From the FDA Drug Label
- 1 Cardiovascular Thrombotic Events ... Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment ... Avoid the use of diclofenac sodium topical solution in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events.
In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1) ]
The FDA drug label does not explicitly address the use of Voltaren (diclofenac) gel in patients with recent Percutaneous Coronary Intervention (PCI). However, based on the information provided for diclofenac sodium topical solution, it can be inferred that NSAIDs, including diclofenac, may increase the risk of cardiovascular thrombotic events in patients with a recent MI.
- The label does mention that diclofenac sodium topical solution is contraindicated in the setting of CABG surgery.
- It also advises to avoid the use of diclofenac sodium topical solution in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. Since PCI and CABG are both procedures related to coronary artery disease, but the label does not directly address PCI, a conservative clinical decision would be to exercise caution when using diclofenac gel in patients with recent PCI, considering the potential increased risk of cardiovascular events 1.
From the Research
Voltaren (diclofenac) gel should generally be avoided in patients with recent Percutaneous Coronary Intervention (PCI). While topical NSAIDs like diclofenac gel have less systemic absorption than oral forms, caution is still warranted. The concern stems from the cardiovascular risks associated with NSAIDs, which can increase the risk of thrombotic events, including heart attack and stroke. These risks are particularly relevant for patients who have recently undergone PCI, as they are already at elevated risk for cardiovascular events and are typically on antiplatelet therapy.
- Key points to consider:
- NSAIDs can interfere with the cardioprotective effects of aspirin and may increase bleeding risk when combined with other antiplatelet medications like clopidogrel.
- A study published in 2020 2 found that diclofenac appeared to be associated with a relatively higher risk of myocardial infarction (MI), similar to that of rofecoxib, compatible with the drug's high COX-2 inhibitory potency.
- Another study from 2013 3 found that major vascular events were increased by about a third by a coxib or diclofenac, chiefly due to an increase in major coronary events.
- If pain management is necessary for these patients, acetaminophen (Tylenol) is generally a safer alternative.
- For localized pain requiring topical treatment, lidocaine patches or capsaicin cream might be considered instead. Any decision to use diclofenac gel in post-PCI patients should involve consultation with the patient's cardiologist to weigh individual risks and benefits.