Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI

J Am Coll Cardiol. 2019 Oct 22;74(16):2015-2027. doi: 10.1016/j.jacc.2019.08.997.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aspirin / therapeutic use*
  • Female
  • Hemorrhage
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / complications
  • Myocardial Infarction / diagnosis
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Myocardial Revascularization / mortality
  • Patient Safety
  • Percutaneous Coronary Intervention / adverse effects*
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Proportional Hazards Models
  • Prospective Studies
  • Risk
  • Stroke / complications
  • Stroke / mortality
  • Thrombosis / complications
  • Thrombosis / mortality
  • Ticagrelor / therapeutic use*
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors
  • Ticagrelor
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT01813435