TY - JOUR
T1 - Ticagrelor monotherapy in patients at high bleeding risk undergoing percutaneous coronary intervention
T2 - TWILIGHT-HBR
AU - Escaned, Javier
AU - Cao, Davide
AU - Baber, Usman
AU - Nicolas, Johny
AU - Sartori, Samantha
AU - Zhang, Zhongjie
AU - Dangas, George
AU - Angiolillo, Dominick J.
AU - Briguori, Carlo
AU - Cohen, David J.
AU - Collier, Timothy
AU - Dudek, Dariusz
AU - Gibson, Michael
AU - Gil, Robert
AU - Huber, Kurt
AU - Kaul, Upendra
AU - Kornowski, Ran
AU - Krucoff, Mitchell W.
AU - Kunadian, Vijay
AU - Mehta, Shamir
AU - Moliterno, David J.
AU - Ohman, E. Magnus
AU - Oldroyd, Keith G.
AU - Sardella, Gennaro
AU - Sharma, Samin K.
AU - Shlofmitz, Richard
AU - Weisz, Giora
AU - Witzenbichler, Bernhard
AU - Pocock, Stuart
AU - Mehran, Roxana
N1 - Publisher Copyright:
© The Author(s) 2021.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - Aims Patients at high bleeding risk (HBR) represent a prevalent subgroup among those undergoing percutaneous coronary intervention (PCI). Early aspirin discontinuation after a short course of dual antiplatelet therapy (DAPT) has emerged as a bleeding avoidance strategy. The aim of this study was to assess the effects of ticagrelor monotherapy after 3-month DAPT in a contemporary HBR population. Methods and results This prespecified analysis of the TWILIGHT trial evaluated the treatment effects of early aspirin withdrawal followed by ticagrelor monotherapy in HBR patients undergoing PCI with drug-eluting stents. After 3 months of ticagrelor plus aspirin, event-free patients were randomized to 12 months of aspirin or placebo in addition to ticagrelor. A total of 1064 (17.2%) met the Academic Research Consortium definition for HBR. Ticagrelor monotherapy reduced the incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding compared with ticagrelor plus aspirin in HBR (6.3% vs. 11.4%; hazard ratio (HR) 0.53, 95% confidence interval (CI) 0.35-0.82) and non-HBR patients (3.5% vs. 5.9%; HR 0.59, 95% CI 0.46-0.77) with similar relative (Pinteraction = 0.67) but a trend towards greater absolute risk reduction in the former [−5.1% vs. −2.3%; difference in absolute risk differences (ARDs) −2.8%, 95% CI −6.4% to 0.8%, P = 0.130]. A similar pattern was observed for more severe BARC 3 or 5 bleeding with a larger absolute risk reduction in HBR patients (−3.5% vs. −0.5%; difference in ARDs −3.0%, 95% CI −5.2% to −0.8%, P = 0.008). There was no significant difference in the key secondary endpoint of death, myocardial infarction, or stroke between treatment arms, irrespective of HBR status. Conclusions Among HBR patients undergoing PCI who completed 3-month DAPT without experiencing major adverse events, aspirin discontinuation followed by ticagrelor monotherapy significantly reduced bleeding without increasing ischaemic events, compared with ticagrelor plus aspirin. The absolute risk reduction in major bleeding was larger in HBR than non-HBR patients.
AB - Aims Patients at high bleeding risk (HBR) represent a prevalent subgroup among those undergoing percutaneous coronary intervention (PCI). Early aspirin discontinuation after a short course of dual antiplatelet therapy (DAPT) has emerged as a bleeding avoidance strategy. The aim of this study was to assess the effects of ticagrelor monotherapy after 3-month DAPT in a contemporary HBR population. Methods and results This prespecified analysis of the TWILIGHT trial evaluated the treatment effects of early aspirin withdrawal followed by ticagrelor monotherapy in HBR patients undergoing PCI with drug-eluting stents. After 3 months of ticagrelor plus aspirin, event-free patients were randomized to 12 months of aspirin or placebo in addition to ticagrelor. A total of 1064 (17.2%) met the Academic Research Consortium definition for HBR. Ticagrelor monotherapy reduced the incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding compared with ticagrelor plus aspirin in HBR (6.3% vs. 11.4%; hazard ratio (HR) 0.53, 95% confidence interval (CI) 0.35-0.82) and non-HBR patients (3.5% vs. 5.9%; HR 0.59, 95% CI 0.46-0.77) with similar relative (Pinteraction = 0.67) but a trend towards greater absolute risk reduction in the former [−5.1% vs. −2.3%; difference in absolute risk differences (ARDs) −2.8%, 95% CI −6.4% to 0.8%, P = 0.130]. A similar pattern was observed for more severe BARC 3 or 5 bleeding with a larger absolute risk reduction in HBR patients (−3.5% vs. −0.5%; difference in ARDs −3.0%, 95% CI −5.2% to −0.8%, P = 0.008). There was no significant difference in the key secondary endpoint of death, myocardial infarction, or stroke between treatment arms, irrespective of HBR status. Conclusions Among HBR patients undergoing PCI who completed 3-month DAPT without experiencing major adverse events, aspirin discontinuation followed by ticagrelor monotherapy significantly reduced bleeding without increasing ischaemic events, compared with ticagrelor plus aspirin. The absolute risk reduction in major bleeding was larger in HBR than non-HBR patients.
KW - ARC-HBR
KW - Aspirin
KW - High bleeding risk
KW - PCI
KW - Ticagrelor monotherapy
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U2 - 10.1093/eurheartj/ehab702
DO - 10.1093/eurheartj/ehab702
M3 - Article
C2 - 34662382
AN - SCOPUS:85122546090
SN - 0195-668X
VL - 42
SP - 4624
EP - 4634
JO - European Heart Journal
JF - European Heart Journal
IS - 45
ER -