Relation of Periprocedural Bleeding Complications and Long-Term Outcome in Patients Undergoing Percutaneous Coronary Revascularization (from the Evaluation of Oral Xemilofiban in Controlling Thrombotic Events [EXCITE] Trial)

• Published in: The American journal of cardiology 2009-04, Vol.103 (7), p.917-922
• Main Authors: Brugts, Jasper Jan, MD, MSc, Mercado, Nestor, MD, PhD, Hu, Stephen, MD, MPH, Guarneri, Mimi, MD, Price, Matthew, MD, Schatz, Richard, MD, Teirstein, Paul, MD, Wijns, William, MD, PhD, Serruys, Patrick W., MD, PhD, O'Neill, William W., MD, Boersma, Eric, PhD
• Format: Article
• Language: English
• Subjects: Administration, Oral; Angioplasty; Angioplasty, Balloon, Coronary - methods; Benzamidines - administration & dosage; Benzamidines - adverse effects; Biological and medical sciences; Cardiology; Cardiology. Vascular system; Cardiovascular; Cardiovascular disease; Clinical outcomes; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Thrombosis - epidemiology; Coronary Thrombosis - prevention & control; Diseases of the cardiovascular system; Dose-Response Relationship, Drug; Double-Blind Method; Electrocardiography; Female; Follow-Up Studies; Glycoproteins; Humans; Incidence; Male; Medical sciences; Middle Aged; Patients; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Postoperative Hemorrhage - blood; Postoperative Hemorrhage - epidemiology; Postoperative Hemorrhage - etiology; Preoperative Care - adverse effects; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Risk Factors; Survival Rate - trends; Thrombocytopenia - blood; Thrombocytopenia - chemically induced; Thrombocytopenia - complications; Thrombosis; Time Factors; Treatment Outcome; United States - epidemiology
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2008.12.017

Several clinical trials have shown that antagonists of the glycoprotein IIb/IIIa receptor decreased the incidence of death, nonfatal myocardial infarction, and the need for urgent revascularization when administered immediately before or during the 24- to 48-hour period after percutaneous coronary intervention (PCI). However, these agents increased the risk of thrombocytopenia and periprocedural bleeding complications. Therefore, the relation between periprocedural bleeding complications during PCI and long-term outcome was assessed in 6,995 patients in the EXCITE trial. Periprocedural bleeding was classified as none, mild, moderate, and severe. Measured outcomes included the incidence of all-cause mortality or the composite end point (cardiovascular disease) of death, myocardial infarction, or stroke. Subjects were followed up for a median of 210 days (7 months). Mean patient age was 59.1 years, and 21.8% were women. Periprocedural bleeding complications occurred in 1,869 patients (26.7%), and blood transfusion was administered to 189 patients (2.7%). In multivariate analysis, periprocedural bleeding complications were significantly associated with increased risk of the composite outcome for mild (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.64 to 0.97), moderate (HR 2.38, 95% CI 1.78 to 3.20), and severe bleeding complications (HR 3.55, 95% CI 2.20 to 5.73) during follow-up. Also, the necessity of blood transfusion was an important predictor of the composite end point (HR 2.61, 95% CI 1.96 to 3.60). Patients in the United States were more likely to be administered a blood transfusion than non-US patients independently of cardiovascular risk factors. In conclusion, moderate and severe periprocedural bleeding complications increased the risk of mortality and incident cardiovascular events after PCI.