The GLOBAL LEADERS study includes a pre-specified sub-study, GLASSY, that showed that ticagrelor monotherapy after one month of dual antiplatelet therapy is non-inferior (but not superior) to conventional treatment in terms of ischemic events. As regards safety, ticagrelor monotherapy did not decrease major bleeding compared with conventional therapy.
The GLOBAL LEADERS randomized 15,991 patients who required coronary angioplasty to 1-month dual antiplatelet therapy followed by 23-month ticagrelor monotherapy vs. 12-month dual antiplatelet therapy followed by 12-month aspirin monotherapy (conventional treatment).
Researchers planned a sub-study in case the experimental therapy with ticagrelor met the non-inferiority criterion, something that happened. This sub-study analyzed its superiority for the combined endpoint of death, infarction, stroke, or urgent revascularization, and also for the prevention of BARC 3 to 5 bleeding (major bleeding according to the Thrombolysis In Myocardial Infarction [TIMI] definition).
After 2 years of follow-up, the combined endpoint occurred in 7.1% of patients with ticagrelor monotherapy vs. 8.4% in the conventional therapy group. These numbers clearly reach non-inferiority (p < 0.001) but not superiority (p = 0.0465).
The rates for BARC 3 to 5 bleeding were literally identical (rate ratio [RR]: 1.00; 95% confidence interval [CI]: 0.75 to 1.33; p = 0.986).
There was a time-dependent effect with the experimental strategy as regards a reduction in infarction (RR: 0.54; 95% CI: 0.33 to 0.88; p = 0.062) and in definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p = 0.007).
Conclusion
Ticagrelor monotherapy after one month of dual antiplatelet therapy after angioplasty with drug-eluting stents is non-inferior, but in no way superior, to conventional treatment. In terms of safety, it did not reduce major bleeding either.
Original title:: Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting.
Reference: Anna Franzone et al. J Am Coll Cardiol 2019;74:2223–34. For the GLASSY Investigators.
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