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Randomized Controlled Trial
. 2019 Oct 22;74(16):2015-2027.
doi: 10.1016/j.jacc.2019.08.997.

Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI

Kuniaki Takahashi  1 , Patrick W Serruys  2 , Ply Chichareon  3 , Chun Chin Chang  4 , Mariusz Tomaniak  5 , Rodrigo Modolo  6 , Norihiro Kogame  1 , Michael Magro  7 , Saqib Chowdhary  8 , Ingo Eitel  9 , Robert Zweiker  10 , Paul Ong  11 , Michael Mundt Ottesen  12 , Jan G P Tijssen  13 , Joanna J Wykrzykowska  1 , Robbert J de Winter  1 , Scot Garg  14 , Hans-Peter Stoll  15 , Christian Hamm  16 , Philippe Gabriel Steg  17 , Yoshinobu Onuma  18 , Marco Valgimigli  19 , Pascal Vranckx  20 , Didier Carrie  21 , Stephan Windecker  19
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Free article
Randomized Controlled Trial

Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI

Kuniaki Takahashi et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse.

Objectives: This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI.

Methods: The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding.

Results: Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754).

Conclusions: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).

Keywords: drug-eluting stent; dual antiplatelet therapy; multivessel percutaneous coronary intervention; ticagrelor monotherapy.

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