What they're saying about late alteplase

Based on thoughts expressed in conversation with other neurologists. Sorry can't attribute but these are high powered people's thoughts
1. No position statement yet exists from ASA or elsewhere
2. Patient selection was no diabetics, NIHSS < 25
3. ATLANTIS a negative study had 30 minute time difference, and twice as many diabetics
4. Genentech has opportunity to go for a label change if they feel the data are compelling
5. DEFUSE and EPITHET suggest use of neuroimaging to guide patient selection
6. An updated metaanalysis may not meet FDA requirement of 2 Randomized clinical trials
7. Improved peristroke care and better systems have led to better outcomes, including glycemic control
8. Better rate of SICH was definitional-- if they defined it as NINDS did, their SICH would have been around 8 % leading to more "pushback"
9.The prior 3-6 hour studies had lots of patients outside the 4 and a half hour window which might account for their negative results
10. Better definition for treatment of tia's needed as well as pushing tpa window
11. Smaller strokes might be better treated up to the longer window
12. Need to review ATLANTIS again http://www.ncbi.nlm.nih.gov/pubmed/10591384?ordinalpos=2&itool=EntrezSys which was Genentech sponsored, highly powered negative study unlike the characterization in NEJM
13. Study should be compared to SAINT study
14. In Atlantis 32% of the placebo and 34% of the tPA treated had NIHSS 0,1at 90 days. Diabetes in 18% placebo, 25% tPA. AF 14%/19%. In ECASS3 43% of the placebo and 50% of the tPA treated had NIHSS 0,1 at90 days. Diabetes 17% placebo, 15% tPA. AF 14%/13%. Though age and NIHSS on entry was not different something different ledto improved outcome in the Europeans. More diabetes and AF in treated group in Atlantis. Would be interesting if Europeans release infarct volume data.