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http://hdl.handle.net/1942/37533
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DC Field | Value | Language |
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dc.contributor.author | Gragnano, Felice | - |
dc.contributor.author | Zwahlen, Marcel | - |
dc.contributor.author | VRANCKX, Pascal | - |
dc.contributor.author | Heg, Dik | - |
dc.contributor.author | Schmidlin, Kurt | - |
dc.contributor.author | Hamm, Christian | - |
dc.contributor.author | Steg, Philippe Gabriel | - |
dc.contributor.author | Gargiulo, Giuseppe | - |
dc.contributor.author | McFadden, Eugene P. | - |
dc.contributor.author | Onuma, Yoshinobu | - |
dc.contributor.author | Chichareon, Ply | - |
dc.contributor.author | Mollmann, Helge | - |
dc.contributor.author | BENIT, Edouard | - |
dc.contributor.author | Janssens, Luc | - |
dc.contributor.author | Leonardi, Sergio | - |
dc.contributor.author | Zurakowski, Aleksander | - |
dc.contributor.author | Arrivi, Alessio | - |
dc.contributor.author | van Geuns, Robert Jan | - |
dc.contributor.author | Huber, Kurt | - |
dc.contributor.author | Slagboom, Ton | - |
dc.contributor.author | Calabro, Paolo | - |
dc.contributor.author | Serruys, Patrick W. | - |
dc.contributor.author | Juni, Peter | - |
dc.contributor.author | Valgimigli, Marco | - |
dc.contributor.author | Windecker, Stephan | - |
dc.date.accessioned | 2022-06-15T14:30:04Z | - |
dc.date.available | 2022-06-15T14:30:04Z | - |
dc.date.issued | 2022 | - |
dc.date.submitted | 2022-06-01T13:52:04Z | - |
dc.identifier.citation | Journal of the American Heart Association, 11 (10) (Art N° e024291) | - |
dc.identifier.uri | http://hdl.handle.net/1942/37533 | - |
dc.description.abstract | BACKGROUND: In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. METHODS AND RESULTS: Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03; P=0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26; P=0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. CONCLUSIONS: Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. | - |
dc.description.sponsorship | European Clinical Research Institute; Biosensors International Ltd, Europe | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.rights | This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. | - |
dc.subject.other | DAPT; intention-to-treat; P2Y(12); inhibitor monotherapy; per-protocol; | - |
dc.subject.other | ticagrelor | - |
dc.title | Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial | - |
dc.type | Journal Contribution | - |
dc.identifier.issue | 10 | - |
dc.identifier.volume | 11 | - |
local.format.pages | 17 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Windecker, S (corresponding author), Bern Univ Hosp, Dept Cardiol, Inselspital, CH-3010 Bern, Switzerland. | - |
dc.description.notes | stephan.windecker@insel.ch | - |
local.publisher.place | 111 RIVER ST, HOBOKEN 07030-5774, NJ USA | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
local.bibliographicCitation.artnr | e024291 | - |
dc.identifier.doi | 10.1161/JAHA.121.024291 | - |
dc.identifier.isi | WOS:000796637400002 | - |
dc.contributor.orcid | Arrivi, Alessio/0000-0003-0001-2522; Asano, Taku/0000-0001-5733-3381; | - |
dc.contributor.orcid | STEG, Philippe Gabriel/0000-0001-6896-2941; Gragnano, | - |
dc.contributor.orcid | Felice/0000-0002-6943-278X | - |
local.provider.type | wosris | - |
local.description.affiliation | [Gragnano, Felice; Windecker, Stephan] Univ Bern, Dept Cardiol, Inselspital, Bern, Switzerland. | - |
local.description.affiliation | [Gragnano, Felice; Calabro, Paolo] Univ Campania Luigi Vanvitelli, Dept Translat Med Sci, Naples, Italy. | - |
local.description.affiliation | [Zwahlen, Marcel; Schmidlin, Kurt] Univ Bern, Inst Social & Prevent Med, Bern, Switzerland. | - |
local.description.affiliation | [Vranckx, Pascal] Jessa Ziekenhuis, Dept Cardiol & Crit Care Med, Hartctr Hasselt, Hasselt, Belgium. | - |
local.description.affiliation | [Vranckx, Pascal] Univ Hasselt, Fac Med & Life Sci, Hasselt, Belgium. | - |
local.description.affiliation | [Heg, Dik] Univ Bern, Clin Trials Unit, Bern, Switzerland. | - |
local.description.affiliation | [Hamm, Christian] Campus Kerckhoff Justus Liebig Univ, Heart Ctr, Giessen, Germany. | - |
local.description.affiliation | [Hamm, Christian] German Ctr Cardiovasc Res DZHK, Partner Site Rhine Main Germany, Mainz, Germany. | - |
local.description.affiliation | [Steg, Philippe Gabriel] Univ Paris, Hop Bichat, AP HP,UMR1148, French Alliance Cardiovasc Trials,Inst Natl Sante, Paris, France. | - |
