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Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting
Anna Franzone1, Eugène McFadden2, Sergio Leonardi3
1Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Insights
Ticagrelor monotherapy after short dual antiplatelet therapy proved noninferior for preventing ischemic events but not superior. This strategy did not reduce major bleeding risk compared to conventional treatment in patients post-stent implantation.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- The GLOBAL LEADERS study evaluated two antiplatelet strategies after percutaneous coronary intervention (PCI).
- 15,991 patients were randomized to 1-month dual antiplatelet therapy (DAPT) followed by ticagrelor monotherapy or 12-month DAPT.
- This ancillary study focused on specific efficacy and safety endpoints.
Purpose of the Study:
- To assess if ticagrelor monotherapy is noninferior, and potentially superior, to conventional DAPT for preventing ischemic events.
- To evaluate if the experimental therapy is superior in preventing major bleeding events (BARC 3 or 5).
- To analyze coprimary efficacy and safety endpoints at 2 years post-PCI.
Main Methods:
- An independent clinical event committee adjudicated events from 7,585 patients at top-enrolling sites.
- Investigator-reported events were analyzed, excluding Q-wave myocardial infarction (MI).
- Coprimary endpoints included all-cause death, nonfatal MI, nonfatal stroke, urgent target vessel revascularization, and BARC 3 or 5 bleeding.
Main Results:
- The experimental strategy (1-month DAPT + ticagrelor) was noninferior to conventional DAPT for the efficacy endpoint (7.14% vs 8.41%; RR 0.85; p<0.001).
- Superiority for the efficacy endpoint was not met (p=0.0465).
- No significant difference in major bleeding rates was observed (RR 1.00; p=0.986).
- A time-dependent effect showed lower MI and stent thrombosis risk with ticagrelor monotherapy after 1 year (p interaction=0.062 and p interaction=0.007, respectively).
Conclusions:
- Ticagrelor monotherapy following a brief DAPT period is noninferior, but not superior, to conventional treatment for preventing ischemic events.
- This strategy did not demonstrate a reduced risk of major bleeding compared to conventional DAPT.
- The findings suggest a potential benefit in reducing MI and stent thrombosis after one year, warranting further investigation.
Background:
The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported.
Objectives:
This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error.
Methods:
An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites.
Results:
The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention.
Conclusions:
Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059).
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