Abstract
Abstract Introduction Bleeding is a concern after percutaneous coronary intervention (PCI) and subsequent dual antiplatelet therapy (DAPT). Purpose We herein report the incidence and risk factors for major bleeding in the Norwegian Coronary Stent Trial (NORSTENT). Materials and methods NORSTENT was a randomized, double blind, pragmatic randomized 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 9 months of DAPT. The patients were followed for a median of five years, with BARC 3–5 major bleeding as one of the safety endpoints. We estimated cumulative incidence by a competing risks model and risk factors through cause-specific Cox models. Results The 12-month cumulative incidence of major bleeding was 2.3%. Independent risk factors for major bleeding were chronic kidney disease (CKD), underweight (<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 = 1.7, 95% CI 1–3-2.2). Conclusions The 12-month cumulative incidence of major bleeding in NORSTENT was higher than reported in previous, explanatory trials. This analysis strengthens the role of CKD, advanced age, and underweight 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. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Northern Norway Regional Health Authority (Helse Nord RHF)
Highlights
Bleeding is a concern after percutaneous coronary intervention (PCI) and subsequent dual antiplatelet therapy (DAPT)
A myocardial infarction (MI) or PCI during followup 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
Summary
Bleeding is a concern after percutaneous coronary intervention (PCI) and subsequent dual antiplatelet therapy (DAPT). Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; we enable the publication of all of the content of peer review and author responses alongside final, published articles. Dual antiplatelet therapy (DAPT) is mandatory after percutaneous coronary intervention (PCI) with stent implantation in order to prevent ischemic events [1]. The risk of ischemic events must be balanced against the risk of major bleeding imposed by the antithrombotic therapy. For this purpose, several risk prediction tools based on randomized controlled trials (RCTs) [3,4] or observational studies [5], have been developed. Pragmatic RCTs, have less strict inclusion and exclusion criteria and produce study populations that more closely resemble clinical practice, still offering the advantage of increased validity through adjudicated clinical endpoints
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