Aim To determine the incidence, type and possible association with mortality of major bleeding in patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) treated with an invasive strategy using predominantly the radial approach and triple antiplatelet therapy.
Methods In the multicentre randomised ABOARD Study, 352 patients with NSTE-ACS were randomised to an ‘immediate percutaneous coronary intervention (PCI)’ strategy or a strategy of PCI on the ‘next working day’. Radial access was predominantly used in this study population. The present subanalysis evaluated the occurrence of major bleeding complications and their association with mortality at 1 month.
Results Patients were treated with a triple antiplatelet therapy using high loading and maintenance doses of clopidogrel and abciximab in 99% of patients receiving PCI. The trans-radial approach was used in the vast majority of patients (84%). During the first 30 days, major bleeding complications (STEEPLE definition) occurred in 5.4% of patients (n=19), with no difference between immediate and delayed intervention. The most common bleeding complications were occult bleeding (36.8% of bleeding, n=7/19) and overt gastrointestinal bleeding (21% of bleeding, n=4/19). Patients with major bleeding had a higher peak concentration of creatinine during hospitalisation (mean±SD, 170±169 vs 97±57 μmol/l; p=0.005) and a 1-month mortality of 26.3%, much higher than patients without bleeding (0.6%, p<0.0001). Major bleeding was strongly associated with 30-day mortality (OR 50.3; 95% CI 10.1 to 249.7; p<0.0001).
Conclusion Despite the predominant use of the radial approach, major bleeding (essentially occult and gastrointestinal) remains a common complication, which is highly associated with mortality in patients with NSTE-ACS treated with optimal antithrombotic therapy.
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Competing interests J-PC has received research grants (to the institution) from Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, Guerbet Medical, Medtronic, Boston Scientific, Cordis, Stago, Fondation de France, INSERM, Fédération Française de Cardiologie and Société Française de Cardiologie, and has served as a consultant (honoraria for past 2 years) for consulting fees from Sanofi-Aventis, Eli Lilly and Bristol-Myers Squibb and lecture fees from Bristol-Myers Squibb, Sanofi-Aventis and Eli Lilly. JS has received research grants from Sanofi-Aventis, Daiichi-Sankyo, Eli Lilly, INSERM, Fédération Française de Cardiologie and Société Française de Cardiologie, consultant fees from Daiichi-Sankyo and Eli Lilly, and lecture fees from AstraZeneca, Daiichi-Sankyo and Eli Lilly. GC has received research grants from Fédération Française de Cardiologie, consulting fees from Eli Lilly, Daiichi Sankyo, CLS Behring and Abbott Vascular, and lecture fees from Eli Lilly, Daiichy Sankyo, Servier, Abbott, CLS Behring and AstraZeneca. SO'C has received research grants from A Menarini and the European Society of Cardiology. FB has received speaker honoraria from Pfizer, Astellas, Sanofi-Aventis and Roche. GM has received research grants from Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, Guerbet Medical, Medtronic, Boston Scientific, Cordis, Stago, Centocor, Fondation de France, INSERM, Fédération Française de Cardiologie, Société Française de Cardiologie, ITC Edison, and Pfizer, consulting fees from Sanofi-Aventis, Eli Lilly, Bristol-Myers Squibb, The Medicines Company, Schering-Plough, Portola, Novartis, Menarini, Eisai, Daiichi Sankyo, Bayer and Boehringer Ingelheim, and lecture fees from Sanofi-Aventis, Eli Lilly, Bristol-Myers Squibb, Merck Sharpe & Dohme, Cordis, GlaxoSmith-Kline, Schering-Plough, Accumetrics, AstraZeneca, Daiichi Sankyo and Menarini.
Ethics approval The protocol was approved by the Comité de Protection des Personnes Ile-de France IV.
Provenance and peer review Not commissioned; externally peer reviewed.
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