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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| Format: | Article |
| Language: | English |
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Wiley
2021-11-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.121.021418 |
| _version_ | 1811311007454199808 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-13T10:10:16Z |
| format | Article |
| id | doaj.art-f2046ed721094811a4bcf71a9a813a01 |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-04-13T10:10:16Z |
| publishDate | 2021-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-f2046ed721094811a4bcf71a9a813a012022-12-22T02:50:57ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802021-11-01102210.1161/JAHA.121.021418Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary SyndromesGjin Ndrepepa0Franz‐Josef Neumann1Maurizio Menichelli2Isabell Bernlochner3Gert Richardt4Jochen Wöhrle5Bernhard Witzenbichler6Katharina Mayer7Salvatore Cassese8Senta Gewalt9Erion Xhepa10Sebastian Kufner11Hendrik B. Sager12Michael Joner13Tareq Ibrahim14Karl‐Ludwig Laugwitz15Heribert Schunkert16Stefanie Schüpke17Adnan Kastrati18Deutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDepartment of Cardiology and Angiology II University Heart Center Freiburg Bad Krozingen Bad Krozingen GermanyDepartment of Cardiology Ospedale Fabrizio Spaziani Frosinone ItalyMedizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar Munich GermanyHeart Center Bad Segeberg Bad Segeberg GermanyDepartment of Cardiology Medical Campus Lake Constance Friedrichshafen GermanyDepartment of Cardiology and Pneumology Helios Amper‐Klinikum Dachau Dachau GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyMedizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar Munich GermanyMedizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyDeutsches Herzzentrum München, Cardiology and Technische Universität München Munich GermanyBACKGROUND 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.https://www.ahajournals.org/doi/10.1161/JAHA.121.021418mortalityprasugrelrandomized controlled trialrecruitment centerticagrelor |
| spellingShingle | 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 Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease mortality prasugrel randomized controlled trial recruitment center ticagrelor |
| 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_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_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_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 |
| topic | mortality prasugrel randomized controlled trial recruitment center ticagrelor |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.121.021418 |
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