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EUROACTION preventive cardiology programme plus intensive smoking cessation with varenicline Catriona Jennings Cardiovascular Research Nurse Imperial College London On behalf of the EUROACTION Plus Group Independent Investigator Grant from Pfizer pharmaceuticals 12 th Annual Spring Meeting on Cardiovascular Nursing Copenhagen, Denmark March 2012 UK Netherlands Spain Italy

12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

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Page 1: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

EUROACTION preventive cardiology programme plus intensive smoking

cessation with varenicline

Catriona Jennings

Cardiovascular Research Nurse

Imperial College London

On behalf of the EUROACTION Plus Group

Independent Investigator Grant from Pfizer pharmaceuticals

12th Annual Spring Meetingon Cardiovascular Nursing

Copenhagen, Denmark March 2012

UK

Netherlands Spain

Italy

Page 2: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

16 weeks assessment

Intervention

20 GeneralPractices

INTERVENTION

PROGRAMME16 weeks

PATIENTS

Study Design

Initial Assessment

PATIENTS PARTNERS

PARTNERS PATIENTS PARTNERS

Randomisation of individualsAt consenting interview

USUAL CARE

Page 3: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

The EUROACTION PLUS preventive cardiology programme

• Focus on smoking cessation

• Optional Varenicline to assist quit attempts

• Comprehensive lifestyle and risk factor management

A nurse led multidisciplinary family based programme for vascular patients, high risk individuals and their partners

Smoking cessation

Increasing

Physical activity

Healthy eating,

Weight

management

Page 4: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

Outcome Measures

• Primary outcome: 7- day point prevalence of abstinencevalidated by breath CO (< 10 ppm) at 16 weeks

• Secondary outcomes: (European goals)– Diet (Mediterranean diet score, food habit questionnaire)

– Physical activity (7 day recall, pedometer, Chester step test, DASI and SF36 FLP)

– BMI ≤ 25 kg/m2 , waist circumference < 94 cm men, 80 cm women

– BP < 140/90 mmHg (<130/80 mmHg diabetes and or CHD)

– TC < 4.5 mmol/l, LDL-C < 2.5 mmol/l

– Glucose < 6 mmol/l

• Cardio-protective drug therapies

• Health Related Quality of Life (Euroqol EQ-5D, Anxiety and Depression HADS)

Page 5: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

Recruitment

N=696 Eligible patients

N=559 High-Risk patientsN=137 Vascular patients

EA+ ARMN=350 patients

N=276 High-Risk patientsN=74 Vascular patients

N=328 Baseline assessmentN=313 Participated in EA+

N=299 85.4%16-weeks assessment

USUAL CARE ARMN=346 patients

N=283 High-Risk patientsN=63 Vascular patients

N=288 83.2%16-weeks assessment

N=346 Primary endpoint N=335 Primary endpoint

Page 6: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

18,8%

51,2%

0%

20%

40%

60%

80%

100%

Usual Care EuroAction+

PRIMARY ENDPOINTSmoking abstinence for last 7 days confirmed

by breath CO <10ppm

Odds Ratio (95% CI) = 4.52 (3.20 to 6.39)

Page 7: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

Smoking abstinence for last 7 days confirmed by breath CO <10 ppm

Page 8: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

18,8%14,7% 16,7%

62,4%

0%

20%

40%

60%

80%

100%

Usual Care arm

Smoking abstinence for last 7 days confirmed by breath CO <10 ppm

Intervention armNot participated

Intervention armParticipated

Not completed

Intervention armParticipatedCompleted

N=335 N=34 N=24 N=266

Page 9: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

37%

80%

7%

27%

52%

87%

16%

38%

0%

20%

40%

60%

80%

100%

Mediterranean Score ≥ 9 Alcohol ≤ 30 g/day At goal for physical activity Chester step test

Usual CareEuroAction+

+15.0%+6.7% to +23.2%

+6.3%+0.1% to +12.7%

Diet and Physical Activity

or oily fish ≥ 3 x/week METs max > 10/9 in m/w

+9.0%+3.7% to +14.3%

+10.5% +0.5% to +20.4%

Page 10: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

43%

53%52% 51%

0%

20%

40%

60%

80%

100%

SBP/DBP < 140/90 mmHg Antihypertensive drug use

Usual CareEuroAction+

Blood Pressure

+9.5%+1.2% to +17.9%

-1.3%-9.5% to +6.8%

130/80 mmHg CVD/diabetes

Page 11: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

73%

81%

36%

74%

81%

48%

0%

20%

40%

60%

80%

100%

HADS Anxiety score < 8 HADS Depression score < 8 EQ-5D VAS score > 75

Usual CareEuroAction+

HRQoL

+0.3%-7.1% to +7.7%

+0.8%-5.8% to +7.4%

+12.0%+3.8% to +20.2%

Page 12: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

Conclusions

• Intensive support from nurses was effective in helping high CVD risk smokers to quit with optional use of varenicline (more successful than usual care)

• The quitters made other lifestyle changes at the same time and therefore reduced their CVD risk

• Health related of quality life improved on the programme

Page 13: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

Acknowledgements• Professor David Wood and the Coordinating Centre Staff at

Imperial College London

• Professor Dirk De Bacquer at the Statistical Centre, University of Ghent

• Smoking Cessation specialists– Dr. Serena Tonstad, Oslo University Hospital, Oslo, Norway

– Professor Peter Hajek and Ronnie Troughton, Tobacco Dependence Research Unit, The Royal London Hospital

• National Coordinators and country teams

– Professor Arno Hoes and team, University Medical Centre Utrecht

– Professor Jose de Velasco and team, University General Hospital of Valencia

– Professor Silvio Brusaferro and team, University Hospital "Santa Maria della Misericordia", Udine, Italy

Page 14: 12 on Cardiovascular Nursing Copenhagen, Denmark March ...assets.escardio.org/Assets/Presentations/CCNAP2012/... · EUROACTION preventive cardiology programme plus intensive smoking

Special thanks….

To all the GPs, Practice managers, data entry staff, administratorsetc who did the field work and especially to the nurses (listed below) in each country who worked so

hard and did a great job

UK• Tracey Nolan• Rosie Dada• Michaela Nuttall and

teamNetherlands• Judith Lurvink• Eveline Fassaert• Brenda Baar

Spain• Vanessa Priego• Cristina Tirado• Clara Bisquert Lloret,

Silvia Gimeno MartosItaly• Tilla Gurisatti• Sabrina Scotti