Journal article
Impact of pre-existing or new-onset atrial fibrillation on 30-day clinical outcomes following transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial.
- Hengstenberg C Division of Cardiology, DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.
- Chandrasekhar J Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Sartori S Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Lefevre T Division of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France.
- Mikhail G Division of Cardiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom.
- Meneveau N Division of Cardiology, CHU Jean Minjoz, Besançon, France.
- Tron C Division of Cardiology, CHU de Rouen, Rouen, France.
- Jeger R Department of Cardiology, University Hospital Basel, Switzerland.
- Kupatt C Division of Cardiology, LMU Munich, Germany.
- Vogel B Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Farhan S Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Sorrentino S Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Sharma M Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Snyder C Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Husser O Division of Cardiology, Deutsches Herzzentrum München, Germany.
- Boekstegers P Division of Cardiology, Helios Heart Center, Siegburg, Germany.
- Hambrecht R Department of Cardiology and Angiology, Klinikum Links der Weser, Bremen, Germany.
- Widder J Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.
- Hildick-Smith D Division of Cardiology, Sussex Cardiac Centre-Brighton & Sussex University Hospitals NHS Trust, Brighton, East Sussex, United Kingdom.
- De Carlo M Division of Cardiology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
- Wijngaard P Division of Cardiology, The Medicines Company, Zurich, Switzerland.
- Deliargyris E Division of Cardiology, The Medicines Company, Parsippany, New Jersey.
- Bernstein D Division of Cardiology, The Medicines Company, Parsippany, New Jersey.
- Baber U Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Mehran R Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- Anthopoulos P Division of Cardiology, The Medicines Company, Zurich, Switzerland.
- Dangas G Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York.
- 2017-05-12
Published in:
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. - 2017
30-day outcomes
bivalirudin or unfractionated heparin
pre-existing or new-onset atrial fibrillation
transcatheter aortic valve replacement
Aged, 80 and over
Aortic Valve Stenosis
Atrial Fibrillation
Cause of Death
Comorbidity
Europe
Female
Follow-Up Studies
Humans
Male
Postoperative Complications
Retrospective Studies
Risk Factors
Survival Rate
Time Factors
Transcatheter Aortic Valve Replacement
United States
English
BACKGROUND
Prior studies have suggested that patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) are at higher risk for adverse cardiovascular events. Whether procedural bivalirudin compared with unfractionated heparin (UFH) has a beneficial effect on early outcomes in these patients is unknown. We examined for the effect of baseline or new-onset AF within 30 days of TAVR and explored for the effect of bivalirudin versus UFH by AF status, on 30-day outcomes from the BRAVO 3 trial.
METHODS
The BRAVO-3 trial multicenter randomized trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin or UFH. We compared AF and no-AF groups and examined for 30-day Bleeding Academic Research Consortium type ≥3b bleeding, major vascular complications and all ischemic endpoints. Adjusted outcomes were analyzed using logistic regression methods.
RESULTS
Of the study population, 41.4% (n = 332) patients had baseline or new-onset AF within 30 days of TAVR, whereas 58.6% (n = 470) had no AF. Patients with AF had greater prevalence of renal dysfunction, lower left ventricular ejection fraction, and higher euroSCORE I compared with their counterparts without AF. Among AF and no-AF patients, there were no significant baseline differences between bivalirudin and UFH groups. At 30 days the incidence of death (6.0 vs. 4.5%, P = 0.324) and stroke (3.9 vs. 2.6%, P = 0.274) was similar in AF vs. no-AF patients. However, new-onset AF (n = 38) was associated with significantly greater crude risk of 30-day stroke compared with no AF (HR 4.49, 95% CI 1.37-14.67). Regardless of AF status, there were no differences in 30-day death (P-int = 0.652) or stroke (P-int = 0.066) by anticoagulation type.
CONCLUSIONS
Prior or new-onset AF is noted in more than one-third of patients undergoing transfemoral TAVR. Despite greater baseline comorbidities than non-AF patients, AF was not associated with significantly higher risk of adjusted 30-day outcomes. In the BRAVO 3 trial, early outcomes were similar regardless of anticoagulant strategy in each group.
Prior studies have suggested that patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) are at higher risk for adverse cardiovascular events. Whether procedural bivalirudin compared with unfractionated heparin (UFH) has a beneficial effect on early outcomes in these patients is unknown. We examined for the effect of baseline or new-onset AF within 30 days of TAVR and explored for the effect of bivalirudin versus UFH by AF status, on 30-day outcomes from the BRAVO 3 trial.
METHODS
The BRAVO-3 trial multicenter randomized trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin or UFH. We compared AF and no-AF groups and examined for 30-day Bleeding Academic Research Consortium type ≥3b bleeding, major vascular complications and all ischemic endpoints. Adjusted outcomes were analyzed using logistic regression methods.
RESULTS
Of the study population, 41.4% (n = 332) patients had baseline or new-onset AF within 30 days of TAVR, whereas 58.6% (n = 470) had no AF. Patients with AF had greater prevalence of renal dysfunction, lower left ventricular ejection fraction, and higher euroSCORE I compared with their counterparts without AF. Among AF and no-AF patients, there were no significant baseline differences between bivalirudin and UFH groups. At 30 days the incidence of death (6.0 vs. 4.5%, P = 0.324) and stroke (3.9 vs. 2.6%, P = 0.274) was similar in AF vs. no-AF patients. However, new-onset AF (n = 38) was associated with significantly greater crude risk of 30-day stroke compared with no AF (HR 4.49, 95% CI 1.37-14.67). Regardless of AF status, there were no differences in 30-day death (P-int = 0.652) or stroke (P-int = 0.066) by anticoagulation type.
CONCLUSIONS
Prior or new-onset AF is noted in more than one-third of patients undergoing transfemoral TAVR. Despite greater baseline comorbidities than non-AF patients, AF was not associated with significantly higher risk of adjusted 30-day outcomes. In the BRAVO 3 trial, early outcomes were similar regardless of anticoagulant strategy in each group.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1002/ccd.27155
- PMID 28493641
- Persistent URL
- https://folia.unifr.ch/global/documents/114484
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