1. The OPTImal CArdiac REhabilitation (OPTICARE) trial:
a randomized, controlled superiority trial of
two extended educational and behavioral intervention programs
Ron T van Domburg and Madoka Sunamura
on behalf of the OPTICARE investigators
Erasmus Medical Center and Capri Cardiac Rehabilitation
Rotterdam

2. No conflict of interests

3. Background
Currently, most patients with Acute Coronary Syndromes (ACS) undergo PCI in the acute phase and are under optimal medical treatment.
As a result, the prognosis of ACS patients increased significantly.
However, cardiac rehabilitation (CR) programs have barely changed since the 1980s.
Few data are available on the optimal CR format in ACS patients.

4. Objectives
To determine the effects of two extended CR programs designed to stimulate permanent adaption of a heart-healthy lifestyle, compared with current standard CR, in ACS patients.

5. Outcome parameters
Systematic COronary Risk Evaluation (SCORE) at 18 Months
Individual SCORE risk function parameters:
Systolic blood pressure, total cholesterol
and smoking behavior
Quality of life
Anxiety
Daily physical activity

6. In- and exclusion criteria
Inclusion
Patients with a documented ACS who were referred for CR.
Exclusion
Heart failure, LVEF<40%, psychological or cognitive impairments which may limit cardiac rehabilitation, COPD, renal failure.

7. Treatment allocation CR-only CR+G CR+T T0 3M 12M 18M standard CR Fup
Face-to-Face
CR+T
Telephone
standard CR
3 group sessions
including fitness training and lifestyle counseling
5-6 telephonic lifestyle counseling sessions
3 physical activity counseling
sessions
Fup
T M 12M 18M

8. Randomization ITT analysis PP analysis OPTICARE trial N=914 CR+G
Face-to-Face
N=309
CR+T
Telephone
N=299
CR-only
N=306
262 completed standard CR
(85.1%)
250 completed standard CR
(83.6%)
306 completed standard CR
(82.7%) PP
analysis
187 completed CR+G
(60.5%)
170 completed CR+T
(56.8%)
306 completed CR-only
(82.7%)
CR+G: standard CR extended with
face-to-face group counseling sessions
CR+T: standard CR extended with telephone counseling sessions
CR-only: standard CR

9. Baseline characteristics
CR+G CR+T CR-only
N=309 N=299 N=306
Age, years
Male, %
Intervention at baseline
PCI, %
CABG, %
No revascularization, n (%)
Prior MI, %
Prior PCI, %
Prior CABG, % 1 1 2
Diabetes, %
Dyslipidemia, %
Current smoking (pre-ACS), %
Hypertension, %

10. Cardiac medication at randomization
(6 weeks post-ACS)
Acetylsalicylic acids
97%
Thienopyridines
86%
Statins
97%
Beta blockers
84%
ACE inhibitors
70% 20 40 60 80
100
Percentage

11. Primary outcome: Score risk function
Intention-to-Treat
Per-Protocol
3.50
3.50
p=0.48
p=0.41
p=0.22
CR-only
3.25
3.25
CR-only
CR+G
p=0.39
CR+T
median SCORE risk function
3.00
median SCORE risk function
3.00
CR+G
CR+T
2.75
2.75
2.50
2.50 3
Months 18 3
Months 18
CR+G: standard CR, extended with group counseling sessions
CR+T: standard CR, extended with telephone
counseling sessions

12. Smoking Intention-to-Treat Smoking Per-Protocol Total cholesterol
50%
50%
40%
40%
CR+G
Percentage smoking
30%
CR-only
30%
p=ns
Percentage smoking
CR-only
20%
CR+T
20%
CR+G
p<0.05
p<0.05
10%
10%
CR+T
preACS 3
Months 18
preACS 3
Months 18
Total cholesterol
Intention-to-Treat
Total cholesterol
Per-Protocol
4.4
CR-only
4.4
p=ns
CR-only
4.2
CR+T
p<0.001
p<0.05
4.2
p<0.001
Total cholesterol
CR+T
Total cholesterol
4.0
CR+G
4.0
3.8
CR+G
3.8
3.6
3.6 3
Months 18 3
Months 18

13. Metabolic parameters SBP (mmHg) Intention-to-Treat SBP (mmHg)
Per-Protocol
140
140
135
p<0.05
135
p<0.05
p=ns
p=ns
Systollic blood pressure
130
Systolic blood pressure
130
125
125
120
120 3
Months 18 3
Months 18
Waist circumference
Intention-to-Treat
Waist circumference
Per-Protocol
105
105
p=ns
CR+T CR
p=ns
Waist circumference (cm)
Waist circumference (cm)
100
100
CR+G 95 95 3
Months 18 3
Months 18

