Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting.
Abstract | BACKGROUND: OBJECTIVES: This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 ( Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. METHODS: An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites. RESULTS: The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post- percutaneous coronary intervention. CONCLUSIONS:
Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059).
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Authors | Anna Franzone, Eugène McFadden, Sergio Leonardi, Raffaele Piccolo, Pascal Vranckx, Patrick W Serruys, Edouard Benit, Christoph Liebetrau, Luc Janssens, Maurizio Ferrario, Aleksander Zurakowski, Roberto Diletti, Marcello Dominici, Kurt Huber, Ton Slagboom, Paweł Buszman, Leonardo Bolognese, Carlo Tumscitz, Krzysztof Bryniarski, Adel Aminian, Mathias Vrolix, Ivo Petrov, Scot Garg, Christoph Naber, Janusz Prokopczuk, Christian Hamm, Philippe Gabriel Steg, Dik Heg, Peter Jüni, Stephan Windecker, Marco Valgimigli, GLASSY Investigators |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 74
Issue 18
Pg. 2223-2234
(11 05 2019)
ISSN: 1558-3597 [Electronic] United States |
PMID | 31672177
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Platelet Aggregation Inhibitors
- Ticagrelor
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Topics |
- Aged
- Coronary Artery Disease
(mortality, therapy)
- Drug Administration Schedule
- Drug-Eluting Stents
- Dual Anti-Platelet Therapy
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Percutaneous Coronary Intervention
- Platelet Aggregation Inhibitors
(therapeutic use)
- Prospective Studies
- Survival Rate
- Ticagrelor
(therapeutic use)
- Treatment Outcome
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