1 Effects of a comprehensive community-based lifestyle intervention in patients with coronary artery disease: the trial   Randomized Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists Ron Peters, MD, PhD on behalf of the study group   Department of Cardiology Academic Medical Center Amsterdam the Netherlands

2 background (1) among patients with coronary artery disease (CAD), lifestyle related risk factors (LRFs) are common main 3 LRFs: overweight physical inactivity smoking improvement of LRFs reduces cardiovascular morbidity and mortality however, modification of LRFs is very challenging

3 background (2) nurse-led care improvesdrug-treated cardiovascular risk factors (BP, LDL-C) quality of life in CAD patients (RESPONSE 1 trial*) however, the impact on LRFs is minimal hospital based approaches may be insufficient to change a patient’s daily routines *Jorstad HT et al. Heart 2013;99:

4 hypothesis LRFs in CAD patients will be improved bynurse-coordinated referral to a comprehensive set of up to three community-based interventions to achieve weight loss, improvement of physical activity, and smoking cessation, encouraging partner participation, on top of usual care.

5 weight activity smoking emphasizes a healthy dietchanging unhealthy behavior regular physical activity group motivation weight activity smoking internet-based program improving physical activity accelerometer online coach, feedback smoking cessation telephone counselling motivational interviewing pharmacologic support

6 design inclusion: ACS and/or coronary revascularization < 8 weeksat least one of the following LRF: BMI>27 kg/m2 physical inactivity: <30 min; 5 times / week smoking (on admission) exclusion: planned revascularization insufficient motivation programs not feasible Hospital Anxiety and Depression Scale >14

7 usual care, guideline basedvisits to the cardiologist cardiac rehabilitation nurse-led secondary prevention program healthy lifestyles drug treated risk factors medication adherence

8 intervention nurse-coordinated referral to up to 3 community-based programs Weight Watchers™ Philips DirectLife™ Luchtsignaal™ the number and sequence of programs was determined by the patient’s risk profile and preference partners were offered participation in the programs

9 primary outcome the proportion of successful patients at 12 monthssuccess defined at patient level as: improvement of at least one LRF without deterioration in the other two objective outcome measurements: weight (kg) 6 Minute Walking Distance (meters) urinary cotinine (>200 microgram/L)

10 enrollment RCT in 15 centers in the Netherlandsfrom April 2013 to July CAD patients screened 824 informed consent and randomized months follow-up 711 primary analysis

11 Baseline characteristicsIntervention (n=360) Control (n=351) age (yrs) 58.2 ±9.0 59.2 ±9.4 female (%) 21 caucasian 94 92 married, cohabitating 83 81 BMI, mean (SD), kg/m2 29.8 ±4.3 29.3 ±4.3 overweight (BMI>27) (%) 75 72 physically inactive 63 62 smoking on admission * 28 25 antiplatelet agents 99 97 lipid lowering drugs β-Blockers (%) 87 ACE inhibitor/ARB (%) 76

12 proportion of successful patientsprimary outcome: proportion of successful patients

13 secondary outcomes Intervention Control Rel. Risk (95% CI) P-valueimprovement in 1 LRF (%) 60 50 1.20 ( ) 0.008 weight reduction >5% (%) 27 14 1.97 ( ) < 0.001 improvement on 6MWD (%) 45 40 1.15 ( ) 0.13 negative urinary cotinine (%) 76 74 1.03 ( ) 0.55 systolic BP<140 mmHg (%) 72 67 1.08 ( ) 0.12 LDL-C <70 mg/dl (%) 34 38 0.88 ( ) 0.23

14 Partners p=0.03 primary outcome control intervention interventiona. all controls (351) b. controls with partner (284) c. controls no partner (67) d. all interventions (360) e. interventions with partner (298) f. interventions no partner (62) g. all interventions with partner (298) h. intervention with participating partner (137) i. interventions with nonparticipating partner (161) a b c g h i d e f primary outcome control intervention intervention ⱳ partner

15 conclusions nurse-coordinated referral of CAD patients and their partners to a comprehensive set of lifestyle programs improves LRFs significantly more than usual care alone partner participation was associated with a higher rate of success this strategy can be easily implemented into daily practice to improve secondary prevention of CAD

16 study group steering committee centers Amphia MC, BredaAtrium MC, Heerlen Catharina MC, Eindhoven Diakonessen MC, Utrecht Flevo MC, Almere Gelderse Vallei, Ede Groene Hart MC, Gouda Leeuwarden MC Martini MC, Groningen MS Twente, Enschede OLVG MC, Amsterdam Rijnstate MC, Arnhem St Antonius MC, Nieuwegein Tergooi MC, Hilversum AMC, Amsterdam Madelon Minneboo, MD Sangeeta Lachman, MD Marjolein Snaterse, MSc Harald Jørstad, MD, PhD Gerben ter Riet, MD PhD Matthijs Boekholdt, MD, PhD Wilma Scholte op Reimer, PhD Ron Peters, MD, PhD, chair

17 Back-ups

18 deterioration in isolated LRFsIntervention (n=360) Control (n=351) any weight gain 164 (46%) 180 (54%) deterioration in 6MWD 77 (21%) 102 (29%) urinary cotinine turned + 21 (6%) 14 (4%)

19 exclusion criteria planned revascularization life expectancy ≤ 2 yearsCHF NYHA class III or IV insufficient motivation visits and/or lifestyle program not feasible no internet access Hospital Anxiety and Depression Scale >14

20 baseline characteristicsIntervention (n=360) Control (n=351) age (yrs) 58.2 ±9.0 59.2 ±9.4 female (%) 21 caucasian 94 92 married, cohabitating 83 81 STEMI 42 39 Non-STEMI 37 35 unstable angina 7 9 stable angina revascularisation 14 18 PCI 76 80 CABG 11

21 No disclosures