October 17, 2019
Ticagrelor Monotherapy Shows Promise for Patients Undergoing Multivessel PCI in GLOBAL LEADERS Study
October 17, 2019—Data from the GLOBAL LEADERS study suggest that long-term ticagrelor monotherapy after 1-month dual antiplatelet therapy (DAPT) can favorably balance ischemic and bleeding risks in patients undergoing multivessel percutaneous coronary intervention (PCI). Kuniaki Takahashi, MD, et al, who published the study in Journal of the American College of Cardiology (JACC), advised that these findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials (2019;74:2015–2027).
The post hoc study investigated the impact of an experimental strategy of 1-month DAPT followed by 23-month ticagrelor monotherapy versus a reference regimen of 12-month DAPT followed by 12-month aspirin monotherapy when used after multivessel PCI.
As summarized in JACC, the GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding.
The investigators found that among the overall study population (n = 15,845), 3,576 (22.4%) patients undergoing multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared with those who underwent single-vessel PCI.
There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio, 0.62; 95% confidence interval, 0.44–0.88; P interaction = .031). This difference was largely driven by a lower risk of all-cause mortality.
In contrast, the risk of BARC type 3 or 5 bleeding was statistically similar between the two regimens (hazard ratio, 0.92; 95% confidence interval, 0.61–1.39; P interaction = .754), reported the GLOBAL LEADERS investigators in JACC.