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J Thorac Cardiovasc Surg 2008;135:405-411
© 2008 The American Association for Thoracic Surgery

Cardiopulmonary Support and Physiology

Preoperative statins for the prevention of atrial fibrillation after cardiothoracic surgery

Kirkeith Lertsburapa, MDa, C. Michael White, PharmDb, Jeffrey Kluger, MDa, Osman Faheem, MDc, Jonathon Hammond, MDd, Craig I. Coleman, PharmDe,*

a Henry Low Heart Center, Hartford Hospital, Hartford, Conn
b University of Connecticut School of Pharmacy, Cardiac Pharmacology Service, Divisions of Cardiology and Drug Information, Hartford, Conn
c University of Connecticut School of Medicine, Department of Internal Medicine, Hartford Hospital, Hartford, Conn
d Divisions of Cardiology and Cardiothoracic Surgery, Hartford Hospital, Hartford, Conn
e University of Connecticut School of Pharmacy, Storrs, Conn

Received for publication April 5, 2007; revisions received August 21, 2007; accepted for publication August 30, 2007.

* Address for reprints: Craig I. Coleman, PharmD, University of Connecticut School of Pharmacy, Pharmacy Practice, 80 Seymour Street, CB309, Hartford, CT 06102. (Email: ccolema{at}harthosp.org).


   Abstract
Top
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 Conclusions
 References
 
Objective: Recent studies have suggested that statins reduce atrial fibrillation after cardiothoracic surgery, but the use of proven prophylactic strategies such as beta-blockers and amiodarone in these studies was not provided. Therefore, we sought to determine whether preoperative statin use could reduce the incidence of post-cardiothoracic surgery atrial fibrillation in a population who already had a high background use of beta-blockers and appreciable use of prophylactic amiodarone.

Methods: Patients undergoing cardiothoracic surgery from the randomized, controlled Atrial Fibrillation Suppression Trials I, II, and III were evaluated in this nested cohort evaluation. The patients' demographics, surgical characteristics, medication use, and incidence of post-cardiothoracic surgery atrial fibrillation (atrial fibrillation >5 minutes duration) were uniformly and prospectively collected as part of Atrial Fibrillation Suppression Trials I, II, and III. Multivariate logistic regression was used to calculate adjusted odds ratios with 95% confidence intervals.

Results: Overall, 331 patients (59.6%) received a statin preoperatively and 224 patients (40.4%) did not. The study population had an average age of 67.8 ± 8.6 years, 77.1% were male, 14.6% had valve surgery, 6.1% had a history of atrial fibrillation, 12.6% had a history of heart failure, 84.0% received postoperative beta-blockade, and 44.1% received postoperative prophylactic amiodarone. In total, 174 patients (31.4%) developed post-cardiothoracic surgery atrial fibrillation. Upon multivariate logistic regression, statin use was associated with a reduction in post-cardiothoracic surgery atrial fibrillation (adjusted odds ratio: 0.60; 95% confidence interval 0.37–0.99). Higher intensity statin dosing (equivalent of ≥40 mg of atorvastatin) seemed to be associated with the greatest reductions in post-cardiothoracic surgery atrial fibrillation (adjusted odds ratio: 0.45; 95% confidence interval 0.21–0.99).

Conclusions: In a population with appreciable beta-blocker and amiodarone use, adjunctive preoperative statin use was still associated with a 40% reduction in patients' odds of developing post-cardiothoracic surgery atrial fibrillation.

Abbreviations and Acronyms AF = atrial fibrillation; CI = confidence interval; CTS = cardiothoracic surgery


   Introduction
Top
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 Conclusions
 References
 
Approximately 666,000 cardiothoracic surgeries (CTS) were performed in the United States in 2003.1Go One of the most common complications after CTS is the development of atrial fibrillation (AF). Although typically self limiting, post-CTS AF can increase a patient's risk for hemodynamic instability and stroke.2Go Moreover, it prolongs the length of stay and increases total hospital costs.2,3Go Beta-blockers and amiodarone are thus commonly used to prevent post-CTS AF and have been effective according to a recent meta-analysis.4Go Even with prophylactic beta-blockade and/or amiodarone, up to 40% of patients still develop post-CTS AF.4-7Go

Given the antiadrenergic effects of beta-blockers and amiodarone, the risks of hypotension, bradycardia, and heart block are elevated. Additional adjunctive strategies to further impede sympathetic functioning will likely exacerbate these adverse events; therefore, a novel strategy for reducing post-CTS AF is required.

