Key result
In patients with total stent length ≥46 mm, ticagrelor monotherapy after 1-month DAPT reduced all-cause death and new Q-wave MI by 34% (HR 0.66) compared to standard 12-month DAPT.
Why the study?
The study was conducted to evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length.
Does 1-month DAPT followed by 23-month ticagrelor monotherapy reduce the composite of all-cause death and new Q-wave MI in patients undergoing PCI with long stenting (TSL ≥46 mm) compared to 12-month DAPT followed by aspirin monotherapy?
RCT (n=15,450)
Open-label
1:1
Yes
Does 1-month DAPT followed by 23-month ticagrelor monotherapy reduce the composite of all-cause death and new Q-wave MI in patients undergoing PCI with long stenting (TSL ≥46 mm) compared to 12-month DAPT followed by aspirin monotherapy?
Hazard Ratio: 0.66 (95% CI 0.49–0.89)
Absolute Event Rate: 3.79% vs 5.68%
p-value: p=0.006
Ticagrelor monotherapy after 1-month DAPT significantly reduces ischemic events without increasing major bleeding in patients undergoing PCI with long stenting (TSL ≥46 mm).
Ticagrelor monotherapy after 1-month DAPT may reduce ischaemic events with similar bleeding in long-stent patients; leaves open confirmation in prospective trials before practice change.
AIMS: The aim of this study was to evaluate the impact of a novel antiplatelet regimen in patients with increasing total stent length (TSL). METHODS AND RESULTS: This is a post hoc analysis of the GLOBAL LEADERS trial, a prospective, multicentre, open-label, randomised trial, investigating the impact of the experimental strategy (one-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in patients with a Biolimus A9-eluting stent (BES). The primary endpoint was the composite of all-cause death and new Q-wave myocardial infarction (MI), and the secondary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years. To investigate the association between total stent length and outcomes, groups were compared in quartiles according to TSL; the fourth quartile group was at significantly higher ischaemic risk at two years. In that stratum (TSL ≥46 mm), the experimental strategy significantly reduced the risk of the primary endpoint (hazard ratio [HR] 0.67, 95% confidence interval [CI]: 0.49-0.90; pinteraction=0.043), while demonstrating a similar risk of BARC type 3 or 5 bleeding (HR 0.99, 95% CI: 0.66-1.49; pinteraction=0.975). CONCLUSIONS: Ticagrelor monotherapy could potentially balance ischaemic and bleeding risks, thereby achieving a net clinical benefit in patients with a TSL ≥46 mm with a BES.
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Takahashi et al. (2020) conducted an RCT in Coronary artery disease requiring percutaneous coronary intervention (n=15,450). Ticagrelor monotherapy vs. 12-month DAPT followed by 12-month aspirin monotherapy was evaluated on Composite of all-cause death and new Q-wave myocardial infarction at two years (in patients with total stent length ≥46 mm) (HR 0.66, 95% CI 0.49-0.89, p=0.006). In patients with total stent length ≥46 mm, ticagrelor monotherapy after 1-month DAPT reduced all-cause death and new Q-wave MI by 34% (HR 0.66) compared to standard 12-month DAPT.
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