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N Engl J Med. 2017 Sep 14;377(11):1033-1042. doi: 10.1056/NEJMoa1707404.

Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke.

Collaborators (695)

Volpi J, Bledsoe D, Chiu D, Guthikonda S, Imperial-Aubin D, Kleiman N, Lin CH, Ling J, Moye S, Rizzo R, Mcintyre P, Nayre C, Wiese J, Tenorio J, Ajike R, Tindel M, Bajwa T, Allaqaband S, Khitha J, Saxena V, Khatri B, Bennett M, Schmidt W, Seaton D, Lobacz D, Waller D, Kavinsky C, Amin Z, Chen M, Conners J, Cutting S, Hijazi Z, Jolly N, Kenny D, Lee V, Mohammad Y, Prabhakaran S, Smit L, Song S, Aubry D, Dvojack S, Faza N, Glase C, Martyniuk A, McDonald J, Sidoti F, Kar S, Lyden P, Makkar R, Nakamura M, Singh R, Dohad S, Song S, Arabyan M, Hussaini A, Kanji R, Khanolkar P, Remba D, Senkbeil L, Shirazi S, Villareal P, Messe S, Cucchiara B, Herrmann H, Luciano J, Mullen M, Sansing L, Shafi N, Augelli E, DeSanto ML, Gallatti N, Kruszewski M, Mannion T, Ventura L, Guttormsen B, Alaswad K, Hibbs S, Kokontis L, Larson G, Mattio T, Price S, West C, Barr S, Gibbs-Buss M, Randall K, Solenski N, Gimple L, Haley EC Jr, Lim DS, Nathan B, Worrall B, Bailes L, Brunk S, Garrison C, McKenzie R, Sprouse N, Thaler D, Feldmann E, Kimmelstiel C, Kolychev D, de Moor M, Toma H, Bettle M, Fariborz P, Huggins H, Joseph A, Gurley J, Lee J, Pettigrew LC, Wallace E, Boggs P, Bowman-Connor S, Evans R, Fowler A, Hatfield M, Lacey E, Rodgers C, Roycraft M, Taul Y, Taylor D, Vanderpool K, Yakubov S, Arce E, Eubank G, Good A, Hicks WJ, Mejilla J, Albon A, Allardyce C, Allison L, Archer B, Bailey A, Crabtree C, Garcia A, Gatrell R, Groezinger K, Hawkins M, Taylor M, Jackson J, Latoche B, Metz W, Mull J, Pletcher M, Sikora L, Tanner K, MacDonald L, Chang I, Fanale C, Pratt R, Wagner J, Derbyshire S, Giglio K, Siegel K, Soltau M, Varner C, Wimmer R, Sethi P, Cooper M, Dohmeier C, Ganji J, Penumalli V, Willis K, Yan Y, Earnhardt L, Fountain J, Hammonds S, Harbison W, Johnson M, Parker G, Pineda CM, Sabir R, Willard J, Delio P, Aragon J, Chen L, Willis PS, Bacon J, Granoff S, Isaacs L, Koches J, Khan U, Lazarine B, Miller T, Price S, Yim S, Sommer R, Khalique O, Kitago T, Willey JZ, Adegbite E, Austin A, Borda T, DeJesus EF, Feri A, Mendez R, Reisman A, Spencer B, Qureshi Y, Ching M, Deline CJ, Kandal A, Leonard GT Jr, Meltser H, Mowla A, Sawyer RN Jr, Pereira L, Shirani P, Ahmed M, Bilal M, Chichelli T, Conover C, Crumlish A, Gagnon R, Holler D, Mehla S, Mustafa G, Parkes K, Marks D, Book D, Cinquegrani M, Helms A, Alonge T, DeBauche C, Gosset J, Harmann L, Kadlec S, Kummer C, Mauermann S, Vannucchi K, Wexler M, Choo J, Rorick M, Sarembock I, Schmerler M, Buscek K, Darlington T, Francis K, Garza