PowerPoint Presentation - NHG

Effect van
primaire cardiovasculaire preventie
op
SCORE voor ouderen
Emma van Bussel, aiotho
Juni 2017
Disclosure belangen NHG spreker
(Potentiële) belangenverstrengeling
Geen
Voor bijeenkomst mogelijk relevante
relaties met bedrijven
Geen
Sponsoring of onderzoeksgeld
Honorarium of andere (financiële)
vergoeding
Aandeelhouder
Andere relatie, namelijk …
Geen
Introductie
Driver et al. BMJ 2008
Introductie
•
Primaire CV preventie is effectief1
•
Onduidelijk of dit ook geldt voor ouderen2
•
Multicomponente CV preventie onder 3526 ouderen in
preDIVA3: neutraal effect op HVZ
•
Mogelijke verklaring: relatief korte follow-up van 5 jaar
1. Piepoli et al. Eur Heart J 2016; 2. de Rezende et al. BMC Public Health
2014; 3. Moll van Charante et al. Lancet 2016
Onderzoeksvraag
Heeft multicomponente primaire cardiovasculaire preventie
effect op intermediaire CV uitkomsten bij ouderen?
Uitkomstmaten
1. SCORE-OP
Index voor: leeftijd, geslacht, roken,
bloeddruk, diabetes, totaal- en
HDL-cholesterol
2. Individuele risicofactoren
preDIVA
116 practices
7772 subjects 70-78 years
14% not eligible
46,7% no informed consent
3526 baseline assessment
no CVD at baseline: 2254 (64%)
vascular care
standard care
4-monthly visit
2 year
component
intervention
blood pressure
lifestyle, medication
smoking
help with cessation
physical activity
counseling
bodyweight
BMI>25: counseling, >30: dietician
cholesterol
TC >5: statin
glucose
> 6.1 mmol/l -> treatment
4 year
6/ 6+ year
Richard et al. Alz Dis Ass Disord 2009
Methode - statistiek
Intention to treat
SCORE-OP en Individuele risicofactoren
Adjusted mean difference middels
linear mixed-effects models
gecorrigeerd voor clustering
Resultaten
Baseline characteristics: demographics
Age in year, mean (SD)
Male, no. (%)
Educational level no. (%)
<7 years
7-12 years
>12 years
Caucasian, no.(%)
Intervention
(n=792)
74.1 (2.4)
297 (38%)
Control
(n=709)
74.1 (2.5)
275 (39%)
165 (21%)
519 (66%)
108 (14%)
755 (95%)
161 (23%)
461 (65%)
87 (12%)
688 (97%)
Resultaten
Baseline characteristics: CVD risk factors
SBP in mmHg, mean (SD)
DBP in mmHg, mean (SD)
Total cholesterol in mmol/L, mean (SD)
HDL cholesterol in mmol/L, mean (SD)
Type 2 diabetes, no. (%)
Current smoking, no. (%)
Intervention
(792)
156.0 (21.0)
81.7 (10.8)
5.44 (0.97)
1.56 (0.41)
145 (18%)
82 (12%)
Control
(709)
154.9 (20.1)
82.3 (10.5)
5.58 (1.09)
1.56 (0.42)
98 (14%)
83 (10%)
Resultaten: effect op SCORE-OP
Effect on SCORE-OP
Outcome
Mean baseline risk, % (SD)
Intervention
10-year CVDmortality risk
14.0 (7.7)
Control
13.9 (7.9)
Resultaten: effect op SCORE-OP
Effect on SCORE-OP
Outcome
10-year CVDmortality risk
Mean baseline risk, % (SD)
Mean risk during study, %
(SD)
Intervention
Intervention
14.0 (7.7)
Control
13.9 (7.9)
23.9 (13.7)
Control
25.0 (14.1)
Resultaten: effect op SCORE-OP
Effect on SCORE-OP
Outcome
10-year CVDmortality risk
Mean baseline risk, % (SD)
Mean risk during study, %
(SD)
Intervention
Intervention
14.0 (7.7)
Control
13.9 (7.9)
23.9 (13.7)
Adjusted mean
difference (95%CI)
Control
25.0 (14.1)
-0.60 (-1.20 to 0.01)
Resultaten: effect op risicofactoren
Adjusted mean difference (95%CI) for individual risk factors of SCORE-OP
Outcome
Mean at baseline
Intervention
Control
Mean during study
Intervention
Control
Adjusted mean
difference (95%CI)
SBP mmHg
156 (21)
155 (20)
149 (19)
151 (21)
-2.39 (-3.90 to -0.87)
Total cholesterol
mmol/L
5.44 (0.97)
5.58 (1.09)
5.24 (1.06)
5.35 (1.10)
-0.03 (-0.12 to 0.02)
HDL-cholesterol
mmol/L
1.56 (0.41)
1.56 (0.42)
1.53 (0.41)
1.54 (0.44)
-0.00 (-0.02 to 0.02)
Smoking status
10.4 (30.5)
11.7 (32.2)
7.1 (25.6)
9.6 (29.4)
-1.85 (-0.35 to -3.36)
Type 2 diabetes
mellitus
18.3 (38.7)
13.8 (34.5)
20.0 (40.0)
16.3 (36.9)
-0.73 (-2.19 to 0.74)
For smoking status and type 2 diabetes mellitus figures reflect the percentage within the population, the adjusted mean difference
reflects the absolute difference in this percentage between study groups.
