Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS

Usman Baber; George Dangas; Dominick Joseph Angiolillo; David Joel Cohen; Samin Kumar Sharma; Johny Nicolas; Carlo Briguori; Jin Yu Cha; Timothy Collier; Dariusz Dudek; Vladimir Dzavik; Javier Escaned; Robert Gil; Paul Gurbel; Christian W. Hamm; Timothy Henry; Kurt Huber; Adnan Kastrati; Upendra Kaul; Ran Kornowski; Mitchell Krucoff; Vijay Kunadian; Steven Owen Marx; Shamir Mehta; David Moliterno; Erik Magnus Ohman; Keith Oldroyd; Gennaro Sardella; Samantha Sartori; Richard Shlofmitz; Philippe Gabriel Steg; Giora Weisz; Bernhard Witzenbichler; Ya-Ling Han; Stuart Pocock; Charles Michael Gibson; Roxana Mehran

doi:10.1093/eurheartj/ehaa670

Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS

Usman Baber
, George Dangas
, Dominick Joseph Angiolillo
, David Joel Cohen
, Samin Kumar Sharma
, Johny Nicolas
, Carlo Briguori
, Jin Yu Cha
, Timothy Collier
, Dariusz Dudek
, Vladimir Dzavik
, Javier Escaned
, Robert Gil
, Paul Gurbel
, Christian W. Hamm
, Timothy Henry
, Kurt Huber
, Adnan Kastrati
, Upendra Kaul
, Ran Kornowski

Mitchell Krucoff, Vijay Kunadian, Steven Owen Marx, Shamir Mehta, David Moliterno, Erik Magnus Ohman, Keith Oldroyd, Gennaro Sardella, Samantha Sartori, Richard Shlofmitz, Philippe Gabriel Steg, Giora Weisz, Bernhard Witzenbichler, Ya-Ling Han, Stuart Pocock, Charles Michael Gibson, Roxana Mehran^*

^*Corresponding author for this work

University of Oklahoma
Icahn School of Medicine at Mount Sinai
University of Florida
University of Missouri at Kansas City
Clinica Mediterranea
London School of Hygiene and Tropical Medicine
Department of Cardiac and Vascular Diseases, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland
Peter Munk Cardiac Centre
Hospital Clínico San Carlos de Madrid
Central Clinical Hospital of Ministry of Interior and Administration in Warsaw, Warsaw, Poland
Sinai Hospital of Baltimore
Kerckhoff Heart Center
The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, Ohio, USA
Klinik Ottakring
Technical University of Munich
Department of Cardiology, 110062 New Delhi, India
Rabin Medical Center Israel
Duke University
Newcastle University
Newcastle upon Tyne Hospitals NHS Foundation Trust
Columbia University
Hamilton Health Sciences
University of Kentucky
Golden Jubilee National Hospital
University of Rome La Sapienza
Department of Cardiology, St. Francis Hospital, Roslyn, 100 Port Washington Blvd, Roslyn, NY 11576, USA
Université Paris Cité
Montefiore Health System
Department of Cardiology, 85221 Dachau, Germany
Shenyang Northern Hospital
Beth Israel Deaconess Medical Center

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

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.

Original language	English
Pages (from-to)	3533-3545
Journal	European heart journal
Volume	41
Issue number	37
DOIs	https://doi.org/10.1093/eurheartj/ehaa670
Publication status	Published - 1 Oct 2020
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1093/eurheartj/ehaa670

Ticagrelor-alone-vsticagrelor-plus-aspirin-following-percutaneous-coronary-intervention-in-patients-with-non-st-segment.pdfFinal published version, 1.47 MBLicence: Taverne

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Baber, U., Dangas, G., Angiolillo, D. J., Cohen, D. J., Sharma, S. K., Nicolas, J., Briguori, C., Cha, J. Y., Collier, T., Dudek, D., Dzavik, V., Escaned, J., Gil, R., Gurbel, P., Hamm, C. W., Henry, T., Huber, K., Kastrati, A., Kaul, U., ... Mehran, R. (2020). Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS. European heart journal, 41(37), 3533-3545. https://doi.org/10.1093/eurheartj/ehaa670

@article{2b9375ebaf3442128ab8aeaab5f2062b,

title = "Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS",

abstract = "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.",

author = "Usman Baber and George Dangas and Angiolillo, \{Dominick Joseph\} and Cohen, \{David Joel\} and Sharma, \{Samin Kumar\} and Johny Nicolas and Carlo Briguori and Cha, \{Jin Yu\} and Timothy Collier and Dariusz Dudek and Vladimir Dzavik and Javier Escaned and Robert Gil and Paul Gurbel and Hamm, \{Christian W.\} and Timothy Henry and Kurt Huber and Adnan Kastrati and Upendra Kaul and Ran Kornowski and Mitchell Krucoff and Vijay Kunadian and Marx, \{Steven Owen\} and Shamir Mehta and David Moliterno and Ohman, \{Erik Magnus\} and Keith Oldroyd and Gennaro Sardella and Samantha Sartori and Richard Shlofmitz and Steg, \{Philippe Gabriel\} and Giora Weisz and Bernhard Witzenbichler and Ya-Ling Han and Stuart Pocock and Gibson, \{Charles Michael\} and Roxana Mehran",

year = "2020",

month = oct,

day = "1",

doi = "10.1093/eurheartj/ehaa670",

language = "English",

volume = "41",

pages = "3533--3545",

journal = "European heart journal",

issn = "0195-668X",

publisher = "Oxford University Press",

number = "37",

}

Baber, U, Dangas, G, Angiolillo, DJ, Cohen, DJ, Sharma, SK, Nicolas, J, Briguori, C, Cha, JY, Collier, T, Dudek, D, Dzavik, V, Escaned, J, Gil, R, Gurbel, P, Hamm, CW, Henry, T, Huber, K, Kastrati, A, Kaul, U, Kornowski, R, Krucoff, M, Kunadian, V, Marx, SO, Mehta, S, Moliterno, D, Ohman, EM, Oldroyd, K, Sardella, G, Sartori, S, Shlofmitz, R, Steg, PG, Weisz, G, Witzenbichler, B, Han, Y-L, Pocock, S, Gibson, CM & Mehran, R 2020, 'Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS', European heart journal, vol. 41, no. 37, pp. 3533-3545. https://doi.org/10.1093/eurheartj/ehaa670

Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS. / Baber, Usman; Dangas, George; Angiolillo, Dominick Joseph et al.
In: European heart journal, Vol. 41, No. 37, 01.10.2020, p. 3533-3545.

Research output: Contribution to journal › Article › Academic › peer-review

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

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.

UR - https://www.scopus.com/pages/publications/85094111623

UR - https://www.ncbi.nlm.nih.gov/pubmed/33085967

U2 - 10.1093/eurheartj/ehaa670

DO - 10.1093/eurheartj/ehaa670

M3 - Article

C2 - 33085967

SN - 0195-668X

VL - 41

SP - 3533

EP - 3545

JO - European heart journal

JF - European heart journal

IS - 37

ER -

Ticagrelor alone vs.Ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS

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