ABSTRACT
Background@#and Purpose The benefit regarding co-treatment with intravenous (IV) thrombolysis before mechanical thrombectomy in acute ischemic stroke with large vessel occlusion remains unclear. To test the hypothesis that clinical outcome of ischemic stroke patients with intracranial internal carotid artery, middle cerebral artery or basilar artery occlusion treated with direct endovascular thrombectomy within 4.5 hours will be non-inferior compared with that of standard bridging IV thrombolysis followed by endovascular thrombectomy. @*Methods@#To randomize 780 patients 1:1 to direct thrombectomy or bridging IV thrombolysis with thrombectomy. An international-multicenter prospective randomized open label blinded endpoint trial (PROBE) (ClincalTrials.gov identifier: NCT03494920). @*Results@#Primary endpoint is functional independence defined as modified Rankin Scale (mRS) 0–2 or return to baseline at 90 days. Secondary end points include ordinal mRS analysis, good angiographic reperfusion (modified Thrombolysis in Cerebral Infarction score [mTICI] 2b–3), safety endpoints include symptomatic intracerebral hemorrhage and death. @*Conclusions@#DIRECT-SAFE will provide unique information regarding the impact of direct thrombectomy in patients with large vessel occlusion, including patients with basilar artery occlusion, with comparison across different ethnic groups.
ABSTRACT
Background and Objectives: There is a paucity of comparative studies on young strokes between populations of different ethnicities and geographical regions. The purpose of this study was to compare the patterns, risk factors and etiologies of ischaemic stroke in younger patients between stroke registries in Malaysia and Australia. Methods: From January 2007 to March 2008, all consecutive ischaemic stroke patients from the age of 18 to 49 were studied. Results: There were 67 patients for Malaysia and 61 for Australia, with 4 deaths in the Malaysian series (case-fatality of 6%), and no deaths for Australia. The mean age was 41.5±8.8 yrs for Malaysia and 40.1±8.8 years for Australia. The ethnic origin was Malays, Chinese and Indian for Malaysia, and Caucasians (85%) for Australia. The sex ratio was M : F = 1.4 : 1 for Malaysia and 1.54 :1 for Australia. The differences in risk factors for Malaysia versus Australia were: Diabetes (OR 7.25; 95% CI 2.78-19.45), hypertension (OR 6.42; 95% CI 2.75-15.22) and chronic renal disease (OR 5.2; 95% CI 1.02-35.87). Conversely, smoking was a signifi cant risk factor for Australia (OR 2.75; 95% CI 1.2-6.37). The Malaysian patients have signifi cantly higher proportions of large vessel atherosclerosis and small vessel occlusion by TOAST classifi cation, accounting for 60% of patients, while the Australian series had greater proportions of cardioembolism and patients in the determined aetiologies category, specifi cally vascular dissection. Conclusion: There were signifi cantly more large vessel atherosclerosis and small vessel occlusion among young Malaysians with ischaemic stroke as compared to Australia.