Hope remains for NeuroFlo stroke intervention

19 May 2011

MedWire News: The novel catheter treatment NeuroFlo did not improve the outcomes of acute stroke patients in a randomized controlled trial, but the researchers say that it may yet prove effective in selected patients.

During treatment, the dual-balloon NeuroFlo catheter is placed in the abdominal aorta and the balloons are inflated to occupy about 70% of the aortic lumen for 45 minutes, resulting in a pressure reduction of about 10–15 mmHg across the two balloons.

This has previously been shown to cause a significant and sustained increase in blood flow velocities in the middle cerebral arteries.

In the Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke (SENTIS) trial, Ashfaq Shuaib (University of Alberta, Edmonton, Canada) and colleagues randomly assigned 515 patients to receive NeuroFlo treatment or standard medical care, with treatment initiated up to 14 hours after symptom onset.

The primary safety endpoint of serious adverse events, including intracranial hemorrhage, and neurologic, renal, and pulmonary events, did not differ between the groups, at rates of 43.9% and 42.8% in the NeuroFlo and control groups, respectively.

But the primary efficacy global endpoint was also unaffected by treatment allocation, with similar proportions of both groups achieving good outcomes on the National Institutes of Health Stroke Scale (NIHSS), the modified Rankin Scale (mRS), the Barthel Index, and the Glasgow Outcome scale.

However, post-hoc analyses revealed fewer stroke-related deaths in the NeuroFlo group, at 7.4%, compared with 14.4% in the control group. It also indicated that patients were significantly more likely to achieve a good outcome (mRS 0–2) with NeuroFlo versus standard treatment if they were treated within 5 hours from symptom onset, had moderately severe stroke (NIHSS 8–14), and were aged 70 years or older.

Shuaib et al say that a restricted treatment window is consistent with trials of other stroke treatments, including thrombolysis. And patients with moderate neurologic deficits tend to have the most to gain from intervention, as those with minor deficits often improve without treatment, whereas those with severe deficits have already sustained significant permanent damage.

“In retrospect, the SENTIS trial may not have selected the appropriate stroke outcome measure cut-points for identifying clinically appropriate patient benefits along the continuum of stroke outcomes in a trial that evaluated an interventional therapy as late as 14 hours after onset,” they comment in the journal Stroke.

“Additional studies may be appropriate to confirm the subgroup trends demonstrated here and to explore the use of this technique in combination with recombinant tissue plasminogen activator, as well as other intra-arterial techniques,” conclude the researchers.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

Stroke 2011; Advance online publication