Evaluation of Varenicline in Smoking Cessation for Patients Post-Acute Coronary Syndrome - EVITA


The goal of the trial was to evaluate treatment with the selective α4β2 nicotine receptor partial agonist varenicline compared with placebo among current smokers hospitalized for an acute coronary syndrome.

Contribution to the Literature: The EVITA trial showed that varenicline initiated during an acute coronary syndrome was effective at achieving smoking cessation.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded

Smokers admitted with an acute coronary syndrome were randomized to varenicline 1 mg twice daily (n = 151) versus placebo (n = 151). Study medications were continued for 12 weeks. All patients received low-intensity counseling.

  • Total number of enrollees: 302
  • Duration of follow-up: 24 weeks
  • Mean patient age: 55 years
  • Percentage female: 26%
  • Percentage diabetics: 22%

Other salient features/characteristics:

  • Mean years smoked: 36 years
  • Mean cigarettes/day at baseline: 22

Inclusion criteria:

  • Smokers ≥18 years of age admitted with an acute coronary syndrome
  • Smoke ≥10 cigarettes per day
  • Motivated to stop smoking

Exclusion criteria:

  • Neuropsychiatric disorder
  • Prior use of varenicline or use of alternative smoking cessation pharmacotherapy at baseline
  • Cardiogenic shock or renal/liver failure
  • Excessive alcohol use
  • Current use of marijuana, noncigarette tobacco products, stimulants/anorectics

Principal Findings:

The primary outcome, prevalence of smoking abstinence at 24 weeks, was 47.3% of the varenicline group versus 32.5% of the placebo group (p = 0.012).

Secondary outcomes:

  • Serious adverse event rates within 30 days of study drug discontinuation: 11.3% with varenicline versus 11.3% with placebo
  • Major adverse cardiovascular events: 4.0% with varenicline versus 4.6% with placebo


Among smokers admitted with an acute coronary syndrome, varenicline was effective at achieving a higher prevalence of smoking abstinence. Although this study was not powered to examine safety, serious adverse events including major adverse cardiovascular events were similar between treatment groups. This trial is important since varenicline has been understudied among individuals with active cardiovascular disease. Pending further studies, varenicline may represent an important medicine to achieve higher smoking cessation rates for patients with active cardiovascular disease.


Eisenberg MJ, Windle SB, Roy N, et al., on behalf of the EVITA Investigators. Varenicline for smoking cessation in hospitalized patients with acute coronary syndrome. Circulation 2015;Nov 9:[Epub ahead of print].

Presented by Dr. Mark Eisenberg at the American Heart Association Scientific Sessions, Orlando, FL, November 9, 2015.

Clinical Topics: Acute Coronary Syndromes, Prevention, Smoking

Keywords: Acute Coronary Syndrome, Benzazepines, Nicotine, Primary Prevention, Quinoxalines, Smoking, Smoking Cessation, Tobacco Use Disorder, AHA Annual Scientific Sessions

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