Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, et al. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar. 22;366(12):1099–1107. PMID 22435369
See Ryan’s review of this paper published a few days ago.
This paper has, of course, got some slightly hyperbolic press that Domhnall pointed me towards.
METHODS
- RCT, open label; alteplase vs tenectaplase at two doses (BI make both but guess which one wil run out of patent first…)
- usual stroke lysis criteria but additional CT perfusing criteria needed.
- Enrolled only 3% of those assessed within 6 hrs; vast majority excluded for “standard CI to alteplase”. Some others were excluded because of criteria specific to this trial.
- “co-primary outcomes” which is a weird thing, I thought there should be one, being primary and all that… Anyway one of the primary outcomes was an imaging based one and the other was improvement in NIHSS at 24hrs. Note that these are different from the standard outcomes in other papers which is a delayed mRS score.
RESULTS
- n = 75 split over 3 groups
- tenectaplase was better at everything, better recovery and lower bleed rates. Though with numbers this small and selection criteria this tight and outcomes that aren’t the same as other trials it’s very hard to know if any of it means anything.
WHAT DOES IT MEAN
- maybe… with all the fancy technology we can now pick out better the people who do well with stroke. In NINDS the mRS 0-1 was 26% and 39% for an NIHSS of 14 whereas here the mRS of 0-1 was 40% and 54% for an NIHSS of 14. Something is getting better it seems. And there’s good evidence that stroke care is better, it’s just not clear that the tPA is making the difference
- or maybe… it’s just a typical trial of something new in the early stages of its research where initial results look wonderful but over time it doesn’t quite pan out.
Note there was a previous prematurely terminated trial (for slow enrolment) of this a while back which didn’t find any difference between alteplase and tenectaplase. It had 112 pts by the way…
I’ll review it when I’ve gone through more of the details. Reference below:
Haley EC, Thompson JLP, Grotta JC, Lyden PD, Hemmen TG, Brown DL, et al. Phase IIB/III trial of tenecteplase in acute ischemic stroke: results of a prematurely terminated randomized clinical trial. Stroke. 2010 Apr.;41(4):707–711. PMC2860601