Background: Current guidelines recommend beta-blockers as the first-line preventive treatment of atrial fibrillation (AF) after cardiac surgery. Despite this, 19% of physicians report using amiodarone as first-line prophylaxis of postoperative AF. Data directly comparing the efficacy of these agents in preventing postoperative AF are lacking. Objective: To determine whether intravenous metoprolol and amiodarone are equally effective in preventing postoperative AF after cardiac surgery. Design: Randomized, prospective, equivalence, open-label, multicenter study. (ClinicalTrials.gov registration number: NCT00784316) Setting: 3 cardiac care referral centers in Finland. Patients: 316 consecutive patients who were hemodynamically stable and free of mechanical ventilation and AF within 24 hours after cardiac surgery. Intervention: Patients were randomly assigned to receive 48-hour infusion of metoprolol, 1 to 3 mg/h, according to heart rate, or amiodarone, 15 mg/kg of body weight daily, with a maximum daily dose of 1000 mg, starting 15 to 21 hours after cardiac surgery. Measurements: The primary end point was the occurrence of the first AF episode or completion of the 48-hour infusion. Results: Atrial fibrillation occurred in 38 of 159 (23.9%) patients in the metoprolol group and 39 of 157 (24.8%) patients in the amiodarone group (P = 0.85). However, the difference (-0.9 percentage point [90% CI, -8.9 to 7.0 percentage points]) does not meet the prespecified equivalence margin of 5 percentage points. The adjusted hazard ratio of the metoprolol group compared with the amiodarone group was 1.09 (95% CI, 0.67 to 1.76). Limitations: Caregivers were not blinded to treatment allocation, and the trial evaluated only stable patients who were not at particularly elevated risk for AF. The withdrawal of preoperative beta-blocker therapy may have increased the risk for AF in the amiodarone group. Conclusion: The occurrence of AF was similar in the metoprolol and amiodarone groups. However, because of the wide range of the CIs, the authors cannot conclude that the 2 treatments were equally effective.
机构:
McMaster Univ, Dept Surg, Hamilton Gen Hosp, Div Cardiac Surg, Hamilton, ON L8L 2X2, CanadaMcMaster Univ, Dept Surg, Hamilton Gen Hosp, Div Cardiac Surg, Hamilton, ON L8L 2X2, Canada
Habbab, Louay M.
Chu, F. Victor
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McMaster Univ, Dept Surg, Hamilton Gen Hosp, Div Cardiac Surg, Hamilton, ON L8L 2X2, CanadaMcMaster Univ, Dept Surg, Hamilton Gen Hosp, Div Cardiac Surg, Hamilton, ON L8L 2X2, Canada
机构:
SSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
SSM Hlth St Marys Hosp, St. Louis, MO 63117 USA
SSM Hlth St Marys Hosp, Dept Internal Med, Second Floor,6420 Clayton Rd, Richmond Hts, MO 63117 USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Polintan, Edgar Theodore
Monsalve, Reejeen
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Our Lady Fatima Univ, Coll Med, Valenzuela City, PhilippinesSSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Monsalve, Reejeen
Menghrajani, Rajiv Hans
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Lincoln Med Ctr, Dept Internal Med, Bronx, NY USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Menghrajani, Rajiv Hans
Sirilan, Kym Yves
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Lincoln Med Ctr, Dept Internal Med, Bronx, NY USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Sirilan, Kym Yves
Nayak, Sandeep Samethadka
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Yale New Haven Bridgeport Hosp, Div Hosp Med, Dept Internal Med, Bridgeport, CT USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Nayak, Sandeep Samethadka
Abdelmaseeh, Peter
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Christiana Care Hosp, Dept Med, Newark, DE USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Abdelmaseeh, Peter
Patarroyo-Aponte, Gabriel
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Univ Texas Hlth Sci Ctr Houston, McGovern Med Sch, Dept Internal Med, Div Pulm Crit Care & Sleep Med, Houston, TX USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Patarroyo-Aponte, Gabriel
Lo, Kevin Bryan
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Thomas Jefferson Univ, Einstein Med Ctr, Dept Med, Sidney Kimmel Coll Med, Philadelphia, PA USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
Lo, Kevin Bryan
Dani, Sourbha S.
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Lahey Hosp & Med Ctr, Dept Cardiol, Burlington, MA USASSM Hlth St Marys Hosp, Dept Internal Med, St Louis, MO USA
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Charleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA
Carter, William H.
Trotter, Christopher C.
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Scott & White Mem Hosp & Clin, Texas A&M Sch Med, Temple, TX 76508 USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA
Trotter, Christopher C.
Kowalski, Tadeus E.
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Univ Cincinnati, Div Forens Psychiat, Cincinnati, OH USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA
Kowalski, Tadeus E.
Modak, Asmita
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Ctr Hlth Serv & Outcomes Res, Charleston, WV USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA
Modak, Asmita
Siddiqui, Yahya
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Ctr Hlth Serv & Outcomes Res, Charleston, WV USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA
Siddiqui, Yahya
Davis, Elaine
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Ctr Clin Sci Res, Charleston, WV USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA
Davis, Elaine
Sampath, Ranathan
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Charleston Area Med Ctr, Hlth Educ & Res Inst, Dept Surg, Charleston, WV USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA
Sampath, Ranathan
Khan, Jamal H.
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Ctr Hlth Serv & Outcomes Res, Charleston, WV USA
Charleston Area Med Ctr, Hlth Educ & Res Inst, Dept Surg, Charleston, WV USACharleston Area Med Ctr, Mem Div, Dept Internal Med, Charleston, WV USA