Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI
Kuniaki Takahashi, Patrick W Serruys, Ply Chichareon, Chun Chin Chang, Mariusz Tomaniak, Rodrigo Modolo, Norihiro Kogame, Michael Magro, Saqib Chowdhary, Ingo Eitel, Robert Zweiker, Paul Ong, Michael Mundt Ottesen, Jan G P Tijssen, Joanna J Wykrzykowska, Robbert J de Winter, Scot Garg, Hans-Peter Stoll, Christian Hamm, Philippe Gabriel Steg, Yoshinobu Onuma, Marco Valgimigli, Pascal Vranckx, Didier Carrie, Stephan Windecker, Kuniaki Takahashi, Patrick W Serruys, Ply Chichareon, Chun Chin Chang, Mariusz Tomaniak, Rodrigo Modolo, Norihiro Kogame, Michael Magro, Saqib Chowdhary, Ingo Eitel, Robert Zweiker, Paul Ong, Michael Mundt Ottesen, Jan G P Tijssen, Joanna J Wykrzykowska, Robbert J de Winter, Scot Garg, Hans-Peter Stoll, Christian Hamm, Philippe Gabriel Steg, Yoshinobu Onuma, Marco Valgimigli, Pascal Vranckx, Didier Carrie, Stephan Windecker
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.
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed