Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI.

Takahashi, Kuniaki; Serruys, Patrick W; Chichareon, Ply; Chang, Chun Chin; Tomaniak, Mariusz; Modolo, Rodrigo; Kogame, Norihiro; Magro, Michael; Chowdhary, Saqib; Eitel, Ingo; Zweiker, Robert; Ong, Paul; Ottesen, Michael Mundt; Tijssen, Jan G P; Wykrzykowska, Joanna J; de Winter, Robbert J; Garg, Scot; Stoll, Hans-Peter; Hamm, Christian; Steg, Philippe Gabriel; ... (2019). Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI. Journal of the American College of Cardiology, 74(16), pp. 2015-2027. Elsevier 10.1016/j.jacc.2019.08.997

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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).

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