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BleeMACS: rationale and design of the study
Fabrizio D'Ascenzo1, Emad Abu-Assi, Sergio Raposeiras-Roubín
1aDipartimento di Scienze Mediche, Divisione di Cardiologia, Città della Salute e della Scienza, Turin, Italy bUniversity Clinical Hospital, Santiago de Compostela, Spain cUniversity Academic Medical Center, Amsterdam, The Netherlands dNorthShore University Hospital, Chicago, Illinois, USA eLibin Cardiovascular Institute of Alberta, Calgary, Canada fSan Carlos Hospital, Madrid gBellvitge Hospital, Barcelona, Spain hAnzhen Hospital, Beijing, China iUniversity Patras Hospital, Athens, Greece jKerckhoff Heart and Thorax Center, Frankfurt, Germany kUniversity Clinical Hospital, Kyoto, Japan lUniversity Clinical Hospital, Warsaw, Poland mInstitute of Heart, Lung and Blood Vessel Disease, Beijing, China nTokai University School of Medicine, Tokyo, Japan oUniversity Bahian Medical School, Salvador, Brazil pDivision of Cardiovascular Medicine, Kanazawa University Graduate School of Medicine, Kanazawa, Japan qUniversity Clinic of Cardiology, Skopje, Macedonia.
Insights
The BleeMACS registry will develop a new risk score to predict major bleeding events within one year after acute coronary syndrome (ACS). This score will improve prognosis prediction for patients receiving modern treatments post-ACS.
Area of Science:
- Cardiology
- Clinical Research
- Public Health
Background:
- Bleeding events post-acute coronary syndrome (ACS) negatively impact patient prognosis.
- Current risk scores for bleeding lack accuracy and fail to predict long-term events or include patients on new antiplatelet agents.
- Percutaneous coronary intervention (PCI) is widely used in ACS management.
Purpose of the Study:
- To develop and validate a risk score for predicting major bleeding events within one year following hospital discharge in ACS patients.
- To address limitations of existing risk scores in contemporary ACS treatment paradigms.
Main Methods:
- The BleeMACS project is a multicenter, international, retrospective registry of over 15,000 ACS patients treated with PCI.
- The primary endpoint is the incidence of major bleeding requiring hospitalization or red cell transfusion within one year.
- A multivariate competing-risks regression model will be used to develop an integer risk score.
Main Results:
- (Study ongoing, results not yet available)
Conclusions:
- The BleeMACS registry collaborative aims to create a validated risk score for major bleeding prediction.
- This score will aid in managing patients receiving contemporary therapies for acute coronary syndrome.
Background:
Bleeding events after an acute coronary syndrome have a negative impact on prognosis. Available risk scores are limited by suboptimal accuracy, prediction of only in-hospital events and absence of patients treated with new antiplatelet agents in the current era of widespread use of percutaneous coronary intervention.
Design:
The BleeMACS (Bleeding complications in a Multicenter registry of patients discharged after an Acute Coronary Syndrome) project is a multicenter investigator-initiated international retrospective registry that enrolled more than 15 000 patients discharged with a definitive diagnosis of acute coronary syndrome and treated with percutaneous revascularization. The primary end point is the incidence of major bleeding events requiring hospitalization and/or red cell transfusion concentrates within 1 year. An integer risk score for bleeding within the first year after hospital discharge will be developed from a multivariate competing-risks regression.
Conclusion:
The BleeMACS registry collaborative will allow development and validation of a risk score for prediction of major bleeding during follow-up for patients receiving contemporary therapies for acute coronary syndrome.
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