Impact of established cardiovascular disease on outcomes in the randomized global leaders trial.

Abstract

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.

• Authors: Scot Garg, Ply Chichareon, Norihiro Kogame, Kuniaki Takahashi, Rodrigo Modolo, Chun-Chin Chang, Mariusz Tomaniak, Farzin Fath-Ordoubadi, Richard Anderson, Keith G Oldroyd, Rod H Stables, Neville Kukreja, Saqib Chowdhary, Gavin Galasko, Stephen Hoole, Azfar Zaman, Christian W Hamm, Philippe G Steg, Peter Jüni, Marco Valgimigli, Stephan Windecker, Yoshinobu Onuma, Patrick W Serruys
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 96 Issue 7 Pg. 1369-1378 (12 2020) ISSN: 1522-726X [Electronic] United States
• PMID: 31854112 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2019 Wiley Periodicals, Inc.

Chemical References

• Platelet Aggregation Inhibitors
• Purinergic P2Y Receptor Antagonists
• Ticagrelor
• Aspirin
• umirolimus
• Sirolimus

Topics

• Aged
• Aspirin (administration & dosage, adverse effects)
• Drug Administration Schedule
• Drug-Eluting Stents
• Dual Anti-Platelet Therapy (adverse effects)
• Female
• Heart Disease Risk Factors
• Humans
• Male
• Middle Aged
• Myocardial Ischemia (diagnostic imaging, mortality, therapy)
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Prospective Studies
• Purinergic P2Y Receptor Antagonists (administration & dosage, adverse effects)
• Recurrence
• Risk Assessment
• Sirolimus (administration & dosage, analogs & derivatives)
• Ticagrelor (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome