Is Sotalol more effective than standard beta-blockers for the prophylaxis of atrial fibrillation during cardiac surgery
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《血管的通路杂志》
Department of Cardiothoracic Surgery, Freeman Hospital, Freeman Road, High Heaton, Newcastle upon Tyne NE7 7AZ, UK
Abstract
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether prophylactic Sotalol was more effective than conventional blockers in the prevention of atrial fibrillation after cardiac surgery. Fifty-one papers were found of which eight presented the best evidence to answer the question. The author, journal, date and country of publication, patient group, relevant outcomes and weaknesses were tabulated. We conclude that prophylactic Sotalol may be more effective than blockers in the prevention of post operative atrial fibrillation, and should not cause an excess of side effects.
Key Words: Review; Evidence based medicine; Thoracic surgery; Atrial fibrillation; Sotalol
1. Introduction
A best evidence topic was constructed according to the structured protocol. This protocol is fully described in the ICVTS [1].
2. Clinical scenario
You are updating a protocol for the prophylaxis of atrial fibrillation after cardiac surgery for your department. For many years the protocol has been to continue the patient's own beta-blockers during the perioperative period, restarting them the day after surgery. A new surgeon in your group suggests that Sotalol, with type III antiarrhythmic properties in addition to Beta-Blockers is superior to this protocol, but other colleagues state that changing the patient's usual medications the day before surgery in this way will lead to a host of complications including bradycardia and hypotension. You resolve to search the literature to see whether it really is worth changing your departmental policy.
3. Three-part question
In [patients undergoing cardiac surgery] is prophylactic [Sotalol compared to conventional Blockers] more effective in reducing the incidence of [atrial fibrillation].
4. Search strategy
Medline 1966 to Oct 2004 using the OVID interface.
[exp Cardiovascular surgical procedures/OR cardiovascular surgical procedures.mp OR exp Thoracic surgery/OR Thoracic surgery.mp OR exp Coronary Artery Bypass/OR Coronary art$ bypass.mp OR cardiopulmonary bypass.mp OR CABG.mp OR coronary artery surgery.mp OR cardiac surgery.mp OR revascularization.mp OR heart surgery.mp] AND [exp atrial fibrillation/OR atrial fibrillation.mp OR AF.mp OR exp atrial flutter OR atrial flutter.mp OR supraventricular tachycardia.mp OR exp Tachycardia, Supraventricular/ OR SVT.mp] AND [exp sotalol/ OR sotalol.mp]
5. Search outcome
A total of 55 articles were identified of which 7 represented the evidence to answer the clinical question. Of note several papers were also found that compared Sotalol to placebo but these were deemed to be irrelevant to our question. A meta-analysis was also found that briefly addressed this topic. These are summarised in Table 1.
6. Comments
All of the seven papers show the reduction in the incidence of post operative atrial fibrillation was greater in those patients treated with prophylactic Sotalol than conventional blockade. Five of the seven papers were statistically significant. The remaining 2 papers showed a non-significant trend to a lower incidence of AF with patients treated with Sotalol.
Auer et al. [2] looked at 253 patients randomised into 4 groups. The group treated with sotalol alone showed a statistically significant reduction in the incidence of AF compared with placebo, the group treated with blocker only showed a non-significant trend to a lower incidence of post op AF. They also showed that patients in both the sotalol and -blocker groups had a higher incidence of bradycardia necessitating a dose reduction or withdrawal of the drug but with no difference between them. Patients on active treatments showed a trend towards a shorter hospital stay but no difference was noted between the active groups.
Janssen et al. [8] looked at 130 patients undergoing coronary artery surgery. 2.4% of patients treated with sotalol developed post operative AF compared to 15.3% of those treated with metoprolol. The difference was statistically significant. There were no major reported side effects in either group.
Parika et al. [5] looked at a total of 191 patients undergoing coronary artery surgery. He showed a significant reduction in the incidence of AF in the group treated with Sotalol (16% vs 32%). He showed doses needed to be increased in 18% of the -blocker and 10% of the Sotalol group, the final doses being 54±14 mg Metoprolol group and 40±0 mg in the sotalol group. Medications were stopped in 1 patient per group.
Surtorp et al. [7] compared high and low dose treatment regimes in both Sotalol and Propranalol groups. Four hundred and twenty-nine patients were studied. The incidence of AF was 13.9% and 18.8% in the low dose Sotalol and Propranalol groups, respectively, and 10.9% and 13.7% in the high dose Sotalol and Propranalol groups. Although these results show a trend to a lower incidence of AF in both the Sotalol treatment groups they are statistically non-significant. Adverse effects resulting in stopping drug were seen in 2 patients in both low dose treatment regimes (2/74 Sotalol and 2/66 Propranalol) and in 14/133 (high dose Sotalol) and 17/156 (high dose Propranalol) patients. Therefore doubling the dose causes no substantial increase in the preventative effects but produces an increase in the unwanted side effects.
