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Title: | Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial | Authors: | 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 Onuma, Yoshinobu VRANCKX, Pascal Valgimigli, Marco Windecker, Stephan Baber, Usman Anderson, Richard Dominici, Marcello Serruys, Patrick W. |
Issue Date: | 2020 | Publisher: | Source: | EuroIntervention, 15 (18) , p. e1605 -e1614 | Abstract: | 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 pm-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991 comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference (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; p(int) =0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (BR 1.29, 95% CI: 0.89-1.86; p=0.180; p(int) =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 (p(int) =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, p(int) =0.01), compared with the reference group. Conclusions: In this pm-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. | Document URI: | http://hdl.handle.net/1942/34567 | ISSN: | 1774-024X | e-ISSN: | 1969-6213 | DOI: | 10.4244/EIJ-D-19-00699 | ISI #: | WOS:000523373500013 | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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