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

Antonio Landi ¹, Dik Heg ², Enrico Frigoli ³

¹Cardiocentro 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.
²The Department of Clinical Research (DCR), University of Bern, Bern, Switzerland.
³Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), Università della Svizzera Italiana, CH-6900, Lugano, Switzerland.
⁴The Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
⁵The Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
⁶Department of Cardiology, CHR Citadelle Liège, Liège, Belgium.
⁷the Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France.
⁸Hospital Alvaro Cunqueiro, Vigo, Spain.
⁹Hospital Virgen de la Arrixaca, Murcia Spain.
¹⁰The First Department of Cardiology, University of Medical Sciences, Poznan, Poland.
¹¹The University Hospital Brno, Medical Faculty of Masaryk University Brno, Czech Republic.
¹²The Interventional Cardiology Unit, Policlinico Casilino, Rome, Italy.
¹³The Department of Cardiology, Bern University Hospital, Bern, Switzerland.
¹⁴The Division of Cardiology, Geneva University Hospitals, Geneva Switzerland.
¹⁵The Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
¹⁶Cardiocentro 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.

⁰Cardiocentro 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.

European Journal of Internal Medicine +

|

May 4, 2024

View abstract on PubMed

Summary

Screening logs reveal that high bleeding risk (HBR) characteristics are common in patients undergoing percutaneous coronary intervention (PCI). However, trial participants showed selection bias compared to the general HBR population.

Area Of Science

Cardiology
Clinical Trials
Health Services Research

Background

Screening logs can assess patient subset prevalence and distribution, mitigating selection biases inherent in randomized trials and real-world registries.
Understanding the real-world prevalence of high bleeding risk (HBR) characteristics is crucial for patient management.
The external validity of clinical trials, like the MASTER DAPT trial, needs evaluation against real-world data.

Purpose Of The Study

To determine the prevalence and distribution of HBR characteristics in patients undergoing percutaneous coronary intervention (PCI).
To assess the external validity of the MASTER DAPT trial by comparing its population to consecutive HBR patients identified via screening logs.

Main Methods

A screening log captured consecutive patients undergoing PCI across 65 trial sites.
Prevalence of HBR characteristics was determined, including the PRECISE-DAPT score, advanced age, oral anticoagulation (OAC) use, and anemia.
Demographic and clinical data of HBR patients who consented for trial participation were compared with all consecutive HBR patients.

Main Results

Of 2,847 consecutive patients, 38.6% were identified as HBR.
The most frequent HBR feature was a PRECISE-DAPT score ≥ 25, followed by advanced age and OAC use.
Consenting HBR patients were older, more likely male, had higher OAC use, and more prior cerebrovascular events, but a lower prevalence of high PRECISE-DAPT scores compared to consecutive HBR patients.

Conclusions

The distribution of HBR criteria differs between consecutive and selectively included HBR patients.
These differences suggest the presence of selection biases within the MASTER DAPT trial population.
Screening logs provide valuable insights into real-world patient populations and potential trial generalizability issues.

Keywords:

Antiplatelet therapy Dual antiplatelet therapy High bleeding risk Percutaneous coronary intervention

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