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N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

Collaborators (731)

Sorajja P, Sun B, Poulose A, Pedersen W, Flavin T, Farivar R, Kshettry V, Eales F, Bae R, Meyer K, Agarwal H, Langdon T, Batter J, Tran T, Fry R, Fox K, Weig L, Pendleton K, den Heijer P, Bentala M, Vos J, Lauryssen L, Coenen C, Driesen I, Poorter M, Schaap J, Oomes-Sistermans C, Smits M, O’Hair D, Bajwa T, Allaqaband S, Werner P, Khandheria B, Waller D, Dunaj W, Byrne T, Caskey M, Loli A, Pershad A, Brady K, Fang HK, Amibile O, Morgan M, Munoz M, Paulus B, Garrett E Jr, Zoghbi G, Samaha J, Wolf B, Hennan JA, Lott J, Stoler R, Hebeler R, Grayburn P, Vallabhan R, Henry C, Roberts B, Willcott L, Khabbaz K, Liu D, Nathan S, Guibone K, Chang J, Manning W, Riley M, Kaufman J, Lim DS, Bladergroen M, Katz MR, Carcedo B, Stacey R, McWalters N, Fail P, Feinberg E II, Dearman R, Allam M, Tedesco V, Abben R, Thompson K, Tassin M, Aubin J, Robert M, Rinaldi M, Skipper E, Downey W, Stiegel R, Rose G, Scherer M, Krueger S, Chawla A, Hockmuth D, McAllister D, Jenson B, Prabhakar G, Verhofste M, Tuttle K, Cheng W, Jilaihawi H, Kar S, Stegic J, Salseth T, Khouw S, Trento A, Ramzy D, Siegel R, Gheorghiu M, Kodali S, George I, Nazif T, Smith C, Naka Y, Hahn R, Khalique O, Lazarte R, Aji J, Bowen F, Kaddissi G, Schell W, Muntazar M, Rosenbloom M, Sabir S, Abreu L, Schreiber T, Henry S, Munir A, Kassas S, Choksi N, Bassett J, Sandidge G, Carl H, Hengstenberg C, Bleiziffer S, Kreuzpointner RJ, Goppel G, Ruge H, Kreuzpointner R, Stroh A, Harrison JK, Hughes C, Wang A, Kiefer T, Sherwood M, Gaca J, Glower D, Velazquez E, Camuglia K, Joye J, Gaudiani V, Rammohan C, Vial C, Nair D, Babaliaros V, Thourani V, Mavromatis K, Lieppe W, Stewart J, Devireddy C, Leshnower B, Sarin E, Miller J, Macheers S, Lerakis S, Merlino J, Frohwein S, Davidson E, Wheeler L, de Jaegere P, Oei F, de Lind van Wijngaarden R, Bekkers J, Birim O, Bolraap G, van de Woestijne P, Kik C, van Geuns RJ, Geleijnse M, Ruiter A, Van Den Berg N, Dauerman H, Schmoker J, Terrien E, Worgan B, Chava S, Moossavi S, Ittleman F, Tischler M, Schneider D, Straight F, Skelding K, Casale A, Long D, Wood K, Harjai K, Singh D, Stella J, Stahl R, Carter R, Burnside J, Burgess B, Kovac J, Spyt T, Marsh AM, Logtens E, Seshiah P, Smith JM, Martin W, Park S, Okum E, Hiratzka L, Gersch K, Hall MM, Reilly S, McKay R, Hagberg R, Keiman F, Underhill D, Fusco D, Hammond J, Krupowies N, Duvall L, Cyr G, Matthews R, Starnes V, Clavijo L, Cunningham M, Naqvi T, Lawrence T, Mullin S, O’Neill W, Paone G, Greenbaum A, Eng M, Borji J, Nemeh H, Morgan J, Zweig B, Parika S, Wang DD, Moltassie J, Hernandez García JM, Such M, Muñoz-Garcia AJ, Alonso-Briales J, Domínguez A, Sanchez Espin G, Mataró López