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N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

Collaborators (898)

Askew J, Sorajja P, Bae R, Eales F, Goessl M, Flavin T, Jay D, Kshettry V, Lesser J, Mudy K, Poulose A, Schneider L, Sun B, Meyer K, Byrne T, Kirshner M, Caskey M, Frey C, Jamal A, Klein N, Maki P, Querry T, Bessette L, Bajwa T, O'Hair D, Crouch J, Allaqaband S, Barragry T, Bernstein P, Crouch J, DeFranco A, Downey F, Haddadian B, Fuad Jan M, Jain R, Khandheria B, Khitha J, Kostopoulos L, Kress D, Nfor T, Port S, Tumuluri R, Weiss E, Werner P, Bennett M, Coselli J, Silva G, Cheong B, Cruz KD, Diez J, Preventza O, Sartoni M, Stainback R, Castro L, Hebeler R, Stoler R, Grayburn P, Henry C, Vallabhan R, Mendez A, Islam A, Rousou A, Galdauskas M, Haider A, Hiser W, Joelson J, Lau E, LaValley G, Scarnici A, Khabbaz K, Popma JJ, Chang J, Guibone K, Laham RJ, Liu D, Manning W, Papazian S, Pinto D, Riley M, Senthilnathan V, Kaufman J, Bladergroen M, Lim DS, Browning C, Chaudhry M, Fiser S, Fisher S, Guirgues L, Johnston K, Barrett J, Patterson K, Fail P, Netherland D, Abben R, Solet D, Benoit D, Lam KY, Tonino WAL, Houthuizen P, Post J, Helmes HJM, Staaltjens L, Steerneman-Geurts F, van Eijck M, Modine T, Sudre A, Coisne A, Delhaye C, Alphand P, Hellal M, Berthoumieu P, Tchétché D, Bonfils L, Dumonteil N, Fondard O, Cottin M, Hupe A, Jacob B, Petit F, Bethea B, Maini B, Ayala I, Pan H, Sanon S, Vafai J, Robbins G, Hughes GC, Harrison JK, Gaca J, Glower D, Kiefer T, Hurwitz Koweek L, Plichta R, Samad Z, Vora A, Wang A, Newbold S, De A, Tsau P, Galli F, Gaudiani V, Joye J, Noir D, Rammohan C, Lamm J, Bekker M, van Mieghem NM, Daemen J, Geleijnse M, Kroon H, Mattace Raso F, Gussinklo T, Huijskens-van Herpen E, Ruiter A, van den Berg N, Verelst S, Larbalestier R, Yong G, Chieng D, Dwivedi G, Ganapathipillai S, Merry C, Shetty S, Stamp N, Venkataraman A, Xu XF, Venn-Edmonds C, Agarwal S, Casale A, Burnside J, Carter R, Derby C, Friscia M, Good C, Harjai K, Singh D, Stella J, Kilbride S, Seshiah P, Smith JM, Martin W, Park S, Reilly S, Kleiman N, Reardon M, Barker C, Little S, Mahmarian J, Ramchandani M, Ruel R, Green L, Mohammadi S, Rodes-Cabau J, Asmeratis L, Baillot R, Bernier M, Chamandi C, Charbonneau É, Dagenais F, Doyle D, Dumont É, Rodriquez Gabella T, Jacques F, Kalavrouziotis D, Lachance D, Laflamme M, De Larochelliére R, Maes F, Nuns Ferreira Neto A, Paradis JM, Pasian S, Perron J, Voisine P, Bergeron A, Tremblay H, Elkins CC, Sparling J, Blaschke J, Chrysant G, Fife J, Sell-Dottin K, Bessen M, Ganzel B, Slaughter M, Solankhi N, Webb AM, Matthews RV, Starnes VA, Clavijo L, Cunningham M, Fleischman F, Hackmann A, Sohn J, Wilcox A, Mullin S, Ando K, Sakaguchi G, Arai Y, Aragaki R, Fujioka S, Hakamada K, Hayashi M, Iida J, Ishizu K, Isotani A, Ito S, Kano M, Kawaguchi T, Kuroda Y, Mori S, Morinaga T, Shirai S, Takiguchi H, Taniguchi T, Teranishi H, Tsubota H, Tsumaru S, Yano M, Uno S, Chevalier B, Farge A, Cormier B, Garot P, Hovasse T, Lefevre T, Carado J, Mottin G, Roger S, Toum V, Hummel B, Muppala M, DeFrain M, Presbrey T, Priest S, Wernow J, Combs W, Singer R, Kansara P, Patrick J, Kleaveland K, Martinez M, Mehta S, Misselback T, Patel N, Wu J, Cornell K, Bagur R, Kiaii B, Chu M, Diamantouros P, McCarty D, McKenzie N, Nagpal D, Teefy P, Fox S, Mardell S, Dev V, Fontana G, Akhondi A, Cash