Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI

Dominick J. Angiolillo; Davide Cao; Usman Baber; Samantha Sartori; Zhongjie Zhang; George Dangas; Shamir Mehta; Carlo Briguori; David J. Cohen; Timothy Collier; Dariusz Dudek; Javier Escaned; C. Michael Gibson; Robert Gil; Kurt Huber; Upendra Kaul; Ran Kornowski; Mitchell W. Krucoff; Vijay Kunadian; David J. Moliterno; E. Magnus Ohman; Keith Oldroyd; Gennaro Sardella; Samin K. Sharma; Richard Shlofmitz; Giora Weisz; Bernhard Witzenbichler; Stuart Pocock; Roxana Mehran

doi:10.1016/j.jcin.2021.04.043

Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI

Dominick J. Angiolillo
, Davide Cao
, Usman Baber
, Samantha Sartori
, Zhongjie Zhang
, George Dangas
, Shamir Mehta
, Carlo Briguori
, David J. Cohen
, Timothy Collier
, Dariusz Dudek
, Javier Escaned
, C. Michael Gibson
, Robert Gil
, Kurt Huber
, Upendra Kaul
, Ran Kornowski
, Mitchell W. Krucoff
, Vijay Kunadian
, David J. Moliterno

E. Magnus Ohman, Keith Oldroyd, Gennaro Sardella, Samin K. Sharma, Richard Shlofmitz, Giora Weisz, Bernhard Witzenbichler, Stuart Pocock, Roxana Mehran

Producción científica: Article › revisión exhaustiva

19 Citas (Scopus)

Resumen

Objectives: The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI). Background: As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age. Methods: The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke. Results: A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (p_interaction = 0.62) and key secondary (p_interaction = 0.77) endpoints and across different age categories. Conclusions: A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.

Idioma original	English
Páginas (desde-hasta)	1434-1446
Número de páginas	13
Publicación	JACC: Cardiovascular Interventions
Volumen	14
N.º	13
DOI	https://doi.org/10.1016/j.jcin.2021.04.043
Estado	Published - jul 12 2021

Nota bibliográfica

Publisher Copyright:
© 2021 American College of Cardiology Foundation

Financiación

This work was supported by an investigator-initiated grant from AstraZeneca. Dr. Angiolillo has received consulting fees or honoraria from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has participated in review activities for CeloNova and St. Jude Medical; has received institutional payments for grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry, Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr. Baber has received speaking honoraria from AstraZeneca and Boston Scientific. Dr. Dangas has received consulting fees and advisory board fees from AstraZeneca; has received consulting fees from Biosensors; and previously held stock in Medtronic. Dr. Mehta has received grant support from and serving on an executive committee and as site investigator for AstraZeneca. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Svelte, Corvia, and Ancora; has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Svelte, Corvia, and Ancora. Dr. Krucoff has received consulting fees or honoraria and research grants from Abbott Vascular, Biosensors, Boston Scientific, CeloNova, Medtronic, and OrbusNeich. Dr. Gibson has received research grant support from AstraZeneca. Dr. Moliterno has received grants from AstraZeneca, during the conduct of the study. Dr. Gibson has received grant support and consulting fees from Angel Medical, Bayer, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson, and Portola Pharmaceuticals; has received consulting fees from The Medicines Company, Eli Lilly, Gilead Sciences, Novo Nordisk, WebMD, UpToDate Cardiovascular Medicine, Amarin Pharma, Amgen, Boehringer Ingelheim, Chiesi, Merck, PharmaMar, Sanofi, Somahlution, Verreseon, Boston Scientific, Impact Bio, MedImmume, Medtelligence, MicroPort, PERT Consortium, and GE Healthcare; holds equity in nference; serves as chief executive officer of the Baim Institute; and has received grant support, paid to the Baim Institute, from Bristol Myers Squibb. Dr. Huber has received lecture fees from AstraZeneca and Bayer. Dr. Weisz has received grant support and advisory board fees from and holds equity in Corindus; has received advisory board fees from and holds equity in Filterlex; serves on an advisory board for and holds options in Trisol; and has received grant support from Abbott, Cardiovascular Systems Inc, and RenalGuard. Dr. Oldroyd has received grant support and lecture fees from AstraZeneca. Dr. Escaned has received consulting and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic; and has received lecture fees from Abiomed, Terumo, and Biosensors. Dr. Sharma has received consulting fees or honoraria from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. Dr. Mehran reports grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Medtronic, Novartis Pharmaceuticals, OrbusNeich; has received personal fees from Abbott Laboratories, Boston Scientific, Medscape/WebMD, Siemens Medical Solutions, PLx Opco dba PLx Pharma, Roivant Sciences, Sanofi, Medtelligence (Janssen Scientific Affairs), and Janssen Scientific Affairs; has received other compensation from Abbott Laboratories, Abiomed, Bristol Myers Squibb, Claret Medical, Elixir Medical, The Medicines Company, Spectranetics/Philips/Volcano, and Watermark Research Partners; and has received nonfinancial support and other compensation from Regeneron Pharmaceuticals and Idorsia Pharmaceuticals. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Financiadores
Beth Israel Deaconess Hospital
CeloNova
Boehringer-Ingelheim
Abbott Laboratories
AMGen
Bristol-Myers Squibb
Eli Lilly and Company
AstraZeneca
Bayer AG
Medtronic
Gilead Sciences
St. Jude Medical Center
Edwards Lifesciences
Chiesi Farmaceutici S.p.A.
Novartis Pharmaceuticals Corporation
CSL Behring GmbH
Boston Scientific Corporation
Regeneron Pharmaceuticals
Abbott Vascular
Medicines Company
Siemens Medical Solutions USA
Scott R. MacKenzie Foundation
Janssen Scientific Affairs LLC
Daiichi Sankyo Company, Limited
Eisai
Idorsia Pharmaceuticals Ltd.
OrbusNeich

