PMID- 28493641 OWN - NLM STAT- MEDLINE DCOM- 20180717 LR - 20180717 IS - 1522-726X (Electronic) IS - 1522-1946 (Linking) VI - 90 IP - 6 DP - 2017 Nov 15 TI - 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. PG - 1027-1037 LID - 10.1002/ccd.27155 [doi] AB - 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. CI - (c) 2017 Wiley Periodicals, Inc. FAU - Hengstenberg, Christian AU - Hengstenberg C AUID- ORCID: 0000-0002-8284-2994 AD - Division of Cardiology, DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. AD - Division of Cardiology, Deutsches Herzzentrum Munchen, Technische Universitat Munchen, Munich, Germany. FAU - Chandrasekhar, Jaya AU - Chandrasekhar J AUID- ORCID: 0000-0001-8776-326X AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Sartori, Samantha AU - Sartori S AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Lefevre, Thierry AU - Lefevre T AD - Division of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Generale de Sante, Massy, France. FAU - Mikhail, Ghada AU - Mikhail G AD - Division of Cardiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom. FAU - Meneveau, Nicolas AU - Meneveau N AD - Division of Cardiology, CHU Jean Minjoz, Besancon, France. FAU - Tron, Christophe AU - Tron C AD - Division of Cardiology, CHU de Rouen, Rouen, France. FAU - Jeger, Raban AU - Jeger R AD - Department of Cardiology, University Hospital Basel, Switzerland. FAU - Kupatt, Christian AU - Kupatt C AD - Division of Cardiology, LMU Munich, Germany. FAU - Vogel, Birgit AU - Vogel B AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Farhan, Serdar AU - Farhan S AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Sorrentino, Sabato AU - Sorrentino S AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Sharma, Madhav AU - Sharma M AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Snyder, Clayton AU - Snyder C AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Husser, Oliver AU - Husser O AD - Division of Cardiology, Deutsches Herzzentrum Munchen, Germany. FAU - Boekstegers, Peter AU - Boekstegers P AD - Division of Cardiology, Helios Heart Center, Siegburg, Germany. FAU - Hambrecht, Rainer AU - Hambrecht R AD - Department of Cardiology and Angiology, Klinikum Links der Weser, Bremen, Germany. FAU - Widder, Julian AU - Widder J AD - Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany. FAU - Hildick-Smith, David AU - Hildick-Smith D AD - Division of Cardiology, Sussex Cardiac Centre-Brighton & Sussex University Hospitals NHS Trust, Brighton, East Sussex, United Kingdom. FAU - De Carlo, Marco AU - De Carlo M AD - Division of Cardiology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. FAU - Wijngaard, Peter AU - Wijngaard P AD - Division of Cardiology, The Medicines Company, Zurich, Switzerland. FAU - Deliargyris, Efthymios AU - Deliargyris E AD - Division of Cardiology, The Medicines Company, Parsippany, New Jersey. FAU - Bernstein, Debra AU - Bernstein D AD - Division of Cardiology, The Medicines Company, Parsippany, New Jersey. FAU - Baber, Usman AU - Baber U AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Mehran, Roxana AU - Mehran R AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. FAU - Anthopoulos, Prodromos AU - Anthopoulos P AD - Division of Cardiology, The Medicines Company, Zurich, Switzerland. FAU - Dangas, George AU - Dangas G AUID- ORCID: 0000-0001-7502-8049 AD - Division of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York. CN - BRAVO-3 Investigators LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170620 PL - United States TA - Catheter Cardiovasc Interv JT - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JID - 100884139 SB - IM MH - Aged, 80 and over MH - Aortic Valve Stenosis/epidemiology/*surgery MH - Atrial Fibrillation/*epidemiology MH - Cause of Death/trends MH - Comorbidity/trends MH - Europe/epidemiology MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Postoperative Complications/*epidemiology MH - Retrospective Studies MH - Risk Factors MH - Survival Rate/trends MH - Time Factors MH - Transcatheter Aortic Valve Replacement/*adverse effects MH - United States/epidemiology OTO - NOTNLM OT - 30-day outcomes OT - bivalirudin or unfractionated heparin OT - pre-existing or new-onset atrial fibrillation OT - transcatheter aortic valve replacement EDAT- 2017/05/12 06:00 MHDA- 2018/07/18 06:00 CRDT- 2017/05/12 06:00 PHST- 2017/04/11 00:00 [received] PHST- 2017/04/30 00:00 [accepted] PHST- 2017/05/12 06:00 [pubmed] PHST- 2018/07/18 06:00 [medline] PHST- 2017/05/12 06:00 [entrez] AID - 10.1002/ccd.27155 [doi] PST - ppublish SO - Catheter Cardiovasc Interv. 2017 Nov 15;90(6):1027-1037. doi: 10.1002/ccd.27155. Epub 2017 Jun 20.