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Efficacy of atorvastatin in prevention of atrial fibrillation after heart valve surgery in the PROFACE trial (PROphylaxis of postoperative atrial Fibrillation After Cardiac surgEry).

ABSTRACT: BACKGROUND:To evaluate the efficacy of perioperative atorvastatin administration for prophylaxis of postoperative atrial fibrillation (POAF) after heart valve surgery. METHODS:Our study included 90 patients with heart valve disease who were scheduled to undergo elective cardiac surgery. Cases with previous AF or preoperative beta-blocker therapy were excluded. Patients were randomized into the atorvastatin group, which included 47 patients who received 40 mg/day of atorvastatin 7 days before and after the surgery and the control group, which included 43 patients. Primary endpoint was the occurrence of POAF. Secondary endpoints included modifications in the preoperative and postoperative levels of the markers of inflammation (C-reactive protein [CRP]), myocardial injury (ultrasensitive troponin T and creatinine phosphokinase MB [CPK-MB]), and cardiac dysfunction (pro-brain natriuretic peptide [proBNP]) related to POAF and changes in the echocardiographic parameters, such as atrial electromechanical interval, A wave, E/A ratio, and Doppler imaging systolic velocity wave amplitude, related to POAF. RESULTS:No relationship between atorvastatin administration and reduction in the incidence of POAF was observed (42.6% in the atorvastatin vs. 30.2% in the control group) (p=0.226). No difference in the levels of CPK-MB, ultrasensitive troponin T, CRP, or proBNP and in the analyzed echocardiographic parameter was detected between both groups. CONCLUSIONS:Atorvastatin in the described dose, was not adequate for the prophylaxis of POAF after heart valve surgery. It was ineffective in controlling the inflammatory phenomena, myocardial injury, and echocardiographic predictors of POAF.

SUBMITTER: Carrascal Y

PROVIDER: S-EPMC4913150 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Efficacy of atorvastatin in prevention of atrial fibrillation after heart valve surgery in the PROFACE trial (PROphylaxis of postoperative atrial Fibrillation After Cardiac surgEry).

Carrascal Yolanda Y Arnold Roman J RJ De la Fuente Luis L Revilla Ana A Sevilla Teresa T Arce Nuria N Laguna Gregorio G Pareja Pilar P Blanco Miriam M

Journal of arrhythmia 20160328 3

<h4>Background</h4>To evaluate the efficacy of perioperative atorvastatin administration for prophylaxis of postoperative atrial fibrillation (POAF) after heart valve surgery.<h4>Methods</h4>Our study included 90 patients with heart valve disease who were scheduled to undergo elective cardiac surgery. Cases with previous AF or preoperative beta-blocker therapy were excluded. Patients were randomized into the atorvastatin group, which included 47 patients who received 40 mg/day of atorvastatin 7 ...[more]

PMID: 27354864

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Project description:Postoperative atrial fibrillation (POAF) is a common complication of cardiac surgery. It has been proven to be associated with an increase in the incidence of early complications and mortality, an increase in the rate of hospital stay duration, and economic costs of their treatment. One of the pharmaceutical drugs recommended by the American College of Cardiology (ACC)/American Heart Association (AHA) for preventing POAF is colchicine (class IIB). However, the results of research on the efficacy and safety of colchicine are ambiguous and, consequently, require further study. Evaluating the efficacy of short-term colchicine administration in the prevention of POAF in patients after open-heart surgery. Double-blind, randomized, placebo-controlled clinical trial. The subjects were randomly assigned to two groups: treatment group (n = 50) with subjects receiving 1 mg of colchicine 24 h before the surgery, as well as on days 2, 3, 4, and 5 in the postoperative period; and the control group (n = 51), receiving placebo on the same schedule. The primary endpoint was the frequency of POAF in both groups within 7 days after surgery. The study included 101 patients (82 men, 19 women). Baseline clinical, laboratory, instrumental, and intraoperative data did not differ statistically significantly between the groups. POAF was detected in 9 patients (18%) of the treatment group and 15 subjects (29.4%) of the control group, which had no statistical significance (odds ratio, OR 0.527; 95% Cl 0.206-1.349; p = 0.178). No statistically significant differences were revealed for most secondary endpoints, as well as between the groups for all laboratory parameters. There were statistically significant differences between the groups solely in the frequency of diarrhea: 16 (32%) patients in the treatment group and 6 (11.8%) subjects in the control group (OR 3.529; 95% Cl 1.249-9.972; p = 0.010). We did not detect any statistical differences between the groups in terms of primary endpoints, which could be due to the insufficient volume of the sample of the study. However, we detected some trends of statistical differences among the groups in terms of some parameters. Unique identifier: NCT04224545.

