PRimary Angioplasty in patients transferred from General community hospitals to specialized PTCA Units with or without Emergency thrombolysis-12 - PRAGUE-12

Aug 28, 2012
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Partially funded by Charles University Research Projects, Prague, Czech Republic
Date Presented:
01/01/2012
Date Published:
01/01/2012
Date Updated:
08/28/2012
Original Posted Date:
08/28/2012
References

Description:

The goal of the trial was to evaluate cardiac surgery with atrial fibrillation (AF) ablation via the MAZE procedure compared with cardiac surgery without the MAZE procedure among patients with AF undergoing open heart surgery.

Hypothesis:

Cardiac surgery with the MAZE procedure will restore/maintain sinus rhythm after surgery.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients at least 18 years of age with at least two episodes of AF in the last 6 months undergoing open heart surgery for coronary bypass or valve repair/replacement

    Number of enrollees: 224
    Duration of follow-up: 1 year
    Mean patient age: 70 years
    Percentage female: 43%

Exclusions:

  • Emergency surgery

Primary Endpoints:

  • Sinus rhythm at 1 year detected by Holter monitor

Secondary Endpoints:

  • Death, MI, stroke, or renal failure requiring dialysis at 30 days
  • Death, major bleeding, stroke, or hospitalization for heart failure at 1 year

Drug/Procedures Used:

Patients with AF undergoing open heart surgery (coronary and/or valvular) were randomized to cardiac surgery with AF ablation via the MAZE procedure (n = 117) versus cardiac surgery without the MAZE procedure (n = 107). Cryomaze was used in 97% of MAZE patients, and in the remaining patients, radiofrequency ablation was used.

Concomitant Medications:

All patients received antiarrhythmic drug therapy, started on the day of surgery. Amiodarone was preferentially used, with sotalol or propafenone as a second-line agent. Antiarrhythmic drugs were discontinued at 3 months if patients were in sinus rhythm.

All patients received warfarin adjusted to international normalized ratio (INR) 2-2.5. Warfarin was discontinued at 6 months if patients remained in sinus rhythm.

Principal Findings:

Overall, 224 patients were randomized. The mean age was 70 years, 43% were women, 81% had hypertension, 35% had diabetes, mean body mass index was 29 kg/m2, mean duration of AF was 15 months, AF was paroxysmal in 22%, persistent in 26%, and permanent in 52% (defined as long-standing persistent), and 78% of patients were in AF preoperatively.

Surgical time was 220 minutes among MAZE patients and 200 minutes among the no MAZE patients (p = 0.003). At the end of surgery, sinus rhythm was present in 59% versus 75% (p < 0.001), respectively.

- Beta-blockers at 1 year: 72% vs. 78%
- Antiarrhythmic drug therapy at 1 year: 31% vs. 22%
- Warfarin at 1 year: 59% vs. 59%

The primary outcome, sinus rhythm at 1 year, occurred in 60.2% of the MAZE group versus 35.5% of the no MAZE group (p = 0.002). Among paroxysmal AF patients, sinus rhythm at 1 year: 62% vs. 58% (p = 1.0). Among persistent AF patients, sinus rhythm at 1 year: 72% vs. 50% (p = 0.19). Among permanent AF patients, sinus rhythm at 1 year: 53% vs. 14% (p < 0.001).

Perioperative complications (death, myocardial infarction [MI], stroke, or renal failure) at 30 days: 10.3% vs. 14.7% (p = 0.41), respectively.

Death, major bleeding, stroke, or hospitalization for heart failure at 1 year: 40.5% vs. 40.2% (p = 0.79), respectively.

- Mortality: 16.2% vs. 17.4%
- Stroke: 2.7% vs. 4.3%
- Hospitalization for heart failure: 23.4% vs. 26.1%
- Major bleeding: 9.9% vs. 9.8%

Left ventricular ejection fraction and left atrial size were similar between groups at 1 year.

Interpretation:

Among patients with AF, surgical ablation improved the occurrence of sinus rhythm 1 year after open heart surgery as detected by a one-time Holter monitor. This was accomplished without an increase in perioperative complications, and adverse events at 1 year were similar. The most significant benefit in maintaining sinus rhythm was observed among patients with permanent AF, which was somewhat unexpected. Long-term follow-up is needed, particularly since >40% of patients had discontinuation of anticoagulation therapy.

References:

Budera P, Straka Z, Osmancik P, et al. Comparison of cardiac surgery with left atrial surgical ablation vs. cardiac surgery without atrial ablation in patients with coronary and/or valvular heart disease plus atrial fibrillation: final results of the PRAGUE-12 randomized multicentre study. Eur Heart J 2012;Aug 28:[Epub ahead of print].

Presented by Dr. Petr Widimsky at the European Society of Cardiology Congress, Munich, Germany, August 28, 2012.

Keywords: Stroke, Myocardial Infarction, Heart Atria, Follow-Up Studies, Warfarin, Renal Insufficiency, Body Mass Index, Heart Failure, Electrocardiography, Ambulatory, Coronary Artery Bypass, Catheter Ablation, Hypertension, Diabetes Mellitus


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