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Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials

Muthiah Vaduganathan1, MD, MPH; Robert A. Harrington2, MD; Gregg W. Stone3, MD; Ph. Gabriel Steg4, MD; C. Michael Gibson5, MS, MD; Christian W. Hamm6, MD; Matthew J. Price7, MD; Renato D. Lopes8, MD, MHS, PhD; Sergio Leonardi9, MD; Efthymios N. Deliargyris10, MD; Jayne Prats11, PhD; Kenneth W. Mahaffey2, MD; Harvey D. White12, DSc; Deepak L. Bhatt1*, MD, MPH; on behalf of the Champion Investigators

1. Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA; 2. Stanford University Medical School, Stanford, CA, USA; 3. Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY, USA; 4. FACT (French Alliance for Cardiovascular Clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique–Hôpitaux de Paris, Paris, France, and NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom; 5. Beth Israel Deaconess Medical Center, Division of Cardiology, Boston, MA, USA; 6. Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany; 7. Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA, USA; 8. Duke Clinical Research Institute and Duke University School of Medicine, Durham, NC, USA; 9. Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; 10. Science and Strategy Consulting Group, Basking Ridge, NJ, USA; 11. Elysis, Carlisle, MA, USA; 12. Green Lane Cardiovascular Service, Auckland, New Zealand

Aims: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI).

Methods and results: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all 3 trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67).

Conclusions: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials. CHAMPION PCI - ClinicalTrials.gov Identifier: NCT00305162; CHAMPION PLATFORM - ClinicalTrials.gov Identifier: NCT00385138; CHAMPION PHOENIX - ClinicalTrials.gov Identifier: NCT01156571.

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