Bleeding and Ischemic Risks of Ticagrelor Monotherapy After Coronary Interventions.

Mendieta, Guiomar; Mehta, Shamir; Baber, Usman; Angiolillo, Dominick J; Briguori, Carlo; Cohen, David; Collier, Timothy; Dangas, George; Dudek, Dariusz; Escaned, Javier; Gil, Robert; Vogel, Birgit; Cao, Davide; Spirito, Alessandro; Huber, Kurt; Kastrati, Adnan; Kaul, Upendra; Kornowski, Ran; Krucoff, Mitchell W; Kunadian, Vijay; Moliterno, David J; Ohman, E Magnus; Sardella, Gennaro; Sartori, Samantha; Sharma, Samin; Shlofmitz, Richard; Steg, P Gabriel; Han, Ya-Ling; Pocock, Stuart; Gibson, C Michael; Mehran, Roxana     «

Mendieta, Guiomar; Mehta, Shamir; Baber, Usman; Angiolillo, Dominick J; Briguori, Carlo; Cohen, David; Collier, Timothy; Dangas, George; Dudek, Dariusz; Escaned, Javier; Gil, Robert; Vogel, Birgit; Cao, Davide; Spirito, Alessandro; Huber, Kurt; Kastrati, Adnan; Kaul, Upendra; Kornowski, Ran; Krucoff, Mitchell W; Kunadian, Vijay; Moliterno, David J; Ohman, E Magnus; Sardella, Gennaro; Sartori, Samantha; Sharma, Samin; Shlofmitz, Richard; Steg, P Gabriel; Han, Ya-Ling; Pocock, Stuart; Gibson, C Mi...     »

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).      «

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 monothe...     »