Impact of established cardiovascular disease on outcomes in the randomized global leaders trial
Scot Garg1, Ply Chichareon2,3, Norihiro Kogame2
1Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust, Blackburn, UK.
Insights
Patients with established cardiovascular disease (CVD) face higher risks after percutaneous coronary intervention (PCI). Prolonged ticagrelor monotherapy did not improve outcomes, highlighting the need to manage modifiable risk factors in these high-risk patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Patients with established cardiovascular disease (CVD) represent a significant subgroup undergoing percutaneous coronary intervention (PCI).
- Optimal anti-platelet strategies post-PCI for patients with established CVD remain an area of active research.
- Established CVD includes prior myocardial infarction, PCI, coronary artery bypass grafting, stroke, or peripheral vascular disease.
Purpose of the Study:
- To evaluate the impact of different anti-platelet strategies on clinical outcomes in patients with established CVD undergoing PCI.
- To compare a one-month dual anti-platelet therapy (DAPT) followed by ticagrelor monotherapy versus standard 12-month DAPT in this patient population.
Main Methods:
- The GLOBAL LEADERS trial was a randomized, superiority trial involving 15,761 patients treated with a biolimus A9-eluting stent.
- A subgroup analysis focused on 6,693 patients (42.5%) with established CVD.
- The primary endpoint was a composite of all-cause death or new Q-wave myocardial infarction (MI) at 2 years. Safety endpoint was BARC 3 or 5 bleeding.
Main Results:
- Patients with established CVD had significantly higher rates of the primary composite endpoint compared to those without established CVD (5.1% vs. 3.3%, p < 0.001).
- The experimental treatment (ticagrelor monotherapy after 1 month) showed a nonsignificant reduction in the primary endpoint in patients with established CVD (4.6% vs. 5.6%, HR 0.82 [0.66-1.02], p=0.07).
- No significant differences in bleeding events were observed between treatment arms in the established CVD group.
Conclusions:
- Established CVD is associated with poorer outcomes after PCI.
- Prolonged monotherapy with a potent P2Y12 inhibitor (ticagrelor) did not significantly mitigate these poorer outcomes.
- There is an increased need to focus on modifiable risk factors in patients with established CVD undergoing PCI.
Objective:
To investigate the impact of different anti-platelet strategies on outcomes after percutaneous coronary intervention (PCI) in patients with established cardiovascular disease (CVD).
Methods:
GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing one-month dual anti-platelet therapy (DAPT) with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. Established CVD was defined as ≥1 prior myocardial infarction, PCI, coronary artery bypass operation, stroke, or established peripheral vascular disease. The primary endpoint was a composite of all-cause death or new Q-wave MI at 2-years. The secondary safety endpoint was BARC 3 or 5 bleeding. Exploratory secondary endpoints were the patient-orientated composite endpoint and net adverse clinical events.
Results:
Among the 15,761 patients in this cohort were 6,693 patients (42.5%) with established CVD. Compared to those without established CVD, these patients had significantly higher rates of the primary (5.1 vs. 3.3%, HR1.59[1.36-1.86], p < .001) and secondary composite endpoints with no significant differences in bleeding. There was a nonsignificant reduction in the primary endpoint in patients with established CVD receiving the experimental treatment (4.6 vs. 5.6%, HR0.82[0.66-1.02], p = .07). When comparing patients without CVD to those with one or three territories of CVD, the hazard ratio for the primary endpoint increased in unadjusted and adjusted models.
Conclusions:
The poorer outcomes in patients with established CVD are not mitigated by prolonged monotherapy with a potent P2Y12 inhibitor suggesting a greater need to focus on modifiable risk factors.
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