Closure or medical therapy for cryptogenic stroke with patent foramen ovale
Anthony J Furlan, Mark Reisman, Joseph Massaro, Laura Mauri, Harold Adams, Gregory W Albers, Robert Felberg, Howard Herrmann, Saibal Kar, Michael Landzberg, Albert Raizner, Lawrence Wechsler, CLOSURE I Investigators, A Furlan, G Albers, H Adams, L Wechsler, R Felberg, M Reisman, M Landzberg, H Herrmann, S Kar, A Raizner, L Mauri, J Massaro, J P Mohr, T Brott, J Keane, M Larson, D Cutlip, M Fisher, V Mandell, T Chung, D Spence, K Sridhar, D Chiu, A Raizner, V Saxena, T Bajwa, I Katzan, C Sila, M Tuczu, L Latson, L Wechsler, W Anderson, D Gervais, P Fail, P Teal, D Ricci, T Lukovits, A Kaplan, M Schneck, F Leya, R Singh, S Cohen, S Kar, C Jaigobin, E Horlick, A Shuaib, D Taylor, J Absher, C Hudak, G Henderson, A Eisenhauer, S Kasner, H Herrmann, K Siller, J Slater, J Frey, R Heuser, G Albers, D Lee, S Pang, D Chu, P Ho, P Delio, J Aragon, I Silverman, R McKay, R Taylor, W Abernathy, F Oser, R Felberg, S Jenkins, S Ramee, G Tietjen, W Colyer, E Aldrich, R Wityk, R Ringel, E Albakri, T Sullebarger, H Adams, P Horwitz, T Fagan, G McIntosh, G Luckasen, R French, J Hermiller, M French, K Hreib, T Piemonte, J Belden, W Dietz, W Likosky, M Reisman, D Gzesh, C Thomas, D McCormick, J Erickson, D Schachter, A Felix, E Frantz, W Tan, R Tyndall, R Kipperman, P Wright, S Levchuck, D Johnston, J Webb, W Helveston, A Martin, C Ivan, A Bruno, S Sadanandan, J Breall, B Silver, A Greenbaum, J Floberg, K Baran, J Cochran, J Thompson, M Elkind, C Wright, R Sommer, S Kittner, B Reicher, M O'Brien, R Pick, A Forteza, Ortiz, E DeMarchena, N Cooke, C Garabedian, R Englander, S Lau, T Banas, K Ramani, W Felton, W Moskowitz, K Remmel, M Recto, S Mallenbaum, J Griffin, P Verro, J Rogers, R Swillie, S Bakir, W El-Feky, A Anwar, W Carroll, P Kanneganti, A Good, S Sivendran, R Welles, K Harjai, R Stephens, A Hosney, K Sanders, L Van Crisco, S Selco, S Farrow, A Rothman, H Echiverri, L McKeever, W Burgin, J Hollander, G Gacioch, M Kalafut, P Teirstein, A Favate, C Staniloae, S Silliman, L Guzman, T Bass, R Hart, S Bailey, N Cooke, B Batkoff, B Dandapani, S Karas, P Cullis, T Davis, K Levin, T Cocke, N Solenski, S Lim, M O'Brien, R Huang, D Easton, Feldmann, D Wiliams, G Eubank, S Yakubov, S Lanthier, R Ibrahim, E Hopkins, S Daniels, J Cavendish, S Ledford, G Kader, D Dobmeyer, E Avery, M Dobbs, McGuire, R Krasuski, D Wright, D Lasorda, R Myers, W Leimbach, G Kelly, P Kramer, E Garland, P Gorman, P Akins, J Kozina, L Wilson, J Maddux, D Cheng, D Sherev, D Winegarner, P Kramer, Anthony J Furlan, Mark Reisman, Joseph Massaro, Laura Mauri, Harold Adams, Gregory W Albers, Robert Felberg, Howard Herrmann, Saibal Kar, Michael Landzberg, Albert Raizner, Lawrence Wechsler, CLOSURE I Investigators, A Furlan, G Albers, H Adams, L Wechsler, R Felberg, M Reisman, M Landzberg, H Herrmann, S Kar, A Raizner, L Mauri, J Massaro, J P Mohr, T Brott, J Keane, M Larson, D Cutlip, M Fisher, V Mandell, T Chung, D Spence, K Sridhar, D Chiu, A Raizner, V Saxena, T Bajwa, I Katzan, C Sila, M Tuczu, L Latson, L Wechsler, W Anderson, D Gervais, P Fail, P Teal, D Ricci, T Lukovits, A Kaplan, M Schneck, F Leya, R Singh, S Cohen, S Kar, C