CI: 0.723, 0.801), and 0.732 (95% CI: 0.701, 0.763), respectively. In the Non-CMP-IV group, the LightGBM, XGBoost, CatBoost and RF models performed the best, with AUC values of 0.738 (95% CI: 0.699, 0.777), 0.732 (95% CI: 0.694, 0.770), 0.724 (95% CI: 0.668, 0.789), and 0.716 (95% CI: 0.656, 0.774), respectively. Analysis of feature importance and SHAP revealed that duration of AF, preoperative left ventricular ejection fraction, postoperative heart rhythm, preoperative neutrophil-lymphocyte ratio, preoperative left atrial diameter and heart rate were significant factors in AF recurrence.ConclusionCMP-IV is effective in treating AF and multiple machine learning models were successfully developed, and several risk factors were identified for AF recurrence, which may aid clinical decision-making and optimize the individual surgical management of AF.

Dataset Information

Rationale and design of a randomized trial of the dapagliflozin evaluation on atrial fibrillation patients followed Cox-Maze IV: the DETAIL-CMIV study.

Background and aims

Methods

Conclusion

Clinical trial registration

Publications

Rationale and design of a randomized trial of the dapagliflozin evaluation on atrial fibrillation patients followed Cox-Maze IV: the DETAIL-CMIV study.

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