The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome: The STADIA Pilot Study

Objective

The STADIA Pilot Study will be used to evaluate the feasibility of conducting a three-year multi-centre trial investigating the long-term safety and efficacy outcomes associated with transdermal nicotine use immediately following an acute coronary syndrome (ACS).

Rationale

Patients who initially survive an ACS are at high risk of recurrent cardiac events or cardiovascular death. Within the first 6 months alone, 12% of patients will die or suffer another ACS, while another 23% will require revascularization for angina. Patients who are able to quit smoking reduce their chances of suffering a recurrent ACS or cardiovascular death within the next year by ≥ 50%. After surviving an ACS, most patients are highly motivated to stop smoking. However, as nicotine is an extremely addictive psychoactive drug, up to 60% of patients who attempt to quit relapse. Hospitalization following an ACS provides an opportunity for smokers to quit, as smoking while in hospital is prohibited. However, abstinence while hospitalized also precipitates intense nicotine withdrawal symptoms, which are largely responsible for the high rates of smoking relapse. Nicotine replacement therapy (NRT) can ameliorate many of these symptoms and increase the chances that smokers continue to abstain from tobacco use after discharge. Of the available NRTs, transdermal nicotine is associated with the least severe cardiovascular effects, as it delivers nicotine more gradually (with lower peak values) than nicotine gum or inhalers. Although transdermal nicotine more than doubles long-term smoking cessation rates when compared with placebo, it is rarely prescribed by physicians in the weeks immediately following an ACS because the possible cardiovascular effects of nicotine after an ACS have yet to be systematically evaluated.

Methods