Background: The global ROCKET AF study evaluated once-daily rivaroxaban vs. warfarin for stroke and systemic embolism prevention in patients with atrial fibrillation (AF). A separate trial, J-ROCKET ...AF, compared the safety of a Japan-specific rivaroxaban dose with warfarin administered according to Japanese guidelines in Japanese patients with AF. Methods and Results: J-ROCKET AF was a prospective, randomized, double-blind, phase III trial. Patients (n=1,280) with non-valvular AF at increased risk for stroke were randomized to receive 15mg once-daily rivaroxaban or warfarin dose-adjusted according to Japanese guidelines. The primary objective was to determine non-inferiority of rivaroxaban against warfarin for the principal safety outcome of major and non-major clinically relevant bleeding, in the on-treatment safety population. The primary efficacy endpoint was the composite of stroke and systemic embolism. Non-inferiority of rivaroxaban to warfarin was confirmed; the rate of the principal safety outcome was 18.04% per year in rivaroxaban-treated patients and 16.42% per year in warfarin-treated patients (hazard ratio HR 1.11; 95% confidence interval 0.87–1.42; P<0.001 non-inferiority). Intracranial hemorrhage rates were 0.8% with rivaroxaban and 1.6% with warfarin. There was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban vs. warfarin (HR, 0.49; P=0.050). Conclusions: J-ROCKET AF demonstrated the safety of a Japan-specific rivaroxaban dose and supports bridging the global ROCKET AF results into Japanese clinical practice. (Circ J 2012; 76: 2104–2111)
The water-swallowing test (WST) is frequently used in clinical practice as a functional assessment to detect aspiration and prevent pneumonia. It is a standardized test used all over the world, but ...the amount of water given varies depending on the examiner. Furthermore, there are very few reports on the simultaneous performance of the WST and videofluorography (VF). This study compared the amount of swallowed water to investigate the reliability of WST to exclude aspiration following acute stroke.
We assessed 111 stroke patients (65 men and 46 women) with suspected dysphagia/difficulty in swallowing and performed VF upon obtaining consent from the patients and their families. Patients were aged between 20 and 98 years (65.6 ± 13.4 years); 64 had cerebral infarction, 26 cerebral hemorrhage, 13 subarachnoid hemorrhage, and 8 had other cerebrovascular disease. The time from stroke onset to VF was 16.6 ± 10.3 days (range, 2-55). WSTs using 5, 10, 30, and 60 ml and the modified WST (MWST) were performed during VF.
We found that the number of instances of choking, cough, wet voice, and aspiration increased with higher amounts of water. The sensitivity and specificity of WST for aspiration ranged from 34.8 to 55.7% and from 78.9 to 93.2%, respectively. The MWST, which used only 3 ml of water, yielded a sensitivity of 55.3% and a specificity of 80.8% for aspiration. There was a positive correlation between the time for one swallow and age, but there was no difference between genders. There was also no connection between clinical findings during WST or the presence of aspiration with the number of swallows, swallowing speed, or time for one swallow.
WSTs are not as powerful as VF as a screening instrument in acute stroke. WSTs with more water detected aspiration with greater sensitivity, but there is no justification for overconfidence when investigating aspiration. We recommend using WST as well as VF to investigate swallowing in stroke patients.
Background:Only a few studies have addressed the optimal start time for oral anticoagulants (OACs) after acute ischemic stroke in patients with nonvalvular atrial fibrillation (NVAF). The aim of this ...retrospective study was to analyze the time of OAC administration after stroke onset.Methods and Results:This study included 300 patients with NVAF who had acute ischemic stroke and were treated with OACs between April 2012 and March 2016. We investigated the time at which OACs were started by anticoagulant type and the relationship between the time of OAC administration and stroke severity (the National Institutes of Health Stroke Scale NIHSS score on admission). Of the 300 patients, 114 and 186 patients received warfarin and direct-acting OACs (DOACs), respectively. Patients in the DOAC group had OAC initiated therapy significantly sooner (3 days) than in the warfarin group (7 days; P<0.001). With regard to stroke severity (NIHSS score <8, mild; 8–16, moderate; >16, severe), the median time for starting therapy was 2, 7, and 11 days for mild, moderate, and severe stroke, respectively. Hemorrhagic events occurred in 3 patients in the warfarin group; however, no hemorrhagic events occurred in the DOAC group.Conclusions:Our study revealed that neurologists began OACs earlier in patients with mild acute cerebral infarction. Even in patients with severe stroke, OACs were started earlier than expected.
In Japan, a new medical specialist system started in 2018 and has established the "Comprehensive Medical Specialist" program. The Japan Medical Agency allows specially-appointed supervisors, such as ...specialists in particular branches of internal medicine, to transfer to the "general practitioner" program. These specialists are often considered as reserve general practitioners. In April 2016, we conducted a survey of 2,666 randomly selected specialists in 11 societies related to the Japanese Society of Internal Medicine. Of the 404 who responded (15.2% response rate), 142 (35.1%) were "certification-oriented." Logistic regression analysis with the outcome of desire for certification as a general practitioner (yes = 1) showed odds of 2.293 (95% confidence interval: 1.379-3.811) for "cannot take the necessary time to prepare" and 12.417 (95% confidence interval: 2.856-53.986) for "should be eligible to take the exam without leaving my current job." Creating an environment that allows specialists in internal medicine across various specialties to prepare for certification as a general practitioner, while continuing to work in their current positions, would help to increase the number of high-quality general practitioners to supply the need in Japan.
