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http://hdl.handle.net/1942/32809
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DC Field | Value | Language |
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dc.contributor.author | Hara, Hironori | - |
dc.contributor.author | van Klaveren, David | - |
dc.contributor.author | Takahashi, Kuniaki | - |
dc.contributor.author | Kogame, Norihiro | - |
dc.contributor.author | Chichareon, Ply | - |
dc.contributor.author | Modolo, Rodrigo | - |
dc.contributor.author | Tomaniak, Mariusz | - |
dc.contributor.author | Ono, Masafumi | - |
dc.contributor.author | Kawashima, Hideyuki | - |
dc.contributor.author | Wang, Rutao | - |
dc.contributor.author | Gao, Chao | - |
dc.contributor.author | Niethammer, Margit | - |
dc.contributor.author | Fontos, Geza | - |
dc.contributor.author | Angioi, Michael | - |
dc.contributor.author | Ribeiro, Vasco Gama | - |
dc.contributor.author | Barbato, Emanuele | - |
dc.contributor.author | Leandro, Sergio | - |
dc.contributor.author | Hamm, Christian | - |
dc.contributor.author | Valgimigli, Marco | - |
dc.contributor.author | Windecker, Stephan | - |
dc.contributor.author | Juni, Peter | - |
dc.contributor.author | Steg, Philippe Gabriel | - |
dc.contributor.author | VERBEECK, Johan | - |
dc.contributor.author | Tijssen, Jan G. P. | - |
dc.contributor.author | Sharif, Faisal | - |
dc.contributor.author | Onuma, Yoshinobu | - |
dc.contributor.author | Serruys, Patrick W. | - |
dc.date.accessioned | 2020-12-09T08:03:39Z | - |
dc.date.available | 2020-12-09T08:03:39Z | - |
dc.date.issued | 2020 | - |
dc.date.submitted | 2020-11-17T13:12:01Z | - |
dc.identifier.citation | CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 13 (8) | - |
dc.identifier.uri | http://hdl.handle.net/1942/32809 | - |
dc.description.abstract | Background: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. Methods and Results: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P=0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P=0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P=0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P=0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P=0.22). Conclusions: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. | - |
dc.description.sponsorship | GLOBAL LEADERS study was sponsored by the European Clinical Research Institute, which received funding from Biosensors International, AstraZeneca, and the Medicines Company. | - |
dc.language.iso | en | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.rights | 2020 American Heart Association, Inc. | - |
dc.subject.other | aspirin | - |
dc.subject.other | mortality | - |
dc.subject.other | myocardial infarction | - |
dc.subject.other | percutaneous coronary intervention | - |
dc.subject.other | ticagrelor | - |
dc.title | Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events | - |
dc.type | Journal Contribution | - |
dc.identifier.issue | 8 | - |
dc.identifier.volume | 13 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Serruys, PW (corresponding author), Natl Univ Ireland, Intervent Med & Innovat, Univ Rd, Galway H91 TK33, Ireland. | - |
dc.description.notes | patrick.w.j.c.serruys@gmail.com | - |
dc.description.other | Serruys, PW (corresponding author), Natl Univ Ireland, Intervent Med & Innovat, Univ Rd, Galway H91 TK33, Ireland. patrick.w.j.c.serruys@gmail.com | - |
local.publisher.place | TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, PA 19103 USA | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1161/CIRCOUTCOMES.120.006660 | - |
dc.identifier.pmid | 32762446 | - |
dc.identifier.isi | WOS:000565274700010 | - |
dc.identifier.url | https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.120.006660 | - |
local.provider.type | wosris | - |
local.uhasselt.uhpub | yes | - |
local.description.affiliation | [Hara, Hironori; Takahashi, Kuniaki; Kogame, Norihiro; Chichareon, Ply; Modolo, Rodrigo; Kawashima, Hideyuki; Tijssen, Jan G. P.] Univ Amsterdam, Acad Med Ctr, Dept Cardiol, Amsterdam, Netherlands. | - |
local.description.affiliation | [van Klaveren, David] Erasmus MC, Dept Publ Hlth, Ctr Med Decis Making, Rotterdam, Netherlands. | - |
local.description.affiliation | [van Klaveren, David] Tufts Med Ctr, Inst Clin Res & Hlth Policy Studies, Predict Analyt & Comparat Effectiveness Ctr, Boston, MA USA. | - |
local.description.affiliation | [Chichareon, Ply] Prince Songkla Univ, Dept Internal Med, Cardiol Unit, Fac Med, Bangkok, Thailand. | - |
local.description.affiliation | [Tomaniak, Mariusz] Univ Campinas UNICAMP, Div Cardiol, Dept Internal Med, Campinas, Brazil. | - |
