Effectiveness of a preventive cardiology programme for high CVD risk persistent smokers: the EUROACTION PLUS varenicline trial.

AIM: The EUROACTION PLUS trial measured the effectiveness of a nurse-led preventive cardiology programme (EUROACTION) offering intensive smoking cessation PLUS optional varenicline for persistent high CVD risk smokers to reduce overall cardiovascular risk compared with usual care (UC) in general practice (GP). METHODS AND RESULTS: A parallel group randomized controlled trial in 20 GP in Italy, Netherlands, Spain, and UK. Six hundred and ninety-six current smokers, (137 vascular disease and 559 high total CVD risk), were randomized 350 to EUROACTION PLUS (EA+) and 346 to UC. Specially, trained nurses offered the EUROACTION preventive cardiology programme addressing smoking cessation, diet, physical activity, and risk factor management to reduce overall cardiovascular risk. The primary endpoint was 7 day point prevalence of self-reported abstinence (validated breath carbon monoxide <10 p.p.m.) at 16 weeks. Secondary outcomes included dietary habits, physical activity, weight, blood pressure (BP), lipid, and glucose management. One hundred and seventy-seven (51%) EA+ patients (91% opted to use varenicline) were abstinent vs. 63 (19%) in UC; OR 4.52 (95% CI: 3.20-6.39). The Mediterranean diet score of ≥9 in 149 (52%) EA+ patients vs. 97 (37%) in UC; OR 1.84 (95% CI: 1.31-2.59). Physical activity target achieved in 46 (16%) EA+ patients vs. 19 (7%) in UC; OR 2.48 (95% CI: 1.41-4.36). Target BP (<140/90 mm Hg) achieved in 150 (52%) EA+ patients vs. 112 (43%) in UC, OR 1.47 (95% CI: 1.05-2.06) with no difference in antihypertensive drugs. There were no differences in management of cholesterol or glucose. CONCLUSIONS: The EUROACTION preventive cardiology programme in high CVD risk smokers using optional varenicline substantially increased smoking abstinence over 16 weeks and also reduced overall cardiovascular risk compared with UC. REC reference: 09/H0402/85; EudraCT number: 2009-012451-18; http://www.controlled-trials.com/ISRCTN22073647, 12 February 2014, date last accessed.