local.description.affiliation | [Gargiulo, Giuseppe] Federico Ii Univ Naples, Dept Adv Biomed Sci, Naples, Italy. | - |
local.description.affiliation | [McFadden, Eugene P.] Cardialysis Core Labs & Clin Trial Management, Rotterdam, Netherlands. | - |
local.description.affiliation | [McFadden, Eugene P.] Cork Univ Hosp, Dept Cardiol, Cork, Ireland. | - |
local.description.affiliation | [Onuma, Yoshinobu] Natl Univ Ireland Galway, Dept Cardiol, Galway, Ireland. | - |
local.description.affiliation | [Chichareon, Ply] Prince Songkla Univ, Dept Internal Med, Fac Med, Cardiol Unit, Hat Yai, Thailand. | - |
local.description.affiliation | [Benit, Edouard] Jessa Hosp, Dept Cardiol, Hasselt, Belgium. | - |
local.description.affiliation | [Mollmann, Helge] St Johannes Hosp, Dept Cardiol, Dortmund, Germany. | - |
local.description.affiliation | [Janssens, Luc] Imelda Ziekenhuis, Heart Ctr, Bonheiden, Belgium. | - |
local.description.affiliation | [Leonardi, Sergio] Univ Pavia, Pavia, Italy. | - |
local.description.affiliation | [Leonardi, Sergio] Fdn IRCCS Policlin San Matteo, Pavia, Italy. | - |
local.description.affiliation | [Zurakowski, Aleksander] Andrzej Frycz Modrzewski Krakow Univ, Krakow, Poland. | - |
local.description.affiliation | [Zurakowski, Aleksander] Amer Heart Poland, Chrzanow, Poland. | - |
local.description.affiliation | [Arrivi, Alessio] Azienda Osped S Maria, Dept Cardiol, Terni, Italy. | - |
local.description.affiliation | [van Geuns, Robert Jan] Radboudumc, Dept Cardiol, Nijmegen, Netherlands. | - |
local.description.affiliation | [Huber, Kurt] Wilhelminenhospital, Dept Med Cardiol & Intens Care Med 3, Vienna, Austria. | - |
local.description.affiliation | [Huber, Kurt] Sigmund Freud Univ, Med Fac, Vienna, Austria. | - |
local.description.affiliation | [Slagboom, Ton] Onze Lieve Vrouw Hosp, Amsterdam, Netherlands. | - |
local.description.affiliation | [Serruys, Patrick W.] Imperial Coll London, Natl Heart & Lung Inst, London, England. | - |
local.description.affiliation | [Serruys, Patrick W.] Natl Univ Ireland, Dept Cardiol, Galway, Ireland. | - |
local.description.affiliation | [Juni, Peter] Univ Toronto, Dept Med, Appl Hlth Res Ctr, Li Ka Shing Knowledge Inst,St Michaels Hosp, Toronto, ON, Canada. | - |
local.description.affiliation | [Valgimigli, Marco] Ente Osped Cantonale, Cardioctr Ticino Inst, Lugano, Switzerland. | - |
local.uhasselt.international | yes | - |
item.contributor | Gragnano, Felice | - |
item.contributor | Zwahlen, Marcel | - |
item.contributor | VRANCKX, Pascal | - |
item.contributor | Heg, Dik | - |
item.contributor | Schmidlin, Kurt | - |
item.contributor | Hamm, Christian | - |
item.contributor | Steg, Philippe Gabriel | - |
item.contributor | Gargiulo, Giuseppe | - |
item.contributor | McFadden, Eugene P. | - |
item.contributor | Onuma, Yoshinobu | - |
item.contributor | Chichareon, Ply | - |
item.contributor | Mollmann, Helge | - |
item.contributor | BENIT, Edouard | - |
item.contributor | Janssens, Luc | - |
item.contributor | Leonardi, Sergio | - |
item.contributor | Zurakowski, Aleksander | - |
item.contributor | Arrivi, Alessio | - |
item.contributor | van Geuns, Robert Jan | - |
item.contributor | Huber, Kurt | - |
item.contributor | Slagboom, Ton | - |
item.contributor | Calabro, Paolo | - |
item.contributor | Serruys, Patrick W. | - |
item.contributor | Juni, Peter | - |
item.contributor | Valgimigli, Marco | - |
item.contributor | Windecker, Stephan | - |
item.fullcitation | Gragnano, Felice; Zwahlen, Marcel; VRANCKX, Pascal; Heg, Dik; Schmidlin, Kurt; Hamm, Christian; Steg, Philippe Gabriel; Gargiulo, Giuseppe; McFadden, Eugene P.; Onuma, Yoshinobu; Chichareon, Ply; Mollmann, Helge; BENIT, Edouard; Janssens, Luc; Leonardi, Sergio; Zurakowski, Aleksander; Arrivi, Alessio; van Geuns, Robert Jan; Huber, Kurt; Slagboom, Ton; Calabro, Paolo; Serruys, Patrick W.; Juni, Peter; Valgimigli, Marco & Windecker, Stephan (2022) Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. In: Journal of the American Heart Association, 11 (10) (Art N° e024291). | - |
item.accessRights | Open Access | - |
item.fulltext | With Fulltext | - |
item.validation | ecoom 2023 | - |
crisitem.journal.eissn | 2047-9980 | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
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JAHA.121.024291.pdf | Published version | 1.63 MB | Adobe PDF | View/Open |
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