Key result
Ticagrelor monotherapy cuts clinically relevant bleeding ~46% vs DAPT without increasing ischemic risk.
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Why the study?
The clinical benefit of ticagrelor monotherapy versus continuation of dual antiplatelet therapy after 3 months of DAPT in high-risk PCI patients was uncertain.
Does ticagrelor monotherapy reduce bleeding without increasing ischemic events in high-risk patients after PCI compared to DAPT?
RCT (n=7,119)
Double-blind
1:1
Yes
Does ticagrelor monotherapy reduce bleeding without increasing ischemic events in high-risk patients after PCI compared to DAPT?
Ticagrelor monotherapy after 3 months of DAPT reduces bleeding across all risk strata without increasing ischemic risk in high-risk PCI patients.
BACKGROUND: In TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention), among high-risk patients undergoing percutaneous coronary intervention (PCI), ticagrelor monotherapy vs continuation of dual antiplatelet therapy (DAPT) with aspirin and ticagrelor after completing a 3-month course of DAPT was associated with reduced bleeding, without an increase in ischemic events. OBJECTIVES: This investigation sought to study the clinical benefit of ticagrelor monotherapy vs DAPT by simultaneously modeling its associated potential bleeding benefits and ischemic harms on an individual patient basis. METHODS: Multivariable Cox regression models for: 1) Bleeding Academic Research Consortium type 2, 3, or 5 (BARC-2/3/5); and 2) cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke (major adverse cardiac and cerebrovascular event [MACCE]) were developed using stepwise forward variable selection. The coefficients in the BARC-2/3/5 and MACCE models were used to calculate bleeding and ischemic risk scores, respectively, for each patient (excluding the coefficient for randomized treatment). RESULTS: In the total study group (N = 7,119), BARC-2/3/5 occurred in 391 (5.5%) patients, and MACCE occurred in 258 (3.6%). There was a consistent reduction in bleeding events associated with ticagrelor monotherapy compared with DAPT across both bleeding and ischemic risk strata (P interaction = 0.54 and 0.11, respectively). Importantly, this benefit associated with ticagrelor monotherapy was not offset by an increase in MACCE at any level of bleeding or ischemic risk. CONCLUSIONS: Three months after PCI, discontinuing aspirin and maintaining ticagrelor monotherapy reduces bleeding in both higher-bleeding risk and lower-bleeding risk patients compared with continued DAPT. This benefit does not appear to be offset by greater ischemic risk. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).
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Mendieta et al. (2023) conducted an RCT in High-risk patients undergoing percutaneous coronary intervention (PCI) (n=7,119). Ticagrelor monotherapy vs. Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor was evaluated on BARC-2/3/5 bleeding (lower bleeding risk stratum, DAPT vs ticagrelor monotherapy) (RR 1.85, 95% CI 1.40-2.46). Ticagrelor monotherapy consistently reduced bleeding compared with DAPT across both lower and higher bleeding risk strata without increasing ischemic events.
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