Ticagrelor Monotherapy Beyond One Month after PCI in ACS or Stable CAD in Elderly Patients Aged Above 75 Years: a Prespecified Analysis of the Randomized GLOBAL LEADERS Trial.

Tomaniak, Mariusz; Chichareon, Ply; Modolo, Rodrigo; Takahashi, Kuniaki; Chang, Chun Chin; Kogame, Norihiro; Spitzer, Ernest; Buszman, Pawel E; van Geuns, Robert-Jan M; Valkov, Veselin; Steinwender, Clemens; Geisler, Tobias; Prokopczuk, Janusz; Sabaté, Manel; Zmudka, Krzysztof; Rademaker-Havinga, Tessa; Tijssen, Jan G P; Jüni, Peter; Hamm, Christian; Steg, Philippe Gabriel; ... (2020). Ticagrelor Monotherapy Beyond One Month after PCI in ACS or Stable CAD in Elderly Patients Aged Above 75 Years: a Prespecified Analysis of the Randomized GLOBAL LEADERS Trial. EuroIntervention, 15(18), e1605-e1614. Europa Digital & Publishing 10.4244/EIJ-D-19-00699

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AIMS

Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue.

METHODS AND RESULTS

A pre-specified analysis of randomized GLOBAL LEADERS (n=15991), 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=2565), the primary endpoint (two-year all-cause mortality or new Q-wave corelab-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 (HR1.29; 95%CI0.89-1.86;p=0.180;pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR2.05, 95%CI1.18-3.55) 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 prespecified, 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.

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