145 EUROACTION PLUS: a randomised controlled trial on preventive cardiology programme plus intensive smoking cessation with Varenicline for vascular and high CVD risk smokers and their partners—principal results

Abstract

Purpose: To determine if the EUROACTION nurse-led preventive cardiology programme for high cardiovascular disease risk smokers with an intensive smoking intervention including Varenicline, could achieve more effective smoking abstinence and to reduce overall cardiovascular (CVD) risk compared to usual care (UC). Methods: EUROACTION PLUS was a randomized controlled intervention trial carried out in general practices across 4 European countries (Italy, the Netherlands, Spain and UK). Smokers 18 to 80 years with vascular disease and 50-80 years at high risk of developing cardiovascular disease (Heartscore > 5% over 10 years, or treated for risk factors or diabetes mellitus (DM) were randomized to EA PLUS programme or UC. The primary outcome was 7 day point prevalence of abstinence validated by breath CO < 10 ppm at 16 weeks. The secondary outcomes were the proportions of patients achieving the European dietary, physical activity, risk factor and therapeutic targets for cardiovascular disease prevention. Results: 350 patients were randomized to EA PLUS and 346 to UC. 16 week follow-up was completed in 299 patients (85%) in EA PLUS and 288 patients (83%) in UC. 51% of patients in the EA PLUS arm were abstinent compared to 19% in UC, OR 4.5 (95% CI 3.2 to 6.4, P < 0.0001). In partners, the 7 day point prevalence of abstinence was significantly higher in EA PLUS (73% vs 37%) compared to UC, OR 4.7 (95% CI 1.9 to 11.5, P < 0.001). 52% of patients in EA PLUS achieved a Mediterranean diet score > 9, compared to 37% in UC (OR 1.84, p < 0.001). 16% in EA PLUS achieved the physical activity target compared to 7% in UC (OR 2.48, p=0.002) with a significantly higher proportion achieving the METSmax target, 38% in EA PLUS vs 27% in UC (OR 1.62, p=0.04). Blood pressure target (<140/ 90 (130/80 diabetes mellitus or vascular disease) was significantly higher in EA PLUS (52% vs 43%; OR 1.47, p=0.03) than UC but there were no diferences in lipid or glucose management. Prescribing of cardioprtective medication was similar in both arms except for lipid lowering drugs; EA PLUS 53% vs UC (45%, p=0.06); high cardiovascular disease risk individuals 48% EA PLUS versus 39% UC p=0.04). Quality of life measured according to the EQ-VAS instrument was significantly higher in EA PLUS patients in comparison to UC patients. Conclusions: 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.