Jaigobin, E Horlick, A Shuaib, D Taylor, J Absher, C Hudak, G Henderson, A Eisenhauer, S Kasner, H Herrmann, K Siller, J Slater, J Frey, R Heuser, G Albers, D Lee, S Pang, D Chu, P Ho, P Delio, J Aragon, I Silverman, R McKay, R Taylor, W Abernathy, F Oser, R Felberg, S Jenkins, S Ramee, G Tietjen, W Colyer, E Aldrich, R Wityk, R Ringel, E Albakri, T Sullebarger, H Adams, P Horwitz, T Fagan, G McIntosh, G Luckasen, R French, J Hermiller, M French, K Hreib, T Piemonte, J Belden, W Dietz, W Likosky, M Reisman, D Gzesh, C Thomas, D McCormick, J Erickson, D Schachter, A Felix, E Frantz, W Tan, R Tyndall, R Kipperman, P Wright, S Levchuck, D Johnston, J Webb, W Helveston, A Martin, C Ivan, A Bruno, S Sadanandan, J Breall, B Silver, A Greenbaum, J Floberg, K Baran, J Cochran, J Thompson, M Elkind, C Wright, R Sommer, S Kittner, B Reicher, M O'Brien, R Pick, A Forteza, Ortiz, E DeMarchena, N Cooke, C Garabedian, R Englander, S Lau, T Banas, K Ramani, W Felton, W Moskowitz, K Remmel, M Recto, S Mallenbaum, J Griffin, P Verro, J Rogers, R Swillie, S Bakir, W El-Feky, A Anwar, W Carroll, P Kanneganti, A Good, S Sivendran, R Welles, K Harjai, R Stephens, A Hosney, K Sanders, L Van Crisco, S Selco, S Farrow, A Rothman, H Echiverri, L McKeever, W Burgin, J Hollander, G Gacioch, M Kalafut, P Teirstein, A Favate, C Staniloae, S Silliman, L Guzman, T Bass, R Hart, S Bailey, N Cooke, B Batkoff, B Dandapani, S Karas, P Cullis, T Davis, K Levin, T Cocke, N Solenski, S Lim, M O'Brien, R Huang, D Easton, Feldmann, D Wiliams, G Eubank, S Yakubov, S Lanthier, R Ibrahim, E Hopkins, S Daniels, J Cavendish, S Ledford, G Kader, D Dobmeyer, E Avery, M Dobbs, McGuire, R Krasuski, D Wright, D Lasorda, R Myers, W Leimbach, G Kelly, P Kramer, E Garland, P Gorman, P Akins, J Kozina, L Wilson, J Maddux, D Cheng, D Sherev, D Winegarner, P Kramer
Abstract
Background: The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population. Closure with a percutaneous device is often recommended in such patients, but it is not known whether this intervention reduces the risk of recurrent stroke.
Methods: We conducted a multicenter, randomized, open-label trial of closure with a percutaneous device, as compared with medical therapy alone, in patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack (TIA) and had a patent foramen ovale. The primary end point was a composite of stroke or transient ischemic attack during 2 years of follow-up, death from any cause during the first 30 days, or death from neurologic causes between 31 days and 2 years.
Results: A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan-Meier estimate) of the primary end point was 5.5% in the closure group (447 patients) as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P=0.37). The respective rates were 2.9% and 3.1% for stroke (P=0.79) and 3.1% and 4.1% for TIA (P=0.44). No deaths occurred by 30 days in either group, and there were no deaths from neurologic causes during the 2-year follow-up period. A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events.
Conclusions: In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. (Funded by NMT Medical; ClinicalTrials.gov number, NCT00201461.).
Source: PubMed