Document Detail


Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.
MedLine Citation:
PMID:  19683639     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In patients with non-valvular atrial fibrillation, embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. We assessed the efficacy and safety of percutaneous closure of the LAA for prevention of stroke compared with warfarin treatment in patients with atrial fibrillation. METHODS: Adult patients with non-valvular atrial fibrillation were eligible for inclusion in this multicentre, randomised non-inferiority trial if they had at least one of the following: previous stroke or transient ischaemic attack, congestive heart failure, diabetes, hypertension, or were 75 years or older. 707 eligible patients were randomly assigned in a 2:1 ratio by computer-generated randomisation sequence to percutaneous closure of the LAA and subsequent discontinuation of warfarin (intervention; n=463) or to warfarin treatment with a target international normalised ratio between 2.0 and 3.0 (control; n=244). Efficacy was assessed by a primary composite endpoint of stroke, cardiovascular death, and systemic embolism. We selected a one-sided probability criterion of non-inferiority for the intervention of at least 97.5%, by use of a two-fold non-inferiority margin. Serious adverse events that constituted the primary endpoint for safety included major bleeding, pericardial effusion, and device embolisation. Analysis was by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00129545. FINDINGS: At 1065 patient-years of follow-up, the primary efficacy event rate was 3.0 per 100 patient-years (95% credible interval [CrI] 1.9-4.5) in the intervention group and 4.9 per 100 patient-years (2.8-7.1) in the control group (rate ratio [RR] 0.62, 95% CrI 0.35-1.25). The probability of non-inferiority of the intervention was more than 99.9%. Primary safety events were more frequent in the intervention group than in the control group (7.4 per 100 patient-years, 95% CrI 5.5-9.7, vs 4.4 per 100 patient-years, 95% CrI 2.5-6.7; RR 1.69, 1.01-3.19). INTERPRETATION: The efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. Although there was a higher rate of adverse safety events in the intervention group than in the control group, events in the intervention group were mainly a result of periprocedural complications. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation. FUNDING: Atritech.
Authors:
David R Holmes; Vivek Y Reddy; Zoltan G Turi; Shephal K Doshi; Horst Sievert; Maurice Buchbinder; Christopher M Mullin; Peter Sick;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  374     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-17     Completed Date:  2009-08-27     Revised Date:  2009-11-23    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  534-42     Citation Subset:  AIM; IM    
Affiliation:
Mayo Clinic College of Medicine, Rochester, MN 55905, USA. holmes.david@mayo.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00129545
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Anticoagulants / adverse effects,  therapeutic use*
Atrial Appendage / physiopathology*
Atrial Fibrillation / complications,  epidemiology,  prevention & control*
Embolism / etiology
Europe / epidemiology
Female
Follow-Up Studies
Heart Catheterization
Hemorrhage / chemically induced
Humans
Kaplan-Meiers Estimate
Male
Middle Aged
Pericardial Effusion / etiology
Proportional Hazards Models
Prostheses and Implants* / adverse effects
Prosthesis Design
Risk Factors
Safety
Stroke / epidemiology,  etiology,  prevention & control*
Treatment Outcome
United States / epidemiology
Warfarin / adverse effects,  therapeutic use*
Chemical
Reg. No./Substance:
0/Anticoagulants; 81-81-2/Warfarin
Investigator
Investigator/Affiliation:
Petr Neuzil / ; H Sievert / ; Sven Mobius-Winkler / ; Peter Sick / ; Kelly Tucker / ; Shephal Doshi / ; Vijay Swarup / ; Marwan Bahu / ; Ramon Quesada / ; Kenneth Huber / ; Vivek Reddy / ; Maurice Buchbinder / ; Brian Whisenant / ; Steven Almany / ; David R Holmes / ; Robert M Siegel / ; Ashok Garg / ; Gregory Mishkel / ; Stephen Ramee / ; Saibal Kar / ; Brijeshwar Maini / ; Ray Matthews / ; Steven Burstein / ; Rodney Horton / ; Paul Mahoney / ; John Onufer / ; Kenneth Baran / ; Stuart Adler / ; Kimberly Skelding / ; John Gurley / ; Miland Shah / ; Steven J Yakubov / ; Angel Leon / ; Peter C Block / ; Peter Fail / ; Richard Abben / ; Mark Reisman / ; Gery Tomassoni / ; Vishwajeth Bhoopalam / ; William Anderson / ; Robert A Pickett / ; Douglas Wolfe / ; Reginald Low / ; Ted Feldman / ; Michael Sallinger / ; James Irwin / ; John Lopez / ; Bradley Knight / ; Scott Lim / ; Larry Chinitz / ; Mehdi Razavi / ; David Wilbur / ; Ferdinand Leya / ; Zoltan G Turi / ; Bryan Raybuck / ; Ron Waksman / ; Horst Sievert / ; Steven Kalbfleisch / ; Michael Mooney / ; William Gray / ; Geoffrey Kunz / ; Malcolm Foster / ; Eric Good / ; Murat Tuzcu / ; Fred St Goar / ; Richard Josephson / ; W Carl Jacobs / ; Rajesh Dave / ; John Young / ; David Lasorda /
Comments/Corrections
Comment In:
Lancet. 2009 Aug 15;374(9689):504-6   [PMID:  19683627 ]
Lancet. 2009 Nov 21;374(9703):1742-3; author reply 1743   [PMID:  19932351 ]
Ann Intern Med. 2009 Nov 17;151(10):JC5-10   [PMID:  19920255 ]
Erratum In:
Lancet. 2009 Nov 7;374(9701):1596

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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