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N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.

Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke.

Collaborators (841)

Kimmelstiel C, Joseph A, Huggins H, Bettle M, Fariborz P, Lee JM, Nassief A, Zajarias A, Balzer D, Lasala J, Beardsley M, Ford A, Newgent J, Myers M, Walker A, Nielsen C, Papamitsakis N, Liu F, Feng W, LaPointe M, Blevins A, Lucas S, Pope BM, Coumert A, Suri F, Parry GJ, Anderson D, Lakshminarayan K, Gruenstein D, Bass J, Walk D, Rolandelli S, Hilbert S, Caldwell E, Thornberg P, Reeder G, Hagler D, Bartleson JD, Goldberg S, Dean L, Jones T, Stewart D, Tanzi P, Schubert G, Gallo M, Troutman C, Fayad P, O’Leary E, Delaney JW, Latson L, Amin Z, Peterson C, Larson L, Phillips M, Delaney K, Cowardin C, Adolphson M, Shah A, Jolly N, Lee M, Norstrom M, Grotta J, Choi J, Noser E, Illoh K, Murtagh B, Denktas A, Gonzales N, Sdringola S, Letsou G, Campbell M, Barreto A, Savitz S, Davidson S, Metts B, Baccam T, Vooltich M, Felker L, Carter C, Underwood C, Brown L, Russell S, Patterson R, Turrentine E, Lehman R, Oxley C, Amory CF, Bernardini G, Velvis H, Murnane MJ, Faist L, Yanoschak J, Yavagal DR, Graca L, Cronin A, Nabors B, Alexandrov A, MacMahon W, Misra VK, Sisson A, Merritt L, Brethour M, Bartle D, Taylor M, Benesch C, Kelly A, Homquist T, Rempe D, Leonhardt A, Pearson N, Zentner J, Satler L, Slack M, Lin M, Laureno R, Pichard A, Choi J, Schlosberg M, Goldstein S, Sievert H, Whitman D, Okubagzi P, Deville M, Daoud T, Bond E, Hemanthia D, Aderotoye A, Shimellis H, Sushinsky S, Lockhart R, George C, Deible R, Lavoie J, Torgeson R, Howery R, Wang D, Bash SE, Nair DS, Parker S, Mathews M, Kattah JC, Schneider D, Talkad AV, Beck J, Howarter A, Stevens J, Bernstein R, Alberts M, Naidech AM, Davidson CJ, Wax D, Bergam D, Lux JD, Belfuss B, Cardenas L, Goodreau L, Fore-Kosterski S, Khan V, Joro P, Muskovich K, Johnson M, Graybeal D, Unwin H, Cigarroa J, Brickner B, Lange RA, Zeller T, Warner J, Dimas V, Lee JD, Salahuddin T, Watts JC, Bhatia D, Gathua N, Huet G, Hernandez D, Blair A, Wright JG, Anderson CA, Hughes RL, Casserly I, Keller J, Groves BM, Kay J, Quaife R, Garcia JA, Hassell KL, Messenger JC, Grinsell J, Chah KC, Robertson M, Schmitt C, Hariton J, Maurer H, Kioussopoulos K, Ivashchenko A, Beland KM, Ziebol L, Abaca E, Brandes L, Martin BJ, Hall C, Perez L, Lewis S, Goldfarb G, Hogan J, Walker J, Bethea C, Campanella F, Wichter MD, Eastman MJ, Jacoby M, Hughes B, Tannenbaum M, Klein M, Marcus R, Inman C, Gehrke J, Petersen L, Youde K, McClead J, Stifel K, Graffagnino C, Goldstein L, Harrison JK, Ward CC, White-Tong K, Pierce CH, Poulose A, Shronts R, Mooney M, Chavez I, Olson S, Peichel G, MacDonald H, Malhotra K, Frischmann L, Arch A, Chhabra A, Noorian A, Rao N, Modir R, Tansy A, Hinman J, Calderon M, Sheth S, Liang C, Ng K, Yallapragada A, Abcede H, Adamczyk P, Raychev R, Song S, Tenser M, Froehler M, Ohanian A, Panagotacos J, Ali L, Towfighi A, Shah S, Tobis J, Liebeskind D, Kim D, Sanossian N, Buck B, Ovbiagele B, Rajajee K, Selco S, Avelar J, Avila G, Fiaz R, Smith H, Gevorgyan R, Douangvila L, Gadhia J, Bell L, Zimmerman N, Haines J, Alvarez A, Duke K, Bagdanovich H, Adams H, Davis P, Horwitz P, Divekar A, Leira E, Lindower P, Sieren J, Olalde H, Drossner M, Morehead M, Simmons T, Lutsep H, Bozorgchami H, Helseth E, Wei K, Lindsay K, Burch G, Clark W, Lowenkopf T, North L, Lee K, Spriggs K, Feest K, Seisler K, Larsen D, Foley J, Cingel M, Dolan M, Enochs S, Ross M, Stone R, Ross S, Newman P, Doherty A, Dugan B, Jenkins JS, Ramee S, White CJ, Collins T, Reilly JP, Hirstius B, Gavin S, Demaerschalk B, Dodick D, Fortuin FD, Ingall T, Lee R, Sweeney J, Aguilar M, Kiernan T, Vargas BB, Capampangan D, Spencer BR, Boyd E, Sila C, Grossman G, Suarez JJ, Pundik S, Sundararajan S, Feen E, Lynch G, Mirabelli J, Siwik E, Landis D, Cunningham MJ, Georgiadis A, Bershad E, Costa M, Cwiklinski V, Gross M, Lemmey D, Hoban M, Murphy C, Korosec D, Mangeshkumar V, Casale P, Clark N, Etter M, Pacelli JP Jr, Kruse L, Knepper K, Hollywood L, Noll D, Beck D, Helms A, Pelech A, Cinquegrani M, Torbey M, Nievera C, Mauermann S, Bieliski MB, DeBauche C, Bright M, Wessel B, Jaszewski S, Gosset J, Zindars V, Lehre R, Alonge A, Hauser N, Harmann L, Kadlec S, Wexler M, Kummer C, Vannuchi K, Gollapudi R, Beyer R, Warner J, Kohlmyer C, Futrell N, Reichwein R, Good D, Kozak M, Davidson W, Weber H, Betterman K, Kelleman J, Ting J, Hitz K, Hess MC, Schaeffer C, Ulsh P, Eicher C, Tadros P, Dafer R, Mulhern K, Wang Y, Gronseth G, Saperstein D, Greening