Ioanna Kosmidou1, Shmuel Chen2, A Pieter Kappetein3, Patrick W Serruys4, Bernard J Gersh5, John D Puskas6, David E Kandzari7, David P Taggart8, Marie-Claude Morice9, Paweł E Buszman10, Andrzej Bochenek10, Erick Schampaert11, Pierre Pagé11, Joseph F Sabik12, Thomas McAndrew2, Björn Redfors2, Ori Ben-Yehuda13, Gregg W Stone14. 1. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Arrhythmia Center, Department of Cardiology, St. Francis Hospital, Roslyn, New York. 2. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 3. Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 4. Imperial College of Science, Technology and Medicine, London, United Kingdom. 5. Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota. 6. Icahn School of Medicine at Mount Sinai, New York, New York. 7. Piedmont Heart Institute, Atlanta, Georgia. 8. Department Cardiac Surgery, John Radcliffe Hospital, Oxford, United Kingdom. 9. Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Paris, France. 10. Medical University of Silesia, Katowice, Poland; American Heart of Poland, Ustron, Poland. 11. Hôpital du Sacré-Coeur de Montréal, Montréal, Canada. 12. Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio. 13. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. 14. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: gs2184@columbia.edu.
Abstract
BACKGROUND: There is limited information on the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD). OBJECTIVES: This study sought to determine the incidence of NOAF following PCI and CABG for LMCAD and its effect on 3-year cardiovascular outcomes. METHODS: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. Outcomes were analyzed according to the development of NOAF during the initial hospitalization following revascularization. RESULTS: Among 1,812 patients without atrial fibrillation on presentation, NOAF developed at a mean of 2.7 ± 2.5 days after revascularization in 162 patients (8.9%), including 161 of 893 (18.0%) CABG-treated patients and 1 of 919 (0.1%) PCI-treated patients (p < 0.0001). Older age, greater body mass index, and reduced left ventricular ejection fraction were independent predictors of NOAF in patients undergoing CABG. Patients with versus without NOAF had a significantly longer duration of hospitalization, were more likely to be discharged on anticoagulant therapy, and had an increased 30-day rate of Thrombolysis In Myocardial Infarction major or minor bleeding (14.2% vs. 5.5%; p < 0.0001). By multivariable analysis, NOAF after CABG was an independent predictor of 3-year stroke (6.6% vs. 2.4%; adjusted hazard ratio [HR]: 4.19; 95% confidence interval [CI]: 1.74 to 10.11; p = 0.001), death (11.4% vs. 4.3%; adjusted HR: 3.02; 95% CI: 1.60 to 5.70; p = 0.0006), and the primary composite endpoint of death, MI, or stroke (22.6% vs. 12.8%; adjusted HR: 2.13; 95% CI: 1.39 to 3.25; p = 0.0004). CONCLUSIONS: In patients with LMCAD undergoing revascularization in the EXCEL trial, NOAF was common after CABG but extremely rare after PCI. The development of NOAF was strongly associated with subsequent death and stroke in CABG-treated patients. Further studies are warranted to determine whether prophylactic strategies to prevent or treat atrial fibrillation may improve prognosis in patients with LMCAD who are undergoing CABG. (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).
RCT Entities:
BACKGROUND: There is limited information on the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD). OBJECTIVES: This study sought to determine the incidence of NOAF following PCI and CABG for LMCAD and its effect on 3-year cardiovascular outcomes. METHODS: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. Outcomes were analyzed according to the development of NOAF during the initial hospitalization following revascularization. RESULTS: Among 1,812 patients without atrial fibrillation on presentation, NOAF developed at a mean of 2.7 ± 2.5 days after revascularization in 162 patients (8.9%), including 161 of 893 (18.0%) CABG-treated patients and 1 of 919 (0.1%) PCI-treated patients (p < 0.0001). Older age, greater body mass index, and reduced left ventricular ejection fraction were independent predictors of NOAF in patients undergoing CABG. Patients with versus without NOAF had a significantly longer duration of hospitalization, were more likely to be discharged on anticoagulant therapy, and had an increased 30-day rate of Thrombolysis In Myocardial Infarction major or minor bleeding (14.2% vs. 5.5%; p < 0.0001). By multivariable analysis, NOAF after CABG was an independent predictor of 3-year stroke (6.6% vs. 2.4%; adjusted hazard ratio [HR]: 4.19; 95% confidence interval [CI]: 1.74 to 10.11; p = 0.001), death (11.4% vs. 4.3%; adjusted HR: 3.02; 95% CI: 1.60 to 5.70; p = 0.0006), and the primary composite endpoint of death, MI, or stroke (22.6% vs. 12.8%; adjusted HR: 2.13; 95% CI: 1.39 to 3.25; p = 0.0004). CONCLUSIONS: In patients with LMCAD undergoing revascularization in the EXCEL trial, NOAF was common after CABG but extremely rare after PCI. The development of NOAF was strongly associated with subsequent death and stroke in CABG-treated patients. Further studies are warranted to determine whether prophylactic strategies to prevent or treat atrial fibrillation may improve prognosis in patients with LMCAD who are undergoing CABG. (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).
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