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Consecutive or selectively included high bleeding risk patients in the MASTER DAPT screening log and trial

A. Landi, D. Heg, E. Frigoli, PAL. Tonino, P. Vranckx, S. Pourbaix, B. Chevalier, A. Iñiguez, E. Pinar, M. Lesiak, P. Kala, M. Donahue, S. Windecker, M. Roffi, PC. Smits, M. Valgimigli, MASTER DAPT Investigators

. 2024 ; 126 (-) : 89-94. [pub] 20240503

Jazyk angličtina Země Nizozemsko

Typ dokumentu časopisecké články, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc24019585

AIMS: Screening logs have the potential to appraise the actual prevalence and distribution of predefined patient subsets, avoiding selection biases, which are inevitably and potentially present in randomised trials and real-world registries, respectively. We aimed to assess the prevalence of high bleeding risk (HBR) characteristics in the real world and the external validity of the MASTER DAPT trial. METHODS AND RESULTS: All consecutive patients who underwent percutaneous coronary intervention (PCI) for at least two consecutive weeks across 65 sites participating in the trial were entered into a screening log. Of 2,847 consecutive patients, 1,098 (38.6 %) were HBR and 109 (9.9 %) consented for trial participation. PRECISE-DAPT score ≥ 25 was the most frequent HBR feature, followed by advanced age, use of oral anticoagulation (OAC) and anaemia. Compared with consecutive HBR patients, consenting patients were older (≥ 75 years: 69 % versus 62 %, absolute standardized difference [SD] 0.16), more frequently male (78 % versus 71 %, absolute SD 0.18), had higher use of OAC (38 % versus 20 %, absolute SD 0.39), treatment with steroids or nonsteroidal anti-inflammatory drugs (10 % versus 5 %, SD 0.16), and prior cerebrovascular events (10 % versus 6 %, absolute SD 0.18) but lower PRECISE DAPT score ≥ 25 (54 % versus 66 %, absolute SD 0.24). CONCLUSIONS: The HBR criteria distribution differed between consecutive versus selectively included HBR patients, suggesting the existence of selection biases in the trial population.

Citace poskytuje Crossref.org

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$a AIMS: Screening logs have the potential to appraise the actual prevalence and distribution of predefined patient subsets, avoiding selection biases, which are inevitably and potentially present in randomised trials and real-world registries, respectively. We aimed to assess the prevalence of high bleeding risk (HBR) characteristics in the real world and the external validity of the MASTER DAPT trial. METHODS AND RESULTS: All consecutive patients who underwent percutaneous coronary intervention (PCI) for at least two consecutive weeks across 65 sites participating in the trial were entered into a screening log. Of 2,847 consecutive patients, 1,098 (38.6 %) were HBR and 109 (9.9 %) consented for trial participation. PRECISE-DAPT score ≥ 25 was the most frequent HBR feature, followed by advanced age, use of oral anticoagulation (OAC) and anaemia. Compared with consecutive HBR patients, consenting patients were older (≥ 75 years: 69 % versus 62 %, absolute standardized difference [SD] 0.16), more frequently male (78 % versus 71 %, absolute SD 0.18), had higher use of OAC (38 % versus 20 %, absolute SD 0.39), treatment with steroids or nonsteroidal anti-inflammatory drugs (10 % versus 5 %, SD 0.16), and prior cerebrovascular events (10 % versus 6 %, absolute SD 0.18) but lower PRECISE DAPT score ≥ 25 (54 % versus 66 %, absolute SD 0.24). CONCLUSIONS: The HBR criteria distribution differed between consecutive versus selectively included HBR patients, suggesting the existence of selection biases in the trial population.
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$a Heg, Dik $u The Department of Clinical Research (DCR), University of Bern, Bern, Switzerland
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$a Frigoli, Enrico $u Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), Università della Svizzera Italiana, CH-6900, Lugano, Switzerland
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$a Tonino, Pim A L $u The Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands
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$a Vranckx, Pascal $u The Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
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$a Pourbaix, Suzanne $u Department of Cardiology, CHR Citadelle Liège, Liège, Belgium
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$a Chevalier, Bernard $u the Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France
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$a Iñiguez, Andrés $u Hospital Alvaro Cunqueiro, Vigo, Spain
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$a Pinar, Eduardo $u Hospital Virgen de la Arrixaca, Murcia Spain
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$a Lesiak, Maciej $u The First Department of Cardiology, University of Medical Sciences, Poznan, Poland
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$a Kala, Petr $u The University Hospital Brno, Medical Faculty of Masaryk University Brno, Czech Republic
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$a Donahue, Michael $u The Interventional Cardiology Unit, Policlinico Casilino, Rome, Italy
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$a Windecker, Stephan $u The Department of Cardiology, Bern University Hospital, Bern, Switzerland
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$a Roffi, Marco $u The Division of Cardiology, Geneva University Hospitals, Geneva Switzerland
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$a Smits, Pieter C $u The Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands
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$a Valgimigli, Marco $u Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), Università della Svizzera Italiana, CH-6900, Lugano, Switzerland; The Faculty of Biomedical Sciences, University of Italian Switzerland (USI), CH-6900 Lugano, Switzerland; The University of Bern, Bern, Switzerland. Electronic address: marco.valgimigli@eoc.ch
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