PLATO

Platelet Inhibition and Patient Outcomes

Patient / Population Intervention / Exposure Comparison Outcome

In 18,624 patients hospitalised with ACS, ticagrelor reduced CV death, MI or stroke compared with clopidogrel, with similar major bleeding.

18,624

Design

Double-blind RCT, 12 mo

Endpoint

CV death, MI or stroke at 12 months

Relevance

Result9.8 % vs 11.7 % (HR 0.84). All-cause mortality also reduced.

Wallentin L, et al. N Engl J Med. 2009;361(11):1045-1057. 10.1056/NEJMoa0904327

Discussion & critique

Regional heterogeneity (notably worse outcomes in the US sites) prompted FDA scrutiny — attributed to higher aspirin doses. Dyspnoea and bradycardia are notable adverse signals.