Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes

BACKGROUND Whether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown. METHODS AND RESULTS This study included 4018 patie...

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Autores principales:	Gjin Ndrepepa, Franz‐Josef Neumann, Maurizio Menichelli, Isabell Bernlochner, Gert Richardt, Jochen Wöhrle, Bernhard Witzenbichler, Katharina Mayer, Salvatore Cassese, Senta Gewalt, Erion Xhepa, Sebastian Kufner, Hendrik B. Sager, Michael Joner, Tareq Ibrahim, Karl‐Ludwig Laugwitz, Heribert Schunkert, Stefanie Schüpke, Adnan Kastrati
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	mortality prasugrel randomized controlled trial recruitment center ticagrelor Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/f2046ed721094811a4bcf71a9a813a01
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spelling	oai:doaj.org-article:f2046ed721094811a4bcf71a9a813a012021-11-16T10:22:43ZAssessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes10.1161/JAHA.121.0214182047-9980https://doaj.org/article/f2046ed721094811a4bcf71a9a813a012021-11-01T00:00:00Zhttps://www.ahajournals.org/doi/10.1161/JAHA.121.021418https://doaj.org/toc/2047-9980BACKGROUND Whether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown. METHODS AND RESULTS This study included 4018 patients with acute coronary syndrome recruited in the ISAR‐REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial. The primary end point was a composite of all‐cause death, myocardial infarction, or stroke. Overall, 3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients). Patients recruited in the LRCs had more favorable cardiovascular risk profiles than patients recruited in the HRCs. The primary end point occurred in 72 patients in the LRCs and 249 patients in the HRCs (cumulative incidence, 7.3% and 8.4%; P=0.267). All‐cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%; P=0.031). There was no significant interaction between the treatment effect of ticagrelor versus prasugrel and patient recruitment category (LRC versus HRC) regarding the primary efficacy end point (LRC: hazard ratio [HR], 1.42 [95% CI, 0.89–2.28]; HRC: HR, 1.33 [95% CI, 1.04−1.72]; P for interaction=0.800). CONCLUSIONS Patients with acute coronary syndrome recruited in a LRC appear to have more favorable cardiovascular risk profiles and lower 1‐year mortality rates compared with patients recruited in a HRC. The recruitment volume did not interact with the treatment effect of ticagrelor versus prasugrel. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.Gjin NdrepepaFranz‐Josef NeumannMaurizio MenichelliIsabell BernlochnerGert RichardtJochen WöhrleBernhard WitzenbichlerKatharina MayerSalvatore CasseseSenta GewaltErion XhepaSebastian KufnerHendrik B. SagerMichael JonerTareq IbrahimKarl‐Ludwig LaugwitzHeribert SchunkertStefanie SchüpkeAdnan KastratiWileyarticlemortalityprasugrelrandomized controlled trialrecruitment centerticagrelorDiseases of the circulatory (Cardiovascular) systemRC666-701ENJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 10, Iss 22 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	mortality prasugrel randomized controlled trial recruitment center ticagrelor Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	mortality prasugrel randomized controlled trial recruitment center ticagrelor Diseases of the circulatory (Cardiovascular) system RC666-701 Gjin Ndrepepa Franz‐Josef Neumann Maurizio Menichelli Isabell Bernlochner Gert Richardt Jochen Wöhrle Bernhard Witzenbichler Katharina Mayer Salvatore Cassese Senta Gewalt Erion Xhepa Sebastian Kufner Hendrik B. Sager Michael Joner Tareq Ibrahim Karl‐Ludwig Laugwitz Heribert Schunkert Stefanie Schüpke Adnan Kastrati Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes
description	BACKGROUND Whether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown. METHODS AND RESULTS This study included 4018 patients with acute coronary syndrome recruited in the ISAR‐REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial. The primary end point was a composite of all‐cause death, myocardial infarction, or stroke. Overall, 3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients). Patients recruited in the LRCs had more favorable cardiovascular risk profiles than patients recruited in the HRCs. The primary end point occurred in 72 patients in the LRCs and 249 patients in the HRCs (cumulative incidence, 7.3% and 8.4%; P=0.267). All‐cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%; P=0.031). There was no significant interaction between the treatment effect of ticagrelor versus prasugrel and patient recruitment category (LRC versus HRC) regarding the primary efficacy end point (LRC: hazard ratio [HR], 1.42 [95% CI, 0.89–2.28]; HRC: HR, 1.33 [95% CI, 1.04−1.72]; P for interaction=0.800). CONCLUSIONS Patients with acute coronary syndrome recruited in a LRC appear to have more favorable cardiovascular risk profiles and lower 1‐year mortality rates compared with patients recruited in a HRC. The recruitment volume did not interact with the treatment effect of ticagrelor versus prasugrel. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.
format	article
author	Gjin Ndrepepa Franz‐Josef Neumann Maurizio Menichelli Isabell Bernlochner Gert Richardt Jochen Wöhrle Bernhard Witzenbichler Katharina Mayer Salvatore Cassese Senta Gewalt Erion Xhepa Sebastian Kufner Hendrik B. Sager Michael Joner Tareq Ibrahim Karl‐Ludwig Laugwitz Heribert Schunkert Stefanie Schüpke Adnan Kastrati
author_facet	Gjin Ndrepepa Franz‐Josef Neumann Maurizio Menichelli Isabell Bernlochner Gert Richardt Jochen Wöhrle Bernhard Witzenbichler Katharina Mayer Salvatore Cassese Senta Gewalt Erion Xhepa Sebastian Kufner Hendrik B. Sager Michael Joner Tareq Ibrahim Karl‐Ludwig Laugwitz Heribert Schunkert Stefanie Schüpke Adnan Kastrati
author_sort	Gjin Ndrepepa
title	Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes
title_short	Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes
title_full	Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes
title_fullStr	Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes
title_full_unstemmed	Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes
title_sort	assessment of impact of patient recruitment volume on risk profile, outcomes, and treatment effect in a randomized trial of ticagrelor versus prasugrel in acute coronary syndromes
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/f2046ed721094811a4bcf71a9a813a01
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Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes

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