Journal Article

Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT)

Wilsgaard, Tom, Eggen, Anne Elise, Bønaa, Kaare Harald, van den Heuvel, Christian, Bendz, Bjørn, Kristensen, Andreas, Holme, Elizabeth, Steigen, Terje, Nordrehaug, Jan Erik, Samuelsen, Per-Jostein, Skogsholm, Anne, Nilsen, Dennis W. T.

2021

Overview

Bleeding is a concern after percutaneous coronary intervention (PCI) and subsequent dual antiplatelet therapy (DAPT). We herein report the incidence and risk factors for major bleeding in the Norwegian Coronary Stent Trial (NORSTENT). NORSTENT was a randomized, double blind, pragmatic trial among patients with acute coronary syndrome or stable coronary disease undergoing PCI during 2008-11. The patients (N = 9,013) were randomized to receive either a drug-eluting stent or a bare-metal stent, and were treated with at least nine months of DAPT. The patients were followed for a median of five years, with Bleeding Academic Research Consortium (BARC) 3-5 major bleeding as one of the safety endpoints. We estimated cumulative incidence of major bleeding by a competing risks model and risk factors through cause-specific Cox models. The 12-month cumulative incidence of major bleeding was 2.3%. Independent risk factors for major bleeding were chronic kidney disease, low bodyweight (< 60 kilograms), diabetes mellitus, and advanced age (> 80 years). A myocardial infarction (MI) or PCI during follow-up increased the risk of major bleeding (HR = 1.67, 95% CI 1-29-2.15). The 12-month cumulative incidence of major bleeding in NORSTENT was higher than reported in previous, explanatory trials. This analysis strengthens the role of chronic kidney disease, advanced age, and low bodyweight as risk factors for major bleeding among patients receiving DAPT after PCI. The presence of diabetes mellitus or recurrent MI among patients is furthermore a signal of increased bleeding risk. Unique identifier NCT00811772; http://www.clinicaltrial.gov.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Acute coronary syndromes / Age Factors / Aged / Aged, 80 and over / Angina / Angina pectoris / Angioplasty / Antiplatelet therapy / Arctic research / Bleeding / Cardiology / Cardiovascular disease / Cardiovascular diseases / Clinical medicine / Complications and side effects / Coronary artery / Coronary artery disease / Coronary vessels / Demographic aspects / Diabetes / Drafting software / Drug-Eluting Stents - adverse effects / Editing / Female / Funding / Heart attacks / Heart diseases / Hemoglobin / Hemorrhage / Hospitals / Humans / Implantation / Implants / Incidence / Ischemia / Kidney diseases / Male / Medical imaging / Medicine / Medicine and Health Sciences / Methodology / Middle Aged / Myocardial Infarction - blood / Myocardial Infarction - epidemiology / Myocardial Infarction - surgery / Patients / Percutaneous Coronary Intervention - adverse effects / Pharmacovigilance / Platelet Aggregation Inhibitors - administration & dosage / Platelet Aggregation Inhibitors - adverse effects / Polar environments / Postoperative Hemorrhage - blood / Postoperative Hemorrhage - epidemiology / Postoperative Hemorrhage - etiology / Risk analysis / Risk Factors / Science and technology / Stents / Subgroups / Surgical implants / Transluminal angioplasty / Validity