Resultaten: effect op risicofactoren
Samenvatting
•
Geen effect op SCORE-OP
•
Intermediaire risicofactoren:
• 2,4 mmHg daling op systolische bloeddruk
• 1,9% daling in roken
Discussie
•
Multifactoriele interventie onder ouderen, breed
generaliseerbaar, met een relatief lange follow-up
•
Mogelijke bias
• Drop-out rate van 39%
•
•
•
•
maar geen verschil in joint model analyse
Hawthorne effect
Klein contrast tussen studie-armen
Studies onder ouderen geven aanwijzingen voor
‘reverse epidemiology’
• Traditionele associatie tussen risicofactoren en HVZ
verdwijnen of veranderen
Conclusie
•
In deze studie: effect op bloeddruk en roken, maar
niet op SCORE-OP
•
Door Hawthorne effect en klein contrast type II fout
niet uit te sluiten
•
Toekomstig onderzoek naar primaire preventie onder
ouderen
• Landen met minder goede CV standaard zorg
• Risicogroep selectie
In samenwerking met
PreDIVA studiegroep (AMC)
Dr. E. Richard
Prof. dr. W.A. van Gool
Dr. E.P. Moll van Charante
Dr. M.P. Hoevenaar-Blom
Statistisch en specialistisch advies
Dr. W.B. Busschers
Prof. dr. R.J.G. Peters
Vragen?
Resultaten: effect op HVZ
Hazard ratios for relative risk of CVD incidence and all-cause mortality in the intervention compared
to the control group, adjusted for clustering.
Outcome
Intervention group
Control group
Hazard ratio (95%CI)
n=1039
n=1215
Total CVD
75/790 (9.5%)
65/715 (9.1%)
0.99 (0.71 to 1.38)
CVD mortality
21/1074 (2.0%)
21/941 (2.2%)
0.87 (0.46 to 1.65)
CVD morbidity
55/821 (6.7%)
45/724 (6.2%)
1.01 (0.68 to 1.50)
CHD morbidity
42/975 (4.3%)
32/870 (3.7%)
1.08 (0.68 to 1.71)
Non-CHD
15/818 (1.8%)
14/721 (1.9%)
0.93 (0.45 to 1.93)
morbidity
All-cause mortality
158/1211 (13.0%)
118/1038 (11.4%)
1.15 (0.88 to 1.49)
CVD: cardiovascular disease, CHD: coronary heart disease. Total CVD: CVD morbidity and mortality, HR: Hazard ratio
Resultaten: subgroep analyses
Subgroup analysis
SCORE-OP: 10 y Mean baseline risk, % (SD) Mean risk during study, % Adjusted mean Difference in
risk of CVD
(SD)
difference
treatment
mortality
Intervention
Control
Intervention Control
(95%CI)
differences
group
group
group
group
(95%CI)
Gender
17.0 (7.8)
17.6 (8.3)
26.6 (13.5)
29.2 (14.2)
-0.70 (-1.64 to 0.11 (-1.05 to
Men (n=572)
Women (n=929)
12.2 (7.0)
0.23)
-0.59 (-1.33 to
0.15)
1.27)
-
0.30 (-0.87 to
1.47)
11.6 6.7)
22.3 (13.5)
22.4 (13.4)
17.8 (7.9)
28.7 (14.1)
30.1 (14.5)
-0.72 (-1.51 to
0.06)
8.7 (4.0)
17.3 (9.9)
18.4 (10.5)
-0.43 (-1.33 to
0.48)
12.4 (6.2)
21.0 (11.2)
23.2 (12.9)
-1.10 (-1.76 to 0.45)
2.64 (1.07 to
4.21)
23.4 (10.4)
36.7 (16.2)
36.2 (15.9)
+1.54 (0.08 to
2.99)
-
Indication for drug treatment
17.6 (7.2)
Indication
(n=874)
8.8 (4.8)
No indication
(n=627)
Type 2 diabetes mellitus
12.2 (6.1)
No T2DM
(n=1258)
21.9 (9.0)
T2DM
(n=243)
-
Figure S2. Mean percentage of targets reached per individual for SBP, LDLcholesterol, smoking status and TC/HDL ratio, during study.
For every biannual measurement round, the mean percentage of targets reached per
individual is given, for the variables SBP, LDL, TC/HDL and smoking status.
BL: Baseline; 2: measurement at 2 year follow-up; 4: measurement at 4 year followup; 6+: measurement at last measurement round (follow-up between 6 and 8 years)
Error bars represent 95% confidence intervals of (unadjusted) one-sample t-tests per
study visit per study arm.