Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study

George Dangas; Usman Baber; Samin Sharma; Gennaro Giustino; Samantha Sartori; Johny Nicolas; Ridhima Goel; Shamir Mehta; David Cohen; Dominick J. Angiolillo; Zhongjie Zhang; Anton Camaj; Davide Cao; Carlo Briguori; Dariusz Dudek; Javier Escaned; Kurt Huber; Timothy Collier; Ran Kornowski; Vijay Kunadian; David J. Moliterno; E. Magnus Ohman; Giora Weisz; Robert Gil; Mitchell W. Krucoff; Upendra Kaul; Keith G. Oldroyd; Gennaro Sardella; Richard Shlofmitz; Bernhard Witzenbichler; Adnan Kastrati; Ya Ling Han; Philippe Gabriel Steg; Stuart Pocock; C. Michael Gibson; Roxana Mehran

doi:10.4244/EIJ-D-21-00721

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study

George Dangas, Usman Baber, Samin Sharma, Gennaro Giustino, Samantha Sartori, Johny Nicolas, Ridhima Goel, Shamir Mehta, David Cohen, Dominick J. Angiolillo, Zhongjie Zhang, Anton Camaj, Davide Cao, Carlo Briguori, Dariusz Dudek, Javier Escaned, Kurt Huber, Timothy Collier, Ran Kornowski, Vijay KunadianDavid J. Moliterno, E. Magnus Ohman, Giora Weisz, Robert Gil, Mitchell W. Krucoff, Upendra Kaul, Keith G. Oldroyd, Gennaro Sardella, Richard Shlofmitz, Bernhard Witzenbichler, Adnan Kastrati, Ya Ling Han, Philippe Gabriel Steg, Stuart Pocock, C. Michael Gibson, Roxana Mehran

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

10 Scopus citations

Abstract

Background: In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Aims: The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. Methods: In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Results: Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; p_interaction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; p_interaction=0.60). In both unadjusted and covariateadjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. Conclusions: As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.

Original language	English
Pages (from-to)	130-1339
Number of pages	1210
Journal	EuroIntervention
Volume	17
Issue number	16
DOIs	https://doi.org/10.4244/EIJ-D-21-00721
State	Published - Mar 2022

Bibliographical note

Publisher Copyright:
© Europa Digital & Publishing 2022. All rights reserved.

Funding

G. Dangas reports receiving consulting fees and advisory board fees from AstraZeneca, consulting fees from Biosensors, and previously holding stock in Medtronic. U. Baber reports speaker honoraria from AstraZeneca and Boston Scientific. S. Sharma has received consulting fees or honoraria from Abbott, Boston Scientific, Abiomed, and Cardiovascular Systems, Inc. S. Mehta has received research grants to the institution from AstraZeneca, Abbott, Boston Scientific, and Sanofi; and has received honoraria for consultancy from AstraZeneca, Bayer, Biosensors, and Sanofi. D. Cohen reports receiving grant support, paid to his institution, and consulting fees from AstraZeneca, Medtronic, Abbott Vascular, and Boston Scientific. D. Angiolillo has received payment as an individual for: a) Consulting fee or honorarium 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; b) participation in review activities from CeloNova, and St. Jude Medical. He has also received institutional payments for grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli-Lilly, Gilead Sciences, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, RenalGuard Solutions, and the Scott R. MacKenzie Foundation. J. Escaned reports receiving consulting fees and lecture fees from Abbott, Philips, Boston Scientific, and Medtronic, and lecture fees from Abiomed, Terumo, and Biosensors. K. Huber reports receiving lecture fees from AstraZeneca and Bayer. V. Kunadian has received personal fees/honoraria from Bayer, Astra Zeneca, Abbott, Amgen, and Daichii Sankyo. D. Moliterno reports grants from AstraZeneca, during the conduct of the study. M. Ohman reports research grants from Abiomed and Chiesi, and consulting fees from AstraZeneca, Cara Therapeutics, Faculty Connection, Imbria, Impulse Medical, Janssen Pharmaceuticals, Milestone Pharmaceuticals, Xylocor, and Zoll Medical. G. Weisz reports receiving grant support and advisory board fees from and holding equity in Corindus, advisory board fees from and holding equity in Filterlex, serving on an advisory board for and holding options in Trisol, and receiving grant support from Abbott, CSI, and RenalGuard Solutions. M. Krucoff reports grants and/or personal fees from Abbott Vascular, Biosensors, Boston Scientific, Celonova, Medtronic, OrbusNeich, and Terumo. K. Oldroyd reports receiving grant support and lecture fees from AstraZeneca; and is employed by Biosensors. G. Sardella reports receiving consulting fees from Abbott, Shockwave, Boston Scientific, and Balmed, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbott, Alvimedica, Shockwave, Medtronic, Biosensors. P.G. Steg reports receiving research grants from Amarin, Bayer, Sanofi, and Servier; compensation for work in clinical trials from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Idorsia, Novartis, Pfizer, Sanofi, and Servier; receiving fees for consulting or speaking from Amgen, BMS/Myokardia, Novo-Nordisk, and Regeneron; TWILIGHT was an international, multicentre, randomised, placebo-controlled trial conducted in 187 sites across 11 countries, as previously described11,13. The Icahn School of Medicine at Mount Sinai designed and sponsored the trial, which was supported by an investigator-initiated grant from AstraZeneca. National regulatory agencies and institutional review boards or ethics committees of participating centres approved the trial protocol. An independent data and safety monitoring board provided external oversight to ensure the safety of the trial participants.

