Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke

Abstract

IMPORTANCEWhether intravenous thrombolysis is needed in combination with mechanical thrombectomy in patients with acute large vessel occlusion stroke is unclear.OBJECTIVE To examine whether mechanical thrombectomy alone is noninferior to combined intravenous thrombolysis plus mechanical thrombectomy for favorable poststroke outcome. Investigator-initiated, multicenter, randomized, open-label, noninferiority clinical trial in 204 patients with acute ischemic stroke due to large vessel occlusion enrolled at 23 hospital networks in DESIGN, SETTING, AND PARTICIPANTS

Treating acute large vessel occlusion stroke: to bridge or not to bridge?

“…2 Simultaneously published with DEVT, the SKIP (Direct Mechanical Thrombectomy in Acute LVO Stroke) trial included 204 patients who had an acute ischaemic stroke with internal carotid artery or middle cerebral artery M1 occlusions presenting within 4.5 hours of stroke onset across 23 sites in Japan. 3 Favourable outcome occurred in 60 patients (59.4%) in the dEVT group and 59 patients (57.3%) in the BT group, with no significant between-group difference (difference, 2.1% (1-sided 97.5% CI −11.4% to ∞); OR 1.09 (1-sided 97.5% CI 0.63 to ∞); p=0.18 for non-inferiority). 3 Noted that the trial used a reduced dose of alteplase (0.6 mg/kg), which did not show the non-inferiority to standard dose of alteplase (0.9 mg/kg).…”

“…3 Favourable outcome occurred in 60 patients (59.4%) in the dEVT group and 59 patients (57.3%) in the BT group, with no significant between-group difference (difference, 2.1% (1-sided 97.5% CI −11.4% to ∞); OR 1.09 (1-sided 97.5% CI 0.63 to ∞); p=0.18 for non-inferiority). 3 Noted that the trial used a reduced dose of alteplase (0.6 mg/kg), which did not show the non-inferiority to standard dose of alteplase (0.9 mg/kg). 4 Herein, we provide an aggregate data metaanalysis of the DIRECT-MT, 1 the DEVT 2 and the SKIP 3 trials.…”

“…The percentage of achieving a Thrombolysis in Cerebral Infarction score 2b-3 was numerically higher in the bridging group, around 5% in DIRECT-MT 1 and 3% in SKIP. 3 The rates of successful recanalisation, 90-day mortality, and symptomatic intracerebral haemorrhage were not significantly different between the dEVT and the BT groups (figure 1).…”

“…The door-to-needle times of DIRECT-MT, 1 DEVT 2 and SKIP 3 were 59 (45-78) min, 61 (49-81) min and 50 min, respectively, which represent a substantial delay in relation to the 40 (29-55) min reported in the HERMES meta-analysis (Highly Effective Reperfusion Evaluated Open access in Multiple Endovascular Stroke Trials) and may have resulted in lower rates of favourable outcomes than what would have been accomplished with shorter door-toneedle times. 7 Moreover, the rates of favourable outcomes noted in DIRECT-MT 1 were significantly lower than those noted in DEVT 2 and SKIP.…”

“…7 Moreover, the rates of favourable outcomes noted in DIRECT-MT 1 were significantly lower than those noted in DEVT 2 and SKIP. 3 This may be related to the differences of stroke aetiology across the trials with varying proportions of undetermined causes and intracranial atherosclerosis. Moreover, whether intravenous tPA infusion was completed in the bridging groups of these three trials prior to thrombectomy began was not reported.…”