TY - JOUR
T1 - Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes
T2 - TWILIGHT-ACS
AU - Baber, Usman
AU - Dangas, George
AU - Angiolillo, Dominick Joseph
AU - Cohen, David Joel
AU - Sharma, Samin Kumar
AU - Nicolas, Johny
AU - Briguori, Carlo
AU - Cha, Jin Yu
AU - Collier, Timothy
AU - Dudek, Dariusz
AU - Dzavik, Vladimir
AU - Escaned, Javier
AU - Gil, Robert
AU - Gurbel, Paul
AU - Hamm, Christian W.
AU - Henry, Timothy
AU - Huber, Kurt
AU - Kastrati, Adnan
AU - Kaul, Upendra
AU - Kornowski, Ran
AU - Krucoff, Mitchell
AU - Kunadian, Vijay
AU - Marx, Steven Owen
AU - Mehta, Shamir
AU - Moliterno, David
AU - Ohman, Erik Magnus
AU - Oldroyd, Keith
AU - Sardella, Gennaro
AU - Sartori, Samantha
AU - Shlofmitz, Richard
AU - Steg, Philippe Gabriel
AU - Weisz, Giora
AU - Witzenbichler, Bernhard
AU - Han, Ya Ling
AU - Pocock, Stuart
AU - Gibson, Charles Michael
AU - Mehran, Roxana
N1 - Publisher Copyright:
© 2020 Published on behalf of the European Society of Cardiology. All rights reserved.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Aims: The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods and results: We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96). Conclusion: Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. Trial registration: Clinicaltrials.gov identifier: NCT02270242.
AB - Aims: The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods and results: We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96). Conclusion: Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. Trial registration: Clinicaltrials.gov identifier: NCT02270242.
KW - Acute coronary syndrome
KW - Bleeding
KW - Ticagrelor
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U2 - 10.1093/eurheartj/ehaa670
DO - 10.1093/eurheartj/ehaa670
M3 - Article
C2 - 33085967
AN - SCOPUS:85094111623
SN - 0195-668X
VL - 41
SP - 3533
EP - 3545
JO - European Heart Journal
JF - European Heart Journal
IS - 37
ER -