K, Shawgo T, Schallert G, Page SJ, Clark B, Shea S, King A, Bush J, Reitz C, McElheney J, Gales T, Smith P, McClymont J, Jones C, Mcginty SE, Watkins L, Chiu J, Gwynn RE, Collins E, Patel HT, Fieldman RC, Sohal M, Ingram J, Miller R, Fletcher E, Vestbjerg B, Huang D, Lada R, Waight D, Lane J, Bowling S, McCormick M, Ruppenthal C, Schisler P, Gilbride E, Krusinski K, Barber D, Leclerc L, Stierl L, O’Connor E, Mihaws S, Montgomery M, Smith G, Petermann K, Sinop S, Forgach E, Thomas M, Gimelli G, Wolff M, Chacon M, Jensen M, Sattin J, Kurle P, Dulli D, Levine R, Harris A, Boyd M, Wollet L, Roginski C, Washburn MJ, Ruys N, Siddiqui F, Kale SP, Wang ZY, Clark J, Mishkel G, DeMartini T, Fritz S, Adams K, Miedwig L, Samson S, Lokaitis BC, Pettigrew LC, Mehra A, Clavijo L, Matthews R, Shavelle D, Sanossian N, Caro J, Mullin S, Shafer B, Kleaveland JP, Castaldo J, Kluck B, Mackin G, Spikol L, Varrato J, Barbour P, Matsumura M, Isayev Y, Castaldo JE, Pandy P, Feldman B, Li Y, Rae-Grant A, Redenbaugh J, Neri J, Margraf J, Kanchana S, Gumulak C, Agonis S, Berman L, Galuska J, Nuschke K, Vermeersch M, Smith J, Gavigan T, Phillips L, Trapp C, Nabhan S, Garas S, Pilcher G, Joseph L, Crews E, Robinson T, Shah M, Bohl R, McCauley C, Karanjia P, Schiller J, Mand K, Beck C, Voda J, Maassen K, Coakley C, Lafranchise EF, Fallis R, Stankewicz M, Prasad S, Koenig M, Crenshaw M, Wheatley R, Kaminski MJ, Fredi J, McPherson J, Owens K, Simion A, Hollis S, Green M, Coman D, Sullenger V, McCarthy J, Cummings-Payne M, Pitts D, Donlevy S, Taylor K, Elmore K, Hill L, Amstutz K, Bromlow K, Duncan R, Slivka A Jr, Cheatham JP, Holzer RJ, Daniels CJ, Mohammed Y, Nasir M, Patel N, Heckman C, Sanger A, Blazak B, Rybka K, Chisolm J, Notestine MA, Agriesti J, Bacharach JM, Viola L, Gordon MR, Paa CJ, Vonk GN, Wasko K, Alizai AM, Koob KG, Miles C, Payne HA, Rossing WR, Zimprich TA, Farley R, Eisenbraun P, Fanale CV, Smith DB, Chang I, Pratt R, Bateman C, Rose D, Soltau M, Brewer K, Varner C, Peacock CL, Erickson D, True J, Peters L, Darbyshire S, Piana R, Zhao D, Fredi J, Kirshner H, Mendes L, Blair-Anton L, Dorsett R, Gordon M, Crook S, Brown D, Wieman B, Hawkins L, Watts C, Francescon J, Markus T, Peagram W, Simonson J, Panetta C, Hanson S, Davenport J, Ostrander M, Barnes S, Schacherer R, Kuno L, Martin D, Jones D, Brown L, Brady L, Khandelwal M, Klapholz M, Maher JM, Solanki P, Kamin S, Mehta K, Mangela V, Zampi J, Armstrong A, Morgenstern L, Rusche-Skolarus L, Wang M, Bach D, Zahuranec D, Brown D, Majersik J, Meurer W, Moscucci M, Brennan-Martinez C, Podolski K, Smith EK, Welch S, Hughes RM, Caulfield T, Redd A, Muir E, Dixon M, Johnson E, White E, Braddy K, Ginete W, Erlemeier S, Holt W, Erickson A, Keinanen T, Rantala A, Rich-Dupree S, Leone C, Neva C, Reiner J, Burger K, Marshall L, Bates V, Meltser H, Leonard GT Jr, Herle A, Gengo FM, Rainka M, Muhitch DJ, Oakes R, Evert D, Mann K, Jamison A, Kumm C, Mishell J, Accad M, Lewis A, Zaroff J, Montes R, Blanchet N, Casias C, Mendoza D, Chau Q, Shay W, Johnson K, Fitzgerald AM, Oshea H, Shaikh S, D’Ambrosio LT, Alford S, Miller M, Mann K, Cleveland K, Sethi P, Willis CK, Dohmeier C, Yan Y, Penumalli VR, Harbison W, Hammonds S, Williard J, Oldemeyer JB, Strote J, McIntosh G, Friedman S, Kaur P, McIntosh K, Olson D, Jaskowiak A, Whisenant B, Ballantyne B, Snyder M, Talreja D, Zweifler R, Griffin J, Hollsten P, McGinty S, Rathbon J, Domingo F, Nelson-Brown H, Hodies C, Astorga T, Goodman V, Wetmore J, Grove D, Chan A, Ho K, Rupka D, Lim-Uy S, Honeyman C, Marchand C, Wedding K, Stevens S, Shuaib A, Taylor D, Pio F, Brebesh B, Kalasayan H, Manosalva A, Wassef A, Basir G, Ghrooda ES, Parthasarathy R, Kate M, Ahmad A, Sharma A, Ibrahimi M, Hameed B, Aladdin Y, Asdaghi N, Mustafa M, Sebastian J, Gupta D, Shahid R, Almalki A, Alotaibi B, Sharafaddinzadeh N, Jerudi M, Schwindt B, Kadribasic NE, Kolodziej D, Gable Y, Dadashova R, Button A, Spence JD, Sridhar K, Diamontouros P, Dias B, Mabb T, Morlog D, Downie C, Paddock L, Miners L, Teal P, Jue J, Gin K, Lee PK, Nair P, Tsang T, Wood D, Murphy C, Yip S, Saw J, Benavente O, Woolfenden A, Beckman J, Murray K, Tang E, Esplana N, Taylor S, Hill MD, Spence F, Schnell G, Prieur T, Traboulsi M, Demchuk A, Watson T, Coutts S, Smith E, Barber P, Stys P, Klein G, Menon B, Shobha N, Moreau F, Fung D, Bal S, Ryckborst K, Kenney C, Fischer K, McClelland M, Aram H, Ibrahim R, Lanthier S, Proietti A, Bergeron M, Crete H, Horlick E, Osten M, Benson L, Jaigobin C, Wu L, Asif N, Chamberlain K, Rapkin J, Larkin B, Horowitz C, Tanke T, Gutfinger D, Davila-Roman V.