J, Faraci P, Hlinka M, McKenna K, Weeks N, Leya F, Tuchek JM, Bakhos M, Lewis B, Perez-Tamayo RA, Sanagala T, Schwartz J, Sawicki K, Inglessis I, Melnitchouk S, Alessandro DD, Dal-Bianco J, Elmariah S, George T, Ghoshhajra B, Jassar A, Palacios I, Passeri J, Sakhuja R, Sundt T, Villavicencio M, Vlahakes GJ, Daher M, Lacappelle K, Piazza N, Buithieu J, DeVarennes B, Martucci G, Sayegh K, Spaziano M, Jiang Z, Katz M, Steinberg D, Gregg D, Powers E, Suranyi P, Richardson S, Fiocco M, Wang J, Gupta D, Kaliyadan A, Mastoor M, Siddiqi N, Sura A, Weissman G, Campbell R, Chang M, Slachman F, Kiefer T, Kozina J, Morris A, Orakzai S, Hogan C, Merritt R, Parvathaneni S, Birchem J, Cochran D, Huang KF, Parameswaran A, Singhal A, Gilmore A, Chawla A, Jensen B, Chia B, Klein M, Marcus R, McAllister D, Onsrud R, Prabhakar G, Schmitt JA, Verhofste M, Tuttle K, Alvarez J, Garrison J, Donovan D, Hamner L, Patel D, Quiroz R, Carreon G, Gooley R, Smith J, Almeida A, Cochrane A, Goldstein J, Gupta V, Ihdayhed A, Joshi P, Lim RY, Lin A, Lockwood S, Machado C, McCormick L, Michail M, Mottram P, Munnur R, Heenan S, Wallace-Mitchell W, Cartier R, Ibrahim R, Asgar A, Basmadjian A, Bonan R, Dorval JF, Henri C, Pham M, Tan S, Blaise P, Pellerin Huet P, Rovin J, Spriggs D, Barry M, Cheng W, Kovach T, Lin L, Navas J, Ofenloch J, Ovadia P, Stone L, Turner N, Jones T, Kanzaki H, Kobayashi J, Amaki M, Fujita T, Fukushima S, Izumi C, Shimahara Y, Uotani M, Esposito R, Rutkin B, Boutis L, Brinster D, Cohen S, Hartman A, Henry S, Jauhar R, Kaplan B, Katz S, Kliger C, Kronzon I, Laighold S, Makaryus J, Mauer G, Mediratta A, Mehla P, Meraj P, Palazzo R, Perk G, Saba S, Scheinerman SJ, Shaban N, Shah A, Steinberg B, Taylor J, Vatsia S, Yu PJ, McGowan K, Ng A, Yakubov S, Arshi A, Blossom G, Buse T, Chapekis A, Duff S, Kander NH, Lyons J, Matros T, Sanchez C, Zadvinskis D, Popelas L, Song H, Zahr F, Chadderdon S, Fuss C, Heitner S, Raman J, Rajotte K, Tibayan F, Fishbein S, Sakata Y, Sawa Y, Hata H, Ichibori Y, Kainuma S, Kawamura T, Kuratani T, Maeda K, Mizote I, Mukai T, Onishi T, Sengoku K, Shimamura K, Toda K, Tsuda M, Yamamoto J, Yoshida S, Yoshikawa Y, Yoshioka D, Ohashi K, Kauten J, Meduri C, Brown WM, Dean D, Gott J, Liu S, Milla F, Mobasseri S, Polsani V, Rajagopal V, Rinehart S, Vannan M, Gray K, Gada H, Mumtaz M, Bachinsky W, Gustafson G, Hancock A, Hodara R, Loran D, Mansoor A, Miller B, Hollister R, Ravinay AT, Brady P, Choong C, McDowall L, Hansen P, Schuster A, Reid E, Batra S, Davis T, Cohen G, Lalonde T, Martin J, Yamasaki H, Bess R, Caputo R, Iskander A, Lutz C, Ranjbaran-Jahromi H, Trasolini N, Zhou Z, Mowers L, Heimansohn D, Hermiller J, Elsner G, Hallett R, Hanan S, Moainie S, Salerno C, Sampson A, Seger D, Walts P, Wandel E, Burkert M, Takanashi S, Tobaru T, Hagiya K, Higuchi R, Mahara K, Nishigawa K, Saji M, Shimizu A, Terada M, Uchimuro T, Nishikawa M, Haldis T, Newman R, Beledash I, Dowsley T, Dyke C, Hankey J, Witte D, Ueda T, Yamazaki S, Kawashima T, Saito S, Takenouchi G, Tani T, Yamasaki K, Sato C, Teirstein P, Azarbal F, Baradarian S, Brewster S, Lutes J, Mellinger D, Stinis C, Tyner J, Wesbey G, Staggs P, Hata M, Tada N, Enta Y, Ishii K, Matsumoto T, Mizutani Y, Munehisa Y, Ootomo T, Sakurai M, Yamaya K, Matsuoka Y, Noguchi K, Saito S, Gunji Y, Hattori S, Shishido K, Tanaka Y, Yamanaka F, Asou K, Heiser J, Merhi W, Berkompas