Summary Background The antiplatelet drug cilostazol is efficacious for prevention of stroke recurrence compared with placebo. We designed the second Cilostazol Stroke Prevention Study (CSPS 2) to ...establish non-inferiority of cilostazol versus aspirin for prevention of stroke, and to compare the efficacy and safety of cilostazol and aspirin in patients with non-cardioembolic ischaemic stroke. Methods Patients aged 20–79 years who had had a cerebral infarction within the previous 26 weeks were enrolled at 278 sites in Japan and allocated to receive 100 mg cilostazol twice daily or 81 mg aspirin once daily for 1–5 years. Patients were allocated according to a computer-generated randomisation sequence by means of a dynamic balancing method using patient information obtained at registration. All patients, study personnel, investigators, and the sponsor were masked to treatment allocation. The primary endpoint was the first occurrence of stroke (cerebral infarction, cerebral haemorrhage, or subarachnoid haemorrhage). The predefined margin of non-inferiority was an upper 95% CI limit for the hazard ratio of 1·33. Analyses were by full-analysis set. This trial is registered with ClinicalTrials.gov , number NCT00234065. Findings Between December, 2003, and October, 2006, 2757 patients were enrolled and randomly allocated to receive cilostazol (n=1379) or aspirin (n=1378), of whom 1337 on cilostazol and 1335 on aspirin were included in analyses; mean follow-up was 29 months (SD 16). The primary endpoint occurred at yearly rates of 2·76% (n=82) in the cilostazol group and 3·71% (n=119) in the aspirin group (hazard ratio 0·743, 95% CI 0·564–0·981; p=0·0357). Haemorrhagic events (cerebral haemorrhage, subarachnoid haemorrhage, or haemorrhage requiring hospital admission) occurred in fewer patients on cilostazol (0·77%, n=23) than on aspirin (1·78%, n=57; 0·458, 0·296–0·711; p=0·0004), but headache, diarrhoea, palpitation, dizziness, and tachycardia were more frequent in the cilostazol group than in the aspirin group. Interpretation Cilostazol seems to be non-inferior, and might be superior, to aspirin for prevention of stroke after an ischaemic stroke, and was associated with fewer haemorrhagic events. Therefore, cilostazol could be used for prevention of stroke in patients with non-cardioembolic stroke. Funding Otsuka Pharmaceutical.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Postural tachycardia syndrome (POTS) can cause orthostatic headache. However, it is difficult to differentiate POTS from spontaneous intracranial hypotension (SIH) caused by cerebrospinal fluid (CSF) ...leaks. We herein report a 53-year-old woman who presented with SIH associated with POTS. A cervicothoracic and lumbar epidural blood patch rapidly improved not only the headache but also the orthostatic tachycardia, suggesting POTS secondary to SIH. This case suggests that a CSF leak can cause secondary POTS. Therefore, POTS should be considered in patients with orthostatic headaches, even in the presence of a CSF leak.
Aims: The efficacy of antiplatelet therapy may vary among different disease subtypes. Prasugrel is generally a more potent, consistent, and fast-acting platelet inhibitor than clopidogrel. This ...sub-analysis of the phase III comparison of PRAsugrel and clopidogrel in Japanese patients with ischemic STROke (PRASTRO-I) trial aimed to assess the differences in efficacy of these treatments for each stroke subtype. Methods: In the PRASTRO-I trial, a total of 3,753 patients with ischemic stroke were recruited from 224 centers throughout Japan and randomized (1:1) to prasugrel (3.75 mg/day) or clopidogrel (75 mg/day) for 96 weeks. For the sub-analysis, strokes were classified as large-artery atherosclerosis, small-artery occlusion (lacunar), stroke of other etiology, and stroke of undetermined etiology. The cumulative incidence of primary events (ischemic stroke, myocardial infarction, and death from other vascular cause) and hazard ratios (HRs) were calculated for each subgroup. Results: For patients with large-artery atherosclerosis, the primary event incidence was 3.8% in the prasugrel group and 4.8% in the clopidogrel group (HR 0.79; 95% confidence interval CI 0.45–1.41). For patients with small-artery occlusion, the incidence was 3.3% in the prasugrel group and 3.9% in the clopidogrel group (HR 0.82; 95% CI 0.45–1.50). For patients with stroke of undetermined etiology, the incidence was 4.6% in the prasugrel group and 3.0% in the clopidogrel group (HR 1.56; 95% CI 0.90–2.72). The incidence of bleeding was similar across subtypes. Conclusions: Although statistical significance was not reached, the efficacy of prasugrel was potentially different between stroke subtypes, warranting further studies.
As the goal of mechanical thrombectomy is shifting toward mTICI-3 rather than mTICI-2b, we sought to clarify the limitation of the effect of mTICI-3. A post-hoc analysis of a registry of large-vessel ...occlusion stroke from 46 centers was conducted. Among 2,420 registered patients, 725 patients with anterior circulation occlusion who achieved successful reperfusion were analyzed. We compared outcomes between patients with mTICI-3 and mTICI-2b, and investigated how the effect of mTICI-3 changed according to baseline characteristics and time course. The proportion of patients with favorable outcomes (mRS 0-2 at day 90) was higher among patients with mTICI-3 compared to those with mTICI-2b (adjusted OR, 2.10; 95% CI, 1.49-2.97). There was no heterogeneity in the effect of mTICI-3 with respect to age, neurological deficit, alteplase use, occluded vessels, or infarct size. mTICI-3 was associated with favorable outcomes when the puncture-to-reperfusion time was <80 minutes (adjusted OR, 2.28; 95% CI, 1.52-3.41), but not when the puncture-to-reperfusion time was ≥80 minutes. A significant heterogeneity was found in the effect of mTICI-3 reperfusion across the puncture-to-reperfusion time subgroups (P for interaction = 0.025). Until when operators should continue the procedure after mTICI-2b has been achieved, needs to be studied.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
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