TY - JOUR
T1 - Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients
T2 - A pre-specified analysis of the GLOBAL LEADERS trial
AU - GLOBAL LEADERS Investigators
AU - Tomaniak, Mariusz
AU - Chichareon, Ply
AU - Modolo, Rodrigo
AU - Takahashi, Kuniaki
AU - Chang, Chun Ching
AU - Kogame, Norihiro
AU - Spitzer, Ernest
AU - Buszman, Pawel E.
AU - van Geuns, Robert Jan
AU - Valkov, Veselin
AU - Steinwender, Clemens
AU - Geisler, Tobias
AU - Prokopczuk, Janusz
AU - Sabaté, Manel
AU - Żmudka, Krzysztof
AU - Rademaker-Havinga, Tessa
AU - Tijssen, Jan G.P.
AU - Jüni, Peter
AU - Hamm, Christian
AU - Gabriel Steg, P.
AU - Onuma, Yoshinobu
AU - Vranckx, Pascal
AU - Valgimigli, Marco
AU - Windecker, Stephan
AU - Baber, Usman
AU - Anderson, Richard
AU - Dominici, Marcello
AU - Serruys, Patrick W.
N1 - Publisher Copyright:
© Europa Digital & Publishing 2020. All rights reserved.
PY - 2020
Y1 - 2020
N2 - Aims: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age. Methods and results: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin). Among elderly patients (>75 years; n=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.58-0.99, p=0.041; pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4% vs 1.4%, p=0.015, pint=0.01), compared with the reference group. Conclusions: In this pre-specified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating. ClinicalTrials.gov identifier: NCT01813435.
AB - Aims: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age. Methods and results: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin). Among elderly patients (>75 years; n=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.58-0.99, p=0.041; pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4% vs 1.4%, p=0.015, pint=0.01), compared with the reference group. Conclusions: In this pre-specified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating. ClinicalTrials.gov identifier: NCT01813435.
KW - ACS/NSTE-ACS
KW - Adjunctive pharmacotherapy
KW - Bleeding
KW - Elderly (>75)
KW - Stable angina
UR - http://www.scopus.com/inward/record.url?scp=85083415775&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-19-00699
DO - 10.4244/EIJ-D-19-00699
M3 - Article
C2 - 31845894
AN - SCOPUS:85083415775
SN - 1774-024X
VL - 15
SP - E1605-E1617
JO - EuroIntervention
JF - EuroIntervention
IS - 18
ER -
