Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial

Patrick W. Serruys, Kuniaki Takahashi, Ply Chichareon, Norihiro Kogame, Mariusz Tomaniak, Rodrigo Modolo, Chun Chin Chang, Hidenori Komiyama, Osama Soliman, Joanna J. Wykrzykowska, Robbert J. de Winter, Maurizio Ferrario, Marcello Dominici, Paweł Buszman, Leonardo Bolognese, Carlo Tumscitz, Edouard Benit, Hans Peter Stoll, Christian Hamm, Philippe Gabriel StegYoshinobu Onuma, Peter Jüni, Stephan Windecker, Pascal Vranckx, Antonio Colombo, Marco Valgimigli

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

AIMS : To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION : Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.

Original languageEnglish
Pages (from-to)2595-2604
Number of pages10
JournalEuropean Heart Journal
Volume40
Issue number31
DOIs
Publication statusPublished - Aug 14 2019

Fingerprint

Percutaneous Coronary Intervention
Hemorrhage
Confidence Intervals
Stents
Therapeutics
Cause of Death
Myocardial Infarction
Ticagrelor
Risk Reduction Behavior
Research
Aspirin
Stroke

Keywords

  • Complex percutaneous coronary intervention
  • Drug-eluting stent
  • Dual antiplatelet therapy
  • Ticagrelor monotherapy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention : insights from the Global Leaders trial. / Serruys, Patrick W.; Takahashi, Kuniaki; Chichareon, Ply; Kogame, Norihiro; Tomaniak, Mariusz; Modolo, Rodrigo; Chang, Chun Chin; Komiyama, Hidenori; Soliman, Osama; Wykrzykowska, Joanna J.; de Winter, Robbert J.; Ferrario, Maurizio; Dominici, Marcello; Buszman, Paweł; Bolognese, Leonardo; Tumscitz, Carlo; Benit, Edouard; Stoll, Hans Peter; Hamm, Christian; Steg, Philippe Gabriel; Onuma, Yoshinobu; Jüni, Peter; Windecker, Stephan; Vranckx, Pascal; Colombo, Antonio; Valgimigli, Marco.

In: European Heart Journal, Vol. 40, No. 31, 14.08.2019, p. 2595-2604.

Research output: Contribution to journalArticle

Serruys, PW, Takahashi, K, Chichareon, P, Kogame, N, Tomaniak, M, Modolo, R, Chang, CC, Komiyama, H, Soliman, O, Wykrzykowska, JJ, de Winter, RJ, Ferrario, M, Dominici, M, Buszman, P, Bolognese, L, Tumscitz, C, Benit, E, Stoll, HP, Hamm, C, Steg, PG, Onuma, Y, Jüni, P, Windecker, S, Vranckx, P, Colombo, A & Valgimigli, M 2019, 'Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial', European Heart Journal, vol. 40, no. 31, pp. 2595-2604. https://doi.org/10.1093/eurheartj/ehz453
Serruys, Patrick W. ; Takahashi, Kuniaki ; Chichareon, Ply ; Kogame, Norihiro ; Tomaniak, Mariusz ; Modolo, Rodrigo ; Chang, Chun Chin ; Komiyama, Hidenori ; Soliman, Osama ; Wykrzykowska, Joanna J. ; de Winter, Robbert J. ; Ferrario, Maurizio ; Dominici, Marcello ; Buszman, Paweł ; Bolognese, Leonardo ; Tumscitz, Carlo ; Benit, Edouard ; Stoll, Hans Peter ; Hamm, Christian ; Steg, Philippe Gabriel ; Onuma, Yoshinobu ; Jüni, Peter ; Windecker, Stephan ; Vranckx, Pascal ; Colombo, Antonio ; Valgimigli, Marco. / Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention : insights from the Global Leaders trial. In: European Heart Journal. 2019 ; Vol. 40, No. 31. pp. 2595-2604.
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abstract = "AIMS : To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95{\%} confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95{\%} CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95{\%} CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95{\%} CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION : Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.",
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T1 - Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention

T2 - insights from the Global Leaders trial

AU - Serruys, Patrick W.

AU - Takahashi, Kuniaki

AU - Chichareon, Ply

AU - Kogame, Norihiro

AU - Tomaniak, Mariusz

AU - Modolo, Rodrigo

AU - Chang, Chun Chin

AU - Komiyama, Hidenori

AU - Soliman, Osama

AU - Wykrzykowska, Joanna J.

AU - de Winter, Robbert J.

AU - Ferrario, Maurizio

AU - Dominici, Marcello

AU - Buszman, Paweł

AU - Bolognese, Leonardo

AU - Tumscitz, Carlo

AU - Benit, Edouard

AU - Stoll, Hans Peter

AU - Hamm, Christian

AU - Steg, Philippe Gabriel

AU - Onuma, Yoshinobu

AU - Jüni, Peter

AU - Windecker, Stephan

AU - Vranckx, Pascal

AU - Colombo, Antonio

AU - Valgimigli, Marco

PY - 2019/8/14

Y1 - 2019/8/14

N2 - AIMS : To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION : Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.

AB - AIMS : To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION : Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.

KW - Complex percutaneous coronary intervention

KW - Drug-eluting stent

KW - Dual antiplatelet therapy

KW - Ticagrelor monotherapy

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