From the Guidelines
Cilostazol (Pletal) is contraindicated in patients with heart failure of any severity due to its potential to worsen cardiac function. The FDA has assigned cilostazol a black box warning specifically prohibiting its use in patients with heart failure, regardless of whether the heart failure is compensated or decompensated, as stated in the 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS guideline for the management of lower extremity peripheral artery disease 1. This contraindication stems from cilostazol's mechanism of action as a phosphodiesterase-3 (PDE3) inhibitor, which increases cyclic adenosine monophosphate (cAMP) levels in cardiac tissue. While this action helps dilate blood vessels and inhibit platelet aggregation, it also has positive inotropic and chronotropic effects that increase cardiac workload and oxygen demand.
Clinical studies with other PDE3 inhibitors have demonstrated increased mortality in heart failure patients, as noted in the 2017 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease 1. Before prescribing cilostazol for peripheral artery disease or other indications, clinicians should thoroughly evaluate patients for any history or symptoms of heart failure. Alternative medications such as antiplatelet agents (aspirin, clopidogrel) or other approaches to manage claudication symptoms should be considered for patients with heart failure who would otherwise be candidates for cilostazol therapy.
Key considerations for using cilostazol in patients with heart failure include:
- The potential for increased cardiac workload and oxygen demand
- The risk of worsening cardiac function
- The availability of alternative treatments for claudication symptoms
- The importance of thorough patient evaluation for heart failure before prescribing cilostazol, as emphasized in the 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease 1 and the 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS guideline for the management of lower extremity peripheral artery disease 1.
In summary, cilostazol is contraindicated in patients with heart failure due to its potential to worsen cardiac function, and alternative treatments should be considered for these patients, as supported by the most recent and highest quality evidence from the 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS guideline for the management of lower extremity peripheral artery disease 1.
From the FDA Drug Label
Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV congestive heart failure. Cilostazol tablets are contraindicated in patients with congestive heart failure of any severity.
- Contraindication: Cilostazol is contraindicated in patients with heart failure of any severity.
- Key consideration: The use of cilostazol in patients with heart failure may decrease survival.
- Clinical decision: Cilostazol should not be used in patients with heart failure due to the potential for decreased survival 2.
From the Research
Considerations for Using Cilostazol in Patients with Heart Failure
- Cilostazol is contraindicated in patients with congestive heart failure, as stated in the study 3 and 4.
- The reason for this contraindication is not explicitly stated in the provided studies, but it may be related to the increased risk of mortality and cardiac arrhythmias associated with cilostazol, particularly in patients with heart failure, as mentioned in the study 5.
- Patients with heart failure should not be given cilostazol, and instead, should be prescribed an antiplatelet drug and encouraged to stop smoking and to exercise regularly, as recommended in the study 5.
- Cilostazol has been shown to increase walking distances and improve quality of life in patients with intermittent claudication, but its use in patients with heart failure is not recommended due to the potential risks, as discussed in the studies 3, 5, 4, and 6.
- The mechanism of action of cilostazol, which involves the inhibition of phosphodiesterase III and related increases in cyclic adenosine monophosphate (cAMP) levels, may also play a role in its contraindication in patients with heart failure, as explained in the study 7.