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Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.

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Citation: Lancet. 387(10034):2218-25, 2016 May 28.PMID: 27053442Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Observational Study | Randomized Controlled Trial | Research Support, N.I.H., Extramural | Research Support, Non-U.S. Gov'tSubject headings: *Aortic Valve Insufficiency/su [Surgery] | *Heart Valve Prosthesis Implantation/mt [Methods] | Aged, 80 and over | Aortic Valve Insufficiency/mo [Mortality] | Aortic Valve Stenosis/mo [Mortality] | Aortic Valve Stenosis/su [Surgery] | Aortic Valve/su [Surgery] | Female | Heart Valve Prosthesis | Heart Valve Prosthesis Implantation/mo [Mortality] | Humans | Length of Stay | Male | Propensity Score | Risk Factors | Transcatheter Aortic Valve Replacement/mo [Mortality] | Transcatheter Aortic Valve Replacement/mt [Methods]Year: 2016 Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007ISSN:

0140-6736

Name of journal: Lancet (London, England)Abstract: BACKGROUND: Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.FINDINGS: At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7.4%; 6.5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of -9.2%; 90% CI -12.4 to -6; p<0.0001) and superior (-9.2%, 95% CI -13.0 to -5.4; p<0.0001) to surgical valve replacement.FUNDING: None.Copyright © 2016 Elsevier Ltd. All rights reserved.INTERPRETATION: TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients.METHODS: In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7.5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes.All authors: Ailawadi G, Alu MC, Babaliaros V, Cohen DJ, D'Agostino RB Jr, Devireddy C, Greason KL, Hahn RT, Herrmann HC, Jaber WA, Kapadia S, Kereiakes D, Kodali S, Leipsic J, Leon MB, Lim S, Mack MJ, Makkar RR, Malaisrie SC, Miller DC, Moses JW, Parvataneni R, Pibarot P, Smalling R, Smith CR, Suri R, Svensson LG, Szeto WY, Thourani VH, Tuzcu EM, Webb JG, Weissman NJ, Whisenant BK, Williams MFiscal year: FY2016Digital Object Identifier:

http://dx.doi.org/10.1016/S0140-6736(16)30073-3

Date added to catalog: 2016-07-15

Holdings ( 1 )
Title notes ( 7 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	27053442	Available		27053442

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007

BACKGROUND: Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.

FINDINGS: At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7.4%; 6.5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of -9.2%; 90% CI -12.4 to -6; p<0.0001) and superior (-9.2%, 95% CI -13.0 to -5.4; p<0.0001) to surgical valve replacement.

INTERPRETATION: TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients.

METHODS: In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7.5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes.

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