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

Vinod H. Thourani; Susheel Kodali; Raj R. Makkar; Howard C. Herrmann; Mathew Williams; Vasilis Babaliaros; Richard Smalling; Scott Lim; S. Chris Malaisrie; Samir Kapadia; Wilson Y. Szeto; Kevin L. Greason; Dean Kereiakes; Gorav Ailawadi; Brian K. Whisenant; Chandan Devireddy; Jonathon Leipsic; Rebecca T. Hahn; Philippe Pibarot; Neil J. Weissman; Wael A. Jaber; David J. Cohen; Rakesh Suri; E. Murat Tuzcu; Lars G. Svensson; John G. Webb; Jeffrey W. Moses; Michael J. MacK; D. Craig Miller; Craig R. Smith; Maria C. Alu; Rupa Parvataneni; Ralph B. D'Agostino; Martin B. Leon

doi:10.1016/S0140-6736(16)30073-3

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

Vinod H. Thourani^*, Susheel Kodali, Raj R. Makkar, Howard C. Herrmann, Mathew Williams, Vasilis Babaliaros, Richard Smalling, Scott Lim, S. Chris Malaisrie, Samir Kapadia, Wilson Y. Szeto, Kevin L. Greason, Dean Kereiakes, Gorav Ailawadi, Brian K. Whisenant, Chandan Devireddy, Jonathon Leipsic, Rebecca T. Hahn, Philippe Pibarot, Neil J. WeissmanWael A. Jaber, David J. Cohen, Rakesh Suri, E. Murat Tuzcu, Lars G. Svensson, John G. Webb, Jeffrey W. Moses, Michael J. MacK, D. Craig Miller, Craig R. Smith, Maria C. Alu, Rupa Parvataneni, Ralph B. D'Agostino, Martin B. Leon

^*Corresponding author for this work

Surgery, Cardiac Surgery Division

Research output: Contribution to journal › Article › peer-review

893 Scopus citations

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. 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. 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. Funding None.

Original language	English (US)
Pages (from-to)	2218-2225
Number of pages	8
Journal	The Lancet
Volume	387
Issue number	10034
DOIs	https://doi.org/10.1016/S0140-6736(16)30073-3
State	Published - May 28 2016

Funding

Edwards Lifesciences sponsored the PARTNER 2A and SAPIEN 3 trials and, alongside the executive committee, collaboratively designed both studies. Edwards Lifesciences funded both studies, participated in the selection and management of sites, and monitored the data. Edwards Lifesciences was not directly involved in the drafting of this manuscript. DCM is supported by National Heart, Lung, and Blood Institute research grant R01 HL67025 . VHT is a member of the PARTNER Trial Steering Committee and a consultant for Edwards Lifesciences, Sorin Medical, St Jude Medical, and DirectFlow. SK has received grants from Edwards Lifesciences and Medtronic, is a member of the PARTNER Trial Executive Committee, and holds equity in Thubrikar Aortic Valve. RRM has received grants from Edwards Lifesciences and St Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. HCH has received grants from Edwards Lifesciences, St Jude Medical, Medtronic, Boston Scientific, Abbott Vascular, Gore, Siemens, Cardiokinetix, and Mitraspan; is a consultant for Edwards Lifesciences and Siemens; and holds equity in Microinterventional Devices. MW has received consulting fees/honoraria from Edwards Lifesciences. WYS has received consulting fees/honoraria from Microinterventional Devices. RTH has received research grant support from Philips Healthcare and consulting fees/honoraria from Edwards Lifesciences. PP holds the Canada Research Chair in Valvular Heart Diseases, Canadian Institutes of Health research, Ottawa, Ontario, Canada, and has received research grant support from Edwards Lifesciences. NJW has received grants from Edwards Lifescience, Abbott Vascular, Medtronic, Sorin, Direct Flow Medical, Boston Scientific, and JenaValve, LGS holds equity in Cardiosolution and Valvexchange, and intellectual property with Postthorax. JGW is a consultant for Edwards Lifesciences and a member of the PARTNER Trial Executive Committee. DCM has received consulting fees/honoraria from Abbott Vascular, St Jude Medical, and Medtronic; and is a member of the PARTNER Executive Committee (no direct compensation). EMT, JWM, MJM, CRS, and MBL are members of the PARTNER Executive Committee (no direct compensation). All other authors declare no competing interests.

