Safety and efficacy comparison between OACs plus single antiplatelet and dual antiplatelet therapy in patients with cerebral venous sinus stenosis poststenting.

BACKGROUND AND PURPOSE: The present strategies regarding poststent management for cerebral venous sinus stenosis (CVSS) are inconsistent. Herein, we compared the safety and efficacy of oral anticoagulants (OACs) plus single antiplatelet therapy and dual antiplatelet therapy for CVSS poststenting. METHODS: A real-world observational study conducted from January 2009 through October 2019 enrolled patients who were diagnosed with CVSS and received stenting. Patients were divided into two groups according to the management they received poststenting. Group 1: OACs plus a single antiplatelet agent (clopidogrel 75 mg or aspirin 100 mg) and Group 2: dual antiplatelet therapy (clopidogrel 75 mg plus aspirin 100 mg). The safety (such as major or minor bleeding or venous thrombosis) and efficacy (the incidences of cerebral venous sinus restenosis, intrastent thrombosis, or stent displacement) of the two groups were compared. RESULTS: There were a total of 110 eligible patients in the final analysis, including 79 females and 31 males with a mean age of 43.42 ± 13.23 years. No major bleeding or venous thrombosis occurred in either of the two groups. Two minor bleeding events occurred in group 2 (one with subcutaneous bleeding points in both lower limbs, another with submucosal bleeding in the mouth), whereas no bleeding events occurred in Group 1. In addition, at the 1-year follow-up, one case of intraluminal restenosis and two cases of in-stent thrombi occurred in Group 2, while none occurred in Group 1. Neither stenosis at stent-adjacent segments nor stent migration was detected in either group during the 1-year following stent placement. CONCLUSION: OACs plus single antiplatelet therapy and dual antiplatelet therapy alone are both safe and efficacious management strategies after CVSS stent placement. The former may have more advantages than the latter for inhibiting intrastent thrombosis. However, further research by larger, multicenter clinical trials is needed.

Advance of antithrombotic treatment in patients with cerebral microbleed.

With the elder proportion increasing and the antithrombotic agents widely using as well as the newly magnetic resonance imaging sequence emerging, the detection rate of cerebral microbleed (CMB) is gradually raising in recent years. As we all know that CMB mainly reflects the severity of deeply small vessel lesions, which predicts hemorrhagic transformation. Whereby, to some patients with both CMB and remarkable antithrombotic indication, treatment becomes a dilemma. We have to face the challenge of weighing the pros and cons of both drug indication and bleeding risk when making a proper decision for patients. This study summarized recent advance on CMB diagnosis and treatment, to provide a useful reference to physicians in their clinical practice.

Chronic remote ischaemic conditioning in patients with symptomatic intracranial atherosclerotic stenosis (the RICA trial): a multicentre, randomised, double-blind sham-controlled trial in China.

BACKGROUND: Intracranial atherosclerotic stenosis (ICAS) is one of the most common causes of stroke worldwide, and it is associated with a high risk of recurrent stroke with currently recommended treatments. We aimed to evaluate the effect of chronic remote ischaemic conditioning on prevention of ischaemic events in patients with symptomatic ICAS. METHODS: The RICA trial is a multicentre, randomised, double-blind, sham-controlled trial at 84 stroke centres in China. Patients aged 40-80 years with ischaemic stroke or transient ischaemic attack attributable to angiographically verified 50-99% stenosis of a major intracranial artery were randomly assigned (1:1), via an interactive web-based system by computer-generated randomisation code, to either remote ischaemic conditioning or sham remote ischaemic conditioning once daily for 12 months and voluntarily thereafter. All investigators and patients were masked to treatment allocation. The primary efficacy endpoint was the time to first occurrence of non-fatal or fatal ischaemic stroke, with survival analysed by the Kaplan-Meier method. Primary and safety analyses were done in the intention-to-treat population. The RICA trial is registered with ClinicalTrials.gov, number NCT02534545. FINDINGS: Between Oct 28, 2015, and Feb 28, 2019, 3033 patients were enrolled and randomly assigned to either remote ischaemic conditioning (n=1517; intervention group) or sham remote ischaemic conditioning (n=1516; sham group). Median follow-up was 3·5 years (IQR 2·7-4·4). A non-fatal or fatal ischaemic stroke occurred in 257 (16·9%) patients in the intervention group compared with 288 (19·0%) patients in sham group. There was no difference in the survival distribution for time to first occurrence of non-fatal or fatal ischaemic stroke (hazard ratio 0·87, 95% CI 0·74-1·03; p=0·12). In the intervention group, 79 (5·2%) patients died from any cause, and in the sham group, 84 (5·5%) patients died from any cause (hazard ratio 0·93, 95% CI 0·68-1·27; p=0·65). No intervention-related serious adverse events were observed. INTERPRETATION: No evidence was found for a difference between remote ischaemic conditioning and sham remote ischaemic conditioning in lowering the risk of ischaemic stroke in patients with symptomatic ICAS. The benefit of remote ischaemic conditioning might have been diluted by poor compliance. Future studies of remote ischaemic conditioning in this population should address challenges in patients' compliance and assess longer term treatment. FUNDING: Ministry of Science and Technology China, Beijing Municipal Education Commission, Beijing Municipal Finance Bureau. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

