Saturday, September 15, 2018

POINT trial

Johnston SC et al. Clopidogrel and aspirin in acute ischemic stroke and high risk TIA.  NEJM; 379:215-225  

Gotta, JC.  Antiplatelet therapy after ischemic stroke or TIA. NEJM 379:291 (editorial)

Chinese trial (CHANCE) previously showed a benefit of dual anti platelets in a Chinese population for a short period after stroke.  This study was a  RCT 1:1 of minor ischemic stroke  (NIHSS of 3 or less) or high risk TIA (ABCD2>4) to receive clopidorel loading dose (600 mg on day one, then 75 mg per day) plus aspirin 50-325 mg po daily (dual anti platelets or DAP), v. aspirin alone.  Primary outcome was the risk of composite ischemic events (Stroke, MI, or CV death). 4881 patients at 269 sites internationally.  After 84 percent enrollment, the trial was halted when trial showed less major ischemic events AND higher risk of major hemorrhage at 90 days than mono therapy.  The effect size was fairly small, with 6.5 % risk in DAP, 5.0 % in aspirin alone.  Major hemorrhage occurred in 0.9 % of DAP, 0.4 percent of aspirin alone. This was a ninety day trial.  

Commment- basic math shows 1.5 percent less major ischemic events, 0.5 percent more major hemorrhage with DAP.  Previously Chinese trial (CHANCE) showed 32 % decreased stroke recurrence with DAP and no increased hemorrhages.

James Grotta- Most of the prevented events were ischemic strokes arguably the most important outcome after TIA/minor stroke.  Most of the bleeding were systemic, nonfatal,nonintracranial hemorrhages.  Most of the benefit occurred int he first week, most of the hemorrhages occurred later.  DAP should be confined to a limited time, eg. the first three weeks.  

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