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Rationale: Enteral nutrition is beneficial for stroke patients with oral intake difficulties. However, it is time consuming and may interfere with routine medical care. Therefore, there is a clinical benefit if enteral nutrition can be safely administered in a short time. Although our retrospective study showed the safety of rapid administration, it remains unclear whether rapid administration of enteral nutrition is as safe as conventional administration. Aim: The randomized study of Enteral Nutrition with Rapid versus conventional administration in acute stroke patients (Rapid EN trial) aims to clarify the safety of rapid feeding of enteral nutrition compared with conventional feeding. Methods and design: This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligible criteria include acute stroke patients who have difficulty with oral intake defined as severe altered consciousness (Japan Coma Scale 10-300) or modified water swallowing test <4. The target enrollment is 700 patients, with 350 patients receiving rapid enteral nutrition at a rate of 100 mL in 5 min (Rapid EN group) and 350 patients receiving conventional enteral nutrition at a rate of 100 mL in 30 min (Conventional EN group). Study outcome: The primary outcome is the incidence of one or more complications of vomiting or diarrhea or pneumonia within 7 days would be non-inferior in the rapid EN group compared to the conventional EN group. Secondary outcomes were total time spent on enteral nutrition within 7 days from enteral nutrition, the incidence of vomiting, diarrhea and pneumonia within 3 or 7 days, and the rate of favorable clinical outcome. Discussion: Since no previous reports have focused on the speed of administration, we felt it was necessary to prove the safety of rapid administration. If this study shows positive results, it will not only benefit patients, but also reduce the burden of medical care. We believe this study is novel and will be useful in clinical practice. Clinical trial registration: https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000046610 Identifier UMIN000046610.
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BACKGROUND AND PURPOSE: Reocclusion after treatment is a concern in endovascular therapy (EVT) for isolated intracranial atherothrombotic stroke-related large vessel occlusion (AT-LVO). However, the optimal EVT technique for AT-LVO has not yet been investigated. This study evaluated the optimal EVT technique for AT-LVO in a real-world setting. MATERIALS AND METHODS: We conducted a historical multicenter registry study at 51 centers that enrolled patients with AT-LVO. We divided the patients into three groups based on the EVT technique: mechanical thrombectomy alone (MT-only), percutaneous transluminal angioplasty (PTA), and stent deployment (Stent). MT alone was classified into the MT-only group, PTA and MT-PTA into the PTA group, and MT-Stent, MT-PTA-Stent, PTA-Stent, and Stent-only into the Stent group. The primary outcome was the incidence of reocclusion of the treated vessels within 90 days of EVT completion. RESULTS: We enrolled 770 patients and analyzed 509 patients. The rates in the MT-only, PTA, and Stent groups were 40.7, 44.4, and 14.9%, respectively. The incidence rate of residual stenosis >70% of final angiography was significantly higher in the MT-only group than in the PTA and Stent groups (MT-only vs. PTA vs. Stent: 34.5% vs. 26.3% vs. 13.2%, p=0.002). The reocclusion rate was significantly lower in the PTA group than in the MT-only group (adjusted hazard ratio [95% confidence interval], 0.48 [0.29-0.80]). Of the patients, 83.5% experienced reocclusion within 10 days after EVT. Alarmingly, a substantial subset (approximately 62.0%) of patients underwent reocclusion within 2 days of EVT. The incidence of modified Rankin scale scores of 0-2 90 days after EVT was not significantly different among the three groups. The incidences of symptomatic intracranial hemorrhage (ICH), any other ICH, and death were not significantly different. CONCLUSIONS: The incidence rate of reocclusion was significantly lower in the PTA group than in the MT-only group. We found no significant difference in reocclusion rates between the Stent and MT-only groups. In Japan, GP IIb/IIIa inhibitors are not reimbursed. Therefore, PTA might be the preferred choice for AT-LVOs due to the higher reocclusion risk with MT-only. Reocclusion was likely to occur within 10 days, particularly within 2 days post-EVT. ABBREVIATIONS: EVT = endovascular treatment; LVO = large vessel occlusion; MT = mechanical thrombectomy; PTA = percutaneous transluminal angioplasty; ICH = intracranial hemorrhage; SD = standard deviation; IQR = interquartile range; HRs = hazard ratios; BMI = body mass index; LDL = low-density lipoprotein; HDL = high-density lipoprotein; DAPT = dual antiplatelet therapy; TAPT = triple antiplatelet therapy.