Inflammation may be a causative factor in the development of postoperative and nonsurgical AF.8-11Go Given the ability of statins to attenuate inflammation,12-14Go previous studies have assessed the relationship between statin use pre-CTS and the subsequent development of AF after surgery.15-18Go Unfortunately, none of these studies assessed statin efficacy when added to appreciable prophylaxis with beta-blockers and amiodarone. Whether statins would still maintain efficacy when added to a population receiving higher levels of prophylactic beta-blockers and amiodarone is not known.

By combining the patient data from 3 randomized and controlled clinical trials, the Atrial Fibrillation Suppression Trials (AFIST) I, II, and III,6,7,19Go we had 555 patients who had undergone CTS from whom to conduct a "nested" study. All of the data were prospectively determined during the trials, end point definitions were the same, postoperative beta-blocker administration was high, and use of prophylactic amiodarone was substantial. We therefore examined the impact of preoperative statin use on the incidence of postoperative AF in this nested population.


   Materials and Methods
Top
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 Conclusions
 References
 
Design and Population
Our study prospectively evaluated a nested cohort of 555 patients who underwent coronary artery bypass grafting and/or valvular surgery as part of the AFIST I, II, and III. This study was approved by the Hartford Hospital Institutional Review Committee after expedited review.

AFIST I6Go was a randomized, double-blind, placebo-controlled trial that assessed the effect of oral amiodarone or placebo on the incidence of AF after cardiac surgery (n = 217). Patients enrolled less than 5 days before surgery received 6 g of amiodarone or placebo during 6 days beginning on preoperative day 1. Patients enrolled at least 5 days before surgery received 7 g during 10 days beginning on preoperative day 5. AFIST II7Go was a 2 x 2 factorial study that assessed the effect of 2 active treatments (amiodarone and atrial septal pacing) on the incidence of AF after cardiac surgery (n = 160). Patients were initially randomized to either amiodarone or placebo and then randomized further to either atrial septal pacing or no pacing. AFIST III19Go was a randomized controlled trial that assessed the effect of aortic fat pad maintenance on the incidence of postoperative AF in patients (n = 178) undergoing coronary artery bypass graft surgery for the first time.

Data with respect to patient demographics, surgical characteristics, medication use, and postoperative AF were prospectively and uniformly collected as part of AFIST I, II, and III. In AFIST I, II, and III, the primary end point was the development of post-CTS AF within 30 days of cardiac surgery. AF was defined as episodes lasting more than 5 minutes as documented by continuous telemetry. Statin use and dose were recorded. The statins were converted to atorvastatin equivalents using the following conversions: atorvastatin 10 mg = simvastatin 5–20 mg, lovastatin 10–40 mg, pravastatin 10–40 mg, fluvastatin 20–80 mg, or cerivastatin 0.1–0.4 mg; atorvastatin 20 mg = simvastatin 40 mg, pravastatin 80 mg; rosuvastatin 5 mg, or cerivastatin 0.8 mg; atorvastatin 40 mg = simvastatin 80 mg or rosuvastatin 10 mg; atorvastatin 80 mg = rosuvastatin 20 mg.20-22Go

Statistical Analysis
Continuous variables are presented as means with standard deviations and were compared between groups using a Student t test or Mann–Whitney test when appropriate. Dichotomous variables are presented as percentages and were compared between groups using a chi-square or Fisher exact test when appropriate.

Because this was an observational study, the investigators had no control over which patients received statins. As a result, significant differences in observed demographic, surgical, and medication use characteristics were expected. To control for these potential confounders and to avoid a biased estimate of treatment effect, we conducted a multivariate logistic regression. Univariate analysis was first performed to examine the relationship between different variables (demographic, surgical, and medication use characteristics) and the development of postoperative AF (dependent variable). All variables that showed a univariate association (P ≤ .20) with AF occurrence or that were previously demonstrated to be strong independent predictors of AF3,6,7,19,23,24Go were then entered into a backward, stepwise multivariate regression model. Adjusted odds ratios and 95% confidence intervals (CIs) were calculated for all independent predictors. Statistical analysis was performed with the Statistical Package for the Social Sciences version 15.0 (SPSS Inc, Chicago, Ill).


