Ticagrelor monotherapy for 23 months after 1-month DAPT did not significantly reduce patient-oriented composite endpoints compared to standard 12-month DAPT (HR 0.93; 95% CI 0.85-1.01; p=0.085).
RCT (n=15,991)
open-label
randomised
Sí
Does 23-month ticagrelor monotherapy following one-month DAPT reduce patient-oriented composite endpoints and net adverse clinical events in patients undergoing PCI?
Ticagrelor monotherapy for 23 months after 1 month of DAPT did not significantly reduce patient-oriented composite endpoints or net adverse clinical events compared to standard 12-month DAPT followed by aspirin in patients undergoing PCI.
Estimación del efecto: HR 0.93 (95% CI 0.85-1.01)
Tasa de eventos absoluta: 13.2% vs 14.2%
valor p: p=0.085
AIMS: The aim of this study was to evaluate the impact of 23-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) on the rates of patient-oriented composite endpoints (POCE) and net adverse clinical events (NACE). METHODS AND RESULTS: The rates of site-reported Academic Research Consortium (ARC)-2 defined POCE (all-cause death, any stroke, any myocardial infarction or any revascularisation) and NACE (POCE or bleeding type 3 or 5 according to the Bleeding ARC BARC) were reported up to two years by intention-to-treat principle in the randomised, multicentre, open-label GLOBAL LEADERS study comparing two antiplatelet strategies in 15,991 patients undergoing PCI. The experimental strategy consisted of aspirin with ticagrelor for one month followed by ticagrelor monotherapy for 23 months, whereas the reference treatment consisted of 12-month DAPT followed by 12-month aspirin monotherapy. At two years, POCE occurred in 1,050 (13.2%) patients in the experimental group and in 1,131 (14.2%) in the reference group (HR 0.93, 95% CI: 0.85-1.01, p=0.085). NACE occurred in 1,145 (14.4%) patients in the experimental group and in 1,237 (15.5%) patients in the reference group (HR 0.92, 95% CI: 0.85-1.00, p=0.057). In pre-specified subgroup analyses, no significant treatment-by-subgroup interactions were found for either POCE or NACE at two years. CONCLUSIONS: The experimental treatment strategy of one-month DAPT followed by 23 months of ticagrelor alone did not result in a significant reduction in the rates of site-reported POCE or NACE, when compared to the reference treatment. ClinicalTrials.gov Identifier: NCT01813435.
Serruys et al. (Sun,) conducted a rct in percutaneous coronary intervention (n=15,991). ticagrelor monotherapy vs. 12-month DAPT followed by 12-month aspirin monotherapy was evaluated on patient-oriented composite endpoints (POCE) (all-cause death, any stroke, any myocardial infarction or any revascularisation) (HR 0.93, 95% CI 0.85-1.01, p=0.085). Ticagrelor monotherapy for 23 months after 1-month DAPT did not significantly reduce patient-oriented composite endpoints compared to standard 12-month DAPT (HR 0.93; 95% CI 0.85-1.01; p=0.085).