Effectiveness of a smoking cessation program for peripheral artery disease patients: a randomized controlled trial.

Objectives: This study tested the effectiveness of a smoking cessation program designed for patients with peripheral artery disease (PAD).

Background: Tobacco use is the leading risk factor for PAD incidence and progression and for ischemic events. Tobacco cessation reduces PAD-related morbidity and mortality, yet few prospective clinical trials have evaluated smoking cessation interventions in PAD patients.

Methods: We recruited outpatients with lower extremity PAD identified from medical records as cigarette smokers. Participants were randomly assigned to an intensive tailored PAD-specific counseling intervention or a minimal intervention. Participants completed surveys at baseline and at 3- and 6-month follow-up. Reported 7-day point prevalent smoking abstinence was confirmed by cotinine or carbon monoxide assessment.

Results: In all, 687 outpatients were identified as probable smokers with lower extremity PAD; 232 met study eligibility requirements; and 124 (53% of eligible) enrolled. Participants were receptive to counselor contact: the median number of sessions was 8.5 (range 0 to 18). Participants randomly assigned to the intensive intervention group were significantly more likely to be confirmed abstinent at 6-month follow-up: 21.3% versus 6.8% in the minimal intervention group (chi-square = 5.21, p = 0.023).

Conclusions: Many long-term smokers with PAD are willing to initiate a serious quit attempt and to engage in an intensive smoking cessation program. Intensive intervention for tobacco dependence is a more effective smoking cessation intervention than minimal care. Studies should be conducted to examine the long-term effectiveness of intensive smoking cessation programs in this population to examine the effect of this intervention on clinical outcomes related to PAD.