Sanjuan et al. [3] looked at 253 patients undergoing Cardiac surgery. AF was seen in 44 patients. The incidence was 10/100 (10%) in the Sotalol group and in 34/153 (22%) in the Atenolol group P=0.013. They also showed that AF resulted in statistically significant longer stays in the CCU and longer hospital stays overall. Adverse effects resulting in withdrawal of treatment was seen in 12 of the Atenolol group and in 16 of the Sotalol group and in 2 of the Sotalol group the drug was reduced.
Nystrom et al. [6] looked at 101 patients randomised to Sotalol or control (half dose pre op B blockade or no treatment if not on pre op. blockade). AF was seen in 5/50 (10%) of the Sotalol group and in 11/40 (27.5%) of patients on half their pre op blocker dose and in 4/11 (36%) patients on no treatment. Eleven patients in the Sotalol group needed dose withdrawal and of these, 5 required withdrawal of the drug, all adverse symptoms resolved following this.
Abdulrahman et al. [4] looked at 191 patients undergoing cardiac surgery and were given low dose Sotalol or Metoprolol. AF was seen in 9/93 (10%) of the Sotalol group and in 22/98 (22%) of the Metoprolol group. Dug withdrawal was necessary in 3/93 (3.2%) of the Sotalol group and in 7/98 (7.1%) of the Metoprolol group.
Crystal et al. [10] showed a lower incidence of AF in the Sotalol group v B Blocker group when both agents were directly compared (12% vs 22%, OR, 0.50;95% CI 0.34 to 0.74), giving a number needed to treat of 10 to prevent- an additional case of AF using Sotalol versus standard -Blockers.
With regard to which regime is optimal. Several of these studies seem to use either 40 mg tds or 80 mg bd starting pre-operatively, and doses higher than this caused an excess of side effects. Thus either of these regimes may be considered optimal.
7. Clinical bottom line
Prophylactic Sotalol may be more effective than blockers in the prevention of post operative atrial fibrillation in elective patients. Sotalol should not cause an excess of side effects.
References
Dunning J, Prendergast B, Mackway-Jones K. Towards evidence-based medicine in cardiothoracic surgery: best BETS. Interactive CardioVasc Thorac Surg 2003;2:405–409.
Auer J, Webber T, Berent R, Puschmann R, Hartl P, Ng CK, Schwarz C, Lehner E, Strasser U, Lamm G, Eber B. A comparison between oral antiarryhmic drugs in the prevention of post operative atrial fibrillation (SPPAF), a randomised placebo controlled trial. Am Heart J 2004;147:636–643.
Sanjuan R, Blasco M, Carbonell N, Jorda A, Nunez J, Martinez-Leon J, Otero E. Postoperative Sotalol versus atenolol for atrial fibrillation after cardiac surgery. Ann Thorac Surg 2004;77:838–843.
Adulrahman O, Dale HT, Levin V, Hallner M, Theman T, Hassapyannes C. The comparative of low dose sotalol vs metoprolol in the prevention of post operative supraventricular arrythmais. Eur Heart J 1999;20:372.
Parikka H, Toivonen L, Heikkila L, Virtnaen K, Jarvinen A. A comparison of sotalol and metoprolol in the prevention of atrial fibrillation after coronary artery bypass surgery. J Cardiovasc Pharmacol 1988;31:67–73.
Nystrom U, Edvardsson N, Breggren H, Pizzarelli GP, Radegran K. Oral sotalol reduces the incidence of atrial fibrillation after coronary artery bypass surgery. Thorac Cardiovasc Surg 1993;41:34–37.
Suttorp MJ, Kingma JH, Tjon Joe Gin RM, van Hemel Nm, Koomen EM, Defauw JA, Adan AJ, Ernst SM. Efficacy and safety of low and high dose sotalol versus propranalol in the prevention of superventricular tachyarrythmias early after coronary artery bypass operations. J Thorac Cardiovasc Surg 1990;100:921–926.
Janssen J, Loomans L, Harink J, Taams M, Brunninkhuis L, van der Starre P, Kootstra G. Prevention and treatment of supraventricular tachycardia shortly after coronary artery bypass grafting: a randomised open trial. Angiology 1986;37:601–609.
