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June 9, 2025Cardiovascular Intervention and Therapeutics3 citationsOpen Access

Long-term bleeding events post-percutaneous coronary intervention in patients with malignancy with and without anticoagulant therapy

YOYasuhiro OtsukaMIMasanobu IshiiSISo Ikebe

Key Result

In patients with malignancy undergoing percutaneous coronary intervention, warfarin therapy was associated with a significantly higher risk of major bleeding events compared to no oral anticoagulant therapy (HR 3.64).

Study Design

Type

Cohort (n=6,451)

Multicenter

Yes

Structured PICO

Does the choice of oral anticoagulant (warfarin vs DOAC) affect the risk of long-term bleeding events in patients with malignancy undergoing PCI?

P
Population
6,451 patients who underwent percutaneous coronary intervention, including 664 with a history of malignancy, followed for 3 years to evaluate the impact of anticoagulant therapy on bleeding events.
E
Exposure
Oral anticoagulant therapy (warfarin or direct oral anticoagulants [DOAC]) in patients with malignancy post-PCI
C
Comparator
Patients with malignancy not receiving oral anticoagulants (OAC), and patients without malignancy
O
Outcome
Incidence of major bleeding events, classified as moderate or severe bleeding according to the Global Use of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) bleeding criteria over 3 yearssafety

In patients with malignancy undergoing PCI, warfarin therapy is associated with a significantly higher risk of long-term bleeding events compared to no OAC, suggesting DOACs may be a safer alternative.

Main Result

Hazard Ratio: 3.64 (95% CI 1.38–9.61)

p-value: p=0.009

Limitations

  • Retrospective study design with potential selection bias and unmeasured confounding factors.
  • Lack of detailed information on the continuation or discontinuation of dual antiplatelet therapy (DAPT) after hospital discharge.
  • Definition of malignancy was based on a history of prior malignancy rather than active malignancy.
  • Potential underestimation of bleeding events due to incomplete follow-up for patients transferred to other hospitals.
  • Small sample sizes in the malignancy groups treated with DOAC and warfarin.

Abstract

Abstract The prevalence of malignancies in patients undergoing percutaneous coronary intervention (PCI) is increasing with aging. Active malignancy is a significant contributor to high bleeding risk. For cancer patients requiring oral anticoagulant (OAC) therapy, the choice between direct oral anticoagulants (DOAC) and warfarin is critical. The aim of this study was to investigate long-term bleeding events in patients with malignancy undergoing PCI. The CLIDAS (Clinical Deep Data Accumulation System) multicenter database includes data from seven tertiary medical hospitals in Japan. This retrospective analysis included 6451 patients who underwent PCI between April 2013 and March 2019 and completed 3-year follow-up. The patients were divided into two groups; No malignancy (n = 5787) and Malignancy group (n = 664). Malignancy was defined by a history of cancer treatment. These groups were further subcategorized based on OAC therapy; (1) No malignancy without OAC (n = 5134), (2) No malignancy with DOAC (n = 261), (3) No malignancy with warfarin (n = 392), (4) Malignancy without OAC (n = 589), (5) Malignancy with DOAC (n = 38), and (6) Malignancy with warfarin (n = 37). The primary outcome was the incidence of bleeding events, defined according to the Global Use of Streptokinase and t-PA for Occluded Coronary Arteries classification of moderate and severe bleeding. The secondary outcomes were major adverse cardiac events (MACE) and net adverse clinical events (NACE). Multivariable Cox regression analysis showed that the malignancy with warfarin group had a significantly higher risk of bleeding events compared to the malignancy without OAC group (hazard ratio HR, 3.64; 95% confidence interval CI, 1.38–9.61, p value = 0.009). No significant differences were observed for MACE (HR, 1.39; 95% CI 0.59–3.25, p value = 0.454) or NACE (HR, 1.62; 95% CI, 0.80–3.29; p value = 0.184). Malignancy patients receiving warfarin were associated with a higher risk of bleeding events. DOACs may represent a preferable alternative to warfarin with regard to bleeding risk in patients with malignancy undergoing PCI. Graphical abstract Patients with malignancy receiving warfarin after PCI experienced a higher incidence of bleeding events. An analysis of 6,451 patients who underwent PCI revealed that only the group of patients with malignancy on warfarin therapy had a significantly higher incidence of bleeding events over the three-year postoperative period. PCI, percutaneous coronary intervention; OAC, oral anticoagulants; DOAC, direct oral anticoagulants; WF, warfarin.

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Cite This Study

Otsuka et al. (2025) conducted a cohort in Ischemic heart disease requiring percutaneous coronary intervention in patients with and without malignancy (n=6,451). Warfarin vs. No oral anticoagulant (OAC) was evaluated on Incidence of major bleeding events (moderate or severe bleeding according to GUSTO criteria) (HR 3.64, 95% CI 1.38-9.61, p=0.009). In patients with malignancy undergoing percutaneous coronary intervention, warfarin therapy was associated with a significantly higher risk of major bleeding events compared to no oral anticoagulant therapy (HR 3.64).

synapsesocial.com/papers/6aa01423603ff62333619781https://doi.org/10.1007/s12928-025-01151-4
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