D, Howard W, Ibanez K, McGary E, Robertson R, Rock D, White D, Paolillo JA Jr, Downey W, Iyengar P, Story J, Aberle S, Ahmad S, Dellinger C, De Los Santos Y, Gettmann M, Kelly LP, Rathod J, Winkler K, Rowe S, Jung R, Lynch J, Kuehn S, Case KM, Gilbert K, Mitchener L, Perry J, Smith M, Weatherfield A, Prieto L, Ching EC, Gebel J Jr, Golden A, Kapadia S, Katzan I, Khawaja Z, Krasuski R, Lu M, Morton J, Preminger T, Qureshi A, Toth G, Uchino K, Wasielewski P, Wisco D, Bradley-Skelton S, Koepp S, Konstantinopoulos P, Kreischer S, Lach D, Richmond A, Strozniak L, Tighe N, Turczyk J, Schneck M, Darki A, Lewis B, Leya F, Lopez J, Morales-Vidal S, Bernier T, Del Priore J, Ray J, Shaffer K, Shore J, Ghani M, Kipperman R, Al-Nabhan N, Norman DL, Perry BF, Schoeffler M, Shah S, Tahirkheli N, Williams J, Wood K, Allen T, Hightower B, Moore J, Ramsey T, Scharrer C, Mallenbaum S, Ball TC, Schmidley JW, Bidanset A, Buchanan K, Perkins J, Viers C, Mahoney PD, Evans PW, Talreja D, Zweifler R, Bullivant M, Calayo T, Desser D, Phillips A, Rathbun J, Miller DJ, Greenbaum A, Guerrero M, Hefzy H, Katramados A, Malik S, Mitsias P, Vivek R, Holmes T, Jones J, Mays-Wilson K, Marzo K, Galler B, Jafir A, Khan W, Naidu S, Suri B, Wirkowski E, Drewes W, Patel D, Feldman T, Dafer R, Levisay J, Munson R, Salinger M, Lynch D, Syed S, Focks C, Lariosa S, Medica K, Skelskey J, Smith AJC, Anderson W, Giurgiutin DV, Hammer M, Horev A, Jadhav A, Jovin T, Jumaa M, Linares G, Malik A, Nanduri S, Ranawat N, Reddy V, Starr M, Totoraitis V, Wechsler L, Zaidi S, Baxendell L, DeCesare S, Dennis L, Enlow M, Farrow C, Kane A, Kunkel M, Massaro L, Hubbard C, Maini B, Shah J, Meise G, Moser L, Nanna C, Tanner L, Todd A, Sanders K, Crisco LV, Gwynn M, Johnston L, Kiely J, Palmer S, Banks C, Barnes C, Ellis-Bailey C, Loy J, McBride M, Patterson A, Skrifvars C, Wold U, Strote J, McIntosh G, Oldemeyer B, Kaczkowski S, McIntosh K, Schmitzer P, Waller B III, Das P, Elijovich L, Ibebuogu U, Khouzam R, Klemis J, Koshy S, Lutterman J, Wahba M, Jones C, Cubeddu R, Cross J, Andrzejewski L, Mahmoudi H, McConnell J, Muradova E, Silva A, Stevenson L, Younus A, McDaniel M, Morris D, Nahab F, Rab S, Carter E, Kim D, Kim YM, Holloway B, Ro J, Sanders T, Wang K, Wilson A, Blum M, Cohen B, Fox S, Shen R, Agar D, Aron MA, Brunetti D, Benner A, Ciprich C, Lobur E, Martinez N, Whisenant B, Call G, Hoesch R, Huan C, Meredith K, Orford J, Allen M, Butler A, Jacketta-Dunyon C, Konery K, Siler D, Hanzel G, Abbas AS, Fellows J, Goldstein JA, Buck S, McNally-McHugh A, Romanoski M, Honeycutt WD, Isa A, Nieves-Quinones D, Cowden A, Honeycutt L, Olson J, Berman D, Cheatham J, Cheatham SL, Heyer G, Holzer R, Lo W, Roach S, Chisolm