   Results
Top
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 Conclusions
 References
 
A total of 555 patients were evaluated, of whom 331 (59.6%) received a statin preoperatively and 224 (40.4%) did not. Overall, the study population had an average age of 67.8 ± 8.6 years, 77.1% were male, 14.6% had valve surgery, 6.1% had a history of AF, 12.6% had a history of heart failure, 84.0% received postoperative beta-blockade, and 44.1% received prophylactic amiodarone. Go Table 1 depicts the results of univariate comparisons of demographic and perioperative characteristics between patients receiving and not receiving a statin. Similarly, comparisons of demographics and perioperative characteristics between patients developing and not developing post-CTS AF are provided in Go Table 2.


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  		Table 1 Patient demographics, surgical characteristics, and medication use by statin use
 

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  		Table 2 Patient demographics, surgical characteristics, and medication use by postoperative cardiothoracic surgery atrial fibrillation status
 
In total, 174 patients (31.4%) developed AF after cardiac surgery (36.6% vs 27.8% in the non-statin and statin groups, respectively; crude odds ratio: 0.68; 95% CI: 0.46–0.96). Of the 174 patients, only 1 developed AF after discharge but within 30 days. On multivariate analysis (Go Table 3), the preoperative use of statins was associated with a statistically significant reduction in AF (adjusted odds ratio: 0.60; 95% CI: 0.37–0.99). Benefit was also seen with nonsteroidal, preoperative beta-blocker, and prophylactic amiodarone administration (P ≤ .04 for all). Age, number of arterial grafts, beta-blocker withdrawal (patient treated with preoperative beta-blocker but not receiving postoperative beta-blocker before onset of AF), and histories of AF, diabetes mellitus, and mitral valve regurgitation were positive risk factors for developing AF after surgery (P ≤ .04 for all).


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  		Table 3 Results of multivariate logistic regression *
 
When subgroup analysis evaluating the impact of different statin dosing intensities was performed, statin doses equivalent to ≥40 mg per day of atorvastatin resulted in the greatest reductions in post-CTS AF (55% reduction) compared with those receiving ≥20 mg but less than 40 mg (43% reduction) or less than 20 mg (25% reduction) (Go Figure 1). In addition, patients receiving the equivalent of at least 20 mg of atorvastatin (n = 144) had a 40% reduction in the odds of developing post-CTS AF (adjusted odds ratio: 0.60; 95% CI: 0.23–0.99) versus patients receiving lower equivalent doses of statin or no statin therapy (n = 411). When patients receiving the equivalent of at least 20 mg of atorvastatin (n = 144) were compared with those receiving only low-intensity statin therapy (n = 187), there was a nonsignificant 29% reduction in post-CTS AF (adjusted odds ratio: 0.71; 95% CI: 0.41–1.25).


Figure 1
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  		Figure 1. Effect of statin dosing intensity on the development of postoperative AF. AF, Atrial fibrillation.

 

   Discussion
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
Conclusions
 References
 
To date, meta-analyses have demonstrated the efficacy of only a few prophylactic strategies to reduce post-CTS AF: beta-blockers, amiodarone, sotalol, magnesium, and biatrial pacing.4,23Go Although beta-blockers, amiodarone, and sotalol are included in the most recent American College of Cardiology/American Heart Association/European Society of Cardiology practice guidelines for the management of post-CTS AF, only amiodarone and beta-blockers have been shown to be effective and safe when combined.24Go However, the use of these therapies can increase the risk of hypotension, bradycardia, and heart block, making it unlikely that additional antiadrenergic drugs can be added to this combination regimen.

Inflammation may be a causative factor in the development of post-CTS AF. Bruins and colleagues9Go documented the presence of an inflammatory process by measuring levels of interleukin-6 and C-reactive protein early in the postoperative period. Their group demonstrated that these inflammatory markers significantly increased after cardiac surgery, with levels of C-reactive protein peaking around postoperative day 2 and coinciding with the peak incidence of atrial arrhythmias.9Go The study was rather small, but these findings were complemented by other reports that substantiated the role of inflammation in the development of both postoperative and nonsurgical AF.8,10,11,18Go Statins were subsequently found to attenuate this inflammation. Kumagai and colleagues13Go showed that atorvastatin was able to decrease C-reactive protein levels while diminishing the AF burden in a canine model of sterile pericarditis. Brull and colleagues25Go noted decreased interleukin-6 levels in patients who received statins before cardiac surgery.

