Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limi ...

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Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention : A Consensus Document From the Academic Research Consortium for High Bleeding Risk

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

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Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk

BACKGROUND  Although several variables have been identified as bleeding determinants (BDs), their occurrence and predictive value in patients undergoing percutaneous coronary intervention (PCI) in the real world remain unclear. We aimed to characterize the rate of BDs in patients undergoing PCI with stent implantation in a large volume tertiary centre. METHODS  We included patients undergoing coronary stenting at our institution from January 2012 to December 2016, and defined post-discharge bleeding (PDB) as bleeding requiring hospitalization or transfusion. Several BDs, identified by the PARIS bleeding and PRECISE-DAPT scores and inclusion criteria of the LEADERS FREE trial, were analysed. RESULTS  In a population of 10,406 subjects who underwent PCI, 2,938 patients (28.2%) had 1, 2,367 (22.8%) had 2 and 2,913 (28.0%) had ≥3 pre-specified BD. Compared with patients without PDB, subjects who experienced PDB were older (70.43 ± 11.94 vs. 65.90 ± 11.54 years, p < 0.0001) with a higher prevalence of common cardiovascular risk factors. One-year PDB occurred in 177 patients (2.4%), and consistently increased according to the number of BDs involved (1.12, 2.11 and 4.35%, respectively; p < 0.0001). Analogously, 1-year rates of post-discharge myocardial infarction or stent thrombosis increased according to the number of BDs (2.44, 3.38 and 4.87%, respectively; p < 0.0001). Only 7 BDs remained independently associated with PDB at 1 year, with anaemia, oral anticoagulant at discharge and malignancy representing the strongest predictors of such risk. CONCLUSION  Many risk factors predispose to PDB; they were often clustered together and conferred additive PDB risk at 1-year of follow-up.

Determinants of Significant Out-Of-Hospital Bleeding in Patients Undergoing Percutaneous Coronary Intervention.

Introduction: Chronic kidney disease (CKD) is commonly present in patients undergoing percutaneous coronary intervention (PCI). These patients frequently present with more complex coronary artery d...

Assessing and minimizing the risk of percutaneous coronary intervention in patients with chronic kidney disease.

Few studies have evaluated outcomes after percutaneous coronary intervention (PCI) in patients with both anemia (hemoglobin

Impact of Chronic Kidney Disease and Anemia on Outcomes After Percutaneous Coronary Revascularization.

Background—Patients with chronic kidney disease (CKD) experience high rates of ischemic and bleeding events after percutaneous coronary intervention (PCI), complicating decisions surrounding dual a...

Incidence, Patterns, and Impact of Dual Antiplatelet Therapy Cessation Among Patients With and Without Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention: Results From the PARIS Registry (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients).

Philippe Gabriel Steg

Papers

Incidence, Patterns, and Impact of Dual Antiplatelet Therapy Cessation Among Patients With and Without Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention: Results From the PARIS Registry (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients).