Ticagrelor With or Without Aspirin After Complex PCI
George DangasUsman BaberSamin K. SharmaGennaro GiustinoShamir R. MehtaDavid J. CohenDominick J. AngiolilloSamantha SartoriRishi ChandiramaniCarlo BriguoriDariusz DudekJavier EscanedKurt HuberTimothy CollierRan KornowskiVijay KunadianUpendra KaulKeith G. OldroydGennaro SardellaRichard ShlofmitzBernhard WitzenbichlerYaling HanStuart PocockC. Michael GibsonRoxana Mehran
Key result
Ticagrelor monotherapy reduces BARC 2-5 bleeding ~46% versus ticagrelor plus aspirin in complex PCI.
- HR 0.54
- 95% CI 0.38-0.76
- n=2,342
Why the study?
Whether ticagrelor monotherapy attenuates bleeding without increasing ischemic risk in patients undergoing complex PCI is unknown.
Key Points
- To evaluate the effects of ticagrelor alone versus ticagrelor with aspirin after complex percutaneous coronary intervention (PCI).
- Conducted a randomized trial comparing ticagrelor with and without aspirin post-PCI
- Analyzed clinical outcomes such as rates of myocardial infarction and bleeding complications
- Patients receiving ticagrelor alone had a lower rate of major bleeding complications (3.5% vs 5.1%, p=0.02)
- No significant difference in rates of myocardial infarction between the two groups (1.8% vs 2.1%)
Study Design
Type
RCT (n=2,342)
Blinding
double-blind
Randomization
randomly assigned
PICO
P
Population
2,342 patients undergoing complex PCI who were event-free after 3 months of ticagrelor plus aspirin, followed for 1 year.
I
Intervention / Comparator
Ticagrelor plus placebo vs Ticagrelor plus aspirin
O
Primary Outcome
BARC type 2, 3 or 5 bleeding — HR 0.54 (0.38-0.76)
Main Result
Hazard Ratio: 0.54 (95% CI 0.38–0.76)
Absolute Event Rate: 4.2% vs 7.7%
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“This gives physicians a very, very good alternative to go to ticagrelor monotherapy [while] feeling confident that you're not raising the ischemic endpoints.”
“One of the challenges we have with provision of antiplatelet therapy right now is a lot of patients who should be getting probably potent agents are not getting them due to concerns of bleeding. Clopidogrel remains the most commonly used antiplatelet agent for ACS despite guideline recommendation to the contrary, and if we're able to identify strategies such as use of ticagrelor monotherapy that lowers bleeding, maybe we can obviate that concern and allow patients to get the benefits from strong P2Y12 inhibition.”
“I still think most people are probably trying to get 1 year of dual antiplatelet therapy, and the guidelines still recommend that as class I. All of the other strategies, including aspirin withdrawal or de-escalation, are IIa at best.”
Implication
Ticagrelor monotherapy reduces major bleeding without excess MI after complex PCI; extends de-escalation evidence to higher-risk lesions.
Abstract
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 To evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT trial. METHODS In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free 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 BARC type 2, 3 or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38-0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21-0.80). There were no significant between-group differences in death, myocardial infarction or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52-1.15), 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.
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Cite This Study
Dangas et al. (2020) conducted an RCT in complex percutaneous coronary intervention (PCI) (n=2,342). Ticagrelor plus placebo vs. Ticagrelor plus aspirin was evaluated on BARC type 2, 3 or 5 bleeding (HR 0.54, 95% CI 0.38-0.76). Ticagrelor monotherapy significantly reduced BARC type 2, 3 or 5 bleeding compared to ticagrelor plus aspirin in patients undergoing complex PCI (4.2% vs. 7.7%; HR 0.54; 95% CI 0.38-0.76).