Funders	Funder number
Faculty Connection
Boehringer-Ingelheim
Abbott Laboratories
AMGen
Bristol-Myers Squibb
AstraZeneca
Merck
Sanofi
Center for Social Inclusion
Gilead Sciences
Janssen Pharmaceuticals
Cidara Therapeutics
Amarin Corporation
Bayer Fund
Scott R. MacKenzie Foundation
MyoKardia
School of Medicine, CHA University
Novo Nordisk A/S
Servier Institute

Keywords

adjunctive pharmacotherapy
bleeding
clinical trials
drug-eluting stent

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.4244/EIJ-D-21-00721

Cite this

Dangas, G., Baber, U., Sharma, S., Giustino, G., Sartori, S., Nicolas, J., Goel, R., Mehta, S., Cohen, D., Angiolillo, D. J., Zhang, Z., Camaj, A., Cao, D., Briguori, C., Dudek, D., Escaned, J., Huber, K., Collier, T., Kornowski, R., ... Mehran, R. (2022). Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study. EuroIntervention, 17(16), 130-1339. https://doi.org/10.4244/EIJ-D-21-00721

@article{114c7c571eba4ad18f776320704b0d7c,

title = "Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study",

abstract = "Background: In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Aims: The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. Methods: In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Results: Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariateadjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. Conclusions: As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.",

keywords = "adjunctive pharmacotherapy, bleeding, clinical trials, drug-eluting stent",

author = "George Dangas and Usman Baber and Samin Sharma and Gennaro Giustino and Samantha Sartori and Johny Nicolas and Ridhima Goel and Shamir Mehta and David Cohen and Angiolillo, {Dominick J.} and Zhongjie Zhang and Anton Camaj and Davide Cao and Carlo Briguori and Dariusz Dudek and Javier Escaned and Kurt Huber and Timothy Collier and Ran Kornowski and Vijay Kunadian and Moliterno, {David J.} and {Magnus Ohman}, E. and Giora Weisz and Robert Gil and Krucoff, {Mitchell W.} and Upendra Kaul and Oldroyd, {Keith G.} and Gennaro Sardella and Richard Shlofmitz and Bernhard Witzenbichler and Adnan Kastrati and Han, {Ya Ling} and Steg, {Philippe Gabriel} and Stuart Pocock and Gibson, {C. Michael} and Roxana Mehran",

year = "2022",

month = mar,

doi = "10.4244/EIJ-D-21-00721",

language = "English",

volume = "17",

pages = "130--1339",

journal = "EuroIntervention",

issn = "1774-024X",

publisher = "EuroPCR",

number = "16",

}

Dangas, G, Baber, U, Sharma, S, Giustino, G, Sartori, S, Nicolas, J, Goel, R, Mehta, S, Cohen, D, Angiolillo, DJ, Zhang, Z, Camaj, A, Cao, D, Briguori, C, Dudek, D, Escaned, J, Huber, K, Collier, T, Kornowski, R, Kunadian, V, Moliterno, DJ, Magnus Ohman, E, Weisz, G, Gil, R, Krucoff, MW, Kaul, U, Oldroyd, KG, Sardella, G, Shlofmitz, R, Witzenbichler, B, Kastrati, A, Han, YL, Steg, PG, Pocock, S, Gibson, CM & Mehran, R 2022, 'Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study', EuroIntervention, vol. 17, no. 16, pp. 130-1339. https://doi.org/10.4244/EIJ-D-21-00721

TY - JOUR

T1 - Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type

T2 - the TWILIGHT-STENT study

AU - Dangas, George

AU - Baber, Usman

AU - Sharma, Samin

AU - Giustino, Gennaro

AU - Sartori, Samantha

AU - Nicolas, Johny

AU - Goel, Ridhima

AU - Mehta, Shamir

AU - Cohen, David

AU - Angiolillo, Dominick J.

AU - Zhang, Zhongjie

AU - Camaj, Anton

AU - Cao, Davide

AU - Briguori, Carlo

AU - Dudek, Dariusz

AU - Escaned, Javier

AU - Huber, Kurt

AU - Collier, Timothy

AU - Kornowski, Ran

AU - Kunadian, Vijay

AU - Moliterno, David J.

AU - Magnus Ohman, E.

AU - Weisz, Giora

AU - Gil, Robert

AU - Krucoff, Mitchell W.

AU - Kaul, Upendra

AU - Oldroyd, Keith G.

AU - Sardella, Gennaro

AU - Shlofmitz, Richard

AU - Witzenbichler, Bernhard

AU - Kastrati, Adnan

AU - Han, Ya Ling

AU - Steg, Philippe Gabriel

AU - Pocock, Stuart

AU - Gibson, C. Michael

AU - Mehran, Roxana

PY - 2022/3

Y1 - 2022/3

N2 - Background: In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Aims: The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. Methods: In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Results: Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariateadjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. Conclusions: As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.

AB - Background: In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Aims: The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. Methods: In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Results: Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariateadjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. Conclusions: As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.

KW - adjunctive pharmacotherapy

KW - bleeding

KW - clinical trials

KW - drug-eluting stent

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M3 - Article

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JO - EuroIntervention

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ER -

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study

Abstract

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