We compared the efficacy and safety of Solitaire with the standard, predicate
mechanical thrombectomy device, AG14699 the Merci Retrieval System.
Methods In this randomised, parallel-group, non-inferiority trial, we enrolled patients from 18 sites (17 in the USA and one in France). Patients were eligible for inclusion if they had acute ischaemic stroke with moderate to severe neurological deficits and were treatable by thrombectomy within 8 h of stroke symptom onset. We used a computer-generated randomisation sequence to randomly allocate patients to receive thrombectomy treatment with either Solitaire or Merci (1: 1; block sizes of four and stratified by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial
Ischemia (TIMI) scale 2 or 3 flow in all treatable vessels without symptomatic intracranial haemorrhage, after up to three passes of the assigned device, as assessed by an independent core laboratory, which was masked to study assignment. Primary analysis was done by intention to treat. A prespecified efficacy stopping rule triggered an early halt to the trial. The study is registered with ClinicalTrials.gov, number NCT 01054560.
Results Between February, 2010, and February, 2011, we randomly allocated 58 patients to the Solitaire group and 55 patients to the Merci group. The primary efficacy outcome was achieved more often in the Solitaire group than it was in the Merci group (61% vs 24%; difference 37% [95% CI 19-53], odds ratio Selleckchem 5-Fluoracil [OR] 4.87 [95% CI 2.14-11.10]; p(non-inferiority)<0.0001, p(superiority)=0.0001). More patients had good 3-month neurological outcome with Solitaire than with Hormones antagonist Merci (58% vs 33%; difference 25% [6-43], OR 2.78 [1.25-6.22]; p(non-inferiority)=0.0001, p(superiority)=0.02). 90-day mortality was lower in the Solitaire group than it was in the Merci
group (17 vs 38; difference -21% [-39 to -3], OR 0.34 [0.14-0.81]; p(non-inferiority)=0.0001, p(superiority)=0.02).
Interpretation The Solitaire Flow Restoration Device achieved substantially better angiographic, safety, and clinical outcomes than did the Merci Retrieval System. The Solitaire device might be a future treatment of choice for endovascular recanalisation in acute ischaemic stroke.”
“Streptomyces lividans is known to produce large amounts of proteins in culture supernatants. In this report, to expand the secretory expression system with a strong promoter derived from phospholipase D of Streptoverticillium cinnamoneum, we expressed three kinds of proteins: transglutaminase from Sty. cinnamoneum (StvcMTG) and beta-1,4-endoglucanase and beta-glucosidase from Thermobifida fusca YX. The StvcMTG gene was introduced into S. lividans using the shuttle vector pUC702 for Escherichia coil and S. lividans, and high level secretory production of StvcMTG (230 mu g/ml in the culture supernatant) was achieved.