MJ, Carasco Chinchilla F, Medina M, de la Tassa CM, Llosa Cortina JC, Del Valle R, Avanzas P, Morales Pérez C, Silva J, De La Hera J, Villa E, Fernandez Maese J, Carrel T, Wenaweser P, Khattab A, Stortecky S, Zuk K, Huber C, Englberger L, Reineke S, Gobev V, Kurmann R, Zurcher F, Shoenenburger C, Whisenant B, Doty J, Miner E, Caine W, Reid B, Clayson S, Jones K, Gonzales M, Allen M, Resar J, Chacko M, Hasan R, Heil B, Shah A, Mandal K, Scortino C, Corretti M, Willhide J, Aharonian V, Pfeffer T, Mansukhani P, Yun K, Bui A, Watanabe C, Tolentino J, Rück A, Corbascio M, Settergren M, Bzck M, Hylander S, Blackman D, Kaul P, Malkin C, Schlossman D, Dzaicin S, Geldard S, Somers K, Kliger C, Brinster D, Patel N, Perk G, Kronzon I, Mihelis E, Teefy P, Kiaii B, Diamantourous P, Bagur R, Chu M, De Jonge W, Mroz L, McLeod C, Weigand A, Fox S, Leya F, Bakhos M, Lewis B, Tuchek JM, Schwartz J, Dajani K, Darki A, Klein W, Sawicki K, Sandhu G, Pochettino A, Eleid M, Gulati R, Bresnahan J, Mathew V, Sarraf M, Alkhouli M, Reeder G, Holmes D, Best P, Swenson C, Greason K, Maalouf J, Nkomo V, Johnson R, de Varennes B, Lachapelle K, Martucci G, Buithieu J, Jiang Z, van Boven A, Boonstra P, Hofma S, Amrane H, Kootstra H, Pultrum M, Blomer H, Van der Wal M, Herder W, Waksman R, Bafi A, Satler L, Pichard A, Corso P, Widell J, Wang Z, Goldstein S, Marcus R, Barnes C, Asgar A, Cartier R, Bonan R, Ibrahim R, Dorval JF, Garceau P, Morin C, Kipperman R, Brown J, Cohen B, English K, Slater J, Xydas S, Magovern C, Koalogiannis K, Van Zile C, Lin L, Rovin J, Spriggs D, Ofenloch J, Barry M, Navas J, Montgomery S, Sharma S, Dangas G, Kini A, Anyanwu A, Stelzer P, Stewart A, Sengupta P, Basnet S, Katz S, Hartman A, Rutkin B, Kaplan B, Jauhar R, Merai P, Esposito R, Yu PY, Rosman D, Trost B, Chan G, Al-Jilaihawi H, Galloway A, Grossi E, Saric M, Van Daele J, Crestanello J, Lilly S, George B, Cheatham J, Mazzaferri E, Kilic A, Orsinelli D, Ryan T, Liptrot R, Ghani M, Bodenhamer RM, Williams JM, Tahirkheli NJ, Randolph J, Raikar G, Dautenhahn D, Williams J, Hanes S, Rajagopal V, Kauten J, Meduri C, Gott J, Dean D, Brown WM, Martin R, Amoroso E, Bachinsky W, Hancock A, Loran D, Eubanks V, Hollister R, Nickenig G, Welz A, Sinning JM, Twelker K, Vasa-Nicotera M, Mellert F, John H, Bieliauskas G, Thyregod G, Thiis J, Andersen H, Arendrup H, Carranza C, Holme S, Kjøller M, Lund J, Perko M, Sander K, Smerup M, Ihlfmann N, Brodersen BB, Lilleor N, Watson D, Kander NH, Stone L, Arshi A, Lyons J, Sanchez C, Blossom G, Duff S, Grewal K, Popelas L, Chhatriwalla A, Allen K, Cohen D, Aggarwal S, Davis JR, Main M, Magalski A, Hall J, Teirstein P, Tyner J, Sharma A, Oyama J, Thompson C, Groves E, Ong D, Atri P, Brewster S, Rubenson D, Hu S, Buchanan T, Mahoney P, Newton J, Talreja D, Murillo J, Zulick