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Acceder al documento

10.1016/j.jcin.2021.04.043

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Angiolillo, D. J., Cao, D., Baber, U., Sartori, S., Zhang, Z., Dangas, G., Mehta, S., Briguori, C., Cohen, D. J., Collier, T., Dudek, D., Escaned, J., Gibson, C. M., Gil, R., Huber, K., Kaul, U., Kornowski, R., Krucoff, M. W., Kunadian, V., ... Mehran, R. (2021). Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI. JACC: Cardiovascular Interventions, 14(13), 1434-1446. https://doi.org/10.1016/j.jcin.2021.04.043

@article{8d66cfcd1ade4809953460980f17e12a,

title = "Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI",

abstract = "Objectives: The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI). Background: As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age. Methods: The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke. Results: A total of 3,113 patients (47.7\%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5\% vs. 8.2\%; hazard ratio: 0.53; 95\% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2\% vs. 4.4\%; hazard ratio: 0.96; 95\% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (pinteraction = 0.62) and key secondary (pinteraction = 0.77) endpoints and across different age categories. Conclusions: A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.",

keywords = "PCI, age, bleeding, thrombosis, ticagrelor monotherapy",

author = "Angiolillo, \{Dominick J.\} and Davide Cao and Usman Baber and Samantha Sartori and Zhongjie Zhang and George Dangas and Shamir Mehta and Carlo Briguori and Cohen, \{David J.\} and Timothy Collier and Dariusz Dudek and Javier Escaned and Gibson, \{C. Michael\} and Robert Gil and Kurt Huber and Upendra Kaul and Ran Kornowski and Krucoff, \{Mitchell W.\} and Vijay Kunadian and Moliterno, \{David J.\} and Ohman, \{E. Magnus\} and Keith Oldroyd and Gennaro Sardella and Sharma, \{Samin K.\} and Richard Shlofmitz and Giora Weisz and Bernhard Witzenbichler and Stuart Pocock and Roxana Mehran",

note = "Publisher Copyright: {\textcopyright} 2021 American College of Cardiology Foundation",