Circadian rhythms may not influence the outcomes of thrombolysis in patients with ischemic stroke: A study from China.

Circadian rhythms can affect physical or mental activities as well as the time of stroke onset. The impact of circadian rhythms on acute ischemic stroke (AIS) patients treated by recombinant alteplase (rt-PA) is still incongruent. This study aims to consider whether the outcomes of thrombolysis differ depending on stroke onset time and rt-PA infusion time in patients with AIS. A total of 447 AIS patients, who underwent rt-PA intravenous infusion within 4.5 hours after stroke onset, were enrolled in this study consecutively from June 2010 through December 2016. All of the patients were grouped based on the stroke onset time and rt-PA infusion time into two exact 12-hour intervals as daytime (06:01-18:00) and nighttime (18:01-06:00) and further divided into four subgroups at 6-hour time intervals (00:01-06:00, 06:01-12:00, 12:01-18:00 and 18:01-24:00). Major neurological improvement at 1 hour, 24 hours and 7 days, 7-day mortality rate and 24-hour hemorrhage transformation was recorded. The results showed that a total of 295 patients (66.4%) appeared with AIS and 252 (56.4%) were treated during daytime. Higher NIHSS at admission was observed when stroke occurred in nighttime, especially during 00:01-06:00. Patients with stroke onset in nighttime especially during 18:01-24:00 had a significant shorter onset-door time and onset-needle time. No differences of the major neurological improvement at 1 hour, 24 hours and 7 days, 24-hour hemorrhagic transformation and 7-day fatality rate were found among either 12-hour time frames or 6-hour time frames according to the time of stroke onset or rt-PA infusion. In conclusion, there was no evidence to predict that circadian rhythms could influence the outcomes of AIS patients treated with rt-PA in China, although stroke onset during nighttime might aggravate neurological impairment before treatment. Further, multicenter and prospective clinical trials with larger number of subjects are still needed to draw more reliable conclusions.

Safety and validity of mechanical thrombectomy and thrombolysis on severe cerebral venous sinus thrombosis.

BACKGROUND: Although the majority of patients with cerebral venous sinus thrombosis (CVST) obtain an optimistic clinical outcome after heparin or warfarin treatment, there remains a subgroup of patients who do not respond to conventional anticoagulation treatment. These patients, especially younger people, as documented by hospital-based studies, have a high morbidity and mortality rate. OBJECTIVE: To verify the safety and efficacy of a dual mechanical thrombectomy with thrombolysis treatment modality option in patients with severe CVST. METHODS: Fifty-two patients diagnosed with CVST were enrolled and treated with mechanical thrombectomy combined with thrombolysis. Patients underwent urokinase 100 to 1500 × 10 IU intravenous sinus injection via a jugular catheter after confirming diagnoses of CVST by using either magnetic resonance imaging/magnetic resonance venography or digital subtract angiography. Information obtained on the patients included recanalization status of venous sinuses as evaluated by magnetic resonance venography or digital subtract angiography at admission, during operation, and at 3- and 6-month follow-up after treatment. RESULTS: The percentage of patients that showed complete and partial recanalization were 87% and 6%, respectively, after mechanical thrombectomy combined with thrombolysis treatment; 8% of the patients showed no recanalization. The modified Rankin Scale scores were 1.0 ± 0.9, 0.85 ± 0.63, and 0.37 ± 0.53 for discharge, and 3- and 6-month follow-up, respectively. A total of 6 patients died despite receiving aggressive treatment. No cases of relapse occurred after 3 to 6 months of follow-up. CONCLUSION: Thrombectomy combined with thrombolysis is a safe and valid treatment modality to use in severe CVST cases or in intractable patients that have shown no adequate response to antithrombotic drugs.