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Title: | Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events | Authors: | Hara, Hironori van Klaveren, David Takahashi, Kuniaki Kogame, Norihiro Chichareon, Ply Modolo, Rodrigo Tomaniak, Mariusz Ono, Masafumi Kawashima, Hideyuki Wang, Rutao Gao, Chao Niethammer, Margit Fontos, Geza Angioi, Michael Ribeiro, Vasco Gama Barbato, Emanuele Leandro, Sergio Hamm, Christian Valgimigli, Marco Windecker, Stephan Juni, Peter Steg, Philippe Gabriel VERBEECK, Johan Tijssen, Jan G. P. Sharif, Faisal Onuma, Yoshinobu Serruys, Patrick W. |
Issue Date: | 2020 | Publisher: | LIPPINCOTT WILLIAMS & WILKINS | Source: | CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 13 (8) | Abstract: | Background: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. Methods and Results: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P=0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P=0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P=0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P=0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P=0.22). Conclusions: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. | Notes: | Serruys, PW (corresponding author), Natl Univ Ireland, Intervent Med & Innovat, Univ Rd, Galway H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com |
Other: | Serruys, PW (corresponding author), Natl Univ Ireland, Intervent Med & Innovat, Univ Rd, Galway H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com | Keywords: | aspirin;mortality;myocardial infarction;percutaneous coronary intervention;ticagrelor | Document URI: | http://hdl.handle.net/1942/32809 | Link to publication/dataset: | https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.120.006660 | ISSN: | 1941-7705 | e-ISSN: | 1941-7713 | DOI: | 10.1161/CIRCOUTCOMES.120.006660 | ISI #: | WOS:000565274700010 | Rights: | 2020 American Heart Association, Inc. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2021 |
Appears in Collections: | Research publications |
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Hironori_Circulation2020_Authorversion.pdf Restricted Access | Peer-reviewed author version | 5.18 MB | Adobe PDF | View/Open Request a copy |
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