Project description:ImportanceNew-onset postoperative atrial fibrillation (POAF) is a common complication of cardiac surgery. However, data on the long-term risk of thromboembolism in patients who develop POAF after heart valve surgery are conflicting. In addition, data on stroke prophylaxis in this setting are lacking.ObjectiveTo assess the long-term risk of thromboembolism in patients developing new-onset POAF after isolated left-sided heart valve surgery relative to patients with nonsurgical, nonvalvular atrial fibrillation (NVAF).Design, setting, and participantsThis observational cohort study was conducted from January 1, 2000, through December 31, 2015, using Danish nationwide registries and the Eastern Danish Heart Surgery Database. Patients who developed POAF after isolated left-sided heart valve surgery (bioprosthetic aortic or mitral valve replacement and/or aortic or mitral valve repair) from 2000 through 2015 were included. These patients were matched with patients with nonsurgical NVAF in a 1:3 ratio by age, sex, heart failure, hypertension, diabetes, a history of thromboembolism, ischemic heart disease, and year of diagnosis. Data analyses took place from January to March 2019.Main outcomes and measuresRates of thromboembolism.ResultsOf the 1587 patients who underwent isolated left-sided heart valve surgery, 741 patients (46.7%) developed POAF during admission. Of the 712 patients with POAF who were eligible for matching, 675 patients were matched with 2025 patients with NVAF and made up the study population. In the matched study population, the median age was 71 (interquartile range, 65-77) years, and 1600 (59.3%) were men. Oral anticoagulation therapy was initiated within 30 days postdischarge in 420 patients with POAF (62.9%) and in 1030 patients with NVAF (51.4%). The crude incidence rates of thromboembolism were 21.9 (95% CI, 17.4-27.6) and 17.7 (95% CI, 15.2-20.6) events per 1000 person-years for patients with POAF and patients with NVAF, respectively. In the adjusted analysis, the long-term risk of thromboembolism was similar in patients with POAF and NVAF (hazard ratio, 1.22 [95% CI, 0.88-1.68]). Oral anticoagulation therapy during follow-up was associated with a lower risk of thromboembolic events in patients with POAF (hazard ratio, 0.45 [95% CI, 0.22-0.90]) as well as patients with NVAF (hazard ratio, 0.63 [95% CI, 0.45-0.87]) compared with no anticoagulation therapy.Conclusions and relevanceNew-onset POAF after isolated left-sided heart valve surgery was associated with a similar long-term risk of thromboembolism as NVAF. These data warrant studies addressing the role of anticoagulation therapy in POAF after left-sided heart valve surgery.

Project description:BackgroundPostoperative atrial fibrillation (POAF) is one of the most common complications after cardiac surgery. POAF is associated with a longer hospital stay, higher healthcare resource utilization, and higher risk of morbidity and mortality. As a result, the American and European guidelines recommend the use of beta-blockers and amiodarone for the prevention of POAF, and in turn, avoid the complications associated with POAF.ObjectivesThe purpose of this study was to determine the incidence, risk factors, and prognostic implications of new-onset POAF after cardiac surgery in adults with congenital heart disease (CHD).MethodsA retrospective study was conducted among adults with CHD who underwent cardiac surgery (2003-2019). POAF and late-onset atrial fibrillation (AF) were defined as AF occurring within and after 30 days postoperatively, respectively.ResultsOf 1,598 patients (mean age 39 ± 13 years, 51% men), 335 (21%) developed POAF. Risk factors associated with POAF were older age, hypertension, left atrial (LA) reservoir strain and right atrial (RA) dysfunction, and nonsystemic atrioventricular valve regurgitation. Of 1,291 patients (81%) with follow-up ≥12 months, the annual incidence of late-onset AF was 1.5% and was higher in patients with POAF compared with those without POAF (5.9% vs 0.4%; P < 0.001). Risk factors associated with late-onset AF were POAF, older age, severe CHD, and LA and RA dysfunction. Of the 1,291 patients, 63 (5%) died during follow-up, and the risk factors associated with all-cause mortality were older age, severe CHD, hypertension, left ventricular systolic dysfunction, and LA and RA dysfunction. POAF was not associated with all-cause mortality.ConclusionsPOAF was common in adults with CHD and was associated with late-onset AF but not all-cause mortality. Atrial dysfunction was independently associated with POAF, late-onset AF, and all-cause mortality. These risk factors can be used to identify patients at risk for POAF and provide a foundation for prospective studies assessing the efficacy of prophylactic therapies in this population.

Dataset Information

Efficacy of atorvastatin in prevention of atrial fibrillation after heart valve surgery in the PROFACE trial (PROphylaxis of postoperative atrial Fibrillation After Cardiac surgEry).

Publications

Efficacy of atorvastatin in prevention of atrial fibrillation after heart valve surgery in the PROFACE trial (PROphylaxis of postoperative atrial Fibrillation After Cardiac surgEry).

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