J, Gimelli G, Bradbury E, Chacon M, Jacobson K, Jensen MB, Mason P, Raval A, Sattin J, Harris A, Roginski C, Vander Ark C, Riddick J, Jarquin-Valdivia AA, Gates S, Beesley C, Blair-Anton B, Coman D, Hank H, Hughett G, Lineberry V, McCarthy J, Simon A, Badger R, DeWitt D, Hannon P, Majersik J, Owan T, Smith B, Tandar A, Tkach A, Wold J, Aitken K, Neuharth RM, Niu S, Preece LP, Tuma J, Brown D, Simmons M, Gruetzmacher C, Jaehn N, Kelly V, McIntosh K, Schaefbauer J, Stauffacher K, Carroll J, Kay J, Kim M, Poisson S, Jones W, Quaife R, Simpson J, Hariton J, Harvey A, Nguyen T, Maurer H, Schmitt C, Tran BK, Wade G, Mattsson E, Jacobsen PH, Kostulas K, Lantz M, Sahlgren B, Bazjenova T, Emmertsen K, Hastrup S, Hougaard KD, Mortensen J, Schmitz ML, von Weitzel-Mudersbach P, Bock V, Dueholm L, Frydendahl D, Madsen LH, Kilian AS, Lindmark K, Thomsen RB, Zachariasen M, Back C, Berning J, Larsen VA, Simonsen S, West A, Dano M, Olesen C, Veng-Olsen T, Waje-Andreassen U, Leirgul E, Naess H, Norgard G, Bjorgo T, Dale LS, Saetveit M, Kaalaas AM, Thue SG, Airaksinen J, Korpela J, Roine S, Ukkonen H, Ylikotila P, Ketola R, Kivi R, Virtamo T, Dellborg M, Eriksson P, Furenas E, Runmarker B, Skoglund K, Hultsberg-Olsson G, Dellborg H, Lindgren A, Andsberg G, Hochbergs P, Holm J, Petersen C, Thilen U, Wictor L, Malmgren E, Nilsson G, Paulsson K, Saha R, Cockburn J, Keeble T, Poliacikova P, Wayne D, Bruce C, Cooter N, Mackenzie A, Parker J, Skipper N, Christensen H, Hansen CK, Höst NB, Jeppesen LL, Krieger D, Nielsen OW, Papina M, Rosenbaum S, Bentsen L, Pedersen A, Spence M, Kodoth V, Lockhart C, McVerry F, Owens C, Watt M, Hunter A, Manoharan G, Smith B, Skjelland M, Aaberge L, Brekke M, Dahl A, Hervold A, Lund C, Lunde K, Maurtveten EH, Skaardal R, Bath P, Appleton J, Henderson R, Krishnan K, Sprigg N, Smith W, Wilkins LM, Buck A, Burton J, Clarke JM, Cox P, Gilzeane N, Havard D, Richardson C, Richardson K, Roffe J, San P, Shelton F, Willmot M, Clift P, Littleton E, Sims D, Thorne S, Thomas A, Cunningham J, Hurley-McCormack J, Isaacs K, McCormack J, Sondergaard L, Arlien-Soeborg P, Hoejgaard J, Christensen PR, Jensen SL, King C, Kristensen LM, Tønder N, Mouritsen E, Petersen M, Kopecky SL, Bell RD, Chimowitz MI, Shapiro TA, Cohen B, Kase CS, Rowley HA, Turan TN.

Abstract

BACKGROUND:

The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions.

METHODS:

In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging.

RESULTS:

We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure.

CONCLUSIONS:

Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).

Comment in

PMID:
28902580
DOI:
10.1056/NEJMoa1707404
[Indexed for MEDLINE]
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