Crystal E, Connolley SJ, Sleik K, Ginger TJ, Yusuf S. Interventions on prevention of post operative atrial fibrillation in patients undergoing heart surgery. A meta-analysis. Circulation 2002;106:75–80.(Anish Patel and Joel Dunn)
Abstract
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether prophylactic Sotalol was more effective than conventional blockers in the prevention of atrial fibrillation after cardiac surgery. Fifty-one papers were found of which eight presented the best evidence to answer the question. The author, journal, date and country of publication, patient group, relevant outcomes and weaknesses were tabulated. We conclude that prophylactic Sotalol may be more effective than blockers in the prevention of post operative atrial fibrillation, and should not cause an excess of side effects.
Key Words: Review; Evidence based medicine; Thoracic surgery; Atrial fibrillation; Sotalol
1. Introduction
A best evidence topic was constructed according to the structured protocol. This protocol is fully described in the ICVTS [1].
2. Clinical scenario
You are updating a protocol for the prophylaxis of atrial fibrillation after cardiac surgery for your department. For many years the protocol has been to continue the patient's own beta-blockers during the perioperative period, restarting them the day after surgery. A new surgeon in your group suggests that Sotalol, with type III antiarrhythmic properties in addition to Beta-Blockers is superior to this protocol, but other colleagues state that changing the patient's usual medications the day before surgery in this way will lead to a host of complications including bradycardia and hypotension. You resolve to search the literature to see whether it really is worth changing your departmental policy.
3. Three-part question
In [patients undergoing cardiac surgery] is prophylactic [Sotalol compared to conventional Blockers] more effective in reducing the incidence of [atrial fibrillation].
4. Search strategy
Medline 1966 to Oct 2004 using the OVID interface.
[exp Cardiovascular surgical procedures/OR cardiovascular surgical procedures.mp OR exp Thoracic surgery/OR Thoracic surgery.mp OR exp Coronary Artery Bypass/OR Coronary art$ bypass.mp OR cardiopulmonary bypass.mp OR CABG.mp OR coronary artery surgery.mp OR cardiac surgery.mp OR revascularization.mp OR heart surgery.mp] AND [exp atrial fibrillation/OR atrial fibrillation.mp OR AF.mp OR exp atrial flutter OR atrial flutter.mp OR supraventricular tachycardia.mp OR exp Tachycardia, Supraventricular/ OR SVT.mp] AND [exp sotalol/ OR sotalol.mp]
5. Search outcome
A total of 55 articles were identified of which 7 represented the evidence to answer the clinical question. Of note several papers were also found that compared Sotalol to placebo but these were deemed to be irrelevant to our question. A meta-analysis was also found that briefly addressed this topic. These are summarised in Table 1.
6. Comments
All of the seven papers show the reduction in the incidence of post operative atrial fibrillation was greater in those patients treated with prophylactic Sotalol than conventional blockade. Five of the seven papers were statistically significant. The remaining 2 papers showed a non-significant trend to a lower incidence of AF with patients treated with Sotalol.
Auer et al. [2] looked at 253 patients randomised into 4 groups. The group treated with sotalol alone showed a statistically significant reduction in the incidence of AF compared with placebo, the group treated with blocker only showed a non-significant trend to a lower incidence of post op AF. They also showed that patients in both the sotalol and -blocker groups had a higher incidence of bradycardia necessitating a dose reduction or withdrawal of the drug but with no difference between them. Patients on active treatments showed a trend towards a shorter hospital stay but no difference was noted between the active groups.
Janssen et al. [8] looked at 130 patients undergoing coronary artery surgery. 2.4% of patients treated with sotalol developed post operative AF compared to 15.3% of those treated with metoprolol. The difference was statistically significant. There were no major reported side effects in either group.
Parika et al. [5] looked at a total of 191 patients undergoing coronary artery surgery. He showed a significant reduction in the incidence of AF in the group treated with Sotalol (16% vs 32%). He showed doses needed to be increased in 18% of the -blocker and 10% of the Sotalol group, the final doses being 54±14 mg Metoprolol group and 40±0 mg in the sotalol group. Medications were stopped in 1 patient per group.
Surtorp et al. [7] compared high and low dose treatment regimes in both Sotalol and Propranalol groups. Four hundred and twenty-nine patients were studied. The incidence of AF was 13.9% and 18.8% in the low dose Sotalol and Propranalol groups, respectively, and 10.9% and 13.7% in the high dose Sotalol and Propranalol groups. Although these results show a trend to a lower incidence of AF in both the Sotalol treatment groups they are statistically non-significant. Adverse effects resulting in stopping drug were seen in 2 patients in both low dose treatment regimes (2/74 Sotalol and 2/66 Propranalol) and in 14/133 (high dose Sotalol) and 17/156 (high dose Propranalol) patients. Therefore doubling the dose causes no substantial increase in the preventative effects but produces an increase in the unwanted side effects.