year = "2021",

month = jul,

day = "12",

doi = "10.1016/j.jcin.2021.04.043",

language = "English",

volume = "14",

pages = "1434--1446",

number = "13",

}

Angiolillo, DJ, Cao, D, Baber, U, Sartori, S, Zhang, Z, Dangas, G, Mehta, S, Briguori, C, Cohen, DJ, Collier, T, Dudek, D, Escaned, J, Gibson, CM, Gil, R, Huber, K, Kaul, U, Kornowski, R, Krucoff, MW, Kunadian, V, Moliterno, DJ, Ohman, EM, Oldroyd, K, Sardella, G, Sharma, SK, Shlofmitz, R, Weisz, G, Witzenbichler, B, Pocock, S & Mehran, R 2021, 'Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI', JACC: Cardiovascular Interventions, vol. 14, n.º 13, pp. 1434-1446. https://doi.org/10.1016/j.jcin.2021.04.043

TY - JOUR

T1 - Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI

AU - Angiolillo, Dominick J.

AU - Cao, Davide

AU - Baber, Usman

AU - Sartori, Samantha

AU - Zhang, Zhongjie

AU - Dangas, George

AU - Mehta, Shamir

AU - Briguori, Carlo

AU - Cohen, David J.

AU - Collier, Timothy

AU - Dudek, Dariusz

AU - Escaned, Javier

AU - Gibson, C. Michael

AU - Gil, Robert

AU - Huber, Kurt

AU - Kaul, Upendra

AU - Kornowski, Ran

AU - Krucoff, Mitchell W.

AU - Kunadian, Vijay

AU - Moliterno, David J.

AU - Ohman, E. Magnus

AU - Oldroyd, Keith

AU - Sardella, Gennaro

AU - Sharma, Samin K.

AU - Shlofmitz, Richard

AU - Weisz, Giora

AU - Witzenbichler, Bernhard

AU - Pocock, Stuart

AU - Mehran, Roxana

PY - 2021/7/12

Y1 - 2021/7/12

N2 - Objectives: The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI). Background: As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age. Methods: The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke. Results: A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (pinteraction = 0.62) and key secondary (pinteraction = 0.77) endpoints and across different age categories. Conclusions: A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.

AB - Objectives: The aim of this study was to assess the impact of age on the safety and efficacy of ticagrelor monotherapy after percutaneous coronary intervention (PCI). Background: As the risk for bleeding and ischemic complications after PCI increases with age, the authors conducted a pre-specified analysis of the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial to evaluate the possible benefits of ticagrelor monotherapy according to age. Methods: The TWILIGHT trial enrolled patients undergoing PCI with drug-eluting stents who fulfilled at least 1 clinical and 1 angiographic high-risk criterion. Age ≥65 years was a clinical entry criterion. After 3 months of dual-antiplatelet therapy with ticagrelor, event-free patients were randomized to ticagrelor plus placebo or ticagrelor plus aspirin for an additional 12 months. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding. The key secondary endpoint was the composite of all-cause death, myocardial infarction, or stroke. Results: A total of 3,113 patients (47.7%) were ≥65 years of age. At 1 year after randomization, ticagrelor monotherapy significantly reduced BARC type 2, 3, or 5 bleeding (4.5% vs. 8.2%; hazard ratio: 0.53; 95% confidence interval: 0.40 to 0.71) without increasing ischemic events (4.2% vs. 4.4%; hazard ratio: 0.96; 95% confidence interval: 0.68 to 1.35) compared with ticagrelor plus aspirin among patients ≥65 years of age. These findings were consistent in patients <65 years of age with respect to the primary (pinteraction = 0.62) and key secondary (pinteraction = 0.77) endpoints and across different age categories. Conclusions: A strategy of ticagrelor monotherapy following 3 months of dual-antiplatelet therapy significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin without an increase in ischemic events, irrespective of age.

KW - PCI

KW - age

KW - bleeding

KW - thrombosis

KW - ticagrelor monotherapy

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SN - 1936-8798

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JO - JACC: Cardiovascular Interventions

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Impact of Age on the Safety and Efficacy of Ticagrelor Monotherapy in Patients Undergoing PCI

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ASJC Scopus subject areas

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