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Safe and Efficacious Use of 1-Month Triple Therapy in Patients with Atrial Fibrillation and High Bleeding Risk Undergoing PCI

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Abstract

Background

The impact of short or prolonged use of triple therapy (TT) on outcomes in patients with atrial fibrillation (AF) and high risk of bleeding undergoing percutaneous coronary intervention (PCI) is unclear. We compared clinical outcomes according to the duration of TT in patients with AF and HAS-BLED ≥ 3 at 1 year of follow-up.

Methods

A prospective observational cohort enrolled 735 patients with AF between 2010 and 2015. Of these, 521 (70.9%) had HAS-BLED ≥ 3 and 380 (72.9%) were discharged on TT. TT was prescribed for 1 month in 233 patients (61.3%). The primary endpoint was the incidence of Bleeding Academic Research Consortium (BARC ≥ 3). The secondary endpoint was the occurrence of ischemic events (cardiac death, MI, stroke, or stent thrombosis).

Results

Patients on 1-month TT had a higher median HAS-BLED. Intracraneal hemorrhage was twofold more frequently in patients on > 1-month TT but without statistical significance (0.9% vs 2.1%, p = 0.20). Rates of the primary endpoint (bleeding BARC ≥ 3) were 8.2% vs 10.9% and did not differ between groups, while secondary endpoint did not occur more frequently in the 1-month TT group compared with the > 1-month TT group (26.6% vs 23.1%). In adjusted multivariate analyses, patients receiving 1-month TT had a similar risk of the primary endpoint compared to those with > 1-month TT (HR 1.47; 95% CI 0.48–4.47, p = 0.50). No difference was found in the secondary ischemic endpoint (HR 1.24; 95% CI 0.77–2.00, p = 0.38).

Conclusions

In patients with AF undergoing PCI at lower ischemic risk and higher bleeding risk, 1 month of TT seems safe and efficacious. Further studies are warranted in patients at high ischemic risk.

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Funding

This study was supported by CIBERCV. No additional external funding was received.

Author information

Authors and Affiliations

  1. Department of Cardiology, Hospital Vall d’Hebron University, Barcelona, Spain

    Antonia Sambola, Berta Miranda, Javier Limeres, Bruno García del Blanco & David García-Dorado

  2. Research Institute Vall d’Hebron, Universitat Autònoma de Barcelona, 119-129, 08035, Barcelona, Spain

    Antonia Sambola, Berta Miranda, Javier Limeres, Bruno García del Blanco & David García-Dorado

  3. Centro Nacional de Investigaciones Cardiovasculares (CNIC) Cardiovascular Research Area, Research Institute CCU, Department of Cardiology, Hospital 12 de Octubre University, Madrid, Spain

    Héctor Bueno

  4. University of Connecticut/Hartford Hospital Evidence-based Practice Center, Hartford, CT, 06102, USA

    Adrian V. Hernandez

  5. Vicerrectorado de Investigación, Universidad San Ignacio de Loyola (USIL), Lima, Peru

    Adrian V. Hernandez

Authors
  1. Antonia Sambola
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  2. Héctor Bueno
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Corresponding author

Correspondence to Antonia Sambola.

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Conflict of interest

Dr. Sambola reports grant from Amgen to the institution, fees from lectures, Amgen, Boehringer-Ingelheim, Bristol-Myers, BMS-Pfizer, Astra-Zeneca, Novartis, Novo-nordisk outside the submitted work. Dr. Bueno reports grants from Instituto de Salud Carlos III; personal fees from Bayer; personal fees from Novartis; grants, personal fees, and non-financial support from AstraZeneca; grants and personal fees from BMS-Pfizer; personal fees from Ferrer; personal fees from MEDSCAPE-the Heart-org; and personal fees from Janssen, outside the submitted work. The remaining authors no have disclosures to declare.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

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Highlights

• Triple therapy during 1 month is safe and efficacious for patients with AF and high risk of bleeding undergoing PCI.

• Bleeding and ischemic events were similar between patients treated on 1-month TT compared with those treated more than 1 month. However, the incidence of endocraneal hemorrhage was lower in patients on short-term TT.

• Triple therapy during 1 month was preferentially used in those at lower ischemic risk and higher bleeding risk.

• One month of TT should be reasonable as duration of treatment for patients with AF at low ischemic risk and high risk of bleeding undergoing PCI.

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Sambola, A., Bueno, H., Miranda, B. et al. Safe and Efficacious Use of 1-Month Triple Therapy in Patients with Atrial Fibrillation and High Bleeding Risk Undergoing PCI. Cardiovasc Drugs Ther 33, 425–433 (2019). https://doi.org/10.1007/s10557-019-06889-7

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  • DOI: https://doi.org/10.1007/s10557-019-06889-7

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