14. At least 6 of the 9 risk factors on target at 18M0%
10%
20%
30%
Intention-to-Treat
Per-Protocol
CR+G CR
CR+T
16.8
13.7
24.5
16.9
21.8
p=0.56
p=0.87
p=0.004
p=0.33
At least 6 of the 9 risk factors on target at 18M
Percentage of patients%
Systolic blood pressure≤140 mmHg
Diastolic blood pressure≤90 mmHg
BMI≤25
Waist circumference (m≤94cm;f≤80cm)
LDL<1.8mmol/L
Total cholesterol≤4.5 mmol/L
Quit smoking
No anxiety
No depression

15. Number of steps per day Intention-to-Treat Per-Protocol 7282 7183 6709
8000
8000
p<0.05
CR+G
7500
CR+G
7500
7282
7183
CR-only
CR-only
7000
p=0.11
7000
p=0.08
Steps per day
6709
Steps per day
6679
6500
6641
6500
CR+T
6545
CR+T
6000
6000
5500
5500 3
Months 18 3
Months 18

16. Quality of Life Quality of Life Intention-to-Treat Per-Protocol
6.0
6.0
Intention-to-Treat
Per-Protocol
CR+G
5.8
CR+T
5.8
p=ns
p=0.004
CR+G
CR+T
p=0.04
5.6
5.6
Quality of Life
Quality of Life
5.4 CR
5.4 CR
5.2
5.2
5.0
5.0 3
Months 18 3
Months 18
Anxiety %
Anxiety %
15%
15%
Intention-to-Treat
Per-Protocol
10% CR
10% CR
p=ns
CR+T
p=ns
Anxiety %
Anxiety %
CR+T
p=0.036
CR+G 5% 5%
CR+G 0% 0% 3
Months 18 3
Months 18

17. Cardiac events at 18 months
CR+G CR+T CR-only Pvalue
N=309 N=299 N=306
Total number of events 83 (27%) 79 (26%) 70 (22%) 0.44
Mortality, n (%) 1 (0) 1 (0) 0 (0) 0.56
Readmissions for ACS
STEMI, n (%) 1 (0) 5 (2) 2 (1) 0.24
NSTEMI, n (%) 5 (2) 3 (1) 3 (1) 0.98
Unstable angina, n (%) 4 (1) 3 (1) 2 (1) 0.64
Other CVD admissions
Stable angina, n (%) 14 (4) 13 (4) 9 (3) 0.64
Chest pain, n (%) 16 (5) 12 (4) 11 (4) 0.53
Arrhythmias, n (%) 6 (2) 4 (1) 2 (1) 0.65
Interventions
CAG, n (%) 8 (3) 5 (2) 7 (2) 0.59
PCI, n (%) 9 (3) 9 (3) 12 (3) 0.85
CABG, n (%) 1 (0) 0 (0) 2 (1) 0.16
Cardiac ER, n (%) 18 (6) 24 (8) 20 (7) 0.90 17

18. Conclusions
Both extended CR programs (face-to-face group and telephone counseling sessions on top of standard CR) as compared with standard CR-only
Were not beneficial with respect to the SCORE risk function.
Factually, most patients largely reached the target levels of the modifiable SCORE risk factors (Systolic BP, total cholesterol and smoking) already at randomization (6 weeks post-ACS), which made it almost impossible to achieve an additional benefit (“ceiling effect”).

19. Conclusions
Extended CR with telephone counseling sessions on top of standard CR as compared with standard CR-only showed
PP analyses (motivated patients)
Less smoking
Lower cholesterol level
Improved quality of life
No benefit for the other end points in the ITT and PP analyses

20. Conclusions
Extended CR with face-to-face group counseling sessions on top of standard CR as compared with standard CR-only showed
ITT analyses
Lower cholesterol levels
PP analyses (motivated patients)
Less smoking
More risk factors on target
Less anxiety
Lower cholesterol levels
Higher quality of life
Trend to more steps/day

21. Acknowledgements OPTICARE team
Nienke ter Hoeve (leadership), Myrna van Geffen, Verena van Marrewijk, Saskia Versluis and all Capri personnel
Scientific Board
Rita van den Berg-Emons, Eric Boersma, Marcel Geleijnse, Henk Stam
CEC committee
Mattie Lenzen, Arend Schinkel
In collaboration with
Medical Service Center of the health insurance company “Zilveren Kruis”
Referral hospitals