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OBJECTIVE	Transcatheter aortic valve replacement ( TAVR ) is an effective treatment option for high-risk patients with severe aortic stenosis .
OBJECTIVE	Different from surgery , transcatheter deployment of valves requires either a balloon-expandable or self-expandable system .
OBJECTIVE	A randomized comparison of these 2 systems has not been performed .
OBJECTIVE	To determine whether the balloon-expandable device is associated with a better success rate than the self-expandable device .
METHODS	The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure .
METHODS	One hundred twenty-one patients were randomly assigned to receive a balloon-expandable valve ( Edwards Sapien XT ) and 120 were assigned to receive a self-expandable valve ( Medtronic CoreValve ) .
METHODS	Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany .
METHODS	Transfemoral TAVR with a balloon-expandable or self-expandable device .
METHODS	The primary end point was device success , which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system , correct position of the device , intended performance of the heart valve without moderate or severe regurgitation , and only 1 valve implanted in the proper anatomical location .
METHODS	Secondary end points included cardiovascular mortality , bleeding and vascular complications , postprocedural pacemaker placement , and a combined safety end point at 30 days , including all-cause mortality , major stroke , and other serious complications .
RESULTS	Device success occurred in 116 of 121 patients ( 95.9 % ) in the balloon-expandable valve group and 93 of 120 patients ( 77.5 % ) in the self-expandable valve group ( relative risk [ RR ] , 1.24 , 95 % CI , 1.12-1 .37 , P < .001 ) .
RESULTS	This was attributed to a significantly lower frequency of residual more-than-mild aortic regurgitation ( 4.1 % vs 18.3 % ; RR , 0.23 ; 95 % CI , 0.09-0 .58 ; P < .001 ) and the less frequent need for implanting more than 1 valve ( 0.8 % vs 5.8 % , P = .03 ) in the balloon-expandable valve group .
RESULTS	Cardiovascular mortality at 30 days was 4.1 % in the balloon-expandable valve group and 4.3 % in the self-expandable valve group ( RR , 0.97 ; 95 % CI , 0.29-3 .25 ; P = .99 ) .
RESULTS	Bleeding and vascular complications were not significantly different , and the combined safety end point occurred in 18.2 % of those in the balloon-expandable valve group and 23.1 % of the self-expandable valve group ( RR , 0.79 ; 95 % CI , 0.48-1 .30 ; P = .42 ) .
RESULTS	Placement of a new permanent pacemaker was less frequent in the balloon-expandable valve group ( 17.3 % vs 37.6 % , P = .001 ) .
CONCLUSIONS	Among patients with high-risk aortic stenosis undergoing TAVR , the use of a balloon-expandable valve resulted in a greater rate of device success than use of a self-expandable valve .
BACKGROUND	clinicaltrials.gov Identifier : NCT01645202 .

