Dr. David Allan Wood,
David Allan Wood (United Kingdom)
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Authors: Wood DA, Jennings CS, Kotseva K, Hoes A, Velasco J, Brusaferro S, Jones J, Mead A, De Bacquer D. on behalf of the EUROACTION Group
Aim: The primary aim of the trial was to determine if the EUROACTION nurse-led preventive cardiology programme in primary care, with an intensive smoking intervention including the optional use of varenicline, could achieve more effective smoking abstinence among persistent smokers with either established vascular disease, or at high risk of developing cardiovascular disease. The secondary aim was to determine if the programme could reduce overall cardiovascular risk. The clinical effectiveness of this comprehensive preventive cardiology strategy, with intensive smoking intervention, was evaluated in general practices across 4 European countries: Italy, The Netherlands, Spain and the United Kingdom. Study design: The study design was a parallel group randomised controlled trial. Vascular patients and people at high risk of developing cardiovascular disease who were current smokers were individually randomised to receive either a professional smoking cessation intervention, which included the optional use of varenicline, delivered in the context of the nurse-led EUROACTION preventive cardiology programme, or their usual care. The primary outcome was the proportion of non-smokers (7day prevalence of non-smoking) validated by breath CO (< 10 ppm) in intervention compared to usual care at 16 weeks. A power calculation (beta 80% and alpha 5%) based on an absolute difference in non-smokers of 10% between the two arms, and assuming a 25% drop-out rate in both arms, required a sample size of 292 patients per arm. The secondary outcomes included the proportions of patients achieving the Joint European Societies lifestyle, risk factor and therapeutic targets for cardiovascular disease prevention. Study population: 1.Vascular patients: Men and women <80 years, with a new or recurrent diagnosis of coronary or other atherosclerotic disease who were continuing to smoke were recruited together with their partners. 2. People at high cardiovascular risk: Men and women , 50 years of age or older but less than 80 years without a history of coronary or other atherosclerotic vascular disease, who were smokers and either (i) newly identified high multifactorial risk individuals: CVD risk ≥ 5% over 10 years, according to HeartScore; or (ii) were being treated with antihypertensive and/or lipid lowering therapies in the last year; or (iii) had diabetes mellitus diagnosed within the last 3 years, were recruited together with their partners. Intervention: The EUROACTION cardiovascular prevention programme (Lancet 2008; 371;1999-2012) is led by nurses who work with General Practitioners (GPs). The nurses are professionally trained to deliver a comprehensive preventive cardiology programme to patients and their partners which includes a smoking cessation intervention with optional use of varenicline. In those who chose to use varenicline this drug treatment was initiated 1 week before the patient’s chosen quit date. The dose of varenicline was titrated as follows: 0.5 mg for days 1 to 3, 0.5 mg twice per day on days 4 to 7, then 1 mg twice per day through week 12. In addition, the nurses followed the EUROACTION protocol to promote a cardio-protective diet, increase physical activity, minimise weight gain due to smoking cessation and manage all other cardiovascular risk factors to goal in order to reduce total cardiovascular risk. The GPs were responsible for prescribing and up-titrating varenicline and all cardio-protective medications. In EUROACTION PLUS a total of 696 patients (137 vascular and 559 high risk patients) were randomised with their informed consent by the end of recruitment on March 31st this year: 350 patients to the intervention arm (EA+) and 346 patients to the usual care (UC) arm. 109 partners were also recruited. 16 week follow-up was completed on July 31st 2011 in 299 patients (85.4%) in EA+ and 288 patients (83.2%) in UC. Outcomes: For the primary endpoint 51.2% of patients in the EA+ programme were abstinent compared to 18.8% in UC at 16 weeks; odds ratio 4.52 (95% CI 3.20 to 6.39, P<0.0001). In those partners who also smoked at the time of recruitment, 73.1% were abstinent in the EA+ arm compared to 36.7% in UC; odds ratio 4.67 (95% CI 1.92 to 11.48, P<0.001). 52.3% of patients in EA+ achieved a Mediterranean diet score ≥ 9, compared to 37.3% in UC (P<0.001). 16.2% in EA+ achieved the physical activity target compared to 7.2% in UC (P=0.002) with a significantly higher proportion achieving the METSmax target (Chester Step test): 37.8% in EA+ versus 27.3% in UC (p=0.04). There was no significant difference in body weight between EA+ and UC at the 16 week follow-up. The proportion of patients achieving the blood pressure target was significantly higher in EA+ (52.4% versus 42.9%; p=0.03) than UC, but there were no differences in lipid or glucose management. Prescribing of cardioprotective drugs was similar in both arms of the trial. Quality of life measured according to the EQ-VAS instrument was significantly higher in EA+ patients in comparison to UC patients. Conclusion: This European trial has demonstrated that the EUROACTION nurse-led preventive cardiology programme, with an intensive smoking cessation intervention including optional varenicline, helps more vascular and high risk patients, together with their partners, to stop smoking and better achieve the other European lifestyle and blood pressure targets for cardiovascular disease prevention than usual medical care.
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