Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke

Abstract

BACKGROUND Endovascular therapy is increasingly used after the administration of intravenous tissue plasminogen activator (t-PA) for patients with moderate-to-severe acute ischemic stroke, but whether a combined approach is more effective than intravenous t-PA alone is uncertain. METHODS We randomly assigned eligible patients who had received intravenous t-PA within 3 hours after symptom onset to receive additional endovascular therapy or intravenous t-PA alone, in a 2:1 ratio. The primary outcome measure was a modified Rankin scale score of 2 or less (indicating functional independence) at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). RESULTS The study was stopped early because of futility after 656 participants had undergone randomization (434 patients to endovascular therapy and 222 to intravenous t-PA alone). The proportion of participants with a modified Rankin score of 2 or less at 90 days did not differ significantly according to treatment (40.8% with endovascular therapy and 38.7% with intravenous t-PA; absolute adjusted difference, 1.5 percentage points; 95% confidence interval [CI], −6.1 to 9.1, with adjustment for the National Institutes of Health Stroke Scale [NIHSS] score [8–19, indicating moderately severe stroke, or ≥20, indicating severe stroke]), nor were there significant differences for the predefined subgroups of patients with an NIHSS score of 20 or higher (6.8 percentage points; 95% CI, −4.4 to 18.1) and those with a score of 19 or lower (−1.0 percentage point; 95% CI, −10.8 to 8.8). Findings in the endovascular-therapy and intravenous t-PA groups were similar for mortality at 90 days (19.1% and 21.6%, respectively; P = 0.52) and the proportion of patients with symptomatic intracerebral hemorrhage within 30 hours after initiation of t-PA (6.2% and 5.9%, respectively; P = 0.83). CONCLUSIONS The trial showed similar safety outcomes and no significant difference in functional independence with endovascular therapy after intravenous t-PA, as compared with intravenous t-PA alone. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00359424.)

Collateral state and the effect of endovascular reperfusion therapy on clinical outcome in ischemic stroke patients

“…2013) was confirmed or if reperfusion could not be achieved within 2 h (Broderick et al. 2013). All interventions were registered with an external quality control program from July 2010 onwards.…”

HERMES: messenger for stroke interventional treatment

“…The collaborators justifiably omitted earlier trials (most notably IMS-3) 6 since these trials were done in an era when CT angiography was not widely available to confirm arterial occlusion and interventions relied on first-generation thrombectomy devices that were subsequently established as less effective and potentially more hazardous than the stent-retriever devices used in most of the trials in HERMES. 7,8 71% are reported to have achieved revascularisation-a standard achievable in expert units using the current generation of endovascular thrombectomy devices.…”

Future trials on endovascular stroke treatment: the not-so-easy-to-pluck fruits

“…It is likely a combination of factors. First, we did not really expect IMS3 [4] that studied evolving endovascular stroke treatment techniques to show a negative result. It was a neutral study due to a combination of factors.…”