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Five-year outcomes in cardiac surgery patients with atrial fibrillation undergoing concomitant surgical ablation versus no ablation. The long-term follow-up of the PRAGUE-12 Study

P. Osmancik, P. Budera, D. Talavera, J. Hlavicka, D. Herman, J. Holy, P. Cervinka, J. Smid, P. Hanak, R. Hatala, P. Widimsky,

. 2019 ; 16 (9) : 1334-1340. [pub] 20190510

Language English Country United States

Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc20028830

BACKGROUND: The long-term effect of concomitant surgical ablation (SA) on clinical outcomes in an unselected population of patients has not been sufficiently reported in randomized studies. OBJECTIVE: The aim of this study was to assess clinical outcomes of the SA after 5 years of follow-up. METHODS: The PRAGUE-12 study was a prospective, randomized clinical trial assessing cardiac surgery with ablation for AF vs cardiac surgery alone. Patients with AF who were also indicated for cardiac surgery (coronary artery disease [CAD], valve surgery) were randomized to SA or control (no ablation) group. All patients were followed for 5 years. The primary endpoint was a composite of cardiovascular death, stroke, hospitalization for heart failure, or severe bleeding. Secondary endpoint was a recurrence of AF. RESULTS: A total of 207 patients were analyzed (SA group = 108 patients, control group = 99 patients). Both groups were similar relative to important clinical characteristics except for CAD, which was more common in the control group. Cumulative incidence curves showed a higher incidence of the primary endpoint in the control group (P = .024, Gray's test). However, after adjusting for all covariables, the difference between groups was not significant (subhazard ratio [SHR] 0.69 [0.47-1.02], P = .068). The incidence of stroke and AF recurrences were significantly reduced in the SA group, and remained significant even after adjustment for all covariables, including CAD (stroke: SHR 0.32 [0.12-0.84], P = .02, AF recurrences: SHR 0.44 [0.31-0.62], P < .001). CONCLUSIONS: Concomitant SA of AF is associated with a greater likelihood of maintaining sinus rhythm and a decreased risk of stroke.

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$a BACKGROUND: The long-term effect of concomitant surgical ablation (SA) on clinical outcomes in an unselected population of patients has not been sufficiently reported in randomized studies. OBJECTIVE: The aim of this study was to assess clinical outcomes of the SA after 5 years of follow-up. METHODS: The PRAGUE-12 study was a prospective, randomized clinical trial assessing cardiac surgery with ablation for AF vs cardiac surgery alone. Patients with AF who were also indicated for cardiac surgery (coronary artery disease [CAD], valve surgery) were randomized to SA or control (no ablation) group. All patients were followed for 5 years. The primary endpoint was a composite of cardiovascular death, stroke, hospitalization for heart failure, or severe bleeding. Secondary endpoint was a recurrence of AF. RESULTS: A total of 207 patients were analyzed (SA group = 108 patients, control group = 99 patients). Both groups were similar relative to important clinical characteristics except for CAD, which was more common in the control group. Cumulative incidence curves showed a higher incidence of the primary endpoint in the control group (P = .024, Gray's test). However, after adjusting for all covariables, the difference between groups was not significant (subhazard ratio [SHR] 0.69 [0.47-1.02], P = .068). The incidence of stroke and AF recurrences were significantly reduced in the SA group, and remained significant even after adjustment for all covariables, including CAD (stroke: SHR 0.32 [0.12-0.84], P = .02, AF recurrences: SHR 0.44 [0.31-0.62], P < .001). CONCLUSIONS: Concomitant SA of AF is associated with a greater likelihood of maintaining sinus rhythm and a decreased risk of stroke.
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$a Budera, Petr $u Cardiocenter, Dept. of Cardiac Surgery, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic. $7 xx0270813
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$a Talavera, David $u Cardiocenter, Dept. of Cardiac Surgery, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
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$a Hlavicka, Jan $u Cardiocenter, Dept. of Cardiac Surgery, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
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$a Holy, Jiri $u Department of Cardiology, Masaryk Hospital in Usti nad Labem, Krajska Zdravotni and UJEP in Usti na Labem, Usti nad Labem, Czech Republic.
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$a Cervinka, Pavel $u Department of Cardiology, Masaryk Hospital in Usti nad Labem, Krajska Zdravotni and UJEP in Usti na Labem, Usti nad Labem, Czech Republic.
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$a Smid, Jiri $u Cardiology Department, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.
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