1. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI
- Author
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Scot Garg, Rodrigo Modolo, Patrick W. Serruys, Robbert J. de Winter, Robert Zweiker, Mariusz Tomaniak, Michael Magro, Norihiro Kogame, Jan G.P. Tijssen, Marco Valgimigli, Christian W. Hamm, Kuniaki Takahashi, Philippe Gabriel Steg, Saqib Chowdhary, Pascal Vranckx, Hans-Peter Stoll, Didier Carrié, Paul Jau Lueng Ong, Ingo Eitel, Ply Chichareon, Joanna J. Wykrzykowska, Chun Chin Chang, Michael Mundt Ottesen, Yoshinobu Onuma, Stephan Windecker, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Microcirculation
- Subjects
Male ,Risk ,medicine.medical_specialty ,Ticagrelor ,medicine.medical_treatment ,Myocardial Infarction ,Hemorrhage ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,Myocardial Revascularization ,Humans ,030212 general & internal medicine ,Prospective Studies ,cardiovascular diseases ,610 Medicine & health ,Aged ,Proportional Hazards Models ,Aspirin ,business.industry ,Hazard ratio ,Percutaneous coronary intervention ,Thrombosis ,Middle Aged ,Stroke ,Regimen ,Treatment Outcome ,Drug-eluting stent ,Conventional PCI ,Female ,Patient Safety ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - 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).
- Published
- 2019