Past observational studies have reported an association between preoperative statin use and reduced rates of post-CTS AF.15-17Go ARMYDA-3 was the first clinical trial to evaluate the impact of statin therapy on post-CTS AF.18Go Two hundred patients undergoing elective CTS were randomized to either atorvastatin (40 mg/d, n = 101) or placebo (n = 99) starting 7 days preoperatively. Post-CTS AF occurred in 35% of patients in the atorvastatin arm and in 57% of patients in the placebo arm, representing a 61% reduction (P = .017) in AF incidence in those who received statins. Before surgery, beta-blockers were used by 72% and 60% of patients in the atorvastatin and placebo arms, respectively, whereas amiodarone was administered to only 1 patient in each group. Similar to the observational studies, no information was given regarding the rates of postoperative beta-blocker and amiodarone therapy; the 57% incidence of post-CTS AF in the placebo group, however, suggests low use of these treatments.

In our study, patients from AFIST I, II, and III received postoperative beta-blockers and amiodarone approximately 84.0% and 44.1% of the time, respectively. As expected, the withdrawal of a beta-blocker postoperatively significantly increased the incidence of AF, and the use of prophylactic amiodarone significantly reduced the incidence of AF after cardiac surgery. Multivariate analysis, however, also demonstrated that statin use before surgery had a positive and independent effect on AF rates. Specifically, patients taking preoperative statins experienced a 40% reduction in their odds of developing postoperative AF, an effect size comparable to that seen in previous statin studies.16,17Go

Although our study was observational in nature, a number of characteristics helped limit the effects of confounding and biases on our results. The use of "nested" data from the previously conducted, prospective, randomized, and controlled AFIST I, II, and III likely reduced the impact of selection, misclassification, surveillance, and researcher bias. Our use of multivariate logistic regression to calculate adjusted odds ratios likely minimized much of the confounding during statistical analysis. Data on most of the commonly accepted independent predictors of post-CTS AF identified in the American College of Cardiology/American Heart Association/European Society of Cardiology AF guidelines were available for use in the multivariate adjustment. Yet even with these measures, there is some degree of bias that cannot be extracted during observational trials, representing a limitation. It is also important to note that our multivariable analysis may suffer from a mild degree of over-fitting.

Our study has other limitations that should be noted. First, we converted all statins to an equivalent dose of atorvastatin; although this was necessary to facilitate our high- versus low-intensity comparison, it should be noted that antifibrillatory effects might not be identical across all statins. Although we were able to show that higher intensity statin therapy was a negative independent predictor of post-CTS AF versus the combined group receiving either no therapy or lower intensity therapy, we did not have adequate power to evaluate higher intensity versus lower intensity therapy by itself. However, the adjusted odds of post-CTS AF with higher intensity statin dosing versus the combined "no therapy plus low intensity" group (adjusted odds ratio = 0.60) were similar to the odds for the lower intensity group alone (adjusted odds ratio = 0.71), suggesting that it is a power issue. Although this may be why we showed a 40% reduction in the odds of post-CTS AF compared with the ARMYDA-3 study, which showed a 61% reduction with atorvastatin 40 mg (a high-intensity therapy), we cannot exclude the possibility that our use of beta-blockers and amiodarone attenuated the benefits in our study or that the results were due to chance or population differences. The impact of dosing intensity on results is clearly the most important area for future research because most patients with coronary disease receive statin therapy, but very few receive high-intensity therapy.26Go Further research using randomized controlled trials will clearly be needed to answer this.


   Conclusions
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusions
References
 
In patients with appreciable prophylactic use of beta-blockers and amiodarone, preoperative statin administration may still be beneficial in reducing the incidence of AF after CTS.


   Footnotes
 
This study was supported by The Patrick and Catherine Weldon Donaghue Medical Research Foundation, West Hartford, Conn. None of the investigators have conflicts of interest to report.


   References
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusions
 References
 

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