Rivaroxaban vs Warfarin Sodium in the Ultra-Early Period After Atrial Fibrillation-Related Mild Ischemic Stroke: A Randomized Clinical Trial.

Importance: In atrial fibrillation (AF)-related acute ischemic stroke, the optimal oral anticoagulation strategy remains unclear. Objective: To test whether rivaroxaban or warfarin sodium is safer and more effective for preventing early recurrent stroke in patients with AF-related acute ischemic stroke. Design, Setting, and Participants: A randomized, multicenter, open-label, blinded end point evaluation, comparative phase 2 trial was conducted from April 28, 2014, to December 7, 2015, at 14 academic medical centers in South Korea among patients with mild AF-related stroke within the previous 5 days who were deemed suitable for early anticoagulation. Analysis was performed on a modified intent-to-treat basis. Interventions: Participants were randomized 1:1 to receive rivaroxaban, 10 mg/d for 5 days followed by 15 or 20 mg/d, or warfarin with a target international normalized ratio of 2.0-3.0, for 4 weeks. Main Outcomes and Measures: The primary end point was the composite of new ischemic lesion or new intracranial hemorrhage seen on results of magnetic resonance imaging at 4 weeks. Primary analysis was performed in patients who received at least 1 dose of study medications and completed follow-up magnetic resonance imaging. Key secondary end points were individual components of the primary end point and hospitalization length. Results: Of 195 patients randomized, 183 individuals (76 women and 107 men; mean [SD] age, 70.4 [10.4] years) completed magnetic resonance imaging follow-up and were included in the primary end point analysis. The rivaroxaban group (n = 95) and warfarin group (n = 88) showed no differences in the primary end point (47 [49.5%] vs 48 [54.5%]; relative risk, 0.91; 95% CI, 0.69-1.20; P = .49) or its individual components (new ischemic lesion: 28 [29.5%] vs 31 of 87 [35.6%]; relative risk, 0.83; 95% CI, 0.54-1.26; P = .38; new intracranial hemorrhage: 30 [31.6%] vs 25 of 87 [28.7%]; relative risk, 1.10; 95% CI, 0.70-1.71; P = .68). Each group had 1 clinical ischemic stroke, and all new intracranial hemorrhages were asymptomatic hemorrhagic transformations. Hospitalization length was reduced with rivaroxaban compared with warfarin (median, 4.0 days [interquartile range, 2.0-6.0 days] vs 6.0 days [interquartile range, 4.0-8.0]; P < .001). Conclusions and Relevance: In mild AF-related acute ischemic stroke, rivaroxaban and warfarin had comparable safety and efficacy. Trial Registration: clinicaltrials.gov Identifier: NCT02042534.

Characteristics of the Drip-and-Ship Paradigm for Patients with Acute Ischemic Stroke in South Korea.

BACKGROUND: Data on the drip-and-ship paradigm in Korea are limited. The present study aimed to evaluate the use of the drip-and-ship paradigm and the time delays and outcomes associated with the paradigm in Korea. METHODS: We used data from the Clinical Research Center for Stroke-5 registry between January 2011 and March 2014. Among patients treated with tissue-type plasminogen activator (tPA), the use of the drip-and-ship paradigm was evaluated, and time delays and functional outcomes at 3 months were compared between patients treated with the paradigm and those treated directly at visits. RESULTS: Among 1843 patients who met the eligibility criteria, 244 patients (13.2%) were treated with the drip-and-ship paradigm. Subsequent endovascular recanalization therapy was used in 509 patients (27.6%). The median time from symptom onset to groin puncture was greater in patients treated with the paradigm than in those treated directly at visits (305 versus 200 minutes, P < .001). In multivariate analysis, the risks of unfavorable functional outcomes and symptomatic intracranial hemorrhage were higher inpatients treated with the paradigm than in those directly treated at visits (odds ratio [OR] 2.15; 95% confidence interval [CI], 1.50-3.08; P < .001 and OR 1.78; 95% CI, 1.02-3.12; P = .041, respectively). CONCLUSIONS: In Korea, the drip-and-ship paradigm was used in less than 15% of all patients treated with tPA. The use of the paradigm might cause an increase in the onset-to-groin puncture time. Additionally, clinical outcomes might be worse in patients treated with the paradigm than in those treated directly at visits.

Impact of Prehospital Intervention on Delay Time to Thrombolytic Therapy in a Stroke Center with a Systemized Stroke Code Program.

BACKGROUND: The use of emergency medical services (EMS) and notification to hospitals by paramedics for patients with suspected stroke are crucial determinants in reducing delay time to acute stroke treatment. The aim of this study is to investigate whether EMS use and prehospital notification (PN) can shorten the time to thrombolytic therapy in a stroke center with a systemized stroke code program. METHODS: Beginning in January 2012, stroke experts in our stroke center received direct calls via mobile phone from paramedics prenotifying the transport of patients with suspected stroke. We compared baseline characteristics and prehospital/in-hospital delay time in stroke patients treated with intravenous recombinant tissue plasminogen activator for 44 months with and without EMS use and/or PN. RESULTS: Intravenous thrombolytic therapy was performed on 274 patients. Of those patients, 215 (78.5%) were transported to the hospital via EMS and 59 (21.5%) were admitted via private modes of transportation. The patients who used EMS had shorter median onset-to-arrival times (62 minutes versus 116 minutes, P < .001). There was no difference in in-hospital delay time between the 2 groups. In 28 cases (13%) of EMS transport, EMS personnel called the clinical staff to notify the incoming patient. Prenotification by EMS was associated with shorter median door-to-imaging time (9 minutes versus 12 minutes, P = .045) and door-to-needle time (20 minutes versus 29 minutes, P = .011). CONCLUSIONS: We found that EMS use reduces prehospital delay time. However, EMS use without prenotification does not shorten in-hospital processing time in a stroke center with a systemized stroke code program.