Efficacy and Safety of Rivaroxaban Versus Aspirin in Embolic Stroke of Undetermined Source and Carotid Atherosclerosis
Por:
Ntaios, G, Swaminathan, B, Berkowitz, SD, Gagliardi, RJ, Lang, W, Siegler, JE, Lavados, P, Mundl, H, Bornstein, N, Meseguer, E, Amarenco, P, Cucchiara, B, Camps-Renom, P, Makaritsis, K, Korompoki, E, Papavasileiou, V, Marti-Fabregas, J, Milionis, H, Vemmos, K, Connolly, SJ, Hart, RG, NAVIGATE ESUS Investigators
Publicada:
1 sep 2019
Resumen:
Background and Purpose- The sources of emboli in patients with embolic stroke of undetermined source (ESUS) are multiple and may not respond uniformly to anticoagulation. In this exploratory subgroup analysis of patients with carotid atherosclerosis in the NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial Versus ASA to Prevent Embolism)-ESUS trial, we assessed whether the treatment effect in this subgroup is consistent with the overall trial population and investigated the association of carotid atherosclerosis with recurrent ischemic stroke. Methods- Carotid atherosclerosis was analyzed either as the presence of mild (ie, 20%-49%) atherosclerotic stenosis or, separately, as the presence of carotid plaque. Primary efficacy outcome was ischemic stroke recurrence. Safety outcomes were major bleeding and symptomatic intracerebral bleeding. Results- Carotid plaque was present in 40% of participants and mild carotid stenosis in 11%. There was no significant difference in ischemic stroke recurrence between rivaroxaban- and aspirin-treated patients among 490 patients with carotid stenosis (5.0 versus 5.9/100 patient-years, respectively, hazard ratio [HR], 0.85; 95% CI, 0.39-1.87; P for interaction of treatment effect with patients without carotid stenosis 0.78) and among 2905 patients with carotid plaques (5.9 versus 4.9/100 patient-years, respectively, HR, 1.20; 95% CI, 0.86-1.68; P for interaction of treatment effect with patients without carotid stenosis 0.2). Among patients with carotid plaque, major bleeding was more frequent in rivaroxaban-treated patients compared with aspirin-treated (2.0 versus 0.5/100 patient-years, HR, 3.75; 95% CI, 1.63-8.65). Patients with carotid stenosis had similar rate of ischemic stroke recurrence compared with those without (5.4 versus 4.9/100 patient-years, respectively, HR, 1.11; 95% CI, 0.73-1.69), but there was a strong trend of higher rate of ischemic stroke recurrence in patients with carotid plaque compared with those without (5.4 versus 4.3/100 patient-years, respectively, HR, 1.23; 95% CI, 0.99-1.54). Conclusions- In ESUS patients with carotid atherosclerosis, we found no difference in efficacy between rivaroxaban and aspirin for prevention of recurrent stroke, but aspirin was safer, consistent with the overall trial results. Carotid plaque was much more often present ipsilateral to the qualifying ischemic stroke than contralateral, supporting an important etiological role of nonstenotic carotid disease in ESUS.
Filiaciones:
Ntaios, G:
Univ Thessaly, Dept Internal Med, Larisa, Greece
Swaminathan, B:
Populat Hlth Res Inst, Hamilton, ON, Canada
Berkowitz, SD:
Bayer US LLC, Pharmaceut Clin Dev Thrombosis, Whippany, NJ USA
Gagliardi, RJ:
Irmandade Santa Casa Misericordia Sao Paulo, Sao Paulo, Brazil
Lang, W:
Sigmund Freud Private Univ, Hosp St John God, Med Fac, Vienna, Austria
Siegler, JE:
Hosp Univ Penn, Dept Neurol, Philadelphia, PA 19104 USA
Lavados, P:
Clin Alemana Santiago, Santiago, Chile
Mundl, H:
Bayer AG, Wuppertal, Germany
Bornstein, N:
Shaare Zedek Med Ctr Jerusalem, Jerusalem, Israel
Meseguer, E:
Hop Xavier Bichat, Neurol Serv, Paris, France
Amarenco, P:
Sorbonne Paris Cite Univ, Paris Diderot, Bichat Hosp, AP HP, Paris, France
Cucchiara, B:
Hosp Univ Penn, Dept Neurol, Philadelphia, PA 19104 USA
Camps-Renom, P:
Hosp Santa Creu & Sant Pau, Serv Neurol, Unitat Malalties Vasc Cerebrals, Barcelona, Spain
Makaritsis, K:
Univ Thessaly, Dept Internal Med, Larisa, Greece
Korompoki, E:
Imperial Coll London, Charing Cross Hosp, Div Brain Sci, London, England
Univ Athens, Sch Med, Dept Clin Therapeut, Athens, Greece
Papavasileiou, V:
Univ Leeds, Sch Med, Leeds Teaching Hosp NHS Trust, Stroke Med, Leeds, W Yorkshire, England
Marti-Fabregas, J:
Hosp Santa Creu & Sant Pau, Serv Neurol, Unitat Malalties Vasc Cerebrals, Barcelona, Spain
Milionis, H:
Univ Ioannina, Fac Med, Sch Hlth Sci, Ioannina, Greece
Vemmos, K:
Hellen Cardiovasc Res Soc, Athens, Greece
Connolly, SJ:
McMaster Univ, Populat Hlth Res Inst, Dept Med Cardiol, Hamilton, ON, Canada
Hart, RG:
McMaster Univ, Populat Hlth Res Inst, Dept Med Neurol, Hamilton, ON, Canada
Bronze
|