Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting.

Franzone, Anna; McFadden, Eugène; Leonardi, Sergio; Piccolo, Raffaele; Vranckx, Pascal; Serruys, Patrick W; Benit, Edouard; Liebetrau, Christoph; Janssens, Luc; Ferrario, Maurizio; Zurakowski, Aleksander; Diletti, Roberto; Dominici, Marcello; Huber, Kurt; Slagboom, Ton; Buszman, Paweł; Bolognese, Leonardo; Tumscitz, Carlo; Bryniarski, Krzysztof; Aminian, Adel; ... (2019). Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting. Journal of the American College of Cardiology, 74(18), pp. 2223-2234. Elsevier 10.1016/j.jacc.2019.08.1038

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BACKGROUND The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported. 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).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Heg, Dierik Hans; Windecker, Stephan and Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0735-1097

Publisher:

Elsevier

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

07 Nov 2019 11:37

Last Modified:

19 Dec 2019 15:15

Publisher DOI:

10.1016/j.jacc.2019.08.1038

PubMed ID:

31672177

Uncontrolled Keywords:

adjudication dual antiplatelet therapy percutaneous coronary intervention ticagrelor

BORIS DOI:

10.7892/boris.134575

URI:

https://boris.unibe.ch/id/eprint/134575

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