Sanjuan et al. [3] looked at 253 patients undergoing Cardiac surgery. AF was seen in 44 patients. The incidence was 10/100 (10%) in the Sotalol group and in 34/153 (22%) in the Atenolol group P=0.013. They also showed that AF resulted in statistically significant longer stays in the CCU and longer hospital stays overall. Adverse effects resulting in withdrawal of treatment was seen in 12 of the Atenolol group and in 16 of the Sotalol group and in 2 of the Sotalol group the drug was reduced.
Nystrom et al. [6] looked at 101 patients randomised to Sotalol or control (half dose pre op B blockade or no treatment if not on pre op. blockade). AF was seen in 5/50 (10%) of the Sotalol group and in 11/40 (27.5%) of patients on half their pre op blocker dose and in 4/11 (36%) patients on no treatment. Eleven patients in the Sotalol group needed dose withdrawal and of these, 5 required withdrawal of the drug, all adverse symptoms resolved following this.
Abdulrahman et al. [4] looked at 191 patients undergoing cardiac surgery and were given low dose Sotalol or Metoprolol. AF was seen in 9/93 (10%) of the Sotalol group and in 22/98 (22%) of the Metoprolol group. Dug withdrawal was necessary in 3/93 (3.2%) of the Sotalol group and in 7/98 (7.1%) of the Metoprolol group.
Crystal et al. [10] showed a lower incidence of AF in the Sotalol group v B Blocker group when both agents were directly compared (12% vs 22%, OR, 0.50;95% CI 0.34 to 0.74), giving a number needed to treat of 10 to prevent- an additional case of AF using Sotalol versus standard -Blockers.
With regard to which regime is optimal. Several of these studies seem to use either 40 mg tds or 80 mg bd starting pre-operatively, and doses higher than this caused an excess of side effects. Thus either of these regimes may be considered optimal.
7. Clinical bottom line
Prophylactic Sotalol may be more effective than blockers in the prevention of post operative atrial fibrillation in elective patients. Sotalol should not cause an excess of side effects.
References
Dunning J, Prendergast B, Mackway-Jones K. Towards evidence-based medicine in cardiothoracic surgery: best BETS. Interactive CardioVasc Thorac Surg 2003;2:405–409.
Auer J, Webber T, Berent R, Puschmann R, Hartl P, Ng CK, Schwarz C, Lehner E, Strasser U, Lamm G, Eber B. A comparison between oral antiarryhmic drugs in the prevention of post operative atrial fibrillation (SPPAF), a randomised placebo controlled trial. Am Heart J 2004;147:636–643.
Sanjuan R, Blasco M, Carbonell N, Jorda A, Nunez J, Martinez-Leon J, Otero E. Postoperative Sotalol versus atenolol for atrial fibrillation after cardiac surgery. Ann Thorac Surg 2004;77:838–843.
Adulrahman O, Dale HT, Levin V, Hallner M, Theman T, Hassapyannes C. The comparative of low dose sotalol vs metoprolol in the prevention of post operative supraventricular arrythmais. Eur Heart J 1999;20:372.
Parikka H, Toivonen L, Heikkila L, Virtnaen K, Jarvinen A. A comparison of sotalol and metoprolol in the prevention of atrial fibrillation after coronary artery bypass surgery. J Cardiovasc Pharmacol 1988;31:67–73.
Nystrom U, Edvardsson N, Breggren H, Pizzarelli GP, Radegran K. Oral sotalol reduces the incidence of atrial fibrillation after coronary artery bypass surgery. Thorac Cardiovasc Surg 1993;41:34–37.
Suttorp MJ, Kingma JH, Tjon Joe Gin RM, van Hemel Nm, Koomen EM, Defauw JA, Adan AJ, Ernst SM. Efficacy and safety of low and high dose sotalol versus propranalol in the prevention of superventricular tachyarrythmias early after coronary artery bypass operations. J Thorac Cardiovasc Surg 1990;100:921–926.
Janssen J, Loomans L, Harink J, Taams M, Brunninkhuis L, van der Starre P, Kootstra G. Prevention and treatment of supraventricular tachycardia shortly after coronary artery bypass grafting: a randomised open trial. Angiology 1986;37:601–609.
Crystal E, Connolley SJ, Sleik K, Ginger TJ, Yusuf S. Interventions on prevention of post operative atrial fibrillation in patients undergoing heart surgery. A meta-analysis. Circulation 2002;106:75–80.(Anish Patel and Joel Dunn)