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Ticagrelor With or Without Aspirin After Complex PCI
George Dangas1, Usman Baber1, Samin Sharma1
1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Insights
Ticagrelor monotherapy significantly reduced bleeding complications in patients with complex percutaneous coronary intervention (PCI). This approach maintained similar ischemic event rates compared to dual antiplatelet therapy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- The optimal antiplatelet strategy following complex percutaneous coronary intervention (PCI) remains under investigation.
- Evaluating ticagrelor monotherapy's safety and efficacy in reducing bleeding without compromising ischemic outcomes is crucial.
Purpose of the Study:
- To assess the impact of ticagrelor monotherapy versus ticagrelor plus aspirin on bleeding and ischemic events in patients undergoing complex PCI.
- To analyze data from the randomized, double-blind, placebo-controlled TWILIGHT trial.
Main Methods:
- Patients completing 3 months of ticagrelor plus aspirin were randomized to 1 year of ticagrelor monotherapy or continued dual therapy.
- Complex PCI included criteria such as multiple vessels/lesions, long stent length, or use of atherectomy.
- Bleeding Academic Research Consortium (BARC) types 2, 3, 5 and ischemic events were primary endpoints.
Main Results:
- Ticagrelor monotherapy significantly lowered rates of BARC types 2, 3, or 5 bleeding (4.2% vs. 7.7%) and BARC types 3 or 5 bleeding (1.1% vs. 2.6%) compared to ticagrelor plus aspirin.
- No significant differences were observed in the rates of death, myocardial infarction, stroke, or stent thrombosis between the groups.
- These findings were specifically analyzed within a subgroup of 2,342 patients who underwent complex PCI.
Conclusions:
- Continuation of ticagrelor monotherapy after an initial period of dual therapy is associated with reduced bleeding incidence in patients with complex PCI.
- Ticagrelor monotherapy did not increase the risk of ischemic events compared to continuing ticagrelor plus aspirin.
- The TWILIGHT trial provides evidence supporting ticagrelor monotherapy as a safer alternative for selected patients post-complex PCI.
Background:
Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown.
Objectives:
The purpose of this study was to evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial.
Methods:
In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization.
Results:
Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38 to 0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21 to 0.80). There were no significant between-group differences in death, myocardial infarction, or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52 to 1.15), nor in stent thrombosis.
Conclusions:
Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
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