local.description.affiliation | [Tomaniak, Mariusz] Erasmus Univ, Dept Cardiol, Erasmus Med Ctr, Rotterdam, Netherlands. | - |
local.description.affiliation | [Wang, Rutao; Gao, Chao] Radboud Univ Nijmegen, Dept Cardiol, Nijmegen, Netherlands. | - |
local.description.affiliation | [Niethammer, Margit] Klinikum Fulda, Med Klin, Herz Thorax Zentrum, Fulda, Germany. | - |
local.description.affiliation | [Fontos, Geza] Gottsegen Hungarian Inst Cardiol, Budapest, Hungary. | - |
local.description.affiliation | [Angioi, Michael] Clin Louis Pasteur Essey les Nancy, Dept Intervent Cardiol, Paris, France. | - |
local.description.affiliation | [Ribeiro, Vasco Gama] Gaia Hosp Ctr, Dept Cardiol, Gaia, Portugal. | - |
local.description.affiliation | [Barbato, Emanuele] Univ Federico II, Div Cardiol, Dept Adv Biomed Sci, Naples, Italy. | - |
local.description.affiliation | [Leandro, Sergio] Inst Nacl Cardiol, Rio De Janeiro, Brazil. | - |
local.description.affiliation | [Hamm, Christian] Campus Univ Giessen, Kerckhoff Heart Ctr, Bad Nauheim, Germany. | - |
local.description.affiliation | [Valgimigli, Marco; Windecker, Stephan] Univ Hosp Bern, Univ Bern, Dept Cardiol, Inselspital, Bern, Switzerland. | - |
local.description.affiliation | [Juni, Peter] St Michaels Hosp, Dept Med Toronto, Appl Hlth Res Ctr AHRC, Li Ka Shing Knowledge Inst, Toronto, ON, Canada. | - |
local.description.affiliation | [Juni, Peter] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada. | - |
local.description.affiliation | [Steg, Philippe Gabriel] Univ Paris, FACT French Alliance Cardiovasc Clin Trials, Hop Bichat, AP HP, Paris, France. | - |
local.description.affiliation | [Steg, Philippe Gabriel] INSERM Unite 1148, Paris, France. | - |
local.description.affiliation | [Steg, Philippe Gabriel] Imperial Coll, Royal Brompton Hosp, Paris, France. | - |
local.description.affiliation | [Verbeeck, Johan] Univ Hasselt, Biostat, Hasselt, Belgium. | - |
local.description.affiliation | [Sharif, Faisal; Onuma, Yoshinobu; Serruys, Patrick W.] Natl Univ Ireland, Dept Cardiol, Galway, Ireland. | - |
local.description.affiliation | [Serruys, Patrick W.] Imperial Coll London, NHLI, London, England. | - |
item.fullcitation | Hara, Hironori; van Klaveren, David; Takahashi, Kuniaki; Kogame, Norihiro; Chichareon, Ply; Modolo, Rodrigo; Tomaniak, Mariusz; Ono, Masafumi; Kawashima, Hideyuki; Wang, Rutao; Gao, Chao; Niethammer, Margit; Fontos, Geza; Angioi, Michael; Ribeiro, Vasco Gama; Barbato, Emanuele; Leandro, Sergio; Hamm, Christian; Valgimigli, Marco; Windecker, Stephan; Juni, Peter; Steg, Philippe Gabriel; VERBEECK, Johan; Tijssen, Jan G. P.; Sharif, Faisal; Onuma, Yoshinobu & Serruys, Patrick W. (2020) Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. In: CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 13 (8). | - |
item.validation | ecoom 2021 | - |
item.accessRights | Restricted Access | - |
item.fulltext | With Fulltext | - |
item.contributor | Hara, Hironori | - |
item.contributor | van Klaveren, David | - |
item.contributor | Takahashi, Kuniaki | - |
item.contributor | Kogame, Norihiro | - |
item.contributor | Chichareon, Ply | - |
item.contributor | Modolo, Rodrigo | - |
item.contributor | Tomaniak, Mariusz | - |
item.contributor | Ono, Masafumi | - |
item.contributor | Kawashima, Hideyuki | - |
item.contributor | Wang, Rutao | - |
item.contributor | Gao, Chao | - |
item.contributor | Niethammer, Margit | - |
item.contributor | Fontos, Geza | - |
item.contributor | Angioi, Michael | - |
item.contributor | Ribeiro, Vasco Gama | - |
item.contributor | Barbato, Emanuele | - |
item.contributor | Leandro, Sergio | - |
item.contributor | Hamm, Christian | - |
item.contributor | Valgimigli, Marco | - |
item.contributor | Windecker, Stephan | - |
item.contributor | Juni, Peter | - |
item.contributor | Steg, Philippe Gabriel | - |
item.contributor | VERBEECK, Johan | - |
item.contributor | Tijssen, Jan G. P. | - |
item.contributor | Sharif, Faisal | - |
item.contributor | Onuma, Yoshinobu | - |
item.contributor | Serruys, Patrick W. | - |
crisitem.journal.issn | 1941-7705 | - |
crisitem.journal.eissn | 1941-7713 | - |
Appears in Collections: | Research publications |
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File | Description | Size | Format | |
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Hironori_Circulation2020_Authorversion.pdf Restricted Access | Peer-reviewed author version | 5.18 MB | Adobe PDF | View/Open Request a copy |
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