Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source
Por:
Hart, RG, Sharma, M, Mundl, H, Kasner, SE, Bangdiwala, SI, Berkowitz, SD, Swaminathan, B, Lavados, P, Wang, Y, Davalos, A, Shamalov, N, Mikulik, R, Cunha, L, Lindgren, A, Arauz, A, Lang, W, Czlonkowska, A, Eckstein, J, Gagliardi, RJ, Amarenco, P, Ameriso, SF, Tatlisumak, T, Veltkamp, R, Hankey, GJ, Toni, D, Bereczki, D, Uchiyama, S, Ntaios, G, Yoon, BW, Brouns, R, Endres, M, Muir, KW, Bornstein, N, Ozturk, S, O'Donnell, MJ, Basson, MMD, Pare, G, Pater, C, Kirsch, B, Sheridan, P, Peters, G, Weitz, JI, Peacock, WF, Shoamanesh, A, Benavente, OR, Joyner, C, Themeles, E and Connolly, SJ
Publicada:
7 jun 2018
Categoría:
Medicine (miscellaneous)
Resumen:
BACKGROUND
Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin.
METHODS
We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source. The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding.
RESULTS
A total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban. The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P=0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P<0.001).
CONCLUSIONS
Rivaroxaban was not superior to aspirin with regard to the prevention of recurrent stroke after an initial embolic stroke of undetermined source and was associated with a higher risk of bleeding.
Filiaciones:
Hart, RG:
Thrombosis & Atherosclerosis Res Inst, Dept Med Neurol, Hamilton, ON, Canada
Sharma, M:
Thrombosis & Atherosclerosis Res Inst, Dept Med Neurol, Hamilton, ON, Canada
Mundl, H:
Bayer, Wuppertal, Germany
Kasner, SE:
Univ Penn, Dept Neurol, Philadelphia, PA 19104 USA
Bangdiwala, SI:
Thrombosis & Atherosclerosis Res Inst, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
Berkowitz, SD:
Bayer US, Pharmaceut Clin Dev Thrombosis, Whippany, NJ USA
Swaminathan, B:
Thrombosis & Atherosclerosis Res Inst, Populat Hlth Res Inst, Hamilton, ON, Canada
Lavados, P:
Clin Alemana Santiago, Santiago, Chile
Wang, Y:
Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China
Beijing Tiantan Hosp, Stroke Ctr, Beijing, Peoples R China
:
Univ Autonoma Barcelona, Hosp Germans Trias & Pujol, Barcelona, Spain
Shamalov, N:
Pirogov Russian Natl Res Med Univ, Moscow, Russia
Mikulik, R:
St Annes Univ Hosp, Int Clin Res Ctr, Brno, Czech Republic
St Annes Univ Hosp, Neurol Dept, Brno, Czech Republic
Cunha, L:
Hosp Univ Coimbra, Ctr Hosp & Univ Coimbra, Coimbra, Portugal
Lindgren, A:
Lund Univ, Dept Clin Sci Neurol, Lund, Sweden
Skane Univ Hosp, Dept Neurol & Rehabil Med, Lund, Sweden
Arauz, A:
Inst Nacl Neurol & Neurocirug, Mexico City, DF, Mexico
Lang, W:
Sigmund Freud Private Univ, Hosp St John God, Med Fac, Vienna, Austria
Czlonkowska, A:
Med Univ Warsaw, Inst Psychiat & Neurol, Dept Neurol 2, Warsaw, Poland
Med Univ Warsaw, Dept Pharmacol, Warsaw, Poland
Eckstein, J:
Univ Hosp Basel, Dept Internal Med, Basel, Switzerland
Gagliardi, RJ:
Irmandade Santa Casa Misericordia Sao Paulo, Sao Paulo, Brazil
Amarenco, P:
Sorbonne Paris Cite Univ, Paris Diderot, Bichat Hosp, AP HP, Paris, France
Ameriso, SF:
Fdn Lucha Enfermedades Neurol Infancia, Inst Neurol Research, Buenos Aires, DF, Argentina
Tatlisumak, T:
Univ Gothenburg, Sahlgrenska Acad, Inst Neurosci & Physiol, Dept Clin Neurosci Neurol, Gothenburg, Sweden
Univ Helsinki, Cent Hosp, Dept Neurol, Helsinki, Finland
Veltkamp, R:
Imperial Coll London, London, England
Hankey, GJ:
Univ Western Australia, Med Sch, Perth, WA, Australia
Sir Charles Gairdner Hosp, Perth, WA, Australia
Toni, D:
Sapienza Univ Rome, Dept Human Neurosci, Rome, Italy
Bereczki, D:
Semmelweis Univ, Dept Neurol, Budapest, Hungary
Uchiyama, S:
Int Univ Hlth & Welf, Sanno Hosp, Tokyo, Japan
Sanno Med Ctr, Tokyo, Japan
Ntaios, G:
Univ Thessaly, Dept Med, Larisa, Greece
Yoon, BW:
Seoul Natl Univ Hosp, Seoul Natl Univ, Coll Med, Seoul, South Korea
Brouns, R:
Vrije Univ Brussel, Fac Med & Pharm, Brussels, Belgium
ZorgSaam Hosp, Dept Neurol, Terneuzen, Netherlands
Endres, M:
Charite Univ Med Berlin, Klin Neurol, Berlin, Germany
Muir, KW:
Queen Elizabeth Univ Hosp, Univ Glasgow, Inst Neurosci & Psychol, Glasgow, Lanark, Scotland
Bornstein, N:
Shaare Zedek Med Ctr, Jerusalem, Israel
Ozturk, S:
Selcuk Univ, Dept Neurol, Konya, Turkey
O'Donnell, MJ:
Natl Univ Ireland, Hlth Res Board Clin Res Facil, Galway, Ireland
Basson, MMD:
Internal Med Karl Bremer Hosp, Tiervlei Trial Ctr & Head, Bellville, South Africa
Pare, G:
Thrombosis & Atherosclerosis Res Inst, Dept Pathol & Mol Med, Hamilton, ON, Canada
Pater, C:
Bayer, Leverkusen, Germany
Kirsch, B:
Bayer, Berlin, Germany
Sheridan, P:
Thrombosis & Atherosclerosis Res Inst, Populat Hlth Res Inst, Hamilton, ON, Canada
Peters, G:
Janssen Res & Dev, Spring House, PA USA
Weitz, JI:
McMaster Univ, Hamilton, ON, Canada
Peacock, WF:
Baylor Coll Med, Houston, TX USA
Shoamanesh, A:
Thrombosis & Atherosclerosis Res Inst, Dept Med Neurol, Hamilton, ON, Canada
Benavente, OR:
Univ British Columbia, Vancouver Stroke Program, Vancouver, BC, Canada
Joyner, C:
Univ Toronto, Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada
Themeles, E:
Thrombosis & Atherosclerosis Res Inst, Populat Hlth Res Inst, Hamilton, ON, Canada
Connolly, SJ:
Thrombosis & Atherosclerosis Res Inst, Dept Med Cardiol, Hamilton, ON, Canada
Green Published, Green Accepted, Bronze
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