ASJC Scopus subject areas

General Medicine

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10.1016/S0140-6736(16)30073-3

Cite this

Thourani, V. H., Kodali, S., Makkar, R. R., Herrmann, H. C., Williams, M., Babaliaros, V., Smalling, R., Lim, S., Malaisrie, S. C., Kapadia, S., Szeto, W. Y., Greason, K. L., Kereiakes, D., Ailawadi, G., Whisenant, B. K., Devireddy, C., Leipsic, J., Hahn, R. T., Pibarot, P., ... Leon, M. B. (2016). Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. The Lancet, 387(10034), 2218-2225. https://doi.org/10.1016/S0140-6736(16)30073-3

@article{b81c9680d03c422ebfd4e8690661ba34,

title = "Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis",

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. 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. 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. Funding None.",

author = "Thourani, {Vinod H.} and Susheel Kodali and Makkar, {Raj R.} and Herrmann, {Howard C.} and Mathew Williams and Vasilis Babaliaros and Richard Smalling and Scott Lim and Malaisrie, {S. Chris} and Samir Kapadia and Szeto, {Wilson Y.} and Greason, {Kevin L.} and Dean Kereiakes and Gorav Ailawadi and Whisenant, {Brian K.} and Chandan Devireddy and Jonathon Leipsic and Hahn, {Rebecca T.} and Philippe Pibarot and Weissman, {Neil J.} and Jaber, {Wael A.} and Cohen, {David J.} and Rakesh Suri and Tuzcu, {E. Murat} and Svensson, {Lars G.} and Webb, {John G.} and Moses, {Jeffrey W.} and MacK, {Michael J.} and Miller, {D. Craig} and Smith, {Craig R.} and Alu, {Maria C.} and Rupa Parvataneni and D'Agostino, {Ralph B.} and Leon, {Martin B.}",

note = "Publisher Copyright: {\textcopyright} 2016 Elsevier Ltd.",

year = "2016",

month = may,

day = "28",

doi = "10.1016/S0140-6736(16)30073-3",

language = "English (US)",

volume = "387",

pages = "2218--2225",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier B.V.",

number = "10034",

}

Thourani, VH, Kodali, S, Makkar, RR, Herrmann, HC, Williams, M, Babaliaros, V, Smalling, R, Lim, S, Malaisrie, SC, Kapadia, S, Szeto, WY, Greason, KL, Kereiakes, D, Ailawadi, G, Whisenant, BK, Devireddy, C, Leipsic, J, Hahn, RT, Pibarot, P, Weissman, NJ, Jaber, WA, Cohen, DJ, Suri, R, Tuzcu, EM, Svensson, LG, Webb, JG, Moses, JW, MacK, MJ, Miller, DC, Smith, CR, Alu, MC, Parvataneni, R, D'Agostino, RB & Leon, MB 2016, 'Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis', The Lancet, vol. 387, no. 10034, pp. 2218-2225. https://doi.org/10.1016/S0140-6736(16)30073-3

TY - JOUR

T1 - Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients

T2 - A propensity score analysis

AU - Thourani, Vinod H.

AU - Kodali, Susheel

AU - Makkar, Raj R.

AU - Herrmann, Howard C.

AU - Williams, Mathew

AU - Babaliaros, Vasilis

AU - Smalling, Richard

AU - Lim, Scott

AU - Malaisrie, S. Chris

AU - Kapadia, Samir

AU - Szeto, Wilson Y.

AU - Greason, Kevin L.

AU - Kereiakes, Dean

AU - Ailawadi, Gorav

AU - Whisenant, Brian K.

AU - Devireddy, Chandan

AU - Leipsic, Jonathon

AU - Hahn, Rebecca T.

AU - Pibarot, Philippe

AU - Weissman, Neil J.

AU - Jaber, Wael A.

AU - Cohen, David J.

AU - Suri, Rakesh

AU - Tuzcu, E. Murat

AU - Svensson, Lars G.

AU - Webb, John G.

AU - Moses, Jeffrey W.

AU - MacK, Michael J.

AU - Miller, D. Craig

AU - Smith, Craig R.

AU - Alu, Maria C.

AU - Parvataneni, Rupa

AU - D'Agostino, Ralph B.

AU - Leon, Martin B.

PY - 2016/5/28

Y1 - 2016/5/28

N2 - 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. 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. 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. Funding None.

AB - 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. 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. 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. Funding None.

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ER -

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

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