Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial

Abstract

Aims To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). Methods and results In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48–0.85] and POCE (HR: 0.80, 95% CI: 0.69–0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67–1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69–0.92; Pinteraction = 0.011). Conclusion Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.

Percutaneous Coronary Intervention Complexity and Risk of Adverse Events in Relation to High Bleeding Risk Among Patients Receiving Drug-Eluting Stents: Insights From a Large Single-Center Cohort Study

“…(3) Together these findings indicated that regardless of HBR, complex PCI was an independent driver of adverse ischemic outcomes without an excess of bleeding events, suggesting that the use of potent P2Y 12 inhibitors may be beneficial to patients who underwent complex percutaneous revascularization. We observed that PCI complexity exerted an adverse impact not only on MACE proportional to the number of complexity criteria present, but also on all individual endpoints including cardiac death, MI, definite/probable ST, and TLR, findings that corroborated results from previous reports [7][8][9][10][11][12]. Intriguingly, subjects with complex PCI did not experience a significant increased risk of clinically relevant bleeding, as compared with the noncomplex PCI group.…”

“…Given the association of anatomical complexity and functional severity of CAD with future cardiovascular events [4,5], the concept of complex PCI and higher-risk indicated population for revascularization has recently been proposed [6,7]. However, there is no universal definition of complex PCI in terms of angiographic and lesion characteristics, in turn causing in a variety of clinical outcomes reported in previous studies [7][8][9][10][11][12]. Although procedural complexity emerges as a correlate of ischemic events, controversial results have been reported in many studies evaluating the adverse impact of complex PCI procedures on bleeding events [7][8][9][10][11][12].…”

“…However, there is no universal definition of complex PCI in terms of angiographic and lesion characteristics, in turn causing in a variety of clinical outcomes reported in previous studies [7][8][9][10][11][12]. Although procedural complexity emerges as a correlate of ischemic events, controversial results have been reported in many studies evaluating the adverse impact of complex PCI procedures on bleeding events [7][8][9][10][11][12]. For instance, some reports suggested the increased risk of bleeding events in patients with high-risk features for stentrelated ischemic events [10][11][12], whereas others refuted this association [7][8][9]13].…”

“…Although procedural complexity emerges as a correlate of ischemic events, controversial results have been reported in many studies evaluating the adverse impact of complex PCI procedures on bleeding events [7][8][9][10][11][12]. For instance, some reports suggested the increased risk of bleeding events in patients with high-risk features for stentrelated ischemic events [10][11][12], whereas others refuted this association [7][8][9]13]. Meanwhile, concomitant high bleeding risk (HBR) may be present, making it challenging for clinical decision-making on the duration and intensity of dual antiplatelet therapy (DAPT) after complex PCI.…”

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial

“…The superiority of the experimental strategy at 2 years was not demonstrated in the parent trial. However, non-specified secondary analyses suggested the potential efficacy of this novel experimental regimen in some specific patient subgroups [12][13][14][15]. To unravel the complex intricacies of the GLOBAL LEADERS trial, the present study aims to investigate the clinical impact of BMI on the novel antiplatelet strategy with ticagrelor monotherapy in patients undergoing PCI.…”