Penumbra announced results of the company-sponsored PROMISE study, demonstrating real-world safety and efficacy of the Penumbra system with ACE 68 and ACE64 reperfusion catheters as frontline treatment in patients with acute ischaemic stroke.
The PROMISE study used the ADAPT (A direct aspiration first pass technique) approach and its results were presented at the International Stroke Conference (ISC 2018) in Los Angeles, USA.
“ADAPT as a frontline approach demonstrated excellent results – both in revascularisation rates and clinical outcomes,” said Peter Schramm, department of Neuroradiology, Universitatsklinikum Schleswig-Holstein, Lubeck, Germany. “In addition, the low mortality rate and strong safety profile indicate that stroke revascularisation with aspiration is safer and more effective with ACE68 and ACE64 than ever before.”
The PROMISE study was a prospective, single-arm multicentre study that enrolled 204 patients across 20 European centres. Core-lab adjudicated mTICI 2b–3 revascularisation was attained in 93.1% of patients, with 39.2% of patients attaining mTICI 3 revascularisation. Clinical independence, measured by modified Rankin Score (mRS) 0–2, was achieved in 61% of patients at 90 days. Key secondary safety related endpoints also demonstrated excellent results: All-cause mortality at 90 days was 7.5%, symptomatic intracranial haemorrhage (sICH) at 24 hours was 2.9% and embolization in new territories was 1.5%. Median procedure time, as measured as groin puncture to mTICI 2b–3 revascularisation, was 31 minutes [20–53].