Sarah B Windle1, Payam Dehghani1, Nathalie Roy1, Wayne Old1, François R Grondin1, Iqbal Bata1, Ayman Iskander1, Claude Lauzon1, Nalin Srivastava1, Adam Clarke1, Daniel Cassavar1, Danielle Dion1, Herbert Haught1, Shamir R Mehta1, Jean-François Baril1, Charles Lambert1, Mina Madan1, Beth L Abramson1, Mark J Eisenberg2. 1. Jewish General Hospital, McGill University (Windle, Eisenberg), Montréal, Que.; Prairie Vascular Research Network (Dehghani), University of Saskatchewan, Regina, Sask.; Centre de santé et de services sociaux de Chicoutimi (Roy), Chicoutimi, Que.; Sentara Cardiovascular Research Institute (Old), Norfolk, Va.; Centre intégré de santé et de services sociaux Chaudière-Appalaches (Grondin), Hôtel-Dieu de Lévis site, Lévis, Que.; Queen Elizabeth II Health Sciences Centre (Bata), Halifax, NS; SJH Cardiology Associates and St. Joseph's Hospital Health Centre (Iskander), Liverpool, NY; Centre intégré de santé et de services sociaux Chaudière-Appalaches (Lauzon), Hôpital de Saint-Georges site, Thetford Mines, Que.; Spartanburg Regional Medical Center (Srivastava), Spartanburg, SC; Valley Regional Hospital (Clarke), Kentville, NS; Toledo Hospital (Cassavar), Toledo, Ohio; Centre de santé et de services sociaux de Beauce (Dion), Beauce, Que.; Heart Center Research (Haught), Huntsville, Ala.; McMaster University and Hamilton Health Sciences (Mehta), Hamilton, Ont.; Dr. Georges-L.-Dumont University Hospital Centre (Baril), Moncton, NB; Florida Hospital Pepin Heart Institute (Lambert), Tampa, Fla.; Sunnybrook Health Sciences Centre (Madan), University of Toronto, Toronto, Ont.; St. Michael's Hospital (Abramson), Toronto, Ont. 2. Jewish General Hospital, McGill University (Windle, Eisenberg), Montréal, Que.; Prairie Vascular Research Network (Dehghani), University of Saskatchewan, Regina, Sask.; Centre de santé et de services sociaux de Chicoutimi (Roy), Chicoutimi, Que.; Sentara Cardiovascular Research Institute (Old), Norfolk, Va.; Centre intégré de santé et de services sociaux Chaudière-Appalaches (Grondin), Hôtel-Dieu de Lévis site, Lévis, Que.; Queen Elizabeth II Health Sciences Centre (Bata), Halifax, NS; SJH Cardiology Associates and St. Joseph's Hospital Health Centre (Iskander), Liverpool, NY; Centre intégré de santé et de services sociaux Chaudière-Appalaches (Lauzon), Hôpital de Saint-Georges site, Thetford Mines, Que.; Spartanburg Regional Medical Center (Srivastava), Spartanburg, SC; Valley Regional Hospital (Clarke), Kentville, NS; Toledo Hospital (Cassavar), Toledo, Ohio; Centre de santé et de services sociaux de Beauce (Dion), Beauce, Que.; Heart Center Research (Haught), Huntsville, Ala.; McMaster University and Hamilton Health Sciences (Mehta), Hamilton, Ont.; Dr. Georges-L.-Dumont University Hospital Centre (Baril), Moncton, NB; Florida Hospital Pepin Heart Institute (Lambert), Tampa, Fla.; Sunnybrook Health Sciences Centre (Madan), University of Toronto, Toronto, Ont.; St. Michael's Hospital (Abramson), Toronto, Ont. mark.eisenberg@mcgill.ca.
Abstract
BACKGROUND:Patients who continue to smoke after acute coronary syndrome are at increased risk of reinfarction and death. We previously found use of varenicline to increase abstinence 24 weeks after acute coronary syndrome; here we report results through 52 weeks. METHODS: The EVITA trial was a multicentre, double-blind, randomized, placebo-controlled trial of varenicline for smoking cessation in patients admitted to hospital with acute coronary syndrome. Participants were randomly assigned (1:1) to receive varenicline or placebo for 12 weeks, in conjunction with low-intensity counselling. Smoking abstinence was assessed via 7-day recall, with biochemical validation using exhaled carbon monoxide. Participants lost to follow-up or withdrawn were assumed to have returned to smoking. RESULTS: Among the 302 participants, abstinence declined over the course of the trial, with 34.4% abstinent 52 weeks after acute coronary syndrome. Compared with placebo, point estimates suggest use of varenicline increased point-prevalence abstinence (39.9% v. 29.1%, difference 10.7%, 95% confidence interval [CI] 0.01% to 21.44%; number needed to treat 10), continuous abstinence (31.1% v. 21.2%, difference 9.9%, 95% CI -0.01% to 19.8%) and reduction in daily cigarette smoking by 50% or greater (57.8% v. 49.7%, difference 8.1%, 95% CI -3.1% to 19.4%). Varenicline and placebo groups had similar occurrence of serious adverse events (24.5% v. 21.9%, risk difference 2.7%, 95% CI -7.3% to 12.6%) and major adverse cardiovascular events (8.6% v. 9.3%, risk difference -0.7%, 95% CI -7.8% to 6.5%). INTERPRETATION:Varenicline was efficacious for smoking cessation in this high-risk patient population. However, 60% of patients who received treatment with varenicline still returned to smoking. Trial registration: ClinicalTrials.gov, no. NCT00794573.
RCT Entities:
BACKGROUND:Patients who continue to smoke after acute coronary syndrome are at increased risk of reinfarction and death. We previously found use of varenicline to increase abstinence 24 weeks after acute coronary syndrome; here we report results through 52 weeks. METHODS: The EVITA trial was a multicentre, double-blind, randomized, placebo-controlled trial of varenicline for smoking cessation in patients admitted to hospital with acute coronary syndrome. Participants were randomly assigned (1:1) to receive varenicline or placebo for 12 weeks, in conjunction with low-intensity counselling. Smoking abstinence was assessed via 7-day recall, with biochemical validation using exhaled carbon monoxide. Participants lost to follow-up or withdrawn were assumed to have returned to smoking. RESULTS: Among the 302 participants, abstinence declined over the course of the trial, with 34.4% abstinent 52 weeks after acute coronary syndrome. Compared with placebo, point estimates suggest use of varenicline increased point-prevalence abstinence (39.9% v. 29.1%, difference 10.7%, 95% confidence interval [CI] 0.01% to 21.44%; number needed to treat 10), continuous abstinence (31.1% v. 21.2%, difference 9.9%, 95% CI -0.01% to 19.8%) and reduction in daily cigarette smoking by 50% or greater (57.8% v. 49.7%, difference 8.1%, 95% CI -3.1% to 19.4%). Varenicline and placebo groups had similar occurrence of serious adverse events (24.5% v. 21.9%, risk difference 2.7%, 95% CI -7.3% to 12.6%) and major adverse cardiovascular events (8.6% v. 9.3%, risk difference -0.7%, 95% CI -7.8% to 6.5%). INTERPRETATION:Varenicline was efficacious for smoking cessation in this high-risk patient population. However, 60% of patients who received treatment with varenicline still returned to smoking. Trial registration: ClinicalTrials.gov, no. NCT00794573.
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