Aggressive Smoking Cessation Trial (ASAP)

Inclusion Criteria42

• Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows:
• i. MI, defined by positive troponin T, troponin I, or CK-MB levels (as defined by institution-specific cut-offs) and ≥ 1 of the following:
• Ischemic symptoms for ≥ 20 min;
• Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
• Development of pathological Q waves on the ECG
• ii. Unstable angina with significant coronary artery disease, defined by all of the following:
• Ischemic symptoms for ≥ 20 min;
• ECG changes indicative of ischemia (ST-segment changes);
• At least one lesion ≥ 50% on angiogram performed during the current hospitalization.
• \[Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.\]
• OR
• Outpatients with the following diagnoses/conditions:
• i. Cardiovascular:
• Coronary artery disease documented with angiography or coronary CT;
• Previous ACS, MI, stable or UA;
• Previous coronary revascularization (e.g. PCI or CABG). ii. Renovascular:
• a. Chronic kidney disease. iii. Cerebrovascular:
• a. Previous cerebral infarction or transient cerebral ischemic attack. iv. Peripheral vascular:
• Abdominal aortic aneurysm > 3.0 cm or previous aortic aneurysm surgery;
• Ankle-brachial pressure index of < 0.9 or intermittent claudication;
• Documented carotid artery disease;
• Lower-limb amputation;
• Previous lower-limb bypass surgery or angioplasty.
• v. ≥1 risk factors:
• BMI ≥ 27 kg/m2;
• Dyslipidemia;
• Family history (first degree relative: parents or siblings only) of coronary heart disease or stroke before the age of 60 years;
• Hypertension;
• Males aged ≥ 55 years/females aged ≥ 60 years;
• Diabetes mellitus. vi. Heart-related conditions:
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• Atrial fibrillation or flutter;
• Cardiomyopathy;
• Heart failure;
• Left ventricular hypertrophy (evidenced by echocardiography or ECG);
• Valvular disease (evidenced by echocardiography).
• Smoked on average ≥ conventional cigarettes/day for the past year;
• Age ≥18 years;
• Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5);
• Able to understand and provide informed consent in English or French;
• If randomized to the combination arm (varenicline and e-cigarette plus counseling), willing and able to purchase e-cigarettes with the following properties: rechargeable, closed system that uses sealed cartridges or pods, tobacco or no flavor only, and nicotine strength of 20 mg/ml (2%) or less;
• Likely to be available for 52 weeks of follow-up.