Comparison of Conservative and Aggressive Smoking Cessation Treatment Strategies in a Vascular Surgery Office Practice

The objective of the current investigation is to evaluate the effectiveness of an intensive
verses conservative smoking cessation program in patients with peripheral arterial disease
in an outpatient setting.

Inclusion Criteria:

1. All patients with confirmed peripheral arterial disease (PAD), defined as at least
one of the following criteria, during the initial Vascular Surgery Office exam and
review of the patient's medical record:

1. Ankle-brachial index of <.90 in at least 1 lower extremity.

2. Toe-brachial index of <.60

3. Objective evidence of arterial occlusive disease in 1 lower extremity by duplex
ultrasonography, magnetic resonance angiography or computed tomographic
angiography

4. prior leg arterial revascularization or amputation due to PAD

2. Patients have to smoke with a minimum of 10 cigarettes per day for a minimum of 5
years.

3. Patients must be able to give informed written consent and be at least 18 years of
age.

Exclusion Criteria:

1. Pregnant women: Smoking Cessation Program medication Chantix (varenicline), Zyban
(bupropion) has been shown to cause decreased fertility and decrease fetal weight in
animal study offspring.

2. Patients less than 18 years of age: Safe and effective use in children has not been
established with Chantix (varenicline) and Zyban (bupropion). These medications are
not approved for use in individuals less than 18 years of old.

3. Patients with a history of a seizure disorder. Zyban (bupropion) is contraindicated
in patients with preexisting seizure disorder.

4. Patients with a history of anorexia nervosa or bulimia nervosa. Patients with these
eating disorders have been shown to have an increased incidence of seizures and Zyban
(bupropion) is contraindicated in patients with a history or anorexia nervosa and
bulimia nervosa.

5. The use bupropion concomitantly with monoamine oxidase inhibitors (MAOIs), including
drugs with MAOI-like activity is contraindicated. Studies with animals indicate that
bupropion-induced adverse reaction and toxicity appear to be enhanced by these
medications.

6. Patients with renal insufficiency;defined as having a Creatinine Clearance (CrCl)
<=50mL/min. Chantix is substantially excreted by the kidneys and the risk of toxic
reactions are greater in patients with impaired renal function. Creatinine Clearance
=[(140-age(yr)]*weight(kg)]/[72*serumCr(mg/dL)].

7. Patients with hepatic insufficiency; defined as having elevated liver function tests
(serum aminotransferases) greater than 1.5 baseline. Zyban is metabolized in the
liver. Half-lives of bupropion and/or its major metabolites are prolonged in patients
with liver disease.

8. Patients with vascular pathology other than PAD (Carotid atherosclerosis, abdominal
aortic aneurysms, venous insufficiency).

9. Subjects with a history of psychiatric illness requiring current treatment with
psychoactive medications, a history of dependence on alcohol or non nicotine
substance in the past year or current use of tobacco products other than cigarettes.