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Randomized Controlled Trial
. 2021 Mar 4;16(3):e0247358.
doi: 10.1371/journal.pone.0247358. eCollection 2021.

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

Per-Jostein Samuelsen  1   2 , Anne Elise Eggen  2 , Terje Steigen  3   4 , Tom Wilsgaard  2 , Andreas Kristensen  3 , Anne Skogsholm  3 , Elizabeth Holme  3 , Christian van den Heuvel  3 , Jan Erik Nordrehaug  5 , Bjørn Bendz  6   7 , Dennis W T Nilsen  5   8 , Kaare Harald Bønaa  9   10
Affiliations
Randomized Controlled Trial

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

Per-Jostein Samuelsen et al. PLoS One. .

Abstract

Introduction: 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).

Materials and methods: 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.

Results: 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).

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 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.

Clinical trial registration: Unique identifier NCT00811772; http://www.clinicaltrial.gov.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Cumulative incidence of major bleeding as defined as Bleeding Academic Research Consortium 3–5 according to the non-parametric cumulative incidence function.
Vertical lines in the magnified portion highlight the cumulative incidence at 30 days, 9 months, and 12 months.
Fig 2
Fig 2. Incidence rate per 1,000 person-years of major bleeding in consecutive 6-month intervals of the follow-up-period.
See this image and copyright information in PMC

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