Bleeding after antithrombotic therapy in patients with acute ischemic heart disease: is it the drugs or how we use them?
Definitions of bleeding must be considered when evaluating results of clinical trials. Assessments of bleeding impact based on clinical criteria may be more relevant to patient outcomes than those based on simple laboratory measures like an isolated change in hemoglobin, that do not appear to affect patient care. The risk of excessive bleeding in patients who receive antiplatelet and antithrombotic therapy is related to a combination of patient characteristics (older age, female sex, impaired renal function), and delivery factors (excessive dosing, stacking of anticoagulants). Investigators should justify components of bleeding endpoints as being clinically meaningful, sufficiently frequent in the study population, and affected by the intervention.
Cohen
Marc
M
The Division of Cardiology, Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, NJ, USA. marcohen@sbhcs.com
Alexander
Karen P
KP
Rao
Sunil V
SV
D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000367:Age Factors; D000368:Aged; D017115:Catheter Ablation; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D012307:Risk Factors; D012737:Sex Factors
D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors