Smoking abstinence 1 year after acute coronary syndrome: follow-up from a randomized controlled trial of varenicline in patients admitted to hospital.

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 Participants lost to follow-up or withdrawn were assumed to have returned to smoking.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.

Varenicline for Smoking Cessation in Hospitalized Patients With Acute Coronary Syndrome.

BACKGROUND: Less than one-third of smokers hospitalized with an acute coronary syndrome (ACS) remain abstinent following discharge. We assessed whether varenicline, begun in-hospital, is efficacious for smoking cessation following ACS. METHODS AND RESULTS: We conducted a multi-center, double-blind, randomized, placebo-controlled trial in which smokers hospitalized with an ACS were randomized to varenicline or placebo for 12 weeks. All patients received low-intensity counseling. The primary end point was point-prevalence smoking abstinence assessed at 24 weeks by 7-day recall and biochemical validation using expired carbon monoxide. A total of 302 patients were randomized (mean age 55±9 years; 75% male; 56% ST-segment elevation myocardial infarction; 38% non-ST-segment elevation myocardial infarction; 6% unstable angina). Patients smoked a mean of 21±11 cigarettes/d at the time of hospitalization and had been smoking for a mean of 36±12 years. At 24 weeks, patients randomized to varenicline had significantly higher rates of smoking abstinence and reduction than patients randomized to placebo. Point-prevalence abstinence rates were 47.3% in the varenicline group and 32.5% in the placebo group (P=0.012; number needed to treat=6.8). Continuous abstinence rates were 35.8% and 25.8%, respectively (P=0.081; number needed to treat=10.0), and rates of reduction ≥50% in daily cigarette consumption were 67.4% and 55.6%, respectively (P=0.05; number needed to treat=8.5). Adverse event rates within 30 days of study drug discontinuation were similar between groups (serious adverse events: varenicline 11.9%, placebo 11.3%; major adverse cardiovascular events: varenicline 4.0%, placebo 4.6%). CONCLUSIONS: Varenicline, initiated in-hospital following ACS, is efficacious for smoking cessation. Future studies are needed to establish safety in these patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00794573.

Smokers and Postcessation Weight Gain After Acute Coronary Syndrome.

BACKGROUND: Smoking cessation and weight management are recommended after acute coronary syndrome (ACS); however, little is known about the effects of smoking cessation on weight change after ACS. We aimed to assess the effect of smoking cessation after ACS on weight over a 12-month follow-up period. METHODS AND RESULTS: Data were prospectively collected from the EVITA (Evaluation of Varenicline in Smoking Cessation for Patients Post-Acute Coronary Syndrome) trial. Weight change was compared among 3 groups of patients: those who were completely abstinent (n=70), those who smoked intermittently (n=68), and those who smoked persistently (n=34). Patients' mean baseline weight was 83.9 kg (SD 17.7) with a mean body mass index of 28.5 (SD 5.4). Patients smoked a mean of 37.7 years (SD 17.7) and a mean of 21.0 cigarettes (SD 9.0) per day prior to their ACS. Weight change varied across groups, with abstainers gaining a mean of 4.8 kg (SD 8.6), intermittent smokers gaining a mean of 2.0 kg (SD 8.9) and persistent smokers losing a mean of 0.7 kg (SD 7.4). At 52 weeks, abstainers were more likely to gain weight than persistent smokers (difference in means 5.5 kg; 95% CI 2.3-8.8). This weight gain was not associated with an increase in the use of antihypertensive or antidiabetic medications. CONCLUSIONS: Following an ACS, significant weight is gained by patients who quit smoking. Weight-management interventions among smokers who quit after ACS should be a focus of investigation in future research so that the cardiovascular benefits achieved by smoking cessation are not offset by weight gain in this high-risk population. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00794573.

Improvement in exercise capacity in asymptomatic and mildly symptomatic adults after atrial septal defect percutaneous closure.

BACKGROUND: Controversy exists as to whether secundum atrial septal defects (ASDs) in asymptomatic or mildly symptomatic New York Heart Association (NYHA) class I or II adult patients should be closed. METHODS AND RESULTS: Thirty-seven patients (24 females; mean age 49.4 years, range 19 to 76) with a mean pulmonary to systemic flow ratio (Qp:Qs) of 2.1 (1.2 to 3.4) had a maximal oxygen uptake (VO2max) determination and echocardiographic measurement of right ventricular dimensions before and 6 months after elective percutaneous closure of ASD. At baseline, mean VO2max was 23.5+/-6.4 mL/kg per minute and was higher in the 15 NYHA I patients than in the 22 NYHA II patients (27+/-6.9 versus 20.8+/-4.6 mL/kg per minute; P=0.0015). VO2max increased significantly at 6 months (23.5+/-6.4 to 26.9+/-6.9 mL/kg per minute; P<0.0001). Improvement was as marked in NYHA I (+22%; P<0.0001) as in NYHA II patients (+12%; P<0.0001), in patients with Qp:Qs 1.2 to 2.0 (+16%; P<0.0001) as in those with Qp:Qs >2 (+12%; P<0.0001), and in patients > or =40 years of age (+14%; P<0.0001) as in those <40 years of age (+16%; P<0.0001). Compared with 15 of 37 patients before closure, 35 of 37 patients were in NYHA I at 6 months. Right ventricular dimensions decreased significantly (P<0.0001). CONCLUSIONS: Adult ASD patients significantly increase their functional capacity after percutaneous defect closure. This is observed even in patients classified as asymptomatic, in those with lesser shunts, and in older patients. These findings suggest that ASD closure in an adult population should be considered even in the absence of symptoms.

Progressive dilation of the diameter of the aortic root in adults with a bicuspid aortic valve.

BACKGROUND: To determine the rate of progression of dilation of the aortic root in adults with a bicuspid aortic valve. METHODS: We reviewed retrospectively the transthoracic echocardiograms of 50 adults with a bicuspid aortic valve. Each patient had had at least two examinations made 12 months apart. Measurements were taken at four levels: at the basal attachment of the leaflets of the valve within the left ventricular outflow tract, at the widest point of the sinuses of Valsalva, at the sinutubular junction, and in the ascending aorta 1 cm beyond the sinutubular junction. RESULTS: Progressive dilation occurred at all levels, ranging from 0.3 mm/yr at the basal attachment within the left ventricular outflow tract to 1.0 mm/yr, 1 cm beyond sinutubular junction. These rates of dilation were greater than the reported rate of 0.8 mm per decade in the normal population. The rate of dilation found in the ascending aorta 1 cm beyond the sinutubular junction was significantly greater than at the other sites (p = 0.005). The 21 patients with baseline measurements greater than 34 mm had a significantly higher rate of progression (p = 0.007). Sex, age, and the degree of valvar obstruction or regurgitation did not significantly influence the rate of progression of dilation. CONCLUSION: There is a significantly higher rate of dilation of the aortic root in adults with a bicuspid aortic valve when compared to the normal population. Periodic evaluation of the ascending aorta is essential in these patients, even after replacement of the aortic valve. Other imaging modalities should be considered if the region beyond the sinutubular junction is not well visualized by transthoracic echocardiography.