Table 3. Adjudicated Cardiovascular Events and All Deaths*

Varenicline (n=353), n (%)Placebo (n=350), n (%)Difference Between Groups, %95% CI for Difference
*Number (percent) of participants as per the decision of the cardiovascular event adjudication committee. Among cardiovascular events reported by study investigators, 9 varenicline and 2 placebo events were adjudicated as not meeting the criteria for the reported cardiovascular event.
†Participants with multiple cardiovascular events of the same type are counted only once per row.
‡Excludes 4 deaths (1 in the varenicline group and 3 in the placebo group) that were adjudicated as noncardiovascular deaths.
Any adjudicated cardiovascular event25 (7.1)20 (5.7)1.4−2.3–5.0
    Coronary artery disease
        Nonfatal MI7 (2.0)3 (0.9)1.1−0.6–2.9
        Need for coronary revascularization8 (2.3)3 (0.9)1.4−0.4–3.2
        Hospitalization for angina pectoris8 (2.3)8 (2.3)−0.02−2.2–2.2
        Hospitalization for congestive heart failure0 (0.0)2 (0.6)−0.6−1.5–0.3
    Cerebrovascular disease
        Nonfatal stroke2 (0.6)1 (0.3)0.3−0.7–1.2
        Transient ischemic attack1 (0.3)1 (0.3)−0.0−0.8–0.8
    Peripheral vascular disease
        New diagnosis or admission for a procedure to treat peripheral vascular disease5 (1.4)3 (0.9)0.6−1.0–2.1
    All causes2 (0.6)5 (1.4)−0.8−2.3–0.6
    Cardiovascular death1 (0.3)2 (0.6)−0.3−1.3–0.7
    Noncardiovascular death1 (0.3)3 (0.9)−0.6−1.7–0.5