Identification and management of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) have been of great interest in the last years, due to the higher incidence of… Click to show full abstract
Identification and management of patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) have been of great interest in the last years, due to the higher incidence of adverse events in this population. However, the lack of standardization in HBR definition has limited trial design, data interpretation, and clinical decision‐making. Recently, The Academic Research Consortium for High Bleeding Risk collaboration proposed a standardized definition for HBR patients, which represents the first pragmatic and consistent approach in this setting. Based on this new definition, several trials have tried to investigate the most appropriate dual antiplatelet therapy (DAPT) regimen in HBR patients. The current European guidelines recommend a short DAPT duration (1 month) for HBR patients after PCI (Class IIb level of evidence C for patients at very HBR, with both chronic and acute coronary syndromes [ACSs]). This regimen has shown indeed to reduce bleeding risk without increasing ischemic events when compared with conventional DAPT duration (3–12 months). Notwithstanding, so far, few data have been published comparing post‐PCI outcomes in HBR and non‐HBR patients when guidelines recommended DAPT regimens are applied. The polymer‐free and carrier‐free Biolimus A9TM‐ coated BioFreedomTM (Biosensors Europe) was the first device that has been tested with a short‐DAPT in HBR patients after PCI. It showed a good safety and efficacy profile, setting the stage for further trials and tests. However, we have limited randomized data on its use in non‐HBR population. In this issue of CCI, Garot et al. reported the results of a multicenter, prospective, all‐comers registry, on the use of BiofreedomTM drug coated stent (DCS) in France. Between April 2019 and April 2020, 1497 patients were enrolled (1006 non‐HBR, 491 HBR mostly due to concomitant anticoagulant therapy [OAC]). HBR patients were significantly sicker and older. Both groups had similar rates of stable coronary disease and ACS. The median duration of DAPT was about 2 months in the HBR group versus 1 year in the non‐HBR group. The rate of HBR patients (32%) was similar to previous studies including all‐comers PCI populations. To note, HBR group showed an increased incidence of both ischemic (cardiac death and target vessel myocardial infarction [MI]) and major bleeding
               
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