Disclosures: Vranckx reports receiving personal fees from AstraZeneca, Bayer Health Care, CLS-Behring, Daiichi Sankyo, The Medicines Company and Terumo. Please see the study for all other authors’ relevant financial disclosures.
September 28, 2021
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Long-term ticagrelor monotherapy after PCI lowers bleeding risk in ACS vs. 1-year DAPT

Disclosures: Vranckx reports receiving personal fees from AstraZeneca, Bayer Health Care, CLS-Behring, Daiichi Sankyo, The Medicines Company and Terumo. Please see the study for all other authors’ relevant financial disclosures.
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Long-term ticagrelor monotherapy after PCI lowered risk for bleeding compared with 1-year dual antiplatelet therapy followed by 1-year aspirin monotherapy in patients with ACS, but not for those with CAD.

According to a new analysis of the GLOBAL LEADERS trial published in the Journal of the American Heart Association, the risk for the primary endpoint of nonfatal new Q-wave MI and all-cause mortality was not significantly different for patients with ACS or stable CAD, in either the long-term ticagrelor (Brilinta, AstraZeneca) monotherapy group or the standard DAPT control arm.

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“Current guidelines recommend DAPT with aspirin and clopidogrel for a duration of 6 to 12 months following PCI in patients with stable CAD and DAPT with aspirin and a potent P2Y12 inhibitor (ticagrelor or prasugrel) for a duration of 12 months in patients with ACS. Long-term aspirin monotherapy is recommended for all patients,” Pascal Vranckx, MD, PhD, interventional cardiologist at Hasselt University in Hasselt, Belgium, and colleagues wrote.

The GLOBAL LEADERS study was a randomized, open-label superiority trial that enrolled more than 15,000 patients with ACS and stable angina scheduled to undergo PCI with a drug-eluting stent who were later assigned to 1 month of aspirin plus ticagrelor followed by 23 months of ticagrelor monotherapy or to a control regimen of 1 year of standard DAPT followed by 1 year of aspirin.

The GLOBAL LEADERS trial

As Healio previously reported, 1 month of ticagrelor and aspirin therapy followed by ticagrelor alone was not superior to 1-year standard DAPT followed by 1-year aspirin monotherapy for reducing deaths or MI at 2 years.

In a subsequent non-prespecified analysis of the GLOBAL LEADERS trial, researchers evaluated the efficacy and safety of ticagrelor monotherapy after 1-month DAPT compared with standard 1-year DAPT in patients who underwent complex PCI, with a primary endpoint of all-cause death or nonfatal new Q-wave MI at 2 years. Researchers found that ticagrelor monotherapy was associated with a net clinical benefit in patients with complex PCI compared with a standard DAPT; however, the effect was not observed in patients with noncomplex PCI.

For the present study, researchers conducted a prespecified subgroup analysis in which participants were stratified into stable CAD and ACS subgroups. The primary composite end point included all-cause mortality or nonfatal new Q-wave MI at 2 years. The secondary safety endpoint was site-reported Bleeding Academic Research Consortium (BARC) grade 3 or 5 bleeding.

Results of the prespecified analysis

A total of 3,750 patients with ACS and 4,230 with CAD were assigned to the experimental group, whereas 3,737 patients with ACS and 4,251 with CAD were assigned to the control arm.

Among patients with ACS, the primary endpoint occurred in 3.92% of the experimental group compared with 4.52% of the control arm (RR = 0.86; 95% CI, 0.69-1.08; P = .189), and in patients with CAD, the primary endpoint occurred in 3.71% of the experimental group compared with 4.23% of the control arm (RR = 0.87; 95% CI, 0.71-1.08; P = .221; P for interaction = .926).

Among patients with ACS, the secondary safety endpoint occurred in 1.95% of the experimental group compared with 2.68% of the control arm (RR = 0.73; 95% CI, 0.54-0.98; P = .037), and in patients with stable CAD, it occurred in 2.13% of the experimental group compared with 1.62% of the control arm (RR = 1.32; 95% CI, 0.97-1.18; P = .081; P for interaction = 007).

“Our analysis suggests that withdrawal of aspirin after a short period of DAPT and continued treatment with ticagrelor monotherapy may represent a safer alternative to the current guideline-recommended treatment for reducing recurrent ischemic events in patients with ACS,” the researchers wrote. “Our analysis does not support the experimental strategy in patients with stable CAD because of the increased, albeit not statistically significant, incidence of bleeding throughout all landmark periods.

“Further research into the optimal antiplatelet regimen in adults with ACS may be a simple yet effective strategy to further improve clinical outcomes,” the researchers wrote.