C, Berkompas D, Fanning J, Wai Sang SL, Mitchell L, Chilton D, Postema K, Yeung A, Miller C, Fearon W, Fischbein M, Liang D, Dash R, Trautman L, ten Berg J, Heijmen R, Bosschaert M, van den Akker B, de Kroon T, Van Deutekom I, Rost I, Oostveen M, Petrosssian G, Robinson N, Berke A, Bercow N, Dimsuyu N, Haag E, Brecker S, Jahangiri M, Chandrasekaran V, Sarsam M, Punzalan R, Stuart A, Brown S, Davis T, Batra S, Yamasaki H, Lalonde T, Martin J, Cohen G, Bess R, Hermiller J, Heimansohn D, Elsner G, Hanan S, Walts P, Moainie S, Segar D, Burkert L, Radhakrishnan S, Fremes S, Wijeysundera H, Czarnecki A, McCaig K, Arbel Y, Christakis G, Cohen G, Ahmed S, Sarker S, Bethea B, Ramos A, Studor K, Altamar I, Dacosta C, Brown D, Ryan W, Potluri S, Szerlip M, Gopal A, Mack M, Brinkman W, Harrington K, Smith R, Gopal D, Snelus P, Barker C, Lin C, Reyes M, Ramchandani M, Ramlawi B, Scheinin S, Little S, Nagueh S, Green L, Spies C, Lau J, Badawi R, Nakamura D, Hart C, Whittaker P, Seto T, Blackburn B, Herrmann H, Bavaria J, Anwaruddin S, Giri J, Li R, Szeto W, Desai N, Vallabhajosyula P, Fishman L, Schwarz T, Siki M, Horlick E, Feindel C, Osten M, Cusimano R, Tsang W, Wu L, Neumann FJ, Beyersdorf F, Comberg T, Rothe J, Büttner HJ, Gick M, Günkel L, Thoma M, Siepe M, Diab N, Pingpoh C, Allgeier M, Jander N, Steiger B, Binder R, Maisano F, Lanz J, Gruner C, Stampfli S, Hager C, Stader M, Sanger U, Costa M, Markowitz A, Simon D, Bezerra H, Attizzani G, Deo S, Elgudin Y, Hoit B, Musarra R, Davis A, Tadros P, Zorn G III, Wiley M, Muehlebach G, Freeman J, Nath J, Mulhem K, Shawgo T, de Marchena E, Salerno T, Ferriera A, Alfonso C, Panos A, Carrillo R, Williams D, Lowery M, Kall CM, Grossman PM, Menees D, Patel H, Romano M, Prager R, Kim K, LaBounty T, Oakley J, Labinaz M, Ruel M, Glover C, Lam K, Chilton C, Charlebois C, Schindler J, Henry L, Navid F, Edelman K, Katz W, Cavalcante J, Crock F, Enlow M, Ling F, Knight P, Narins C, Stuver T, Forbes J, Yeagar C, Robbins M, Ball S, Crenshaw M, Fredi J, Petracek M, Ahmad R, Baker M, Mendes L, Adams K, Giacomini J, Burdon T, Buchbinder M, Fann J, Mitchell RS, Heidenreich P, Baer J, Applegate R, Kon N, Gandhi S, Zhao D, Kincaid E, Pu M, Upadhya B, White W, Schwartz R, Schubach S, Goncalves J, Marzo K, Senicola T, Stepinowski K, Forest J, Mangi A, Cleman M, Lansky A, Darr U, Dewar M, Yun J, Sugeng L, Levesque L.

Abstract

BACKGROUND:

Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk.

METHODS:

We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement.

RESULTS:

A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group.

CONCLUSIONS:

TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

PMID:
28304219
DOI:
10.1056/NEJMoa1700456
[Indexed for MEDLINE]

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