D, Decker J, Fanning J, Franey L, Langholz D, Lueng S, Moriarity A, Shin A, Helm E, Jansz P, Muller D, Connelan M, Hungerford S, Roy D, Arriagada A, Heijmen R, Bosschaert M, Kelder J, Swaans M, van den Akker A, Gheorghe L, Helwig-Vernooij JC, Petrossian G, Robinson N, Bercow N, Berke A, Cao J, Lee P, Mihalatos D, Ren X, Jennings J, Krug P, Santiago L, Knight P, Ling F, Krishnamoorthy V, Narins C, Prasad S, Schwarz K, Stuver T, Yeager C, Fremes S, Radhakrishnan S, Ahmed S, Jimenez-Juan L, McCaig K, Toma J, Wijeysundera H, Sarker S, Gafoor S, Lehr E, Atianzar K, Barnhart G, Brockenbrough K, Buckler J, Hickey J, McCulloch M, Millan J, Muni N, Penev I, Petrescu OM, Ray A, Ryan P, Rekai C, Youssef S, Zhang M, Drouhard A, Stead A, Hurt J, Noel T, Batchelor W, Murrah CP, Saint D, Plasay B, McGiffin D, Walton A, Duffy S, Lew P, Marasco S, Stub D, Thomson H, Zimmet A, Holland S, Resar J, Chacko M, Corcoran P, Corretti M, Hasan R, Madrazo J, Milner M, Siegenthaler M, Zimmerman S, Fisher M, Adams D, Sharma S, Anyanwu A, Dangas G, Filsoufi F, Kini A, Kovacic J, Perk G, Sanz J, Stelzer P, Swain J, Kiernan M, Sharma M, Lilly S, Rushing G, Boudoulas K, Galizia M, O'Neil S, Orsinelli D, Ryan T, Whitson B, Liptrot R, Tadros P, Zorn G, Anderson D, Ash R, Bormann S, Daon E, Ferrell R, Freeman J, Hockstad E, Kramer J, Meuhlebach G, Mulhern K, Nath J, Pope K, Wiley M, Shawgo T, Dauerman H, Ittleman F, Alkhalil I, Azarbal A, Gentchos G, Lahoud R, Leavitt B, Parsee A, Schneider D, Terrien E, Tischler M, Walsh R, Worgan B, Henderson A, Feindel C, Horlick E, Cusimano RJ, Hanneman K, Mezody M, Osten M, Ouzounian M, Sun Y, Tsang W, Wu L, Glotzbach J, Welt F, Appleby D, Ibrahim H, Jensen L, McKellar S, Selzman C, Shah R, Sharma V, Tandar A, Sander C, Markowitz A, Attizzani G, Bezerra H, Costa M, Deo S, Elgudin Y, Gikeson R, Hoit B, Kalra A, Medalion B, Park S, Sareyyupoglu B, Simon D, Atkinson R, Carroll J, Fullerton D, Cleveland J, Gama K, Juselius W, Messenger J, Moloo J, Quaife R, Reece TB, Wiktor D, Schrock K, Griffith B, Gupta A, Barr B, Jeudy J, McCumbers R, Salenger R, Taylor B, Akbari F, de Marchena E, Salerno T, Alfonso C, Cohen M, Ghersin E, Lowery M, Marincic X, Chetcuti S, Deeb GM, Bach D, Bhat A, Bhave N, Bolling S, Boyle MJ, Burris N, Fukuhara S, Geml R, Grossman PM, Haft J, Kenaan M, Kim K, LaBounty T, Menees D, Pagani F, Patel H, Prager R, Romano M, Tang P, Yang B, Ziarkiewicz M, Oakley J, Gleason TG, Schindler J, Choi C, Christensen E, Crock F, Harinstein M, Henry L, Katz W, Kliner D, Lacomis J, Lee JS, Navid F, Sultan I, Enlow-Germovsek M, Kaiser C, Robbins M, Barton B, Crenshaw M, Fredi J, See R, Adams K, El-Gamel A, Pasupati S, Davis M, Jogia P, Khurana A, McCormack D, Nair R, Abercrombie K, Low L, Kon N, Zhao D, Applegate R, Gandhi S, Kincaid T, Upadhya B, Vasu S, McDaniel S, Ramlawi B, Ali O, Skiles J, Thwing C, Lane S, Forrest J, Mangi A, Cleman M, Darr U, Dewar M, Geirsson A, Kaple R, Sugeng L, McManus S.

Abstract

BACKGROUND:

Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients.

METHODS:

We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods.

RESULTS:

Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2).

CONCLUSIONS:

In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

PMID:
30883053
DOI:
10.1056/NEJMoa1816885
[Indexed for MEDLINE]

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