Abstract

BACKGROUND:

Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown.

METHODS:

In a multicenter, randomized, open-label trial, with blinded adjudication of end-point events, we randomly assigned patients 18 to 60 years of age who had a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group). The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization. The results of the analysis of the primary outcome from the original trial period have been reported previously; the current analysis of data from the extended follow-up period was considered to be exploratory.

RESULTS:

We enrolled 980 patients (mean age, 45.9 years) at 69 sites. Patients were followed for a median of 5.9 years. Treatment exposure in the two groups was unequal (3141 patient-years in the PFO closure group vs. 2669 patient-years in the medical-therapy group), owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat population, recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical-therapy group, resulting in rates of 0.58 events per 100 patient-years and 1.07 events per 100 patient-years, respectively (hazard ratio with PFO closure vs. medical therapy, 0.55; 95% confidence interval [CI], 0.31 to 0.999; P=0.046 by the log-rank test). Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical-therapy group (hazard ratio, 0.38; 95% CI, 0.18 to 0.79; P=0.007). Venous thromboembolism (which comprised events of pulmonary embolism and deep-vein thrombosis) was more common in the PFO closure group than in the medical-therapy group.

CONCLUSIONS:

Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270 .).

PMID:
28902590
DOI:
10.1056/NEJMoa1610057
[Indexed for MEDLINE]
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