The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

Trials

Daniel Andreas Steinbrüchel²  Christian Gluud³  Per Winkel³  Henrik Nissen¹  Peter Skov Olsen²  Peter Bo Hansen⁴  Lars Willy Andersen⁴  Olaf Franzen⁵  Nikolaj Ihlemann⁵  Lars Søndergaard⁵  Hans Gustav Thyregod² 

[1] Department of Cardiology, Odense University Hospital, Sdr. Boulevard 29, DK 5000, Odense, Denmark;Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100, Copenhagen, Denmark;Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Tagensvej 22, DK 2100, Copenhagen, Denmark;Department of Cardiac Anesthesia, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100, Copenhagen, Denmark;Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100, Copenhagen, Denmark

关键词: Randomised clinical trial design;    Surgical aortic valve replacement;    Transcatheter aortic valve implantation;    Aortic valve prosthesis;    Aortic valve stenosis;   

Others  :  1094970
DOI  :  10.1186/1745-6215-14-11

 received in 2012-05-14, accepted in 2012-12-18,  发布年份 2013

【 摘 要 】

Background

Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting.

Methods/Design

This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012.

Discussion

The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis.

Trial registration

ClinicalTrials.gov: NCT01057173

【 授权许可】

   
2013 Thyregod et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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