BACKGROUND: Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention (PCI). No uniform definitions exist for major and minor bleeding. Hematomas > or =5 cm at the femoral puncture site are considered major bleeding events in some trials and minor in others. Limited information is available on the incidence and clinical relevance of hematomas > or =5 cm in PCI patients. METHODS: Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas > or =5 cm on ischemic outcomes (mortality, nonfatal myocardial infarction, or urgent target vessel revascularization) up to day 30 and all-cause 1-year mortality. Hematoma data were available for 3,342 of 3,528 patients in STEEPLE. Patients with (n = 103) and without (n = 3,239) hematomas > or =5 cm were evenly distributed across treatment groups. RESULTS: No differences were observed in 30-day ischemic outcomes between patients with and without hematomas (5.8% vs 5.9%, respectively; P = .96). No transfusions were observed in patients with hematomas as compared with patients without hematomas (0% and 0.4%, respectively; P = .52). A greater reduction in hemoglobin was observed (pre- vs post-PCI) in patients with hematomas as compared with patients without hematomas (-0.84 vs -0.35 g/L, P < or = .001). No significant difference in all-cause 1-year mortality was observed between patients with and without hematomas (0.0% vs 1.7%, P = .98). CONCLUSIONS: After PCI, hematomas > or =5 cm had no effect on 30-day ischemic events or 1-year mortality. Although there is no agreed classification for large hematomas, the lack of a relationship between hematomas > or =5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE. Copyright 2010 Mosby, Inc. All rights reserved.
RCT Entities:
BACKGROUND: Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention (PCI). No uniform definitions exist for major and minor bleeding. Hematomas > or =5 cm at the femoral puncture site are considered major bleeding events in some trials and minor in others. Limited information is available on the incidence and clinical relevance of hematomas > or =5 cm in PCI patients. METHODS: Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas > or =5 cm on ischemic outcomes (mortality, nonfatal myocardial infarction, or urgent target vessel revascularization) up to day 30 and all-cause 1-year mortality. Hematoma data were available for 3,342 of 3,528 patients in STEEPLE. Patients with (n = 103) and without (n = 3,239) hematomas > or =5 cm were evenly distributed across treatment groups. RESULTS: No differences were observed in 30-day ischemic outcomes between patients with and without hematomas (5.8% vs 5.9%, respectively; P = .96). No transfusions were observed in patients with hematomas as compared with patients without hematomas (0% and 0.4%, respectively; P = .52). A greater reduction in hemoglobin was observed (pre- vs post-PCI) in patients with hematomas as compared with patients without hematomas (-0.84 vs -0.35 g/L, P < or = .001). No significant difference in all-cause 1-year mortality was observed between patients with and without hematomas (0.0% vs 1.7%, P = .98). CONCLUSIONS: After PCI, hematomas > or =5 cm had no effect on 30-day ischemic events or 1-year mortality. Although there is no agreed classification for large hematomas, the lack of a relationship between hematomas > or =5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE. Copyright 2010 Mosby, Inc. All rights reserved.
Authors: Marco Valgimigli; Paolo Calabrò; Bernardo Cortese; Enrico Frigoli; Stefano Garducci; Paolo Rubartelli; Giuseppe Andò; Andrea Santarelli; Mario Galli; Roberto Garbo; Alessandra Repetto; Salvatore Ierna; Carlo Briguori; Ugo Limbruno; Roberto Violini; Andrea Gagnor Journal: J Cardiovasc Transl Res Date: 2014-01-07 Impact factor: 4.132
Authors: Bimmer E P M Claessen; Wouter J Kikkert; Loes P Hoebers; Hassina Bahadurzada; Marije M Vis; Jan Baan; Karel T Koch; Robbert J de Winter; Jan G P Tijssen; Jan J Piek; José P S Henriques Journal: Neth Heart J Date: 2015-09 Impact factor: 2.380
Authors: John P Vavalle; Robert Clare; Karen Chiswell; Sunil V Rao; John L Petersen; Neal S Kleiman; Kenneth W Mahaffey; Tracy Y Wang Journal: JACC Cardiovasc Interv Date: 2013-07 Impact factor: 11.195
Authors: Thomas A Meijers; Adel Aminian; Koen Teeuwen; Marleen van Wely; Thomas Schmitz; Maurits T Dirksen; Rene J van der Schaaf; Juan F Iglesias; Pierfrancesco Agostoni; Joseph Dens; Paul Knaapen; Sudhir Rathore; Jan Paul Ottervanger; Jan-Henk E Dambrink; Vincent Roolvink; A T Marcel Gosselink; Renicus S Hermanides; Niels van Royen; Maarten A H van Leeuwen Journal: BMJ Open Date: 2020-07-20 Impact factor: 2.692